The possibility of a 2025 approval looks to be off the table for Actinium Pharmaceuticals Inc.’s Iomab-B, at least in the U.S., with the FDA now requesting a head-to-head study demonstrating overall survival before it will consider approving the radiotherapy candidate for use in patients with active relapsed or refractory acute myeloid leukemia. Given the further work required, Actinium said it will seek a partner for Iomab-B, while focusing on other programs, including its next-generation conditioning program, Iomab-ACT. The move, however, caught investors off guard, particularly given the positive readout on complete remission rate from the phase III Sierra study, with company shares (NASDAQ:ATNM) down 74% in midmorning trading.

Markets tumble amid jobs report and recession speculation

Stocks tumbled on Monday, with the Dow Jones Industrial Average falling more than 1,000 points at the open amid a disappointing jobs report released by the Labor Department on Aug. 2. Analysts noted speculation of a U.S. recession tied to labor market fears, combined with election uncertainty and the Federal Reserve’s maintenance of interest rates at a 23-year high as contributing factors.

BMS adjusts pipeline by dropping $1.3B+ Agenus deal

Bristol Myers Squibb Co. (BMS) has terminated its $1.3 billion-plus deal for Agenus Inc.’s anti-TIGIT bispecific antibody AGEN-1777. In May 2021, BMS paid Agenus a non-refundable $200 million up front in cash for the licensing, manufacturing and commercialization agreement, then a $20 million milestone payment in December 2021 and another clinical milestone payment in January 2024 for $25 million. A phase I dose-escalation BMS study of solid tumors is done and the phase II portion dose expansion combination study of the therapy with Opdivo (nivolumab) began in December 2023. Agenus said it was told by BMS on July 30 that the drug was being returned “as part of a broader strategic realignment” of its development pipeline.

US HHS scores another IRA win

The U.S. Department of Health and Human Services (HHS) is 6-1 so far in blocking court challenges to the Medicare price negotiation program mandated by the Inflation Reduction Act (IRA). The department scored its latest victory last week when a federal district judge in New Jersey tossed a complaint filed by Novo Nordisk Inc. Besides repeating his past decisions in cases that raised similar constitutional arguments, Judge Zahid Quraishi agreed with HHS that the court lacked jurisdiction over the Centers for Medicare & Medicaid Services’ selection of drugs for negotiations and that Novo Nordisk lacked standing, even though six of its drug products were bundled together so they would qualify for the first round.

Post-Sage blowup and others, ET work marches on

Sage Therapeutics Inc.’s recent phase II fizzle with SAGE-324 in essential tremor (ET) was hardly the first in the space, and the hunt goes on for a safe, effective treatment. Among those chalking failures are Jazz Pharmaceuticals plc and Neurocrine Biosciences Inc. Due to roll out phase III data in ET during the second half of this year is Praxis Precision Medicines Inc., which is developing Nav blocker ulixacaltamide, also known as PRAX-628. Endpoint and trial-size strategies have made some on Wall Street hopeful.

Mediwound takes Next step toward global commercialization

Mediwound Ltd. reported that the Next protocol for its Nexobrid enzymatic debridement agent achieved complete debridement in 94.9% of adults and all children treated and removed all eschar within 24 hours. The results put more power behind a partnership with Vericel Corp. that introduced Nexobrid into the U.S. in the fourth quarter of 2023. New collaborations in Europe, Japan and India position the “best-in-class” product to replace surgical removal as the standard of care for eschar removal in burns globally, said Joshua Jennings of TD Cowen.

Forcing tumor cells to get with the re-program

Cellular immunotherapy is the Lamine Yamal of cancer therapy. It is easy to forget how young the field is – and that as stunning as it is to watch in action already, it is still reaching its full potential. One aspect of doing so is working in a broader range of tumor types. The field made a giant step toward that goal with last week’s approval of Tecelra (afamitresgene autoleucel, Adaptimmune Therapeutics plc), the first CAR T cell to be approved for treatment of a solid tumor. Tecelra targets MAGE-A4 and was approved for the treatment of advanced synovial sarcoma.

Also in the news

4D Molecular, Adaptimmune, Algernon, Amlogenyx, Amylyx, Bayer, Bridgene, Cellectis, Galapagos, GSK, Lipella, Octapharma, Polypid, Ultragenyx, Uniqure, Vertex