Companies Developing COVID-19 Therapies

We have initiated a Phase 2 study of IMBRUVICA (ibrutinib) in patients with COVID-19 infection. The goal of this study is to determine whether IMBRUVICA is able to improve patient outcomes by diminishing the immune response known as the cytokine storm that contributes to the morbidity and mortality in COVID-19.  See: Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With CoronaVirus Induced Disease 2019 (COVID-19) and Pulmonary Distress

Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial (CATCO)

https://clinicaltrials.gov/ct2/show/NCT04330690?term=abbvie&recrs=acdfk&cond=COVID&draw=2&rank=1

AbbVie Partnering with Global Authorities to Determine Efficacy of HIV Drug in Treating COVID-19

Unconfirmed media reports from China claim Kaletra/Aluvia (lopinavir/ritonavir) is effective in COVID-19 treatment.
- AbbVie does not have access to Chinese clinical information and therefore cannot confirm its accuracy
- AbbVie donated Aluvia to the Chinese government for experimental use against COVID-19
- AbbVie is working with global health authorities to determine the efficacy and safety of lopinavir/ritonavir against COVID-19

Adaptive Biotechnologies and Microsoft launch groundbreaking ImmuneCODE database to share populationwide immune response to the COVID-19 virus - Adaptive Biotechnologies Corp. on June 11 launched ImmuneCODE with Microsoft Corp. to begin sharing one of the largest, most detailed views of the immune response to COVID-19 in real time based on de-identified data generated from thousands of COVID-19 blood samples from patients around the globe. The open database contains detailed information on the extraordinarily diverse set of T cells shown to specifically recognize unique features of the COVID-19 virus, called antigens, with unprecedented speed and scale. See also: Adaptive Biotechnologies and Microsoft expand partnership to decode COVID-19 immune response and provide open data access 

Adaptive Biotechnologies Launches immunoSEQ T-MAP COVID, First Molecular T Cell Monitoring Tool for SARS-CoV-2 - Adaptive Biotechnologies announced August 4 the launch of immunoSEQ^® T-MAP™ COVID, a proprietary research product and data analysis service to accurately and reproducibly measure the T-cell immune response to vaccines in development and track the persistence of that response over time. This product leverages data by Snyder et al., made available today that map T cells from over 1,000 patients to specific SARS-CoV-2 antigens that elicit an immune response. These data also demonstrate that SARS-CoV-2-specific T cells are persisting in recovered patients for over 90 days, adding important information to the ongoing effort to define immunity to COVID-19.

Amgen And Adaptive Biotechnologies Announce Strategic Partnership To Develop A Therapeutic To Prevent Or Treat COVID-19 - Adaptive will extend its high throughput platform to rapidly screen the massive genetic diversity of the B cell receptors from individuals that have recovered from COVID-19. This enables the identification of tens of thousands of naturally occurring antibodies from survivors of COVID-19 to select those that neutralize SARS-CoV-2.

Akari Therapeutics Announces International Clinical Development Program of Nomacopan for the Potential Treatment of COVID-19 Pneumonia - Akari Therapeutics, Plc (Nasdaq: AKTX), a Phase III biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, announces its intention to develop nomacopan as a potential treatment for COVID-19 pneumonia through integrated clinical trial programs in U.S., U.K. and Brazil.

• Nomacopan has been shown in clinical trials to inhibit both complement C5 activation and leukotriene B4 (LTB4), and has significant potential to simultaneously inhibit both microthrombi as well as block multiple cytokines (the cytokine storm) which together drive COVID-19 pneumonia and associated organ damage.
• Ongoing clinical readouts expected throughout remainder of 2020

Akari Therapeutics Reports Second Quarter 2020 Financial Results and Highlights Recent Clinical Progress - Akari Therapeutics, a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, announced financial results for the second quarter ended June 30, 2020, as well as recent clinical progress.

• Pivotal Phase III study in patients with bullous pemphigoid (BP) expected to start H1 2021 following recent successful end-of-Phase II meeting with FDA
• Enrollment in the pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) pivotal program expected to commence in Q4 2020

Clinical Study: Coronet 1 Emergency Use study at UC Health

Alexion Provides Update on Phase 3 Study of ULTOMIRIS^® (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19 

•  Independent data monitoring committee recommends pausing study enrollment due to lack of efficacy in pre-specified interim analysis
• Company will conduct further analysis of trial data to determine next steps
• No new safety findings were observed for ULTOMIRIS use in COVID-19 –

For more information, contact us at covid.requests@alexion.com.

Algernon Announces 50% Enrollment in Multinational 2b/3 Human Study of Ifenprodil for Treatment of COVID-19 - Algernon has now enrolled 75 patients, which is 50% of its enrollment target, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19. The Company is now projecting that the study will be completed in November 2020 with a planned data readout before the end of Q4, 2020. The multinational Phase 2b/3 human trial for COVID-19 is entitled, "A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patients with Confirmed COVID-19 Disease." The trial has begun as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 trial. The data from the Phase 2b study will determine the number of patients needed to reach statistical significance in the Phase 3 trial.

Algernon Receives Clearance from Health Canada for Ifenprodil COVID-19 Phase 2b/3 Multinational Clinical Trial - NP-120 (Ifenprodil) is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells and T-cells, neutrophils. The trial will begin as a Phase 2b study and after an interim analysis is performed on the first 100 patients, the data will determine the number of expected patients needed to reach statistical significance in a Phase 3 trial. With positive preliminary data, the clinical trial will move directly from a Phase 2b into a Phase 3. 

Read more here: https://algernonpharmaceuticals.com/covid-19-global-treatment-initiatives/ 

Vir and Alnylam Expand Collaboration to Advance Investigational RNAi Therapeutics Targeting Host Factors for the Treatment of COVID-19 - Under their agreement, the companies will utilize Alnylam’s recent advances in lung delivery of novel conjugates of siRNA – the molecules that mediate RNAi – together with Vir’s infectious disease expertise and established capabilities, to bring forward one or more siRNAs to treat SARS-CoV-2 and potentially other coronaviruses as well. The collaboration will focus on development of siRNAs that Alnylam recently identified that target highly conserved regions of coronavirus RNAs.The two named targets include angiotensin converting enzyme-2 (ACE2) and transmembrane protease, serine 2 (TMPRSS2). ACE2 is known to be the viral entry receptor for SARS-CoV-2 and other coronaviruses, while TMPRSS2 is believed to cleave the SARS-CoV-2 spike protein to facilitate cellular attachment. 

See also Vir Biotechnology's entry in the Company Directory.

Disease/Category-Specific EA Policies/Criteria

http://www.alnylam.com/medical-professionals/expanded-access-program/

Altimmune Completes First Development Milestone Toward a Single-Dose Intranasal COVID-19 Vaccine

Altimmune and the University of Alabama at Birmingham to Collaborate on Development of Single-Dose, Intranasal COVID-19 Vaccine

see also:  https://altimmune.com/adcovid/

Amgen And Adaptive Biotechnologies Announce Strategic Partnership To Develop A Therapeutic To Prevent Or Treat COVID-19 - Adaptive will extend its high throughput platform to rapidly screen the massive genetic diversity of the B cell receptors from individuals that have recovered from COVID-19. This enables the identification of tens of thousands of naturally occurring antibodies from survivors of COVID-19 to select those that neutralize SARS-CoV-2. Amgen will then leverage its world-class antibody engineering and drug development capabilities to select, develop and manufacture antibodies designed to bind and neutralize SARS-CoV-2. deCODE Genetics, a subsidiary of Amgen located in Iceland, will provide genetic insights from patients who were previously infected with COVID-19.

See also Adaptive Biotechnologies entry in the Company Directory

APEIRON’s respiratory drug product to start pilot clinical trial to treat coronavirus disease COVID-19 in China. APEIRON Biologics AG today announced that it has received regulatory approvals in Austria, Germany and Denmark to initiate a Phase II clinical trial of APN01 to treat COVID-19. APN01 is the recombinant form of the human angiotensin-converting enzyme 2 (rhACE2), and has the potential to block the infection of cells by the novel SARS-CoV-2 virus (COVID-19), and reduce lung injury. The Phase II trial aims to treat 200 severely infected COVID-19 patients, and the first patients are expected to be dosed shortly.

Press release

APEPTICO's solnatide IMP has been approved for Compassionate Use by the Austrian Federal Office for Safety in Health Care (BASG) for the treatment of patients infected by the novel coronavirus SARS-CoV-2 and subsequently developing severe pulmonary dysfunction (severe COVID-19). APEPTICO, a privately-held biotechnology company from Vienna, Austria, is developing peptide-based medicinal products to treat life-threatening pulmonary dysfunctions, such as severe respiratory failure, oedematous respiratory failure (lung oedema), acute respiratory distress syndrome (ARDS), primary graft dysfunction (PGD) following lung transplantation, high altitude pulmonary oedema (HAPE) and pseudohypoaldosteronism type 1B (PHA1B). 

Applied Therapeutics Announces IND and Investigator-Initiated Studies of AT-001 in Critical COVID-19 Patients - A COVID-19 IND has been opened with the FDA for AT-001, a novel potent Aldose Reductase inhibitor in global Phase 3 development for Diabetic Cardiomyopathy. Multiple AT-001 investigator-initiated trials are now underway to address acute lung inflammation and cardiomyopathy in critical COVID-19 patients. Several New York City hospitals have initiated Emergency Investigational Drug applications for AT-001 use in critical COVID-19 patients.  AT-001 is currently being accessed in these New York City hospitals via “Named Patient” Emergency INDs or Investigator-Initiated Trials, depending on the patient circumstance and hospital institution.  Institutions that have initiated trials include Mount Sinai, NYU, and Columbia. To date, all patients treated under Emergency INDs have demonstrated improvement in cardiopulmonary function.  Additional data is being gathered through studies on the effect of AT-001 therapy in critical COVID-19 patients.

See also: Cardiovascular Effects of COVID-19

LUNAR-COV19 - Arcturus is combining its self-replicating mRNA STARR™ Technology with their LUNAR® RNA medicine delivery technology to developing a prophylactic vaccine against COVID-19. The combination of these two technologies results in (1) an mRNA vaccine that can be produced more rapidly than conventional adjuvanted protein based vaccine; (2) a significant reduction in the mRNA dose required to elicit a protective immune response; and (3) an increase in the duration of antigen expression potentially yielding protection from COVID-19 with a single dose.

Arcturus Therapeutics and Duke-NUS Medical School Partner to Develop a Coronavirus (COVID-19) Vaccine using STARR™ Technology

Results from First Clinical Study Using Danoprevir to Treat Naive and Experienced COVID-19 Patients - The data from this small-sample clinical study showed that danoprevir combined with ritonavir is safe and well tolerated in all patients. After 4 to 12-day treatment of danoprevir combined with ritonavir, all eleven moderate COVID-19 patients enrolled, two naive and nine experienced, were discharged from the hospital as they met all four conditions as follows: (1) normal body temperature for at least 3 days; (2) significantly improved respiratory symptoms; (3) lung imaging shows obvious absorption and recovery of acute exudative lesion; and (4) two consecutive RT-PCR negative tests of SARS-CoV-2 nucleotide acid (respiratory track sampling with interval at least one day).

Progress of the Small Sample Clinical Trial of Ganovo® and Ritonavir Combination Therapy on Novel Coronavirus Pneumonia

COVID-19 vaccine AZD1222 clinical trials resumed in the UK - Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so. On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.

University of Oxford potential COVID-19 vaccine Phase III clinical trial initiated in the US - Development of the potential COVID-19 vaccine has expanded into a Phase III clinical trial in the US to assess the safety, efficacy and immunogenicity of the potential vaccine for the prevention of COVID-19. The trial is funded by US Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.

Available at: https://clinicaltrials.gov/ct2/show/NCT04516746?term=NCT04516746&draw=2&rank=1

see also: Development of COVID-19 vaccine AZD1222 expands into US Phase III clinical trial across all adult age groups

D8110C00001 is a Phase III randomised, double-blind, placebo-controlled multicentre study assessing the safety, efficacy, and immunogenicity of AZD1222 compared to placebo for the prevention of COVID-19, in up to 30,000 participants across approximately 100 trial centres in and outside the US. Trial participants aged 18 years or over who are healthy or have medically stable chronic diseases, and are at increased risk for being exposed to the SARS-CoV-2 virus and COVID-19 will be randomised in a 2:1 ratio to receive two intramuscular doses of either 5 x10¹⁰ viral particles of AZD1222 or saline placebo four weeks apart, on day one and 29. Randomisation will be stratified by age (≥ 18 to < 65 years, and ≥ 65 years), with at least 25% of participants to be enrolled in the older age range. Individuals interested in participating in the Phase III D8110C00001 vaccine trial can visit https://www.c19vaccinestudy.com or www.CoVPN.org websites for more information.

Researching antibodies to target COVID-19 - More than 50 virology, protein engineering, clinical and bioprocess experts across BioPharmaceuticals R&D and Operations are working on this effort, using proprietary antibody discovery technology that was previously developed under an agreement with the US Defense Advanced Research Projects Agency (DARPA) as part of the Pandemic Preparedness Platform program. As part of the DARPA program, the technology enabled AstraZeneca scientists to rapidly discover potential therapeutic antibodies for influenza-A in less than 60 days. The Chinese Academy of Sciences (China) and Vanderbilt University Medical Center (US) are providing AstraZeneca with genetic sequences for antibodies they have discovered against SARS2-CoV-2 for further in silico and in vitro assessment.

MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

We are running a Pivotal Phase 2/3 clinical trial evaluating MultiStem cell therapy in COVID-19 induced ARDS patients. This trial is a multicenter study with an open-label, single active treatment arm for cohort 1 followed by a double-blind, randomized, placebo-controlled Phase 2/3 portion. The primary objectives of the MACOVIA study are to evaluate the safety and efficacy of MultiStem therapy as a treatment for subjects with moderate to severe ARDS due to COVID-19.

For more info: https://www.athersys.com/clinical-trials/ards/default.aspx

Bausch Health Initiates VIRAZOLE® (Ribavirin for Inhalation Solution, USP) Clinical Study in Patients with COVID-19 - a clinical trial program in Canada evaluating an investigational use of VIRAZOLE® (Ribavirin for Inhalation Solution, USP) in combination with standard of care therapy to treat hospitalized adult patients with respiratory distress due to COVID-19. Because ribavirin is a synthetic nucleoside that works to stop viral replication, VIRAZOLE may be effective in reducing the severity of COVID-19 infection. VIRAZOLE is currently approved in several countries around the world, including the United States and Canada, for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV).

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19

BioAegis is currently evaluating data from our Phase 2 clinical study of recombinant human plasma gelsolin (rhu-pGSN) added to standard of care for treatment of patients with severe COVID-19 pneumonia. Primary outcome measures will evaluate efficacy and safety. Specific details of the protocol can be reviewed at: https://clinicaltrials.gov/ct2/show/NCT04358406 (March 2021)

This human protein enhances the body’s ability to manage excess inflammation without suppressing immune function, unlike currently approved anti-inflammatory treatments.

April, 2020: Small NJ Biotech Firm, BioAegis Therapeutics, Accelerating Multiple Clinical Trial Submissions for Severe COVID-19 Pneumonia Patients

BioCryst Pharmaceuticals is developing its drug galidesivir as a potential treatment for more than 20 RNA viruses. But SARS-CoV-2, the virus that causes COVID-19, will no longer be one of them. 

The Durham company has reported early stage clinical trial results showing that treatment with the experimental antiviral offered COVID-19 patients no benefit compared to a placebo. The study wasn’t designed to demonstrate clinical efficacy, and small Phase 1 clinical trials typically enroll healthy volunteers to assess a drug’s safety before testing the drug on sick patients. Galidesivir achieved the safety measure with no serious problems associated with the drug. 

Nevertheless, the BioCryst study, funded by the National Institute of Allergy and Infectious Diseases (NIAID), failed to provide signs that the drug could treat COVID-19 infection. 

Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well tolerated in previously reported Phase 1 trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS.

Biomarck's BIO-11006 has two active INDs, including one is for respiratory disease. We have commenced enrollment in Phase 2 controlled clinical studies in Acute Respiratory Distress Syndrome (ARDS). See below for more information.

Evaluation of Safety & Efficacy of BIO-11006 Inhalation Solution in Patients With ARDS

A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer

Disease/Category-Specific EA Policies/Criteria

biomarck pharmaceuticals intends to support children with difficult to treat cancers such as Rhabdomyosarcoma and Neuroblastoma. This may be done by a compassionate use program under the Investigator IND of the treating hospital. This effort will be done in support of the concepts of non-profit organizations such as the Miami based Live Like Bella Foundation (Learn More) which supports children with cancer, their families and research into childhood cancer.

BIO-11006 is an investigational peptide medication delivered by nebulizer which has shown activity in the laboratory and in animal studies in certain types of cancer. It has been granted FDA acceptance to begin studies in adult lung cancer. BIO-11006 has been given to over 200 patients with COPD (chronic bronchitis and emphysema) and been shown to have a good safety profile at the recommended dose. It has not been given to children or cancer patients in controlled clinical studies.

Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine - The collaboration aims to accelerate development of BioNTech’s potential first-in-class COVID-19 mRNA vaccine program, BNT162, which is expected to enter clinical testing by the end of April 2020. 

FDA Grants CalciMedica Permission to Begin Dosing CM4620-IE in Patients with Severe COVID-19 Pneumonia under a Newly Opened IND 

• Regions Hospital in St. Paul, Minnesota has begun a Phase 2 clinical study of CM4620-IE in patients with severe COVID-19 pneumonia who develop hypoxemic respiratory failure and are at risk for progression to acute respiratory distress syndrome, and Henry Ford Hospital in Detroit is expected to begin shortly after

• CM4620-IE is a potent and selective small molecule that may prevent pulmonary endothelial damage and lessen the cytokine storm in COVID-19

• CM4620-IE has demonstrated clinical safety and potential efficacy in patients with hypoxemia secondary to systemic inflammatory response syndrome in the setting of acute pancreatitis

• The open-label Phase 2a clinical trial aims to enroll 60 patients with severe COVID-19 pneumonia and a PaO2/FiO2≤300, patients who are risk to progress to mechanical ventilation. Forty patients will be assigned to CM4620-IE plus standard of care and 20 assigned to standard of care alone. The therapy will be delivered intravenously with the aim of keeping COVID-19 patients with severe pneumonia, whose breathing is rapidly declining, from “crashing” and needing ventilators by decreasing inflammation in the lungs. 

CanSinoBIO’s Investigational Vaccine Against COVID-19 Approved for Phase 1 Clinical Trial in China - The vaccine candidate is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform. Results from preclinical animal studies of “Ad5-nCoV” show that the vaccine candidate can induce strong immune response in animal models. The preclinical animal safety studies demonstrated a good safety profile.

A Phase I Clinical Trial in 18-60 Adults

Capricor Initiates Compassionate Use Program for Severe COVID-19 Patients using CAP-1002, its Novel Cell Therapy - CAP-1002 mitigates the release of anti-inflammatory cytokines as well as macrophage activation in a number of models of inflammation including sepsis and autoimmune diseases. 

CAP-1002 in Severe COVID-19 Disease - Compassionate Use Program

New Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002 - Over the course of one month, six critically ill COVID-19 patients, all suffering from acute respiratory distress syndrome (ARDS) and five of whom were on mechanical ventilatory support, were safely treated with CAP-1002. Of the six patients treated, four of them have been discharged. 

Disease/Category-Specific EA Policies/Criteria

Capricor Initiates Compassionate Use Program for Severe COVID-19 Patients using CAP-1002, its Novel Cell Therapy

CAP-1002 in Severe COVID-19 Disease - Compassionate Use Program

CEL-SCI to Develop LEAPS COVID-19 Immunotherapy in Collaboration with University of Georgia Center for Vaccines and Immunology 

• Initial studies with COVID-19 coronavirus aim to replicate prior successful preclinical experiments of LEAPS against H1N1pandemic flu in mice conducted with National Institutes for Allergies and Infectious Diseases (NIAID)
• Treatment targeted for patients who are at highest risk of dying from COVID-19 due to tissue damage from infection to the lungs

CEL-SCI Initiates Development of Immunotherapy to Treat COVID-19 Coronavirus Infection

• Immunotherapy using LEAPS peptide technology may be able to reduce COVID-19 viral load and tissue damage resulting from infection in the lungs.

Celularity Announces FDA Clearance of IND Application for CYNK-001 in Coronavirus, First in Cellular Therapy - Celularity Inc., a clinical-stage company developing allogeneic cellular therapies from human placentas, has announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for the use of its proprietary CYNK-001 in adults with COVID-19. With this, Celularity will commence a Phase I/II clinical study including up to 86 patients with COVID-19. 

Other companies mentioned: Sorrento Therapeutics, United Therapeutics/Lung Biotechnology

Cerecor Announces FDA Clearance of IND for CERC-002 in COVID-19 Induced ARDS - Cerecor will proceed with a proof-of-concept clinical trial of its anti-LIGHT monoclonal antibody CERC-002 in patients with COVID-19 cytokine storm induced Acute Respiratory Distress Syndrome (ARDS). The study will assess the efficacy and safety of CERC-002. The first patient is expected to enroll in June and top-line data are expected in the fourth quarter of 2020. The randomized, multi-center, double-blind, placebo-controlled trial will enroll approximately 82 subjects hospitalized with COVID-19 ARDS. 

Dynavax and Clover Biopharmaceuticals Announce Research Collaboration to Evaluate Coronavirus (COVID-19) Vaccine Candidate with CpG 1018 Adjuvant 

• Dynavax is providing CpG 1018, the adjuvant contained in U.S. FDA-approved HEPLISAV-B vaccine, to support the rapid development of Clover’s COVID-19 vaccine
• Clover advancing evaluation of its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer)

Clover and GSK Announce Research Collaboration to Evaluate Coronavirus (COVID-19) Vaccine Candidate with Pandemic Adjuvant System - Clover Biopharmaceuticals has entered into a research collaboration with GSK for its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer). GSK will provide Clover with its pandemic adjuvant system for further evaluation of S-Trimer in preclinical studies. 

Clover Successfully Produced 2019-nCoV Subunit Vaccine Candidate and Detected Cross-Reacting Antibodies from Sera of Multiple Infected Patients - Clover has successfully produced its trimeric Spike-protein (“S-Trimer”) subunit vaccine candidate for 2019-nCoV via a mammalian cell expression system. In addition, Clover scientists have used the newly obtained S-Trimer and successfully detected antigen-specific antibody in sera from multiple fully recovered patients who were previously infected by the virus

CureVac and CEPI extend their Cooperation to Develop a Vaccine against Coronavirus nCoV-2019

COVID-19 Conference Call https://www.curevac.com/news/conference-call-on-current-developments

CytoDyn’s Phase 2 Study of Leronlimab for Mild-to-Moderate COVID-19 Selected for Oral Presentation at the Special isirv-AVG Virtual Conference on ‘Therapeutics for COVID-19’ -  An oral presentation was given at the Special isirv-Antiviral Group Conference on ‘Therapeutics for COVID-19.’ Additional details can be found on the conference web site here. 

see also: https://www.clinicaltrials.gov/ct2/show/NCT04347239?term=leronlimab&cond=Covid19&draw=2&rank=2 for late onset intervention therapies 

Novant Health Initiates Phase 2 COVID-19 Trial with CytoDyn’s Leronlimab - Novant Health is initiating patient enrollment in CytoDyn’s Phase 2 randomized clinical trial for COVID-19 patients with mild-to-moderate indications.  Novant Health is the first site in the southeastern United States to initiate this Phase 2 trial and the second clinical trial site in the nation.

Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients - Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.

Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU and Extubated with Reduced Pulmonary Inflammation

CytoDyn Reached Its Enrollment Target for Phase 2 COVID-19 Trial for Mild to Moderate Indication – Primary End Point Announcement Is Next - CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

Available Therapies via Single-Patient EA

A Compassionate Use Study of Leronlimab in Breast Cancer

Eiger BioPharmaceuticals Announces First COVID-19 Patients Dosed with Peginterferon Lambda - Approximately 120 patients with mild COVID-19 at the Stanford University School of Medicine will be randomized 1:1 to a single subcutaneous dose of Lambda or normal saline placebo to evaluate the efficacy of Lambda in reducing the duration of viral shedding of SARS-CoV-2 virus and in reducing duration of symptoms and hospitalization in patients with mild COVID-19.  Patients will be followed for 28 days.

Available Therapies via Single-Patient EA

• Lonafarnib
• Pegylated Interferon Lambda
• Avexitide

Disease/Category-Specific EA Policies/Criteria

The Hutchinson-Gilford Progeria Syndrome and Progeroid Laminopathy Managed Access Program

Eiger BioPharmaceuticals, the distributor of the drug lonafarnib, is sponsoring a Managed Access Program (MAP) for eligible patients with Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) or a Progeroid Laminopathy (PL).  The protocol governing this program can be viewed at ClinicalTrials.gov. The MAP study number is NCT03895528.  Clinigen is the administrator of the lonafarnib MAP for HGPS and PL.

Patients or family members desiring more information about this program should speak to their doctors  or contact The Progeria Research Foundation at 978-535-2594 or e-mail info@progeriaresearch.org.  Patients and family members should not contact Clinigen.  Clinigen is only authorized to speak with doctors.

For treating doctors with questions about the MAP, please contact Clinigen’s Medicine Access Team at +44 (0) 1932 824123 or email medicineaccess@clinigengroup.com.  The doctor may also e-mail Eiger at ProgeriaMA@eigerbio.com or Eigeraccess@eigerbio.com.

Lilly Announces Proof of Concept Data for Neutralizing Antibody LY-CoV555 in the COVID-19 Outpatient Setting - Lilly announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment of symptomatic COVID-19 in the outpatient setting. The trial enrolled mild-to-moderate recently diagnosed COVID-19 patients across four groups (placebo, 700 mg, 2800 mg, and 7000 mg).

see: https://clinicaltrials.gov/ct2/results?cond=&term=nct04497987&cntry=&state=&city=&dist= 

Lilly's Neutralizing Antibodies and COVID-19 Fact Sheet 

Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial - Lilly announced initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). ACTT-2 included more than 1,000 patients and began on May 8 to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.

Eli Lilly and Company announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study Olumiant (baricitinib) as an arm in NIAID's Adaptive COVID-19 Treatment Trial. Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT^®, is approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Given the inflammatory cascade seen in COVID-19, baricitinib's anti-inflammatory activity has been hypothesized to have a potential beneficial effect in COVID-19 and warrants further study in patients with this infection. https://investor.lilly.com/news-releases/news-release-details/lilly-begins-clinical-testing-therapies-covid-19

see also: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=baricitinib&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

AbCellera and Lilly to Co-develop Antibody Therapies for the Treatment of COVID-19 - AbCellera and Lilly will select from 500+ unique antibodies isolated from one of the first U.S. patients who recovered from COVID-19 to create antibody therapeutics for treatment and prevention of COVID-19

As part of the global effort to investigate potential therapeutics for COVID-19 and our support of independent research, Merck KGaA, (EMD Serono's parent company) recently donated a supply of interferon beta-1a (Rebif®) to the French Institut National de la Santé et de la Recherche Médicale (INSERM) following a request for use in a clinical trial.

The trial is sponsored by INSERM and its launch has been announced by the French Health authorities on March 11, 2020. To date, Merck KGaA, Darmstadt, Germany’s interferon beta-1a is not approved by any regulatory authority for the treatment of COVID-19 or for use as an antiviral agent.

See: Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

Emergent BioSolutions Partners with U.S. Government for Comprehensive Response to Expedite Development of Plasma-Derived Therapy for COVID-19 - 

• BARDA to provide $14.5 million in funding to support development of COVID-Human Immune Globulin (COVID-HIG), a human plasma-derived therapy candidate being developed as a potential treatment for COVID-19 in severe hospitalized and high-risk patients
• NIAID to include COVID-HIG product candidate in one of its clinical studies for assessment of treatments for COVID-19 upon availability of clinical material
• Emergent will seek a path forward with the FDA for the development of COVID-HIG and possible use under Emergency Use Authorization (EUA)

EpiVax, Inc., is using advanced computational tools to accelerate a COVID-19 vaccine candidate (EPV-CoV19) for healthcare workers (HCW) into clinical trials in 6 months. EpiVax has announced its partnership with GAIA Vaccine Foundation (“GVF”) to crowd-source funds for the project and its pledge to make a free license available to developing countries who qualify, in the context of this partnership.

COVID-19 Coverage (multiple press releases). https://epivax.com/home/vaccine-services/covid-19

Eusa Pharma and the Papa Giovanni XXIII Hospital, Bergamo, Italy announce initiation of an observational case-control study of Siltuximab in patients with COVID-19 who have developed serious respiratory complications.

For more information: https://www.eusapharma.com/news/eusa-pharma-and-the-papa-giovanni-xxiii-hospital/

Fujifilm announces the start of a phase III clinical trial of influenza antiviral drug “Avigan Tablet” on COVID-19 and commits to increasing production

For more information: https://www.fujifilm.com/jp/en/news/hq/3211?_ga=2.116910662.1504568395.1585764405-146260470.1585764405

Information of Avigan Tablet in relation to COVID-19 

Avigan Tablet was approved for manufacture and sale in Japan in 2014 as an influenza antiviral drug. The drug is to be considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza antiviral drugs are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses. Thus, while the Japanese government has a certain stockpile of the drug, Avigan Tablet has never been distributed in the market and is not available at hospitals and pharmacies in Japan or overseas.

Favipiravir, the active pharmaceutical ingredient of Avigan Tablet, has a mechanism of action that prevents the propagation of viruses. The drug may potentially have an antiviral effect on the novel coronavirus as it is classified into the same type (single-stranded RNA virus) as influenza virus. However, at this stage, clinical application of Avigan Tablet to treat Coronavirus disease (Covid-19) is under study and preparation in order to obtain clear evidence of the drug's efficacy and safety.

Avigan Tablet has not been approved for marketing in any countries other than Japan. If any other national government or regulatory authority decides the use of Avigan Tablet, Fujifilm group intends to cooperate sincerely with the supply of Avigan Tablet to such countries in consultation and coordination with the Japanese government.

Marketed as Favilavir by  Zhejiang Hisun Pharmaceuticals (China)

Fulcrum Therapeutics Announces Initiation of Multi-Center Phase 3 (LOSVID) Trial with Losmapimod for Hospitalized COVID-19 Patients - The LOSVID trial is a Phase 3, international, multicenter trial designed to assess the safety and efficacy of a 15 mg twice per day oral dose of losmapimod compared to placebo for 14 days on top of standard of care in approximately 400 patients hospitalized with COVID-19 and at risk of progression to critical illness based on older age and elevated systemic inflammation. 

For more information, email clinicaltrials@fulcrumtx.com.

Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia

Genentech Initiates Phase III Clinical Trial Of Actemra In Hospitalized Patients With Severe COVID-19 Pneumonia

COVID-19 response page

On March 23, 2020, we announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase III clinical trial (COVACTA) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia. Learn more about the COVACTA clinical trial here.

Additionally, to further support U.S. COVID-19 response efforts, Genentech will provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services (HHS).

Multiple ongoing clinical trials involving Actemra (tocilizumab). For a list, go to: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=tocilizumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

Single-Patient EA Policies/Criteria

https://www.gene.com/patients/investigational-medicines/criteria

COVID-19 Vaccine Project

NuGenerex Immuno-Oncology, a Subsidiary of Generex Biotechnology (NGIO) has signed a development and commercial licensing agreement with partners in China to develop a vaccine against the SARS-COV-2 coronavirus. The agreement provides exclusive rights to the Ii-Key- SARS-COV-2 peptide vaccines in China; NGIO retains worldwide rights to the Ii-Key peptide vaccines.

Generex Receives Contract from Chinese Partners to Develop a COVID-19 Vaccine Using Ii-Key Peptide Vaccines

https://www.globenewswire.com/news-release/2020/02/27/1992098/0/en/Generex-Provides-Coronavirus-Update-Generex-Receives-Contract-from-Chinese-Partners-to-Develop-a-COVID-19-Vaccine-Using-Ii-Key-Peptide-Vaccines.html

COVID-19 Resource Page

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

Expanded Access Remdesivir (RDV; GS-5734™) - for DOD/military personnel only

Emergency Access to Remdesivir Outside of Clinical Trials

Remdesivir Clinical Trials

An Open Letter from our Chairman and CEO (March 28, 2020)

An Update on COVID-19 from our Chairman & CEO (April 4, 2020)

"Gilead is providing the entirety of this existing supply at no cost, to treat patients with the most severe symptoms of COVID-19. The 1.5 million individual doses are available for compassionate use, expanded access and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations." 

Disease/Category-Specific EA Policies/Criteria

Emergency Access to Remdesivir Outside of Clinical Trials

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

Expanded Access Remdesivir (RDV; GS-5734™) - for DOD/military personnel only

Remdesivir Clinical Trials

GSK COVID-19 vaccine development collaboration with Clover Biopharmaceuticals begins clinical trials - Clover Biopharmaceuticals initiates phase 1 study using GSK pandemic adjuvant in combination with COVID-19 vaccine candidate SCB-2019. Preliminary safety and immunogenicity results for the Phase 1 study are expected in August 2020. In parallel, the planning for a global Phase 2b/3 vaccine efficacy trial has begun, with initiation targeted later in 2020.

Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19 - Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. GSK will contribute its proven pandemic adjuvant technology to the collaboration. 

GSK and Vir Biotechnology enter collaboration to find coronavirus solutions - We have announced a collaboration with Vir Biotechnology to use Vir’s monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options for COVID-19. Subject to regulatory review, the companies plan to proceed directly into a phase 2 clinical trial within the next three to five months. 

Through the COVID-19 Therapeutics Accelerator, GSK will make available compounds from its libraries for screening for activity against COVID-19.

Single-Patient EA Policies/Criteria

http://www.gsk.com/media/3368/compassionate-use.pdf

Go to GSK Compassionate Use Request Portal at https://gsk-cu-portal.idea-point.com/ to make a request.

Grifols completes development of very high sensitivity molecular test to detect SARS-CoV-2 virus - a specific TMA (Transcription-Mediated Amplification) molecular test that permits the detection of the SARS-CoV-2 virus in plasma, blood and respiratory samples.

Grifols Announces Formal Collaboration with US Government to Produce the First Treatment Specifically Targeting COVID-19 - Grifols will collect plasma from convalescent COVID-19 patients, process this specific plasma into a hyperimmune globulin and support the necessary preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can successfully be used to treat COVID-19 disease. This initiative is a result of a collaboration between Grifols, the U.S. Food and Drug Administration (FDA), the U.S. Biomedical Advanced Research Authority (BARDA), and other Federal health agencies.

People Who Have Recovered from COVID-19 Can Now Donate their Convalescent Plasma in select Grifols U.S. Plasma Donor Centers - Grifols has begun identifying, screening and selecting volunteer donors who have recovered from COVID-19 to donate their plasma in select U.S. cities. The plasma will be used to produce a hyperimmune globulin that, if proven effective, could potentially treat the disease.

Phase III clinical trial to evaluate lenzilumab for the prevention and treatment of cytokine storm arising from COVID-19. 

• Lenzilumab neutralizes granulocyte macrophage colony stimulating factor (GM-CSF) a key cytokine in the initiation of cytokine storm
• GM-CSF is up-stream of interleukin-6 (IL-6) in the development of cytokine storm
• GM-CSF is up-regulated in COVID-19 patients and may cause a harmful immune response, which contributes to cytokine storm in patients at risk of developing acute respiratory distress syndrome (ARDS)

FDA Approves Emergency IND Use of Humanigen’s Lenzilumab for Compassionate Use in COVID-19 Patients 

Lenzilumab for Compassionate Use - Humanigen is now accepting enquiries regarding lenzilumab for compassionate use.

I-Mab Announces IND Clearance from FDA for TJM2 to Treat Cytokine Release Syndrome (CRS) Associated with Severe Coronavirus Disease 19 (COVID-19) - TJM2, also known as TJ003234, is an I-Mab-discovered neutralizing antibody against human granulocyte-macrophage colony stimulating factor (GM-CSF), an important cytokine that plays a critical role in acute and chronic inflammation. The proposed clinical trial is a multi-center, randomized, double-blind, placebo-controlled, three-arm study to evaluate the safety, tolerability and efficacy of TJM2 in reducing the severity of complications as well as levels of multiple cytokines in patients with severe COVID-19.

Compassionate Use Open-Label Anti-CD14 Treatment in Patients With SARS-CoV-2 (COVID-19) - This protocol proposes to use IC14, a recombinant chimeric monoclonal antibody (mAb) recognizing human CD14, to block CD14-mediated cellular activation in patients early in the development of ARDS. The binding of IC14 to human CD14 prevents CD14 from participating in the recognition of PAMPs and DAMPs due to SARS-CoV-2 infection. The putative mechanism of action of IC14 in ARDS is blockade of PAMP and DAMP interactions with CD14, thus attenuating the inflammatory cascade that leads to increased endothelial and epithelial permeability and injury resulting in alveolar injury and fluid accumulation characteristic of ARDS.

Available Therapies via Single-Patient EA

Compassionate Use Open-Label Anti-CD14 Treatment in Patients With SARS-CoV-2 (COVID-19)

Incyte Announces Plans To Initiate A Phase 3 Clinical Trial Of Ruxolitinib (Jakafi®) As A Treatment For Patients With COVID-19 Associated Cytokine Storm - Incyte also intends to launch an Expanded Access Program in the United States to allow eligible patients with COVID-19 associated cytokine storm to receive Jakafi (ruxolitinib). (Jakavi/Jakafi is marketed by Novartis outside the United States. In the United States, the product is marketed by Incyte, Inc.)

As the Phase 3 study and EAP protocols are awaiting potential approval by the FDA, questions or inquiries regarding the availability of ruxolitinib for compassionate use or independent research should be made to:

U.S. Medical Information
1-855-4MED-INFO (1-855-463-3463)
medinfo@incyte.com.

Single-Patient EA Policies/Criteria

Questions or inquiries regarding the availability of ruxolitinib for compassionate use or independent research should be made to:

U.S. Medical Information
1-855-4MED-INFO (1-855-463-3463)
medinfo@incyte.com.

InflaRx Doses First Patient in Multicenter Randomized Clinical Trial in Severe Progressed COVID-19 Pneumonia in Europe upon Receipt of Initial Positive Human Data with InflaRx’s anti-C5a Technology - Announces the enrollment of the first patient into a randomized clinical trial investigating the safety and efficacy of IFX-1, the company´s monoclonal anti-C5a antibody, in patients with severe COVID-19-induced pneumonia. The company has received initial positive human data from two initial patients suffering from COVID-19-induced severe pneumonia who were treated with BDB-001, an anti-C5a antibody produced by BDB from the IFX-1 cell line, in China. Data from the two patients are part of a larger investigation on the role of complement activation in COVID-19 which have been made publicly available through a pre-print server and have not been independently validated by InflaRx.

We have been conducting an exploratory translational study, called EXPLORE COVID-19, in collaboration with La Timone, North and Laveran hospitals and the Marseille Immunopôle/AP-HM immunoprofiling laboratory at La Timone hospital, Marseille, to analyze immune cells in COVID-19 patients at different stages of the disease. Researchers reported an increase in soluble C5a, a highly inflammatory peptide of the complement cascade, which was elevated based on the severity of the disease in patients with pneumonia and acute respiratory distress syndrome (ARDS). 

On April 28, 2020, we announced that the first patient was dosed in a randomized, double-blind Phase II clinical trial, evaluating the safety and efficacy of our anti-C5aR antibody, avdoralimab, in COVID-19 patients with severe pneumonia. The primary objective of this investigator-sponsored trial, named FORCE (FOR COVID-19 Elimination), is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by ARDS.  

For more info: First patient dosed in avdoralimab Phase II clinical trial in COVID-19 patients with severe pneumonia

and MARSEILLE-BASED TASKFORCE ANNOUNCES THE RESULTS OF EXPLORE COVID-19 TRANSLATIONAL STUDY

https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=%22Innate+Pharma%22&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

Innovation has received inquiries asking about Brilacidin’s potential to treat the coronavirus (COVID-19) given the urgent worldwide need to find effective treatments for this deadly epidemic.

For more information, contact:  covid19@ipharminc.com

The linked PDF (click here), updated on March 1, is an informational overview summarizing the scientific rationale for Brilacidin as a potential coronavirus (COVID-19) treatment. Brilacidin, and other defensin-mimetics similar in structure, have been tested against various clinical isolates of both gram-positive and gram-negative pathogens, with strong activity exhibited across multiple isolates. Enveloped viruses, like the coronavirus, have also been tested, with activity noted. University of Pennsylvania scientists who conducted early Brilacidin research are optimistic about the multi-tiered advantages of Brilacidin to elicit a response, particularly when accompanied by drug optimization, formulation and delivery work, which is supported in the academic literature.

Inovio Collaborating With Beijing Advaccine To Advance INO-4800 Vaccine Against New Coronavirus In China - The goal of this collaboration is to leverage Advaccine's expertise to run a Phase 1 trial in China in parallel with Inovio's clinical development efforts in the U.S.

Inovio Selected by CEPI to Develop Vaccine Against New Coronavirus - Inovio is developing INO-4800 through Phase 1 human testing in the U.S. to evaluate safety and immunogenicity with the support of an initial grant up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

Inovio Accelerates Timeline for COVID-19 DNA Vaccine INO-4800

INOVIO Receives New $5 Million Grant to Accelerate Scale Up of Smart Delivery Device for Its COVID-19 Vaccine

Ology Bioservices, Inovio Partner To Manufacture COVID-19 DNA Vaccine With $11.9 Million Department of Defense Grant

Initiation of two-centre compassionate use study involving namilumab in the treatment of individual patients with rapidly worsening COVID-19 infection in Italy 

This study is in cooperation with the Humanitas research group, under the leadership of Professor Carlo Selmi, head of the Rheumatology and Clinical Immunology Unit at Humanitas Research Hospital and Associate Professor of Internal Medicine at Humanitas University. The study will take place in Bergamo and Milan, Italy.

Namilumab is the Company’s wholly-owned, phase III-ready, fully human monoclonal antibody therapy targeting granulocyte-macrophage colony stimulating factor (GM-CSF), currently in late-stage clinical development for the treatment of rheumatoid arthritis and ankylosing spondylitis.

COVID-19 Updates from Janssen

https://www.janssen.com/covid19

Johnson & Johnson has identified a lead COVID-19 vaccine candidate (with two back-ups), which will progress into the first manufacturing steps. The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process. BARDA and Johnson & Johnson have also expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. 

Anecdotal, unsubstantiated reports claim that darunavir has antiviral effect against COVID-19. Johnson & Johnson has no evidence that darunavir has any effect against SARS-CoV-2, the virus that causes COVID-19

Single-Patient EA Policies/Criteria

http://www.janssen.com/sites/www_janssen_com/files/janssen_pre-approval_access_policy_022017.pdf

Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19 and a Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use

Johnson & Johnson to Expand Partnership with U.S. Department of Health & Human Services to Accelerate the Discovery of Potential COVID-19 Treatments

Johnson & Johnson has identified a lead COVID-19 vaccine candidate (with two back-ups), which will progress into the first manufacturing steps. The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process. BARDA and Johnson & Johnson have also expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. 

Anecdotal, unsubstantiated reports claim that darunavir has antiviral effect against COVID-19. Johnson & Johnson has no evidence that darunavir has any effect against SARS-CoV-2, the virus that causes COVID-19

Karyopharm to Evaluate Low Dose Selinexor as a Potential Treatment for Hospitalized Patients with COVID-19 - Will initiate a global randomized clinical trial for low dose oral selinexor in hospitalized patients with severe COVID-19. Selinexor, marketed as XPOVIO^®, is currently approved at higher doses by the Food and Drug Administration (FDA) as a treatment for patients with relapsed or refractory multiple myeloma. Selinexor is an oral, selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1. The proposed clinical trial to treat hospitalized patients with COVID-19 would be the first study of an XPO1 inhibitor in patients with severe viral infections.

Karyopharm Announces Dosing of First Patient in Randomized Study Evaluating Low Dose Selinexor in Patients with Severe COVID-19 - First patient enrolled in a randomized Phase 2 clinical study evaluating low dose oral selinexor in hospitalized patients with severe COVID-19. This global study is expected to enroll approximately 230 patients at clinical sites in the U.S., Europe, and Israel. 

Available Therapies via Single-Patient EA

Patients with the following conditions who meet certain inclusion/exclusion criteria may be provided access to selinexor:

• Patients with relapsed or refractory multiple myeloma
• Patients with relapsed or refractory diffuse large b-cell lymphoma (DLBCL)
• Patients with advanced sarcoma
• Patient with other diseases in which selinexor has been studied in clinical trials will be assessed on a case-by-case basis

Available Therapies via Single-Patient EA

LJPC-0118 (I.V. artesunate) 

Artesunate for malaria is currently offered by the Centers for Disease Control and Prevention (CDC) under an Expanded Access Treatment Protocol.  It can be requested from CDC via the CDC Malaria Hotline.

CDC Malaria Hotline Information:

Monday through Friday, 9:00 am-5:00 pm, Eastern Time: 770-488-7788 or toll-free 855-856-4713
For consultation after hours: 770-488-7100 and ask to speak with a CDC Malaria Branch clinician.

For indications other than malaria, please contact La Jolla’s Medical Information Contact Center

• 9:00am – 6:00pm EST, Monday-Friday, via telephone at (800) 651-3861
• anytime via email at medicalinformation@ljpc.com

Laurent Pharmaceuticals Joins Battle Against COVID-19 - The company is planning to test its lead drug LAU-7b in patients with COVID-19 disease, as part of a Phase 2 clinical trial. LAU-7b is a novel once-a-day oral form of fenretinide, an investigational drug under development by Laurent Pharmaceuticals for its ability to help control inflammation in the lungs.  Laurent is working closely with regulatory authorities in Canada and United States, planning to initiate a randomized, placebo-controlled Phase II clinical study, within a month. The study will involve approximatively 200 patients diagnosed with COVID-19 and at risk to develop lung complications, for a treatment duration of 14 days.

Mallinckrodt Supports Investigator-Initiated Study at Massachusetts General Hospital to Assess Effectiveness of Inhaled Nitric Oxide in Patients with Severe Acute Respiratory Distress Syndrome Due to COVID-19 - an investigator-initiated clinical study at Massachusetts General Hospital evaluating the potential benefits of inhaled nitric oxide as a treatment for pulmonary complications in patients infected with COVID-19. Mallinckrodt's support to Massachusetts General Hospital includes providing funding as well as INOmax^® (nitric oxide) gas, for inhalation, to facilitate the study. The study is titled "Inhaled Nitric Oxide Gas Therapy in Mechanically Ventilated Patients with Severe Acute Respiratory Syndrome in COVID-19." See: Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19

Mallinckrodt and Novoteris Receive Clearance from Health Canada to Start Pilot Trial of High-Dose Inhaled Nitric Oxide Therapy for COVID-19 Infection and Associated Lung Complications -  Mallinckrodt plc and Novoteris, LLC announced that the Therapeutic Products Directorate of Health Canada has cleared the companies' joint pilot clinical trial, entitled "Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections" application to investigate the use of Thiolanox^®, a high-dose inhaled nitric oxide therapy for the treatment of patients infected with novel coronavirus (SARS-CoV-2) at Vancouver Coastal Health Authority facilities. The investigative therapy employs Novoteris' Inhaled Nitric Oxide Delivery Device (INODD) and Mallinckrodt's high-concentration, 5000 PPM nitric oxide gas for inhalation canisters. The study will investigate the therapy's safety and effectiveness in treating COVID-19 and its associated lung complications. The companies expect to begin recruiting patients in the coming days.

MediciNova Announces Plans to Initiate a Clinical Trial of MN-166 (ibudilast) for COVID-19 Acute Respiratory Distress Syndrome (ARDS) - MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. The lead Principal Investigator (PI) for this trial is Dr. Geoffrey Chupp, Professor of Medicine (Pulmonology), Director of the Yale Center for Asthma and Airway Disease and Director of the Pulmonary Function Laboratory at Yale-New Haven Hospital.  

MediciNova Announces Plans to Develop MN-166 (ibudilast) for Severe Pneumonia and Acute Respiratory Distress Syndrome (ARDS) - MediciNova’s decision to pursue development of this indication was based on positive results of a recent preclinical study in an animal model of ARDS (Med Sci Monit, 2020; 26: e922281). Results of this preclinical study showed that ibudilast treatment reversed histological changes observed in the ARDS mouse model including inflammation, hemor­rhage, alveolar congestion, and alveolar wall edema.

Single-Patient EA Policies/Criteria

Currently, MediciNova is not accepting requests from patients or their advocates (including treating physicians) under the Expanded Access/Compassionate Use Program because of its focus on planned Phase 3 trials to evaluate MN-166 (ibudilast). 

US NIH Trials Network to Conduct COVID-19 Phase 2/3 Trial - Mesoblast Limited has announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials.

Moderna Confirms Discussions with the Ministry of Health, Labour and Welfare to Supply Japan with 40 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - Moderna confirmed that the Company is engaged in discussions with the Ministry of Health, Labour and Welfare of Japan (MHLW) to potentially purchase 40 million or more doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support Japan’s aim of providing vaccines to the public as soon as possible. Under the terms of this arrangement, the vaccine would be supplied by Moderna, Inc. and distributed in Japan by Takeda Pharmaceutical Co., Ltd. (NYSE: TAK) beginning in the first half of 2021, if the vaccine receives regulatory approval. Kato Katsunobu, Minister of MHLW, announced the discussions in a meeting with media today in Japan.

Moderna to Present New Interim Clinical Data About mRNA Vaccine Against COVID-19 (mRNA-1273) at Advisory Committee on Immunization Practices (ACIP) Meeting - Moderna announced its presentation at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) August Meeting. The live presentation can be viewed online here.This presentation includes new interim safety and immunogenicity data from the cohorts of older adults in the NIH-led Phase 1 study of mRNA-1273, Moderna’s vaccine candidate against COVID-19. The ACIP presentation slides will be available under “Events and Presentations” in the Investors section of the Moderna website.

Moderna Confirms Advanced Discussions with European Commission to Supply Europe with 80 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - Moderna has concluded advanced exploratory talks with the European Commission to supply 80 million doses of mRNA-1273 as part of the European Commission’s goal to secure early access to safe and effective COVID-19 vaccines for Europe.The potential purchase agreement with the European Commission of 80 million doses provides for an option for Member States to purchase an additional 80 million doses for a total of up to 160 million doses. The discussions are intended to ensure that Member States have access to Moderna’s vaccine. The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September. 

Moderna Announces Supply Agreement with U.S. Government for Initial 100 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - The U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S. government’s goal of securing early access to safe and effective COVID-19 vaccines for the American people. The award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, this announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion. 

Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus - Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.

see also: https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19 - This page summarizes key milestones  to advance mRNA-1273, Moderna's vaccine candidate against the novel coronavirus.

Read more about developing therapeutics and vaccines for coronaviruses 

NIAID has also supported the clinical testing of two promising antibody-based therapeutics, which prevent the virus from infecting and entering cells.  NIAID conducted a phase 1 clinical trial of  SAB-301, an experimental MERS treatment developed from cattle that make human antibodies.  This was shown to be safe and well tolerated in healthy adults. More recently, NIAID supported a Phase I clinical trial of a combination of two monoclonal antibodies, REGN3048 and REGN 3051, and demonstrated this combination was also safe and well tolerated.  Planning for follow on Phase 2/3 efficacy studies using SAB-301 is currently ongoing with partners where MERS is endemic, including the Kingdom of Saudi Arabia.

NIH clinical trial of investigational vaccine for COVID-19 begins

Disease/Category-Specific EA Policies/Criteria

Developing Therapeutics and Vaccines for Coronaviruses

https://www.niaid.nih.gov/diseases-conditions/coronaviruses-therapeutics-vaccines

NIAID has also supported the clinical testing of two promising antibody-based therapeutics, which prevent the virus from infecting and entering cells.  NIAID conducted a phase 1 clinical trial of  SAB-301, an experimental MERS treatment developed from cattle that make human antibodies.  This was shown to be safe and well tolerated in healthy adults. More recently, NIAID supported a Phase I clinical trial of a combination of two monoclonal antibodies, REGN3048 and REGN 3051, and demonstrated this combination was also safe and well tolerated.  Planning for follow on Phase 2/3 efficacy studies using SAB-301 is currently ongoing with partners where MERS is endemic, including the Kingdom of Saudi Arabia.

NIH clinical trial of investigational vaccine for COVID-19 begins

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins

COVID-19 Information Center https://www.novartis.com/coronavirus

Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness

Novartis announces plan to initiate clinical study of Jakavi® in severe COVID-19 patients and establish international compassionate use program - Novartis to establish compassionate use program for COVID-19 patient access and undertake steps to ensure uninterrupted supply of Jakavi for currently licensed indications. (Jakavi/Jakafi is marketed by Novartis outside the United States. In the United States, the product is marketed by Incyte, Inc.)

The multiple sclerosis drug Gilenya and fever drug Ilaris are also being studied for their effect on complications related to COVID-19.

Novartis donates 20,000 doses of hydroxychloroquine for COVID-19 PEP clinical trial. For more information:

https://www.us.sandoz.com/news/media-releases/novartis-donates-20000-doses-hydroxychloroquine-covid-19-pep-clinical-trial

https://newsroom.uw.edu/news/does-antimalarial-drug-prevent-covid-19-study-seeks-answers

https://depts.washington.edu/covid19pep/

Novartis donation: Consignment of 30 million hydroxychloroquine tablets ships to US Department of Health and Human Services

https://www.sandoz.com/news/media-releases/novartis-donation-consignment-30-million-hydroxychloroquine-tablets-ships-us

Available Therapies via Single-Patient EA

Novartis considers granting managed access to investigational or pre-approval products via single patient access provided the Managed Access criteria are fulfilled.

Novavax Awarded Funding from CEPI for COVID-19 Vaccine Development - Novavax has produced and is currently assessing multiple recombinant nanoparticle vaccine candidates in animal models prior to advancing to clinical trials. Initiation of Phase1 clinical testing is expected in late spring of 2020. Novavax’ COVID-19 vaccine candidates were created with its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. Novavax recently entered into an agreement with Emergent BioSolutions, Inc. (Emergent) to provide contract development and manufacturing services, supplying Novavax with vaccine product for preclinical testing and for use in its Phase 1 clinical trial. 

Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine® in Patients with COVID-19 Associated Respiratory Illness. The study at University Hospital Ghent in Belgium will evaluate the effect of Leukine on lung function and patient outcomes. For the treatment of COVID-19 associated acute hypoxic respiratory failure and ARDS, Leukine will be used in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator.

Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine - Companies will jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection Collaboration aims to accelerate global development of BNT162, leveraging expertise and resources of both companies Builds on 2018 agreement to jointly develop an mRNA-based influenza vaccine. See also: Racing to Develop a Potential COVID-19 Vaccine with Unprecedented Partnership 

Pfizer Shares Safety Data on Azithromycin-Hydroxychloroquine Combination - Recently, a group of French researchers disclosed results of an independent study in France exploring the use of hydroxychloroquine in 20 patients for the potential treatment of COVID-19 diseasei . Among those 20 patients, six also received Pfizer’s product, azithromycin (Zithromax®). In that study, the proportion of patients with virologic cure after 6 days (as indicated by negative PCR tests) was higher in the 20 patients who received hydroxychloroquine as compared to the 16 controls. The highest rate of cure was seen in those that also received azithromycin—all six of those patients achieved virologic cure. In light of these preliminary findings, and as Pfizer interprets the data in the context of previous research into other infectious diseases, the company would like to share additional information that may facilitate the further exploration of this combination.

Pfizer Outlines Five-Point Plan to Battle COVID-19

Single-Patient EA Policies/Criteria

www.pfizercares.com

PharmaMar has submitted a Phase II clinical trial of Aplidin® (plitidepsin) for the treatment of COVID-19 to the Spanish Medicines Agency - The objective of the trial is to evaluate the efficacy and safety of plitidepsin as a treatment for COVID-19 (SARS-CoV-2) in hospitalized patients. Plitidepsin, which is approved in Australia for the treatment of multiple myeloma, has also demonstrated efficacy as an antiviral in in vitro studies conducted at the Spanish CSIC's National Biotechnology Center against the human coronavirus HCoV-229E, and previously against other types of virus at the Carlos III Health Institute.

PharmaMar reports positive results for Aplidin® against coronavirus HCoV-229E

Available Therapies via Single-Patient EA

There is an Expanded Access Program (EAP) for lurbinectedin to treat patients in the United States (U.S.) with relapsed Small Cell Lung Cancer (SCLC), who are unable to enter clinical trials and there are no appropriate alternative treatments.

Healthcare professionals wishing to request access to lurbinectedin under the EAP or who would like to find out more should do so by emailing Lurbinectedin.EAP@Bionical-Emas.com.

See also A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA

Pluristem Expands its Compassionate Use Program: Treated First COVID-19 Patient in U.S. Under FDA Single Patient Expanded Access Program - The patient was treated with PLX cell therapy at Holy Name Medical Center in New Jersey, an acute care facility that is currently an active site for Pluristem’s Phase III critical limb ischemia (CLI) study. Prior to treatment with PLX, the patient was critically ill with respiratory failure due to acute respiratory distress syndrome (ARDS) and was under mechanical ventilation in an intensive care unit (ICU) for three weeks.

• All treated patients were in Intensive Care Units (ICU) on ventilators and suffered from Acute Respiratory Distress Syndrome (ARDS)
• 100% survival rate for all seven patients
• 6 patients completed 1 week follow up; the seventh patient was treated on April 5 2020
• 4 of the 6 (66%) patients that completed 1 week follow up demonstrated improvement in respiratory parameters
• 3 of the 6 (50%) patients that completed 1 week follow up are in advanced stages of weaning from ventilators
• Pluristem plans to apply for initiation of multinational clinical trial for treatment of complications associated with COVID-19

For more information: https://www.pluristem.com/wp-content/uploads/2020/04/PSTI-COVID-19-First-Patient-in-US-FINAL-FOR-RE… and https://www.pluristem.com/wp-content/uploads/2020/04/PSTI-PR-Follow-up-on-Covid-19-treatments-FINAL-FOR-RELEASE.pdf 

See also: Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization

Pulmotect’s PUL-042 Shows Promising Pre-Clinical Efficacy in Preventing Lethal Coronavirus Infection - Experiments conducted at the University of Texas Medical Branch at Galveston (UTMB) show pre-clinical efficacy in mice protecting against both the lethal SARS-associated coronavirus (SARS-CoV) and the MERS-associated coronavirus (MERS-CoV). In mouse models, a single inhaled dose of PUL-042 was shown to protect the host from SARS-CoV, and the drug significantly reduced the amount of virus in the lungs after infection with either the SARS-CoV or MERS-CoV viruses.

The Use PUL-042 Inhalation Solution to Prevent COVID-19 in Adults Exposed to SARS-CoV-2

The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

Opaganib - COVID-19 - RedHill is working to develop opaganib (Yeliva, ACB294640) for COVID-19. Opaganib has a unique mechanism of action, with both anti-inflammatory and anti-viral activity, targeting a critical host factor, which minimizes the potential development of resistance due to viral mutations. RedHill is advancing a development program evaluating opaganib as a therapy for patients with severe COVID-19 infection, which includes two ongoing clinical studies:

• A global randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study (NCT04467840)
   
• A U.S. randomized, double-blind, placebo-controlled Phase 2 study (NCT04414618)

RedHill Biopharma’s Phase 2/3 COVID-19 Study Approved in Mexico - The global Phase 2/3 study with opaganib is set to enroll up to 270 patients with severe COVID-19 across 40 clinical site. The global Phase 2/3 study has been approved in Mexico, the UK and Russia and is also under review in Italy, Brazil and additional countries. Enrollment in a parallel U.S. Phase 2 study in patients with severe COVID-19 is approximately 50% complete and is expected to be completed this month. Potential submission of global emergency use applications planned as early as Q4/2020.

RedHill Biopharma Announces Approval of Compassionate Use of Opaganib for COVID-19 in Italy  

RedHill Announces First COVID-19 Patient Treated with Opaganib in Israel Under Compassionate Use 

Available Therapies via Single-Patient EA

COVID-19 - Yeliva (opaganib)

Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)

RECOVERY COVID-19 phase 3 trial to evaluate REGENERON'S REGN-COV2 investigational antibody cocktail in the UK - Regeneron and the University of Oxford announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY), one of the world's largest randomized clinical trials of potential COVID-19 treatments, will evaluate Regeneron's investigational anti-viral antibody cocktail, REGN-COV2. The Phase 3 open-label trial in patients hospitalized with COVID-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.

REGENERON Announces Start of REGN-COV2 Phase 3 Covid-19 Prevention Trial in Collaboration With National Institute Of Allergy And Infectious Diseases (NIAID) - A Phase 3 trial will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate), and is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized (or "ambulatory") patients with COVID-19.

Developing REGN-COV2 (see: https://www.regeneron.com/covid19) - REGN-COV2 is a novel anti-viral antibody cocktail that is being studied for its potential both to treat people with COVID-19 and to prevent SARS-CoV-2 infection. REGN-COV2 is currently being studied in four late-stage clinical trials: two Phase 2/3 trials for the treatment of hospitalized and non-hospitalized (“ambulatory”) COVID-19 patients, the open-label, Phase 3 RECOVERY trial of hospitalized COVID-19 patients in the UK, and a Phase 3 trial for the prevention of COVID-19 in uninfected people who are at high-risk of exposure to a COVID-19 patient (such as the patient’s housemate). The Phase 3 prevention trial is being jointly conducted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The safety of REGN-COV2 is also being evaluated in a Phase 1 healthy volunteer study.

If you are interested in participating in one of Regeneron's COVID-19 clinical trials, please complete a brief online screener at ClinLife.com/COVID to see if you qualify.

Based on recent clinical data from studies in China with another IL-6 inhibitor, we believe there is a potential role for Kevzara^® (sarilumab) in the treatment of severe and critical hospitalized patients with COVID-19. Together with our collaborators at Sanofi, we are conducting controlled clinical studies to evaluate Kevzara in this setting. The use of Kevzara to treat people with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.

For more info, go to:  Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19

See also: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=sarilumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

See also Sanofi in company directory.

Single-Patient EA Policies/Criteria

Renibus Therapeutics will evaluate and respond to a request that it receives on a case-by-case basis.

Available Therapies via Single-Patient EA

RBT-9 for the treatment of COVID-19 at the early stage (Stage I) of infection in patients who are at high risk for disease progression.

Ridgeback Biotherapeutics Announces MHRA Clearance to Begin Human Testing of EIDD-2801 in the UK for COVID-19 and the Start of Phase 1 - This action by the MHRA allowed Ridgeback to commence Phase 1 in the UK on Friday April 10^th. EIDD-2801 is a direct acting anti-viral nucleoside analogue.  Essentially, EIDD-2801 tricks RNA viruses into including the wrong building blocks as it tries to reproduce itself.  This leads to dramatically reduced levels of virus in animals infected with a wide variety of RNA viruses when treated with EIDD-2801.  EIDD-2801 has been shown to treat MERS and SARS (two severe coronavirus infections) in animals when given after an infection has been established.  When given prophylactically EIDD-2801 is able to prevent significant manifestations of disease in animals challenged with MERS and SARS.    

FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19 - The U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application by Drug Innovation Ventures at Emory (DRIVE), LLC, wholly owned by Emory University, for an orally available antiviral compound, EIDD-2801, exclusively licensed to Ridgeback Biotherapeutics.  This action by the FDA allows Ridgeback to initiate human clinical testing of EIDD-2801 in the United States. EIDD-2801 prevents the replication of SARS-CoV-2, the virus that causes COVID-19, and has shown potent activity against SARS-CoV and MERS-CoV in animal models of infection. In addition to coronaviruses, EIDD-2801 has broad spectrum activity against a number of diseases of public health concern, including influenza, chikungunya, Ebola, and equine encephalitis (VEE and EEE). The antiviral is orally available and, in addition to COVID-19, is being developed for the treatment of seasonal and pandemic influenza under a contract awarded to Emory Institute for Drug Development by the National Institute of Allergy and Infectious Diseases (NIAID) and for Venezuelan and Eastern equine encephalitis virus (VEEV and EEEV) by the Defense Threat Reduction Agency (DTRA). 

Disease/Category-Specific EA Policies/Criteria

mAb114 is currently under study in the Democratic Republic of the Congo through an Expanded Access Protocol administered as part of the Monitored Emergency Use of Unregistered and Investigational Interventions for Ebola virus disease (MEURI).

Frequently requested information about Roche medicines and COVID-19: https://medinfo.roche.com/

Includes fact sheets on:

Actemra/RoActemra (tocilizumab) - Download

Ocrevus (ocrelizumab) - Download

Tamiflu (oseltamivir) - Download

Roche statement on coronavirus (Update 19.03.2020)

Other companies mentioned/involved:  Chugai Pharmaceuticals; Zhejiang Hisun Pharmaceuticals

Multiple ongoing clinical trials involving Actemra (tocilizumab). For a list, go to: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=tocilizumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

Single-Patient EA Policies/Criteria

https://www.roche.com/dam/jcr:035f3847-505e-484c-b5f6-f666790791de/24_Position%20on%20Pre%20Approval%20Access%20on%20Investigational%20Medicinal%20Products_reviewed_March%202019.pdf

Roivant Announces Development of Anti-GM-CSF Monoclonal Antibody to Prevent and Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19

• Gimsilumab is a monoclonal antibody that targets GM-CSF, a pro-inflammatory cytokine found to be up-regulated in COVID-19 patients
• Emerging clinical evidence in COVID-19 patients suggests that GM-CSF contributes to immunopathology caused by SARS CoV-2 in patients with or at risk of developing ARDS
• ARDS is a serious complication of COVID-19 which necessitates hospitalization and mechanical ventilation or other life support measures
• A Phase 1 study of gimsilumab conducted by Roivant completed dosing last month following extensive non-clinical research; gimsilumab treatment has been associated with a favorable safety and tolerability profile to date

First patient outside U.S. treated in global Kevzara® (sarilumab) clinical trial program for patients with severe COVID-19

• Phase 2/3 trial initiated in Italy, Spain, Germany, France, Canada and Russia and is enrolling patients immediately
• Kevzara inhibits IL-6, which may play a role in driving the inflammatory immune response that causes acute respiratory distress syndrome observed in patients with severe COVID-19 infection
• Sanofi is leading trials outside the U.S., while Regeneron is leading U.S. trials

For more info, go to:  Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19

See also: https://clinicaltrials.gov/ct2/results?cond=COVID+OR+SARS+OR+MERS+OR+CORONAVIRUS&term=sarilumab&strd_s=01%2F01%2F2020&strd_e=&cntry=&state=&city=&dist=&Search=Search&recrs=a&recrs=b&recrs=c&recrs=d&recrs=f&recrs=k

See also Regeneron in the company directory

Sanofi and Translate Bio collaborate to develop novel mRNA vaccine candidate against COVID-19

On the 18th March Synairgen announced that it has received expedited approvals from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) to conduct a trial of SNG001 in COVID-19 patients. Synairgen is developing a formulation of IFN-beta, called SNG001, for direct delivery to the lungs via nebulisation, to treat and/or prevent LRT illness caused by respiratory viruses. Synairgen’s Phase II trial in COVID-19 patients, called SG016 (EudraCT: 2020-001023-14), is a double-blind, placebo-controlled trial. Initially, the pilot phase of the study involving 100 COVID-19 patients, is taking place across a number of NHS trusts in the United Kingdom.

https://www.synairgen.com/covid-19/

Commencement of dosing in COVID-19 trial

Synairgen to start trial of SNG001 in COVID-19 imminently

Disease/Category-Specific EA Policies/Criteria

On the 18^th March Synairgen announced its plans to initiate a pilot clinical trial of SNG001 in COVID-19 patients. The trial will provide data on the efficacy of inhaled interferon beta in the treatment of ambulatory and hospitalised patients infected with SARS-CoV-2. Since the announcement, we have received a number of requests for SNG001 supplies to treat individuals outside the trial. As SNG001 is an experimental drug, untested as to safety and efficacy in this patient group, we regret that we are unable to fulfil any such request at this time. Synairgen’s team is working very hard to establish these measures in a well-controlled environment as quickly as possible. https://www.synairgen.com/

Takeda Initiates Development of a Plasma-Derived Therapy for COVID-19 - Takeda is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals with COVID-19. Hyperimmune globulins are plasma derived-therapies that have previously been shown to be effective in the treatment of severe acute viral respiratory infections and may be a treatment option for COVID-19. 

This research requires access to source plasma from people who have successfully recovered from COVID-19 or who have been vaccinated, once a vaccine is developed. These convalescent donors have developed antibodies to the virus that could potentially mitigate severity of illness in COVID-19 patients and possibly prevent it. BioLife Plasma Services, part of Takeda, has implemented a protocol for collecting plasma from healthy individuals who have recovered from COVID-19 to enable development of a potential therapy for COVID-19, made from human plasma. For more information, go to https://pub.s1.exacttarget.com/3xhgrthonqe?_ga=2.157390458.1771561704.1585853136-1731863841.1585853136

Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy - Other companies involved in this alliance include CSL Behring, Octapharma, and Biotest AG

CoVIg-19 Plasma Alliance Builds Strong Momentum Through Expanded Membership and Clinical Trial Collaboration

Disease/Category-Specific EA Policies/Criteria

EXPANDED ACCESS TO INVESTIGATIONAL DRUGS

https://www.takedaoncology.com/medicines/expanded-access-to-investigational-drugs/

Vanda Pharmaceuticals, Northwell Health Conduct ODYSSEY Trial In Patients With Severe COVID-19 Pneumonia - Enrollment of the first patient in Vanda's clinical trial, ODYSSEY VLY-686-3501 (NCT04326426), at Lenox Hill Hospital in New York City. ODYSSEY is a Phase III double-blind placebo-controlled trial investigating the efficacy and safety of tradipitant, a neurokinin-1 receptor antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 (COVID-19) infection. This novel coronavirus is associated with a lower respiratory tract inflammation that often progresses to Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation.

See also:

Vanda Pharmaceuticals Announces Initiation of "CALYPSO" to Study the Role of Genetic Variation in COVID-19 Infections in Collaboration With University of Washington Medicine

Vanda Pharmaceuticals Inc. And The University of Illinois at Chicago Announce Partnership To Identify Novel Antivirals Against COVID-19

Vaxart to Test Cross-Reactivity of its COVID-19 Oral Tablet Vaccine Against Omicron - Vaxart plans to test the cross-reactivity of its oral tablet COVID-19 vaccine candidate against the Omicron SARS-CoV-2 variant in two different studies expected to begin January 2022.

In the first study, Vaxart will test the activity of its Phase II COVID-19 oral vaccine candidate against Omicron by analyzing mucosal and serum samples from subjects to whom the vaccine was administered in Vaxart’s current COVID-19 vaccine Phase II trials. In the second study, Vaxart will conduct an animal Omicron challenge study to assess how its current Phase II COVID-19 vaccine candidate performs in comparison to an Omicron-specific vaccine candidate that Vaxart is developing. 

Vaxart deliberately engineered its COVID-19 vaccine candidate to be cross-reactive against emerging variants based on Vaxart scientists’ early recognition of the risk of emerging variants of SARS-CoV-2. In May 2021, the Company announced Phase I clinical test results demonstrating that its vaccine candidate, VXA-CoV2-1, produced broad cross-reactive T cell and IgA responses against other, non-COVID coronaviruses.

Vaxart Announces Publication of Complete Data from Preclinical COVID-19 Oral Vaccine Hamster Challenge Study in Journal of Infectious Diseases - The Journal of Infectious Diseases has published complete data from Vaxart’s preclinical Hamster Challenge Study. The study shows Vaxart’s COVID-19 oral vaccine candidate’s potential efficacy in preventing SARS-CoV-2 infection.

Vaxart Provides Update on its Oral COVID-19 Vaccine Program - Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, has produced five COVID-19 vaccine candidates for testing in its preclinical models.  Each of the COVID-19 vaccine constructs is based on a different coronavirus antigen combination, and Vaxart expects to advance the best performing vaccine to manufacturing for clinical trials.

Recruiting Clinical Trial: A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine

VBI Vaccines Announces New Preclinical Data and Initiation of VBI-2905 Clinical Study Targeting Broadened Immunity Against COVID-19 and Variants of Concern 

• New preclinical data demonstrate VBI-2905 induced robust neutralizing and antibody binding activity, as a 2-dose course and as a single booster dose, against COVID-19 and variants of concern including Beta and Delta
• Data also demonstrate trivalent VBI-2901 induced robust and consistent levels of immunity against the ancestral COVID-19 strain and a panel of variants including Beta, Delta, Kappa, and Lambda
• First subject dosed in Phase 1b portion of ongoing study to assess VBI-2905 as (i) a 1-dose booster in individuals previously immunized with an mRNA vaccine, and (ii) a primary 2-dose series in unvaccinated individuals
• Initial VBI-2905 data expected early Q1 2022, subject to speed of enrollment

VBI Vaccines Announces Initial Positive Phase 1 Data for its eVLP Vaccine Candidate Against COVID-19 - announcing positive Phase 1 data from its Phase 1/2 trial of the first of its enveloped virus-like particle (eVLP) COVID-19 vaccine candidates, VBI-2902a, in healthy adults age 18-54 years of age. The 5µg dose of VBI-2902a, which expresses an optimized SARS-CoV-2 spike antigen and is adjuvanted with aluminum phosphate, was generally well-tolerated and elicited potent immune responses significantly higher than those seen in human convalescent sera. The data establish a robust human proof-of-concept, at a low dose without the use of a next-generation adjuvant, demonstrating the potency of the eVLP particulate delivery platform against COVID-19.

VBI Vaccines Announces Initiation of Enrollment in Adaptive Phase 1/2 Study of Prophylactic COVID-19 Vaccine Candidate, VBI-2902 

Pan-Coronavirus Prophylaxis - VBI is applying its eVLP Platform in the development of a preventative pan-coronavirus vaccine candidate targeting COVID-19, severe acute respiratory syndrome (“SARS”), and Middle East respiratory syndrome (“MERS”). Enveloped virus-like particle (“eVLP”) vaccines closely mimic the structure of viruses found in nature, but without the viral genome, potentially yielding safer and more potent vaccine candidates.

VERO Biotech is increasing its commitment to support the treatment of patients afflicted with complications of COVID-19 with GENOSYL® Delivery System (DS), the first and only FDA-approved tankless system for the delivery of inhaled nitric oxide. As a result of the first patient treated at home with GENOSYL® (nitric oxide) gas for inhalation, and the ongoing COVID-19 pandemic, VERO’s three-point response includes:

• Emergency access of GENOSYL to patients with COVID-19 complications for outpatient treatment
• Access to local Atlanta-based hospitals via Emergency Treatment Protocol (ETP)
• Significant increase in local Atlanta hiring to meet production demand for GENOSYL

Nitric oxide is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, nitric oxide targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate.

For more information: https://www.vero-biotech.com/vero-biotech-commits-to-atlanta-healthcare-providers-patients-and-hiring-expansions-during-covid-19-pandemic/

FDA Grants VERO Biotech Expanded Access Emergency Use for the Treatment of Patients with COVID-19, with the GENOSYL^® DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide

Join Us In The Fight Against The Coronavirus! Vir Biotechnology is conducting a research study for COVID-19 patients who have recovered from this infection. Consider donating your blood to help researchers better understand this virus. Email at virus@vir.bio or visit https://www.vir.bio/virus/

GSK and Vir Submit Emergency Use Authorization Application to FDA for Intramuscular Administration of Sotrovimab for the Early Treatment of COVID-19 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced the submission of an application to the FDA requesting an amendment to the Emergency Use Authorization (EUA) for sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, to include intramuscular (IM) administration. The EUA for sotrovimab was granted by the FDA in May 2021 as an investigational single-dose intravenous (IV) (500 mg) infusion SARS-CoV-2 monoclonal antibody for the early treatment of COVID-19, and the companies are requesting an expansion to the EUA to also include IM administration (500 mg).

GSK and Vir Biotechnology Announce United States Government Agreement to Purchase Additional Supply of Sotrovimab, Authorized for the Early Treatment of COVID-19 - The US government will purchase an additional 600,000 doses of sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, enabling further nationwide access to sotrovimab for patients. The additional 600,000 doses will be delivered throughout the first quarter of 2022. This agreement is an amendment to earlier commitments announced with the US government in November 2021. Preclinical data generated through both pseudo-virus and live virus testing demonstrate sotrovimab retains activity against all tested SARS-CoV-2 variants of concern including Delta and Omicron.

Vir Biotechnology Announces New Research Describing the Structural Basis of SARS-CoV-2 Omicron Immune Evasion and Receptor Engagement - New preclinical research published to the preprint server bioRxiv, describing the structural basis and magnitude by which the new SARS-CoV-2 Omicron variant (B.1.1.529) evades antibody mediated immunity, as well as its enhanced ability to bind to the human ACE-2 receptor. Data define the specific Omicron mutations and their detrimental impact on the binding of the majority of tested monoclonal antibody (mAbs) therapies that target the receptor binding motif of the spike protein, a region that is more prone to mutate. Further, these data add to the growing body of evidence from recent pseudo- and live virus neutralization findings demonstrating that sotrovimab retains activity against the Omicron variant, as well as all tested variants of concern. This study was conducted in close collaboration with David Veesler, Ph.D., Associate Professor of Biochemistry, University of Washington & Investigator, Howard Hughes Medical Institute, and members of his laboratory. Sotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody developed in partnership with GlaxoSmithKline for the early treatment of COVID-19.

Vir and Alnylam Expand Collaboration to Advance Investigational RNAi Therapeutics Targeting Host Factors for the Treatment of COVID-19 - This expansion includes up to three additional targets focused on host factors for SARS-CoV-2, including ACE2 and TMPRSS2, both of which are considered critical for viral entry, with the potential for an additional host target to emerge from Vir’s functional genomics work.

GSK and Vir Biotechnology enter collaboration to find coronavirus solutions - Promising antibody candidates for SARS-CoV-2 to be accelerated into phase 2 clinical trials within the next three to five months

See more news releases here.