Rare Daily Staff
Sana Biotechnology signed a non-exclusive license agreement with Chinese biotechs IASO Biotherapeutics and Innovent Biologics for commercial rights to a clinically validated fully human BCMA CAR construct CT103A 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 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 that has shown promising clinical safety and efficacy data in China.
CT103A is being 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 as 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.
The latest data from the phase 1/2 clinical study of CT103A, jointly presented by IASO Bio and Innovent at the 63rd American Society of Hematology Annual Meeting in Atlanta, demonstrated an overall response rate of 94.9 percent, a minimal residual disease (MRD) negativity rate of 93.7 percent, and a complete response/stringent complete response (CR/sCR) rate of 58.2 percent 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 percent, with 61.5 percent of those patients achieving very good partial response (VGPR) or better and 46.2 percent achieving CR/sCR. In February 2021, CT103A was granted Breakthrough Therapy designation by China’s National Medical Products Administration for the treatment of RRMM.
Sana is focused on creating and delivering engineered cells as medicines for patients that can repair and control genes, replace missing or damaged cells, and making its therapies broadly available to patients.
“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, head of T Cell Therapeutics at Sana. “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.”
Photo: Terry Fry, head of T Cell Therapeutics at Sana Biotechnology