Agreement combines IASO Bio and Innovent’s CAR construct, validated in clinical trials, with Sana’s in vivo and ex vivo engineered cell therapy programs
Sana Biotechnology, Inc., a company focused on creating and delivering engineered cells as medicines, IASO Biotherapeutics (“IASO Bio”), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative medicines, and Innovent Biologics (“Innovent”, HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today jointly announced that the companies entered into an agreement pursuant to which Sana obtained from IASO Bio and Innovent non-exclusive commercial rights to a clinically validated fully-human BCMA CAR construct for use in certain in vivo gene therapy and ex vivo hypoimmune cell therapy applications. IASO Bio and Innovent will receive an upfront payment and are entitled to receive up to approximately $204 million in potential development and regulatory milestone payments across up to six products, as well as royalties.
B cell maturation antigen (BCMA) has been validated as a target for autologous CAR T therapy in relapsed/refractory multiple myeloma. The fully-human BCMA CAR construct licensed to Sana is a key part of an autologous BCMA-directed CAR T cell therapy product (Innovent: IBI326, IASO Bio: CT103A), which has shown promising clinical safety and efficacy profiles in China.
The latest data from the phase 1/2 clinical study was jointly presented by Innovent and IASO Bio at the 63rd American Society of Hematology Annual Meeting in Atlanta (Abstract # 547). IBI326 demonstrated an overall response rate of 94.9%, a minimal residual disease (MRD) negativity rate of 93.7%, and a complete response/stringent complete response (CR/sCR) rate of 58.2% in 79 RRMM patients. IBI326 also demonstrated activity in patients who had previously received CAR T therapy: among 13 such patients, the ORR was 76.9%, with 61.5% of those patients achieving very good partial response (VGPR) or better and 46.2% achieving CR/sCR (Trial Registration# NCT05066646). In February 2021, IBI326 was granted Breakthrough Therapy Designation by China’s National Medical Products Administration for the treatment of RRMM.
“Innovent is pleased that the BCMA CAR construct, co-developed and clinically validated with IASO Bio, has been recognized by Sana for further investment,” said Dr. Wei Xu, Innovent’s Vice President and R&D Head of Cell Therapy. “This license enables Sana to develop next generation products, using its proprietary technology, potentially benefiting even more relapsed/refractory multiple myeloma patients globally. We look forward to collaborating with Sana to address currently untreatable diseases.”
“We are very pleased to enter a collaboration with Sana,” said Dr. Wen (Maxwell) Wang, CEO and Chief Medical Officer of IASO Bio. “The potential of our fully-human BCMA CAR construct to treat patients with relapsed/refractory multiple myeloma has been validated in clinical trials of our BCMA autologous CAR T product candidate jointly developed by Innovent and us. We are excited to help maximize the value of CT103A by combining our CAR construct with Sana’s novel technologies and capabilities with the potential to benefit a broader patient population. We also have the potential to expand our product pipeline through a right of first negotiation to develop and commercialize Sana’s products targeting BCMA using the licensed CAR construct in the Greater China region.”
“Our commitment to address the unmet need for patients remains a priority as we move various multiple myeloma programs towards the clinic as early as next year,” said Terry Fry, M.D., Sana’s Head of T Cell Therapeutics. “We are excited to have access to a fully-human BCMA CAR construct that has been validated in clinical trials. We are optimistic this agreement will accelerate Sana’s progress with our allogeneic BCMA-directed CAR T product candidate and in vivo CAR T product candidates using our fusogen platform.”