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Artiva Walks Away From Autoimmune Cell Therapy After Two Deaths, Cutting 94% of Staff
Artiva Biotherapeutics is ending work on AlloNK, a natural killer cell therapy made from donor cells, in autoimmune diseases such as rheumatoid arthritis, systemic sclerosis and myositis. Two patients died. One developed leukoencephalopathy, a potentially fatal brain reaction that an investigator tied to fludarabine, the chemotherapy used to prepare patients for treatment; the FDA then asked Artiva to pause a Phase 2a trial. The other died suddenly about two months into treatment, cause undetermined. Artiva says neither death appears related to AlloNK, but it also says responses weren't durable enough to justify more development. It will lay off 94% of staff and review its options with $319.1 million in cash.
Why it matters: Artiva is the third company to recently report deaths in an autoimmune cell therapy trial, after Novartis and Bristol Myers Squibb. It also blames fludarabine, a chemo widely used to prep patients for cell therapy, for one death, and plans to publish those findings.
BioPharma Dive →Clinical & Regulatory
Pfizer's Myeloma Drug Beat Doctors' Choice of Standard Regimens in Phase 3
Elrexfio, a bispecific antibody that links myeloma cells to T cells so they get killed, met its main goal in the 523-patient MagnetisMM-32 trial. After relapse on lenalidomide and an anti-CD38 drug, it delayed progression versus doctors' pick of three standard combos, with 68% estimated progression-free at 18 months. Serious infections were more common (27.5% vs 18.1%). Pfizer will file the data; in the U.S. it's now approved only after four prior lines of therapy.
Pfizer via National Law Review →Deals & Money
Ferring Pays Up to $1.4 Billion for a Startup That Grows Eggs Outside the Body
Swiss drugmaker Ferring is buying Gameto, whose Fertilo technology uses stem cell-derived ovarian support cells to grow eggs outside the body. Gameto says that could cut the need for hormone injections and shrink IVF and egg-freezing cycles to as little as three days, versus about two weeks of daily shots today. Fertilo is cleared in Australia and parts of Latin America and is in Phase 3 in the U.S. The upfront price wasn't disclosed.
BioPharma Dive →Anthropic Bought a Biotech With One Employee
Anthropic disclosed it acquired Mithril Medicine, an Atlas Venture-backed startup with one full-time employee, Cody Tranbarger, who used Claude, Anthropic's AI, to coordinate research across 11 outside labs. Mithril works on two rare muscular dystrophies, and Anthropic says one program showed encouraging mouse results within 18 months. Anthropic wants to learn where AI struggles in drug development; Mithril's own report logged six errors in its best recent week.
The Neuron →Policy
FDA Proposes One Approval for Many Custom Gene Edits
A new FDA draft guidance would let a sponsor cover multiple variants of an individualized gene editing therapy, such as versions aimed at different mutations in the same gene, in one biologics license application. Today each variant needs its own application and studies, which a top FDA gene therapy official called infeasible. A new variant that stays within preset limits, the individualized feature space, and is expected to be safe and active would count as a manufacturing change, not a new product.
RAPS →Judge Lets Lilly Keep Running Ads That Say Zepbound Beats Wegovy
U.S. District Judge Zahid Quraishi denied Novo Nordisk's request for a preliminary injunction, an early court order, to stop Lilly's ads calling Zepbound the stronger obesity drug. Novo argued the ads leaned on old trials against lower Wegovy doses. The judge found Novo hadn't shown meaningful harm, since Wegovy prescriptions held steady while the ads ran. Novo notes the case itself isn't decided.
BioPharma Dive →