On January 10, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), 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, reported 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 (Press release, Sana Biotechnology, JAN 10, 2022, View Source [SID1234598496]). 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.
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B cell maturation antigen (BCMA) has been validated as a target for autologous CAR T therapy in relapsed and/or refractory multiple myeloma (RRMM). The BCMA CAR licensed from IASO Bio and Innovent to Sana is a key part of an autologous BCMA-directed CAR T cell therapy product (IASO Bio: CT103A, Innovent: IBI326) that has shown promising clinical safety and efficacy data in China.
The latest data from the phase 1/2 clinical study was jointly presented by IASO Bio and Innovent at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta (Abstract # 547). CT103A 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. CT103A 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, CT103A was granted Breakthrough Therapy Designation by China’s National Medical Products Administration for the treatment of RRMM.
"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."
"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."
"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."
About CT103A/IBI326 (BCMA CAR-T)
CT103A is an innovative therapy co-developed by IASO Bio and Innovent Biologics. Previous studies indicate subjects with relapsed/refractory multiple myeloma (RRMM) who received high-dose BCMA-targeting CAR T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR T cells will not be effective. To solve this dilemma, CT103A has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinge and transmembrane, and 4-1BB co-stimulatory and CD3ζ activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform and integrated in house manufacture process improvement, CT103A has shown promising efficacy data in China. In February 2021, CT103A was granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for the treatment of RRMM. In addition to multiple myeloma, IASO Bio is investigating CT103A in patients with autoimmune diseases.