The FDA has halted the clinical entry of Takeda and Denali Therapeutics’ Alzheimer’s disease med. Daiichi Sankyo is closing its Plexxikon R&D operation as antibody-drug conjugates become its focus. Learning from Bristol Myers Squibb’s launch pitfall, Legend Biotech and Johnson & Johnson are building in-house manufacturing capacity for their upcoming CAR-T therapy launch. And more.
The FDA has blocked Denali Therapeutics’ entry into human trials for its Alzheimer’s disease candidate DNL919. The clinical hold came just days after Takeda exercised its option to co-develop the antibody transport vehicle, which is designed to activate TREM2 to improve microglial function. Denali had planned to kick off a phase 1 trial in the first half of this year.
Daiichi Sankyo is shutting down its Plexxikon R&D operation in South San Franciso. Since an acquisition in 2011, the unit delivered two FDA-approved cancer drugs: Turalio and Zelboraf. But now, the Japanese company has shifted its focus to its antibody-drug conjugate programs. The site and its 60 employees will get the ax by the end of March.
Manufacturing bottlenecks slowed the rollout of Bristol Myers Squibb’s multiple myeloma CAR-T therapy Abecma. To prevent supply shortfalls, Legend Biotech and Johnson & Johnson have been building in-house manufacturing facilities in China, Europe and the U.S. for their FDA decision-pending rival drug, cilta-cel. The two plan to take a “sequential approach” to the initial launch, a Legend executive said.
Novartis and BeiGene plan to submit PD-1 inhibitor tislelizumab for FDA approval in previously treated non-small cell lung cancer this year, Novartis Oncology chief Susanne Schaffert, Ph.D., said. The FDA’s Richard Pazdur, M.D., recently indicated the agency will take a harder look at PD-1/L1 submissions, including those based on trials conducted outside the U.S.
South Korean conglomerate SK Group has invested $350 million in the Centers for Breakthrough Medicines and became the second-largest shareholder of the U.S. CDMO specializing in cell and gene therapy. SK’s latest move followed a 2021 acquisition of a 70% stake in French cell and gene therapy CDMO Yposkesi.
Chinese CDMO ZhenGe Biotech, which focuses on large molecules, has raised $100 million in a series C, bringing its total fundraising haul to $225 million. The money will be used to bolster R&D capabilities and build several 15,000-liter production lines.
Sana Biotechnology is gaining nonexclusive access to a BCMA CAR construct from Chinese companies IASO Biotherapeutics and partner Innovent Biologics for in vivo gene therapies and ex vivo hypoimmune cell therapies. Sana said it would pay for up to six products, with potential milestone payments reaching up to $204 million.
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