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.
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).
Galapagos NV is making a decisive shift away from its small-molecule roots, sealing the simultaneous acquisition of CAR T-cell therapy specialist Cellpoint BV and fully-human antibody company Aboundbio Inc. The Cellpoint deal is by far the largest, with Galapagos paying €125 million (US$132 million) cash up front, with a further €100 million to come in milestones. The price for Aboundbio of Pittsburgh, is $14 million.
Atara Biotherapeutics Inc. is keeping the faith and figuring out next steps with its next-generation, mesothelin-directed CAR T-cell therapies after Bayer AG ended their exclusive worldwide licensing agreement, signed in late 2020. The setup included funding and development of ATA-3271, an armored allogeneic T-cell immunotherapy, and an autologous version, ATA-2271, for high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer.
Inceptor Bio LLC, a company developing cell therapies for difficult-to-treat cancers, has closed a $37 million series A financing led by Kineticos Ventures, the second fund founded by Inceptor CEO Shailesh Maingi. Altogether, about 40 investors have supported the company's efforts, he told BioWorld. Proceeds from the round, which follows a $26 million seed financing in 2021, will support moving Inceptor's lead CAR T program into phase I testing, a move targeted for the second half of 2023, and continued development of rare CAR-macrophage and CAR-natural killer cell programs.
For Kevin Friedman, the secret to making newly emergent Kelonia Therapeutics Inc. a success is reducing complexity and keeping everything as simple as possible. The Boston-based company just raised $50 million in series A funding to further its development of genetic medicines encompassing a range of diseases.
“We’re still a far cry from reproducible, durable benefits” with CAR T cells targeting solid tumors, Crystal Mackall told the audience at the 2022 annual meeting of the American Association for Cancer Research (AACR). But “we’re beginning to see some signals.” Mackall is the founding director of the Stanford Center for Cancer Cell Therapy.
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