About BioCanRx
Funded by the Government of Canada’s Strategic Science Fund, BioCanRx provides funding to translate promising biotherapeutic discoveries from the lab to the clinic, with a particular emphasis on enabling work to support clinical trial applications. Moving through our development pipeline, projects flow progressively towards the clinic. Through three distinct research funding programs in our development pipeline – Catalyst, Enabling Studies, and Clinical Trials, projects flow progressively towards the clinic.
BioCanRx bolsters these three programs through access to specialized core facilities in the network (such as infrastructure to produce biotherapeutics for use in human clinical trials) and through our Clinical, Social and Economic Impact (CSEI) research program that evaluates and best positions the technologies for future intake into the health care system.
Catalyst Program
The Catalyst Program supports short-term, early-stage projects that can advance to the next stage in the BioCanRx research pipeline or generate scientific tools and methods that can be used by other BioCanRx network researchers.
Optimization of Epitope-Flanking Regions in an Off-The Shelf Ovarian Cancer RNA Vaccine
BioCanRx Contribution: $320,000
Project Value: $2,164,352
Project Leads: Dr. Claude Perreault, Université de Montréal; Dr. Pierre Thibault, Université de Montréal
About the project: There are an estimated 30,000 new cases of ovarian cancer (OC) in North America each year. The research team and others consider that developing an off-the-shelf RNA vaccine based on OC-specific antigens represents a most promising strategy to elicit curative anti-OC immune responses. The team discovered 91 such antigens in primary human OC tumors using a disruptive proteogenomic approach. Their objective is now to design a vaccine that maximizes the immune response against OC-specific antigens. The question of immunogenicity is paramount in cancer immunotherapy, particularly given that patients’ immune functions may be compromised by age and prior chemotherapy treatments. The team demonstrated in humans that the presentation of antigens to immune cells depends on the molecular environment of the antigens (e.g., the flanking regions). Furthermore, they showed in mice that changing the composition of antigen-flanking regions in an RNA vaccine dramatically impacts the strength of the anti-tumor immune response. Their project aims to identify and optimize the most effective flanking sequences for an anti-OC RNA vaccine. Epitopea, the industry partner for this project, is prepared to launch a Phase I clinical trial upon completion of this project.
Development of Reovirus-Based, Orally Administered, Colon Cancer Vaccines
BioCanRx Contribution: $350,000
Project Value: $1,518,550
Project Lead: Dr. Tommy Alain, CHEO Research Institute, University of Ottawa
About the project: Colorectal cancer represents the second and third leading cause of death from cancer in Canadian men and women, respectively. This year 27,000 Canadians will be diagnosed with the disease and 10,000 will die from it. This project will examine the potential of oral administration of Reoviruses for colorectal cancer treatment and prevention of recurrence.
The team’s data demonstrate that orally-administered Reoviruses can restrict colon cancer progression. Importantly, they have developed a strategy to bioengineer Reovirus to display cancer antigens and thus improve its immunotherapeutic properties. The team will generate safe and cancer-specific Reoviruses that, when administered orally, will eliminate malignant polyps and act prophylactically to prevent their recurrence. The ultimate goal is to have the Reovirus-based cancer vaccine platform ready for clinical trial development, offering a unique and novel immunotherapeutic approach to patients.
Developing Reoviruses as an oral-based cancer vaccine therapeutic approach against colorectal cancer is a novel and distinct approach. Furthermore, this unique Reovirus project presents several innovative advantages as it will produce safe and stable recombinant particles that can be orally administered to limit the progression of, prevent recurrence, and provide a treatment for this often-fatal disease of colorectal cancer.
EV-STIM to Prevent Postoperative Immunosuppression and Metastases
BioCanRx Contribution: $445,000
Project Value: $945,000
Project Leads: Dr. Rebecca Auer, Ottawa Hospital Research Institute; Dr. Brian Lichty, McMaster University; Dr. Jennifer Quizi, Ottawa Hospital Research Institute
About the project: Surgical removal of tumors is the primary treatment for solid cancers, but surgery can weaken the immune system and heighten the risk of cancer recurrence or spread. This is due to cancer-killing immune cells losing their ability to function after surgery. A key contributor to their dysfunction is another population of cells, called MDSCs (myeloid-derived suppressor cells), that are known to suppress immune cells. MDSCs have been shown to increase in number and become more suppressive after surgery, and therefore the team has named them surgery-induced MDSCs (sxMDSCs).
Recent studies show that activating certain pathways in these MDSCs can weaken their ability to suppress. This finding suggests a potential for new therapies. With this project, the team will investigate the effects of activating these cellular pathways in sxMDSCs to restore the function of cancer-killing immune cells after surgery. This will be achieved by delivering targeted cell particles, called extracellular vesicles (EVs) that contain genes and proteins which will activate cellular pathways to reduce the effectiveness of these suppressive cells. With this project, the team will demonstrate if these EVs can restore the function of cancer-killing immune cells in humans and mice after surgery. Additionally, they will investigate whether these particles can reduce the recurrence and spread of cancer in mice after surgery. Lastly, the team will develop a manufacturing process for these EVs that can be scaled for future therapeutic applications.
Enabling Studies Program
The Enabling Studies Program funds work required to prepare and position biotherapeutic products and platforms for clinical testing in patients. It bridges the traditionally difficult-to-fund translational work to take a product from the laboratory to clinical testing. Data collected in these projects enables completion of a clinical trials application for Health Canada.
Development of GMP-Grade Anti-Nectin-4 Radioimmunoconjugates, and Clinical Trial Enabling Studies for Phase 1 Trial Against Nectin-4 Positive NSCLC and TNBC
BioCanRx Contribution: $730,000
Project Value: $2,587,450
Project Lead: Dr. Humphrey Fonge, Université Laval
About the project: Triple negative BC (TNBC) and non-small cell lung cancer (NSCLC) are two of the leading causes of cancer deaths indicating more effective treatments are in urgent need. Nectin-4 is a protein that is overexpressed in many cancers including in 60-70% of TNBC and 60% of NSCLC, and no radiotherapeutics targeting this antigen have been reported. We have developed novel radiolabeled antibody targeting Nectin-4 and showed it is effective against these cancers in mice. In addition, the radiolabeled antibody was synergistic with immune checkpoint blockade immunotherapy. Our goal is to produce clinical-grade drug product and conduct a phase 1 trial. The ultimate milestones are to develop “research cell bank”, “master cell bank”, clinical-grade anti-Nectin-4 antibody and radiolabeled antibody conjugates that meet regulatory guidelines. The deliverables include chemistry manufacturing control (CMC) of the drugs and a phase 1 trial package.
This “homemade” radiolabeled anti-Nectin-4 antibody with a market potential >$17B can result in unprecedented socioeconomic benefits.
Enabling a Phase I Clinical Trial of a Novel Single Domain Mesothelin-Specific Chimeric Antigen Receptor (CAR) T-Cell Therapy for Ovarian Cancer and Other Solid Tumours
BioCanRx Contribution: $605,000
Project Value: $1,689,673
Project Leads: Dr. Brad Nelson, BC Cancer; Dr. Jennifer Quizi, Ottawa Hospital Research Institute
About the project: While Chimeric Antigen Receptor (CAR) T cell therapies have been successful in treating certain blood cancers, their application to solid tumours remains challenging. To address this, in close collaboration with the National Research Council, the team has developed a novel CAR that uses an innovative “nanobody” against a protein called mesothelin (Meso), which is frequently overexpressed by ovarian, pancreatic and other solid tumours. The team’s lead MesoCAR shows unparalleled efficacy in mouse tumour models, with 100% of mice achieving complete, durable tumour regressions. In collaboration with the Canadian-Led Immunotherapies for Cancer (CLIC) consortium, they are advancing MesoCAR from mouse models to a phase I clinical trial at three Canadian centres. This project will finalize pre-clinical safety assessments of MesoCAR, initiate production of clinical-grade lentivirus and CAR-T cells, and design a clinical trial protocol. By the end of funding, the team will be ready to manufacture clinical-grade lentivirus and finalize CAR-T cell production methods to enable a Clinical Trial Application to Health Canada in 2026. This project has the ambitious goal of “breaking the solid tumour barrier” using an exceptionally promising made-in-Canada CAR-T cell product.
Enabling Cell Manufacturing and Regulatory Compliance for CLIC-02: A Phase I Clinical Trial of a Novel Made-In-Canada CD22-Specific CAR-T Cell Product
BioCanRx Contribution: $730,000
Project Value: $3,706,410
Project Leads: Dr. Kevin Hay, BC Cancer; Dr. Brad Nelson, BC Cancer
About the project: Patients with aggressive B-cell leukemias and lymphomas that are resistant to standard therapies have a dismal outcome, with survival measured in months. Chimeric antigen receptor (CAR) T cell therapy targeting CD19, a marker on these cancers, has proven highly effective for treating such patients and has recently become standard of care. Unfortunately, however, 50-60% of patients show resistance to CD19 CAR-T cell therapy. To help such patients, the team leveraged BioCanRx support to develop a new CAR-T cell product targeting a different B-cell marker called CD22. They recently opened a phase I clinical trial to evaluate this new CD22 CAR-T cell product in leukemia and lymphoma patients at seven clinical sites across Canada.
BioCanRx will now support costs assosicated with: (1) manufacturing CD22 CAR-T cells for 24 adult and pediatric leukemia and lymphoma patients; (2) performing essential regulatory procedures to meet Health Canada requirements; and (3) developing essential assays to measure CAR-T cell safety and potency. This trial offers an urgently needed new treatment option for Canadian patients while substantially increasing the size and global impact of our CAR-T cell consortium.
Hospital-Based TIL Manufacturing to Provide Standard of Care Immunotherapy for Melanoma
BioCanRx Contribution: $730,000
Project Value: $1,870,000
Project Leads: Dr. Simon Turcotte, Centre hospitalier de l’Université de Montréal; Dr. Jennifer Quizi, Ottawa Hospital Research Institute
About the project: Melanoma, a severe skin cancer, often resists current treatments. In the U.S. and parts of Europe, Tumor Infiltrating Lymphocyte (TIL) immunotherapy is reimbursed as standard care, with up to 50% of refractory melanoma patients responding and 20% achieving long-term remission.
Canada urgently needs sustainable access to TIL therapy. Commercial TIL products from the U.S. cost over half a million dollars each, making them unsustainable for Canada’s public health care system. However, European countries have shown that hospital-based point-of-care manufacturing can produce safe, effective TIL at reduced costs. This model improves access, controls expenses, creates high-quality jobs, and supports research to enhance TIL efficacy.
The teams’ project will leverage existing cellular laboratories at the Ottawa Hospital and the Centre hospitalier de l’Université de Montréal to develop an affordable, point-of-care TIL product. This will enable the conduct of a clinical study to gather data to support TIL as part of standard care and create a transferable manufacturing process for other Canadian sites.
Establishing a Canadian Platform for Cell Therapy Release Testing
BioCanRx Contribution: $730,000
Project Value: $1,665,915
Project Lead: Dr. Douglas Mahoney, University of Calgary
About the project: The research team plans to establish a Canadian quality control (QC) platform for CAR T cells and other cell-based therapies, which harness the immune system to fight cancer. These therapies require rigorous QC testing to ensure safety, efficacy, and regulatory compliance. Currently, critical tests are often outsourced internationally, leading to delays, high costs, and logistical challenges. This project will develop and implement critical QC assays in-house to support three clinical trials – GCAR1 (CAR T therapy for solid tumors), BCAR1 (BCMA-CAR T therapy for multiple myeloma), and DNT1 (allogeneic T cell therapy for AML). By building adaptable protocols for emerging therapies and collaborating with Canadian partners, they will create a harmonized, scalable QC network to ensure inter-laboratory consistency and seamless assay transfer. Aligned with BioCanRx’s mandate to advance biotherapeutics, this initiative will reduce barriers for researchers, lower costs, and accelerate the clinical translation of innovative cancer treatments. By strengthening local capacity, this project positions Canada as a leader in cell and gene therapy, delivering life-saving therapies to patients faster.
Clinical Trials Program
The Clinical Trials Program provides funds for Phase I/II clinical trials of novel cancer biotherapies that have been substantially developed in Canada.
Phase I Study of TBI-2001 for Patients with Relapsed or Refractory CD19+ B-Cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
BioCanRx Contribution: $674,295
Project Value: Partner contribution undisclosed
Project Lead: Dr. Marcus Butler, University Health Network
About the project: Chimeric antigen receptor T cell (CAR T cell) therapy is based on modifying white blood cells in the lab so that these cells can fight cancer. Infusing these CAR T cells into patients with cancer has shown great success as a therapy for some types of cancers. However in some patients, the cancer eventually returns. To improve this therapy, researchers at the Princess Margaret Cancer Centre in Toronto have discovered a new technology that can make CAR T cells better at fighting cancer. This therapy is now being evaluated in a clinical trial for Canadian patients. The results in the initial group of patients are promising.
BioCanRx funding will support treating additional groups of patients. At the end of this trial, the best dose of CAR T cells will be identified for further evaluation in the clinic, and insights will be gained into how to predict side effects and how well the therapy will work.
An Open-Label, Multicenter, First-In Human Clinical Trial of PTX-102 mRNA Vaccine In Patients with Advanced Solid Tumors
BioCanRx Contribution: $998,300
Project Value: $11,048,300
Project Lead: Dr. Amit Oza, Princess Margaret Cancer Centre
About the project: The research centers on PTX-102, an innovative mRNA vaccine designed to boost the immune system’s ability to fight various cancers, including ovarian, melanoma, and lung cancer. PTX-102 works by instructing the body to recognize and attack specific markers found on cancer cells, while sparing healthy tissues. This approach aims to generate a strong and targeted immune response, potentially reducing the tumor’s capacity to grow and spread. The primary goal of the study is to evaluate the safety of PTX-102 in a small group of patients and determine the optimal dose for use in future clinical trials. Researchers will closely monitor the patients to assess how effectively the vaccine activates the immune system and to identify any early signs of its potential to control cancer progression. This study will also explore immune response markers, providing insights into how the vaccine interacts with the body’s natural defenses. This research is closely aligned with BioCanRx’s mission to advance promising cancer immunotherapies. PTX-102 offers the potential to provide a new therapeutic option for patients who do not respond well to current treatments, addressing an important unmet need in oncology.
Clinical, Social and Economic Impact (CSEI) Program
The objective of the CSEI Program is to develop potential solutions to social, legal, ethical, economic or health-systems barriers facing BioCanRx biotherapeutic products and platforms as they progress through the translational pipeline from preclinical research to clinical trials.
Improvements In Quality of Life, Health Utility, Cost, and Return to Work for Lymphoma Patients After Chimeric Antigen Receptor T Cell therapy in a Real-World Setting
BioCanRx Contribution: $200,000
Project Value: $235,000
Project Leads: Dr. Kelvin Chan, Sunnybrook Research Institute; Dr. William Wong, University of Waterloo; Dr. Anca Prica, University Health Network; Dr. Pierre Villeneuve, The Ottawa Hospital; Dr. Amaris Balitsky, Hamilton Health Sciences; Dr. Stuart Peacock, BC Cancer
About the project: Chimeric antigen receptor (CAR)T-cells have transformed oncology treatment, offering the potential to cure certain end-stage cancers including lymphoma. While shown to be effective, the extremely high cost of CAR T-cell therapies (>$450,000 USD), together with a substantial use of health care resources, will make this therapy among the most challenging drug reimbursement problems in Canada in the 2020s. CADTH (now CDA), in their funding recommendation, called for “the collection of standardized outcomes data…to generate real-world evidence, for consideration in future reassessments”. A critical missing, part of the evidence required to formulate CAR T-cell treatment policy relates to patient perspectives. Data are missing information on: i) whether treatment improves health related quality of life (HRQOL); and ii) patient borne costs of the therapy, including lost work productivity. Our goal is to generate evidence to determine the burden of the disease related to CAR T-cell therapy by :1) Evaluating the impact of CAR T-cell therapy on HRQOL in eligible patients with lymphoma; 2) Obtaining estimates of costs associated with CAR T-cell therapy and 3) Evaluating the cost-effectiveness of CAR T-cell therapy.
Insights from this study will have direct relevance to and will enable the cost-effectiveness analyses and decision making of CAR T-Cell therapies with a Canadian context.
Understanding the Economic Value of Decentralized CAR-T Therapies for Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia
BioCanRx Contribution: $199,978
Project Value: $199,978
Project Lead: Dr. Kednapa Thavorn, Ottawa Hospital Research Institute
About the project: CAR-T cell therapy is a groundbreaking cancer treatment that has given new hope to patients with certain blood cancers, such as acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma. It offers a chance for long-term survival, especially for those who have not responded to traditional treatments. However, CAR-T therapy is difficult to produce, very expensive, and currently available only at a few specialized centers in Canada. This makes it hard for many patients to access the treatment.
The team’s study will assess the costs and benefits of producing CAR-T therapy closer to where patients receive care—an approach known as point-of-care (POC) manufacturing—compared to producing it only at specialized centers (commercial CAR-T therapy) and other treatment options. First, the team will estimate the total costs of POC-manufactured CAR-T therapy and identify key cost drivers. Next, they will use a mathematical model to compare the costs and health outcomes of different CAR-T manufacturing approaches to determine which provides the best value for patients and the healthcare system. Finally, they will conduct a budget impact analysis to estimate the financial effects of expanding POC manufacturing in Canada, helping policymakers understand its affordability and potential impact on healthcare budgets.
Labpartners: Co-Creation of Best Practice Training Resources for Preclinical Patient Engagement In Cancer-Immunotherapy Research
BioCanRx Contribution: $200,000
Project Value: $250,000
Project Lead: Dr. Manoj Lalu, Ottawa Hospital Research Institute
About the project: Preclinical patient engagement integrates patient perspectives into laboratory-based research to enhance its relevance and impact. Facilitating patient engagement at this early stage of the research process ensures patient perspectives are addressed and incorporated into research designs prior to costly clinical translation. The interdisciplinary LabPartners research group is addressing key challenges and knowledge gaps in this emerging field.
LabPartners’ goals include: a) fostering meaningful preclinical patient engagement, b) building researcher and patient partner capacity for engagement, and c) promoting best practices. To achieve these goals, the team has developed a process framework describing how preclinical patient engagement should be implemented. This proposal focuses on field testing, refining, and disseminating the LabPartners framework to ensure its utility and impact.
