World's first clinical trial of immune-boosting strategy to protect cancer patients from COVID-19

In the race to find new ways to prevent and treat COVID-19, Canadian researchers have launched an innovative clinical trial focussed on strengthening the immune system for one of the most vulnerable populations - cancer patients.

The trial involves IMM-101, a preparation of safe, heat-killed bacteria that broadly stimulates the innate, or "first-response," arm of the immune system. The researchers hope that boosting cancer patients' immune systems with IMM-101 will protect them from developing severe COVID-19 and other dangerous lung infections.

Researchers from The Ottawa Hospital came up with the idea for the trial and worked with the Canadian Cancer Trials Group (CCTG) at Queen's University to design and run it in centres across the country. Funding and in-kind support, valued at $2.8 million, is being provided by the Canadian Cancer Society, BioCanRx, the Ontario Institute for Cancer Research, The Ottawa Hospital Foundation, The Ottawa Hospital Academic Medical Organization, ATGen Canada/NKMax, and Immodulon Therapeutics, the manufacturer of IMM-101.

"An effective vaccine that provides specific protection against COVID-19 could take another year or more to develop, test, and implement," says Dr. Rebecca Auer, study lead, surgical oncologist and Director of Cancer Research at The Ottawa Hospital and associate professor at the University of Ottawa. "In the meantime, there is an urgent need to protect people with cancer from severe COVID-19 infection, and we think this immune stimulator, IMM-101, may be able to do this."

"We know the immune systems of cancer patients are compromised both by their disease and the treatments they receive placing them at much higher risk of severe complications from COVID-19," says Dr. Chris O'Callaghan, CCTG Senior Investigator, who will be overseeing this important national trial. "These patients are unable to practice social isolation due to the need to regularly attend hospital to receive critically important cancer treatment."

The trial, called CCTG IC.8, has been approved by Health Canada and is expected to open at cancer centres across Canada this summer. People who are interested in participating should speak with their cancer specialist.

Additional quotes

COVID-19 has led to a quickly changing environment. Just as many businesses and organizations have had to adapt, some cancer researchers are also pivoting their work to address the unique challenges brought on by this pandemic. Thanks to the quick-thinking and innovation of Drs. Auer and O'Callaghan and with the support of Canadian Cancer Society donors, we are now able to conduct the world's first clinical trial to prevent severe COVID-19 infections in people with cancer and help them live longer, healthier lives."

Andrea Seale, CEO, Canadian Cancer Society

"This trial could support an important change to the standard of care for cancer patients by administration of IMM-101 prior to starting cancer treatment," says Dr. John Bell, Scientific Director of BioCanRx. "Accelerating to the clinic, biotherapeutics that can enhance the quality of life of those living with cancer, is central to the BioCanRx mission."

"There is a clear and urgent medical need for safe and effective ways to prevent SARS-CoV-2 infection and severe COVID-19 disease, especially for cancer patient populations," says Dr. Thomas-Oliver Kleen, Chief Scientific Officer at Immodulon. "Immodulon is excited about this phase III trial and hopes that IMM-101 will provide increased protection against COVID-19 in these vulnerable patients."

"OICR is excited to be collaborating on such a landmark clinical trial supporting cancer patients in this unprecedented time," says Dr. Laszlo Radvanyi, President & Scientific Director of the Ontario Institute for Cancer Research. "IMM-101 may be an effective approach to protect our vulnerable patients not only against COVID-19, but also to boost their immune system to fight cancer."

"Natural killer (NK) cells are the first line of anti-viral defense and, as such, a robust innate immune system and, in particular NK cell activity, is essential for protection against viruses such as SARS-CoV-2," says Dr. Katia Betito, President of ATGen Canada/NK Max. "The possibility of boosting the immune system in high-risk patients such as those with cancer with a product like IMM-101 would be a major step in protecting this vulnerable population. We are excited to see whether our NK Vue test can provide a much-needed tool for the evaluation and follow-up of these patients."