RESEARCH

Made-in-Canada CAR T Platform

Chimeric Antigen Receptor modified T cells – known as CAR T – are a powerful new tool for treating cancer.

What is CAR T Therapy?

How it Works

CAR T cell therapy starts by extracting a patient’s immune cells from their body and separating out the T cells. The T cells are genetically engineered to recognize the patient’s tumour, then returned to the body in large numbers.

Impact

The re-engineered T cells specifically attack and kill cancer cells. This approach has shown dramatic responses in some patients with advanced cancers – including pediatric and adult patients with blood cancers. Researchers are also working on innovative approaches to improve the efficacy of CAR T cell therapy in solid tumors.

Barriers to Access

Traditionally requires substantial infrastructure and expertise.
Limited number of CAR T clinical trials in Canada compared to the USA.
Variability in access across provinces due to differences in health systems and reimbursement decisions.

Cancer Program

Building Canadian-Led Immunotherapies in Cancer

Since its inception in 2015, BioCanRx has recognized the need to

Early Collaboration

After collaborating at a conference in 2016, BioCanRx network investigators in Ottawa, Vancouver and Victoria began developing the safe and efficient production of CAR T cell therapy in Canada using a point-of-care (POC)-compatible method – closed and automated CAR T cell manufacturing equipment to fully capitalize on the advantages of automation. The therapeutic product that was developed, a CD19-targeting CAR T cell therapy called CLIC-1901, is fully made in Canada.

Clinical-Grade Plasmids: Developed in the GLP lab of Dr. Robert Holt at BC Cancer’s Genome Sciences Centre, Vancouver.
GMP Lentiviral vector: Manufactured at the Biotherapeutics Manufacturing Centre at the Ottawa Hospital Research Institute
Cell product: Final GMP product manufactured at Dr. Brad Nelson’s facility, The Conconi Family Immunotherapy Lab at BC Cancer, Victoria.

CLIC-1901

The First Clinical Trial

Launched in 2019, led by:
• Principal Investigator Dr. Natasha Kekre (The Ottawa Hospital)

• Co-investigator Dr. Kevin Hay (BC Cancer in partnership with the Vancouver General Hospital)

About the trial:

• The trial, “CLIC-01” is designed for patients aged 18–75 with acute lymphoblastic leukemia and non-Hodgkin’s lymphoma that has relapsed or is not responding to standard therapies.

• In June 2022, the team published results from their first 30 patients,

• The trial has now treated approximately 100 patients, with some of the earliest participants now reaching 4 to 5 years post-treatment with no signs of disease – a remarkable outcome in very sick patients who were out of options.

“Today I turned 41, a milestone many thought I would never reach. My daughter now 17 just entered her last year of high school and I am here to see her off. 11 days from now will be 4 years post CAR T cell therapy and still no evidence of disease.”

“At my check-up 30 days after getting my T-cells back, I was almost clear of cancer. The scan showed that there was almost nothing left. I was gobsmacked.”

The CLIC Platform

Supporting Expansion to Treat a Greater Number of Patients using CAR T Cell Therapies

CLIC is currently expanding its CAR T manufacturing and clinical trial know-how to other sites in Canada in order to enable access to novel CAR T cell therapies to an increased number of patients and in more provinces while also laying down the foundation to facilitate the treatment of other cancers. Today, additional BioCanRx-supported products in the CLIC pipeline include:

CLIC-2201: a CD22-targeting CAR T undergoing clinical testing in the Phase 1 CLIC-02 trial for adult and pediatric patients with relapsed/refractory blood cancers
MesoCAR: a mesothelin-targeting CAR T for solid tumors, at the clinical trial-enabling stage

Investments

Reach

Made-in-Canada

Made-in-Canada CAR T

The CLIC Network

Plasmid manufacturing: BC Cancer Genome Sciences Centre (Vancouver)
Lentivirus manufacturing: Ottawa Hospital Research Institute Biotherapeutics Manufacturing Centre
CAR T cell manufacturing: BC Cancer Conconi Family Immunotherapy Lab (Victoria); Ottawa Hospital Research Institute Biotherapeutics Manufacturing Centre
Clinical trial sites – adult: Vancouver General Hospital; Arthur J.E. Child Comprehensive Cancer Centre (Calgary); CancerCare Manitoba (Winnipeg); The Ottawa Hospital; Princess Margaret Cancer Centre (Toronto)
Clinical trial sites – pediatric: BC Children’s Hospital (Vancouver); Alberta Children’s Hospital (Calgary); The Hospital for Sick Children (Toronto)

CLIC Platform Expansion

Research Investments

BioCanRx has invested >$10M, with an additional >$18M contributed by partners, to support research projects that continue to expand the CLIC platform through development and clinical trials of new cellular immunotherapies, increased biomanufacturing and quality control testing capacity, health system adoption and health economic assessments, and patient engagement.

Learn more about these projects and others contributing to the CLIC platform here

Targeted Investments in Next-Generation Manufacturing

Additionally, BioCanRx announced significant, targeted investments to build domestic CAR T cell manufacturing and to bolster GMP viral vector biomanufacturing. Combined, this almost $3.4M investment is focused on enabling the translation of cutting-edge biotherapeutics through expanding biomanufacturing capacity in Canada for the benefit of Canadian cancer patients.

Supporting the CLIC Platform

Innovative Clinical Trial Design and Health System Implementation Studies

BioCanRx supports CLIC patient engagement, clinical trial protocol development, and health technology assessment-related research through its CSEI program. In a BioCanRx-funded CSEI project, Dr. Kednapa Thavorn, OHRI, is studying how a domestic CAR T cell manufacturing approach could impact Canada’s publicly funded healthcare system and benefit patients. By assessing the cost efficacy of locally produced CAR T cells under the CLIC manufacturing model, Dr. Thavorn’s research supports ongoing efforts to produce personalized immunotherapies more efficiently and affordably, improving access for patients across the country.