ME Therapeutics Holdings Inc., a publicly listed biotechnology company focused on developing innovative cancer therapies in the field of immuno-oncology, today announced a significant milestone in its in vivo CAR cell therapy program. The Company’s subsidiary, ME Therapeutics Inc., has entered into a technology license agreement with the National Research Council of Canada (NRC) to secure exclusive rights to the NRC’s proprietary nanobody-based CD22 binder. The agreement, dated October 15, 2025, provides ME Therapeutics with a platform to further develop and commercialize next-generation CAR therapies targeting B-cell cancers.
The licensed technology grants ME Therapeutics exclusive commercial rights to utilize the NRC’s CD22 binder in Chimeric Antigen Receptor (CAR) therapy applications, including in vivo CAR-T and myeloid CAR (CAR-M) approaches. This license allows the Company to explore novel treatment paradigms aimed at enhancing immune cell function within the tumor microenvironment, offering hope to patients with relapsed or refractory B-cell malignancies.
“As a Canadian-owned biotechnology company, we are honoured to advance this home-grown nanobody asset as part of our next-generation in vivo CAR cell therapy program,” said Salim Dhanji, CEO of ME Therapeutics. “This milestone underscores our commitment to developing cutting-edge immuno-oncology candidates, including therapies designed to reprogram immune cells in the tumor microenvironment using advanced nanobody technology. We are excited to collaborate with partners and advance these potentially life-saving treatments for cancer patients with limited therapeutic options.”
CD22 is a key target in B-cell malignancies, particularly in patients who have relapsed following CD19 CAR-T therapy. Maintaining CD22 expression in these patients offers a strategic opportunity for CAR therapies to target residual malignant cells, potentially improving outcomes in populations with few effective treatment options.
Nanobody technology, as exemplified by the NRC’s CD22 binder, offers several advantages over traditional antibody formats. Nanobodies are smaller, highly stable, and simpler to manufacture, allowing for greater flexibility in design and application. These properties make them ideally suited for in vivo CAR-T and CAR-M approaches, enabling therapies that can be delivered directly to patients without the complexities associated with conventional ex vivo manufacturing processes. By leveraging the unique characteristics of nanobodies, ME Therapeutics aims to create CAR therapies that are more accessible, effective, and adaptable for both relapsed/refractory patients and potentially as part of first-line treatment regimens.
“This agreement represents a meaningful example of Canadian innovation being translated into real-world therapies,” said Sue Twine, Director General of the NRC’s Human Health Therapeutics Research Centre. “The NRC’s nanobody-based CD22 binder was developed through years of rigorous research, supported by the NRC’s Cell and Gene Therapy Challenge program. Licensing this technology to a Canadian company for next-generation CAR applications exemplifies how publicly funded research can drive the development of innovative, affordable treatments that have the potential to benefit patients both nationally and internationally.”
The NRC’s CD22 binder is currently being evaluated in an investigator-driven Phase 1 clinical trial (NCT06208735) as part of an autologous CAR-T therapy. The trial is designed to assess the safety and efficacy of the technology in both pediatric and adult patients with B-cell malignancies, offering early insights into the clinical potential of this nanobody-based approach.
Under the terms of the License Agreement, ME Therapeutics has obtained rights to develop and commercialize CAR therapies using the CD22 binder in multiple territories, including Australia, Brazil, Canada, China, Europe, India, Israel, Japan, New Zealand, Singapore, South Korea, and the United States. The rights granted are exclusive within the CAR therapy field for autologous CAR cell therapy products outside of Canada, and fully exclusive for all other CAR therapy applications across the licensed territories. Furthermore, the agreement permits ME Therapeutics to sublicense its rights, providing flexibility to form strategic collaborations that can accelerate development and commercialization efforts.
Financial terms of the agreement include an upfront license fee payable within twelve months of signing, along with ongoing royalties based on sales revenue from both autologous and allogeneic or in vivo CAR cell therapy products. Royalties are subject to a minimum annual amount and milestone payments are also structured based on clinical and regulatory progress. These milestone payments are tied to key development stages, including initiation of Phase 1 and Phase 2 trials, commencement of registration trials, and six months following first regulatory approval of a product within the licensed territories. The License is set to remain in effect until the expiry of the last claim of the last patent associated with the technology.
“This licensing agreement strengthens ME Therapeutics’ position as a leader in next-generation in vivo CAR cell therapy,” added Mr. Dhanji. “The NRC’s CD22 nanobody is a powerful asset that complements our ongoing pipeline efforts, supporting the development of therapies capable of addressing unmet needs in oncology. By harnessing this technology, we aim to deliver innovative CAR-T and CAR-M therapies that have the potential to improve patient outcomes and transform the landscape of cancer treatment.”
The acquisition of the CD22 nanobody license reflects a broader trend in immuno-oncology toward modular, highly adaptable CAR platforms that can be engineered to target specific tumor antigens while minimizing off-target effects. By combining the unique properties of nanobodies with in vivo CAR strategies, ME Therapeutics is poised to develop therapies that are not only clinically effective but also scalable and accessible, potentially lowering the barriers to treatment for patients worldwide.
ME Therapeutics’ collaboration with the NRC highlights the value of translating publicly funded research into commercially viable therapies. By bridging the gap between innovative academic research and industry development, the Company is advancing its mission to bring next-generation immuno-oncology therapies to patients in need, reinforcing Canada’s position as a hub for cutting-edge biotechnology innovation.
With the licensing of the NRC CD22 nanobody, ME Therapeutics continues to expand its pipeline of CAR-based therapies, demonstrating its commitment to leveraging novel science to develop transformative treatments. This milestone positions the Company for future growth and collaboration in the global CAR therapy landscape, bringing hope to patients with challenging B-cell malignancies and advancing the field of precision immuno-oncology.
