China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
Immunesensor Therapeutics Inc. has presented preclinical data on the stimulator of interferon genes (STING) agonist IMSA-101 which is designed to modify the tumor microenvironment in solid tumors and thus improve the trafficking and infiltration of CAR T-cell therapy into the tumor.
Autolus Therapeutics Inc. has picked up plenty of financial momentum, about $600 million worth, in its runup to a November 2024 PDUFA date for its CD19 CAR T therapy. Helping propel that momentum is Biontech SE, another CAR T therapy developer. For $50 million cash, Biontech bought the rights to use Autolus’ manufacturing and commercial infrastructure in the U.K. so it can advance its CAR T-cell BNT-211 program in the clinic.
Six weeks after the U.S. FDA issued an alert, the EMA is following suit and starting a review of the safety of six approved CAR T-cell cancer therapies, following 23 reports of patients developing secondary cancers. The EMA said such malignancies were considered “an important potential risk” at the time of approval and are included in the risk management plan. Close monitoring is in place, with companies required to conduct long-term safety and efficacy follow-up studies and to file safety update reports.
If there had been any lingering market concerns following the temporary partial clinical hold earlier this year for Arcellx Inc.’s multiple myeloma CAR T-cell therapy, CART-ddBCMA, they were likely put to rest as partner Gilead Sciences Inc.’s Kite unit expanded the scope of the firms’ late 2022 collaboration to include lymphomas. At the same time, Kite exercised an option to negotiate a license for Arcellx’s ARC-Sparx program, ACLX-001, in multiple myeloma.
In one of the larger biopharma IPOs in 2023, Cargo Therapeutics Inc. pulled in $281.3 million on Nov. 10, selling 18.75 million shares at $15 each, the low end of its price range. The market debut comes just eight months after the San Mateo, Calif.-based company raised $200 million in an oversubscribed series A round.
Nearly a year and a half after an interim analysis cast doubt on the future of Atara Biotherapeutics Inc.’s phase II study of ATA-188 in treating non-active progressive multiple sclerosis (PMS), the newly released primary analysis didn’t change much.
Cytomed Therapeutics Ltd. has signed a memorandum of understanding (MOU) with Hangzhou CNK Therapeutics Co. Ltd. allowing Cytomed to utilize CNK's Piggybac technology to permanently graft the chimeric antigen receptor (CAR) gene into its γδ T cells via a non-viral gene editing method.
Immpact Bio USA Inc. has received FDA clearance of its IND application for IMPT-514, a bispecific CD19/CD20 chimeric antigen receptor (CAR) T therapy for the treatment of active, refractory systemic lupus erythematosus (SLE).
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