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).
An updated trial protocol providing expanded bridging therapies are part of the agreement between the U.S. FDA and Arcellx Inc. that allows the lifting of the partial clinical hold on the company’s pivotal phase II study of CAR T-cell therapy CART-ddBCMA in multiple myeloma (MM).
Avencell Therapeutics Inc. has received approval from the EMA for its clinical trial application (CTA) for AVC-201 for the treatment of relapsed/refractory acute myeloid leukemia (AML) and other selected hematologic malignancies positive for CD123. A phase I study will be conducted in Germany.
Maxcyte Inc. and Vittoria Biotherapeutics Inc. have signed a strategic platform license agreement for use of Maxcyte’s Flow Electroporation technology and Expert platform by Vittoria Biotherapeutics. Under the agreement, Vittoria will obtain nonexclusive clinical and commercial rights to use Maxcyte’s Flow Electroporation technology and Expert platform, and will pay Maxcyte platform licensing fees and program-related revenue.
Poseida Therapeutics Inc. has received FDA clearance of its IND application for P-CD19CD20-ALLO1, an allogeneic dual chimeric antigen receptor (CAR) T-cell product candidate being developed for relapsed or refractory B-cell malignancies in partnership with F. Hoffmann-La Roche Ltd. The company is actively focused on opening clinical sites for a phase I study in adults with relapsed or refractory B-cell malignancies.
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