Another made-in-Canada CAR-T trial based on Canadian manufacturing capability

By Heather Blumenthal


Over its lifetime, BioCanRx has funded important research into immunotherapy, helping to make a promising new avenue for cancer treatment a reality for Canadians whose cancer has not responded to other treatments. An equally important part of its work, however, has been developing the infrastructure needed to provide manufacturing and testing capacity here in Canada, through its support of core facilities across the country.


Today, thanks to BioCanRx’s investment, we have the capacity to manufacture CAR-T (chimeric antigen receptor) cells, one of the most promising avenues for immunotherapy, here in Canada. CAR-T therapy involves enriching a cancer patient’s own T cells with a CAR gene that contains receptors that bind to specific proteins, or antigens, found on the surface of cancer cells. This helps the patient’s own immune system better fight the cancer.


Now BioCanRx is funding the clinical trials and enabling studies for clinical trials that have been made possible by this manufacturing capability.


First, there was CLIC-01, led by the Ottawa Hospital Research Institute’s Dr. Natasha Kekre and focussing on the CD19 antigen. Now, Dr. Kevin Hay of the BC Cancer Research Institute (with additional support from the BC Cancer Foundation) is leading the development of a second clinical trial (CLIC-02) focussing on the CD22 antigen, which will be the first deliverable in the antigen-to-clinic pipeline BioCanRx has been developing.


Both these trials are targeting B-cell blood cancers and, says Dr. Hay, “are inter-related in terms of developing CAR-T therapies for patients.” They also share personnel, ensuring that each project learns from the others, and also help each other out in practical ways. This new trial also ties into another BioCanRx enabling study led by the National Research Council’s Dr. Scott McComb, who is developing CARs targeting multiple B-cell cancer antigens at the same time, one of which is the CD22 CAR that Dr. Hay is using in his research as the basis for the CLIC-02 trial.


The CLIC-01 trial is based on CD19-targeting receptors, for which there are other, commercial products available. The novelty of that first project, says Dr. Hay, was the use of a Canadian biomanufacturing facility to manufacture the CD19 CAR-T cells. His project, focussing on the CD22 target, is, he says, “coming in closer to the ground level,” as there are currently no approved CD22-based therapies commercially available, in Canada or elsewhere in the world.


“We are getting CAR-T clinical trials to Canadian patients earlier and earlier,” he says.


The work will fill an important gap in options for treating B-cell blood cancers, as not all patients respond to CD19 CAR-T therapy.


Currently, Dr. Hay is assembling the research and knowledge needed to support a clinical trial application (CTA) to Health Canada, which he expects to happen by the end of this year. With Health Canada approval, he then plans to have two phase 1 trials running simultaneously, one for leukemia and one for lymphoma. The trials will focus on determining the optimal dose for the CAR-T therapy by starting at a low level and gradually increasing it if there prove to be no toxic side effects at the lower level. He has already secured funding from the Canadian Institutes of Health Research (CIHR) for the lymphoma trial and is waiting to hear results from other funding applications for the leukemia trial, so that, with Health Canada approval in hand, he and his team will be able to get both CLIC-02 trials underway as quickly as possible.


The project, and its potential results, underscore the importance of BioCanRx’s integrated approach to advancing cancer treatment, one that brings together researchers, their research and the infrastructure they need to improve outcomes for and, ultimately, save the lives of people with cancer.



Heather Blumenthal has been writing about health and health research for more than 20 years and never loses her fascination with the advances Canadian researchers are making.