Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure

Inclusion Criteria:

- Patient must be undergoing (or be planned to undergo) active treatment for one or more
solid malignancy, lymphoma or myeloma. active treatment includes adjuvant, neoadjuvant
and palliative intent treatment with surgery, radiation, chemotherapy, targeted
therapy or immunotherapy.

- Patients must have one or more of the following risk factors [CDC 2019] for a severe
COVID-19 infection:

- Age > 65 years old

- Hypertension (on medications);

- Type 1 or 2 Diabetes (on medication)

- A relevant chronic condition as per the investigator based on the medical record,
including:

- heart (e.g. heart failure, coronary artery disease, congenital heart
disease, cardiomyopathies, and pulmonary hypertension)

- lung (e.g. chronic obstructive pulmonary disease (COPD including emphysema
and chronic bronchitis), moderate to severe asthma, idiopathic pulmonary
fibrosis and cystic fibrosis)

- liver cirrhosis

- serious kidney disease requiring dialysis

- Receiving systemic therapy (such as cytotoxic chemotherapy, immunotherapy or
targeted agents excluding single-agent hormonal therapy)

- Body Mass Index > 40

- Living in a nursing home or long term care facility

- Patient must have a life expectancy of >6 months as assessed by the investigator

- Patient must have an ECOG Performance Status ≤ 2

- Patient has adequate organ function appropriate for the therapy the patient is planned
to receive in the opinion of the investigator and based on local assessment and
practices.

- Patient is aged ≥ 18 years

- Patient has agreed to receive pneumococcal vaccination and a seasonal influenza
vaccination in accordance with Canadian Guidelines.

- Patient is able (i.e. sufficiently fluent) and willing to complete the health utility
questionnaires in either English or French.

- Patient consent must be appropriately obtained in accordance with applicable local and
regulatory requirements. Each patient must sign a consent form prior to enrollment in
the trial to document their willingness to participate.

- Patient must be willing to provide identifying information including provincial health
insurance number to facilitate data linkage and follow up.

- Patients must be accessible for treatment and follow-up. Investigators must assure
themselves the patients enrolled on this trial will be available for complete
documentation of the treatment, adverse events, and follow-up.

- Women/men of childbearing potential must have agreed to use a highly effective
contraceptive method throughout the treatment period and for at least 3 months after
discontinuation of treatment.

Exclusion Criteria:

- Patient previously received treatment with IMM-101.

- Patient cannot have either at present or in the past, a positive test for COVID-19
infection. If a patient has been tested for COVID-19, result must be confirmed as
negative prior to enrollment.

- Patient cannot have experienced "flu-like symptoms" within 14 days prior to
enrollment, including fever, extreme fatigue, new or worsening cough, myalgias, new or
worsening dyspnea, and/or sputum production.

- Patient is receiving concomitant treatment with another investigational product or has
received such treatment within the 3 weeks prior to enrollment.

- Patient has any co-existing active infection that, in the opinion of the Investigator,
may increase the risk associated with study participation or study drug
administration, impair the ability of the subject to receive protocol therapy,
interfere with the patient's participation for the full duration of the study, or is
not in the best interest of the patient to participate.

- Patient has previously experienced an allergic reaction to any mycobacterial product,
including the BCG vaccine.

- Patients with superficial bladder cancer or any other condition currently receiving or
planned to be treated with BCG.

- Patient has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
or a known history of or is known to have a positive test for Hepatitis B (HBsAg
reactive) or Hepatitis C (HCV RNA [qualitative]).

- Patients with prior or concurrent leukemia.

- Patient has had a prior bone marrow transplant.

- Patient is pregnant or breast-feeding

- Patient has documented history of clinically severe autoimmune disease or a syndrome
that requires systemic steroids or immunosuppressive agents. This includes patient
requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone
equivalent, or depot corticosteroids in the 6 weeks before enrollment) or
immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporine, etc.) within
the 14 days prior to enrollment. Inhaled or topical steroids, and adrenal replacement
steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of
active autoimmune disease. Steroids used for premedication prior to chemotherapy or as
part of a chemotherapy regimen are allowed.