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).