The agreement strengthens ME Therapeutics’ next-generation in vivo CAR cell therapy platform, expanding its pipeline targeting B-cell malignancies through innovative nanobody-based technologies.
ME Therapeutics Holdings Inc. (“ME Therapeutics” or the “Company”) (CSE: METX) (FSE: Q9T), a publicly listed biotechnology company focused on developing novel immuno-oncology therapeutics, announced that its wholly owned subsidiary, ME Therapeutics Inc., has entered into a technology license agreement dated October 15, 2025, with the National Research Council of Canada (NRC). The agreement grants ME Therapeutics exclusive commercial rights to use the NRC’s proprietary nanobody-based CD22 binder for the development of Chimeric Antigen Receptor (CAR) therapies, including both in vivo CAR-T and myeloid CAR (CAR-M) platforms.
This collaboration represents a major step forward in ME Therapeutics’ mission to pioneer next-generation immunotherapies that leverage nanobody technology to reprogram immune responses in cancer. The newly acquired nanobody asset will play a central role in the company’s expanding in vivo CAR cell therapy pipeline, which aims to overcome key limitations of conventional CAR-T therapies and extend their benefits to a broader range of cancer types.
Strengthening a Canadian Legacy in Next-Generation Immunotherapy
“As a Canadian-owned company, we are honoured to advance this home-grown nanobody asset as part of our in vivo CAR cell therapy program,” said Salim Dhanji, CEO of ME Therapeutics. “This milestone strengthens our commitment to develop innovative immuno-oncology candidates, including next-generation CAR therapies that can reprogram immune cells in the tumour microenvironment using advanced nanobody technology. We look forward to working with partners to bring these potentially life-saving treatments to cancer patients with currently limited options.”
The NRC’s nanobody-based CD22 binder represents a significant advancement in biologics engineering. Nanobodies, also known as single-domain antibodies, are derived from the unique immune systems of camelids and are prized for their small size, high stability, and exceptional binding affinity. These attributes make them well-suited for genetic engineering and integration into sophisticated CAR constructs designed for in vivo delivery or use in engineered myeloid cells.
By harnessing the NRC’s technology, ME Therapeutics gains access to a validated molecular tool that could accelerate the development of next-generation, off-the-shelf CAR therapies. This approach holds promise for addressing the persistent challenges of manufacturing complexity, relapse after treatment, and limited patient accessibility associated with first-generation CAR-T therapies.
Expanding the Therapeutic Potential of CD22-Targeted CAR Therapies
The CD22 antigen has emerged as a compelling target for immunotherapy in B-cell malignancies, particularly in patients who relapse after receiving CD19-targeted CAR-T therapies. CD22 expression often remains stable in such cancers, allowing it to serve as a viable alternative target for CAR-based approaches.
The NRC’s nanobody-based CD22 binder offers several advantages over traditional antibody-based CAR constructs. These include:
- Improved molecular stability and solubility, which enhance manufacturability and performance in complex biological environments.
- Simplified design flexibility, allowing for multivalent or bispecific CAR configurations.
- Reduced immunogenicity, due to their compact, humanized design.
According to ME Therapeutics, integrating the nanobody-based CD22 binder into in vivo CAR-T and CAR-M platforms could create a new generation of precision therapies capable of targeting cancers more effectively while minimizing adverse effects. These technologies also open the door for non-viral gene delivery systems and direct in vivo reprogramming of immune cells, eliminating the need for complex ex vivo manufacturing processes.
NRC Partnership: Translating Public Research into Clinical Innovation
The National Research Council of Canada, through its Human Health Therapeutics Research Centre, has long been a cornerstone of biomedical innovation in Canada. The development of the CD22 nanobody binder was supported through the NRC’s Cell and Gene Therapy Challenge Program, a national initiative designed to accelerate breakthroughs in regenerative and immune-based medicine.
“We are pleased to license this Canadian-made, publicly-owned nanobody-based CD22 binder to a Canadian company for use in next-generation CAR applications,” said Sue Twine, Director General of the NRC’s Human Health Therapeutics Research Centre. “This technology was developed through years of dedicated NRC research, with support from our Cell and Gene Therapy Challenge program. It is a compelling example of publicly funded research enabling innovative next generation tools that can support development of affordable, cutting-edge treatments for Canadian patients.”
The binder is currently being studied in an investigator-driven Phase 1 clinical trial (NCT06208735), which is assessing its safety and efficacy as part of an autologous CD22-directed CAR-T therapy in both pediatric and adult patients. Early findings from this ongoing study will inform the design of future in vivo applications pursued by ME Therapeutics.
Details of the Licensing Agreement
Under the terms of the License Agreement, ME Therapeutics gains exclusive rights to use and commercialize the NRC’s CD22 nanobody binder for CAR therapy applications across multiple jurisdictions, including Australia, Brazil, Canada, China, Europe, India, Israel, Japan, New Zealand, Singapore, South Korea, and the United States (collectively referred to as the “Territory”).
The agreement grants ME Therapeutics:
- Exclusive rights in the authorized field of use for autologous CAR cell therapy products in all regions of the Territory, except in Canada.
- Exclusive rights in all jurisdictions of the Territory for any CAR therapies other than autologous CAR products, including in vivo and allogeneic CAR platforms.
The company also retains the ability to sub-license its rights, allowing for potential collaborations with other biotech or pharmaceutical partners to accelerate global development and commercialization.
In exchange for the license, ME Therapeutics will pay the NRC an upfront fee within 12 months of the agreement’s execution and make royalty payments tied to sales revenue from autologous, allogeneic, or in vivo CAR therapies developed under the license. Additionally, the agreement stipulates a minimum annual royalty and milestone payments triggered upon:
- Initiation of dosing in Phase 1 trials,
- Initiation of Phase 2 clinical trials,
- Initiation of a registration (pivotal) trial, and
- Six months following the first regulatory approval of the first product within the Territory.
The license will remain in effect until the expiration of the final active patent claim related to the technology, securing ME Therapeutics’ position as a leader in nanobody-based CAR therapy innovation for years to come.
Positioning ME Therapeutics as a Leader in Nanobody-Based CAR Innovation
This licensing agreement reinforces ME Therapeutics’ strategy of integrating Canadian scientific innovation with global therapeutic ambition. The company’s expanding pipeline now includes multiple preclinical and clinical-stage assets focused on reprogramming immune cell activity within the tumor microenvironment, aiming to overcome resistance mechanisms that limit the success of existing therapies.
By acquiring exclusive access to the NRC’s CD22 nanobody binder, ME Therapeutics strengthens its foundation for developing next-generation in vivo CAR-T and CAR-M platforms—technologies that could transform how cell-based cancer therapies are delivered and scaled.
As Dhanji emphasized, “We believe nanobody-based cell therapies represent the future of immuno-oncology. By combining the scientific excellence of the NRC with our expertise in CAR design and clinical translation, ME Therapeutics is well-positioned to drive a new wave of accessible, effective, and scalable cancer treatments.”
With the global CAR-T market projected to exceed $25 billion by 2030, ME Therapeutics’ bold move to secure exclusive rights to a key nanobody-based target underscores its long-term vision: to position Canada as a global leader in cell and gene therapy innovation, while delivering transformative solutions to patients in need.
