ME Therapeutics licenses NRC's CD22 nanobody asset

Executive Summary

• ME Therapeutics Holdings Inc. (via subsidiary ME Therapeutics Inc.) has entered into an exclusive technology license agreement with the National Research Council of Canada (NRC) to license a proprietary nanobody-based CD22 binder.
• The license grants exclusive commercial rights for the CD22 binder to be used in chimeric antigen receptor (CAR) therapy, specifically for in vivo CAR-T and myeloid CAR (CAR-M) approaches, across major global markets.
• The agreement includes an upfront license fee, royalty payments on sales, and significant milestone payments tied to clinical trial initiation and regulatory approval.

Key Details

• Parties: ME Therapeutics Inc. (Licensee) and the National Research Council of Canada (NRC) (Licensor).
• Asset: Proprietary nanobody-based CD22 binder, developed through NRC research and the Cell and Gene Therapy Challenge program.
• Scope of License:
  • Field of Use: Chimeric antigen receptor (CAR) therapy, including in vivo CAR-T and myeloid CAR (CAR-M) approaches.
  • Territory: Australia, Brazil, Canada, China, Europe, India, Israel, Japan, New Zealand, Singapore, South Korea, and the United States.
  • Exclusivity: Exclusive rights within the field of use for autologous CAR cell therapy products in the territory (except in Canada); exclusive in all jurisdictions for any CAR cell therapies other than autologous CAR cell therapy products.
  • Sublicensing: The company retains the right to sublicense its rights under the agreement.
• Financial Terms:
  • Upfront Fee: Payable within 12 months of entry into the license agreement.
  • Royalties: Payable to the NRC based on sales of autologous CAR cell therapy products and sales revenue from allogeneic or in-vivo CAR cell therapy products, subject to a minimum yearly royalty.
  • Milestone Payments: Payable for each product upon:
    • Initiation of dosing in Phase 1 trials.
    • Initiation of dosing in Phase 2 clinical trials.
    • Initiation of dosing in a registration trial.
    • Six months after the first regulatory approval of the first product anywhere in the territory.
• Strategic Context: The CD22 binder addresses relapsed B-cell cancers following CD19 CAR-T therapy. Nanobody technology offers advantages in stability, synthesis, and design flexibility compared to traditional antibodies.
• Current Status: The nanobody-based CD22 binder is currently being evaluated in an investigator-driven Phase 1 clinical trial (NCT06208735) assessing safety and efficacy in pediatric and adult patients.

Notable Quotes

• Salim Dhanji, CEO of ME Therapeutics: "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... 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."
• Sue Twine, Director General of NRC's Human Health Therapeutics Research Centre: "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... 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."