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 are moving at unprecedented speed to develop a vaccine.

Immunocompromised individuals and the elderly have an increased susceptibility to COVID-19 and risk of developing inadequate anti-SARS-COV-2 vaccine responses. IMM-101 is being investigated to protect these vulnerable populations.

IMM-101 and COVID-19

IMM-101 is being investigated for the prevention of severe COVID-19 in an investigator-sponsored study. Based on the observed safety and efficacy in previous cancer studies, IMM-101 has the potential to be rapidly deployed to address the COVID-19 emergency and the challenges posed by the current lack of effective treatments and vaccines.

IMM-101 is based on heat-killed, environmental, saprophytic mycobacteria (Mycobacterium obuense). In contrast to BCG (live-attenuated mycobacteria), which is already being tested in several COVID-19 protection studies, IMM-101 can be given safely to immunocompromised individuals. It acts as a multi-targeting, systemic modulator of the innate and adaptive immune system and is expected to have a positive impact on the immune status and be able to potentially alter viral disease trajectory1:

  • 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 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 to protect against severe COVID-19 and other viral respiratory diseases in an investigator sponsored Phase III study. The trial is being conducted in 1500 cancer patients by the Canadian Cancer Trials Group (CCTG) at Queen’s University in Kingston, Ontario, started enrolment early Q4- 2020. Once recruitment is complete, patients will be followed-up for 12 months.

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.