A surgical oncologist at The Ottawa Hospital will lead a $2.8 million Canada-wide clinical trial that seeks to protect cancer patients from COVID-19 by strengthening their depleted immune systems.
If it proves successful, the approach could help not only cancer patients, but anyone vulnerable to COVID-19 because of immune systems weakened by age or disease.
“We think harnessing innate immunity could be one of our best weapons for fighting COVID-19 — and could easily be adapted to tackle future pandemics,” said Dr. Rebecca Auer, director of cancer research at The Ottawa Hospital, and the study lead.
The clinical trial involves IMM-101, an immune-boosting biotherapeutic made with a heat-killed bacterium, Mycobacterium obuense, found in soil and water.
Developed as an immunotherapy cancer treatment, IMM-101 has demonstrated the ability to
activate the body’s first line of defence, including the natural killer (NK) cells responsible for guarding against viral and bacterial infections. It h
as been safely used in other clinical trials with cancer patients.
“An effective vaccine against COVID-19 could take another year or more to develop, test, and implement,” said Auer, an 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.”
The researchers hope that boosting cancer patients’ immune systems with IMM-101 will protect them from developing COVID-19 or other respiratory illnesses, such as the flu, that can force delays in their treatment.
Cancer patients are often vulnerable to infection because chemotherapy indiscriminately targets fast-dividing cells, whether cancer cells or immune cells. The cancer itself can also attack a patient’s bone marrow, where most immune cells are made.
More than 90,000 people in Ontario received chemotherapy or radiation treatments last year alone, and COVID-19 has greatly complicated their care.
The clinical trial, approved by Health Canada, is expected to launch later this summer. It will enrol 1,500 patients — including about 250 in Ottawa — at nine cancer centres across the country.
Patients in the study will be randomly assigned to two groups: One that receives regular care, and one that has IMM-101 added to it.
Those in the latter group will be given three doses of IMM-101 over the course of 45 days then carefully observed for COVID-19, other flu-like illnesses, and respiratory infections.
Researchers want to understand if patients who receive IMM-101 are less likely to develop such illnesses.
There’s considerable evidence to support the scientific theory on which the trial is built.
Immune boosters have been
successfully used for years in veterinary medicine
to prevent the transmission of respiratory viruses in cattle, horses and other animals.
clinical trials in Europe
are now testing the ability of the BCG vaccine — a tuberculosis vaccine that contains a live, weakened strain of
Mycobacterium bovis —
to prime the immune system against COVID-19. Research has shown BCG can train the immune system to better fight all kinds of respiratory infections.
“It’s like sending your innate immune system to the gym for a while,” Auer explained. “So when it comes back to attack the next pathogen, it’s much stronger and better.”
Researchers believe that an individual’s innate immune system response helps to explain why some people get severely ill with COVID-19 while others have only mild symptoms.
Innate immune cells, such as NK cells, recognize and attack a broad spectrum of infectious agents based on their general characteristics. (Our second line of defence, known as the adaptive immune system, recognizes specific features of a bacterium or virus, and those that it has previously encountered.)
But BCG and other live vaccines can’t be given to cancer patients, so Auer and her colleagues looked for an alternative and found IMM-101. Even though it’s not a live vaccine, IMM-101 creates a response because the innate immune system recognizes it as a foreign invader.
Researchers from The Ottawa Hospital worked with the Canadian Cancer Trials Group at Queen’s University to design the clinical trial.
Funding and support has also come from the Canadian Cancer Society, BioCanRx, the Ontario Institute for Cancer Research, The Ottawa Hospital Foundation, The Ottawa Hospital Academic Medical Organization, ATGen Canada/NKMax, a biotechnology company, and Immodulon Therapeutics, the manufacturer of IMM-101.
The clinical trial is expected to completed by the end of the year.
Auer warned that COVID-19 will not be the last pandemic.
“I imagine that if this trial was positive, this would be something you could have in your back pocket when the next pandemic came,” she said. “You’d be able to say, ‘We have something that works and can protect high risk people.’”
Copyright Postmedia Network Inc., 2020