The COVID-19 pandemic has rapidly expanded across the whole world with many countries responding through a combination of containment and mitigation strategies to level the demand for hospital beds and protect the most vulnerable and healthcare workers from infection. The medical and scientific communities moved at unprecedented speed to develop vaccines, which have proven highly successful in protecting against severe disease and are being used world-wide to vaccinate people as fast as possible.

Immunocompromised individuals and frail elderly have an increased susceptibility to COVID-19 and risk of developing inadequate anti-SARS-COV-2 vaccine responses.

IMM-101 and COVID-19

IMM-101 is based on heat-killed, environmental, saprophytic mycobacteria (Mycobacterium obuense). In contrast to BCG (containing live-attenuated mycobacteria), which is being tested in several COVID-19 protection studies, IMM-101 can be given to immunocompromised individuals, such as cancer patients. It acts as a multi-targeting, systemic modulator of the innate and adaptive immune system and is expected to have a positive impact on immune status and be able to potentially alter viral disease trajectory and enhance the immune response to vaccines1:

  • as prophylaxis, with enhanced innate memory and increased basal systemic type 1 immunity preventing viral establishment;
  • as treatment for patients in very early stages of disease by enhancing the induction and activation of cytotoxic T cells required for killing virally infected host cells; and
  • as adjuvant for current and future COVID-19 vaccines to enhance anti-antigen immune responses and skewing them towards the desired type 1 cellular immune response, creating the crucially important memory T cells.

IMM-101 is being evaluated as an agent to protect against severe COVID-19 and other viral respiratory diseases and to improve vaccine responses in cancer patients in an investigator sponsored study.  The trial is being conducted in patients with all kinds of different cancers and treatments by the Canadian Cancer Trials Group (CCTG) at Queen’s University in Kingston, Ontario and started enrolment in early Q4-2020. Patients will be followed-up for 12 months and initial results are expected in H1-2022.

1: Kleen et al, 2020. Mitigating Coronavirus Induced Dysfunctional Immunity for At-Risk Populations in COVID-19: Trained Immunity, BCG and “New Old Friends”. Front. Immunol. 2020.