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.