With a lot riding on an adcom later this week, Spectrum Pharmaceuticals Inc. took a hit this morning when the U.S. FDA released a briefing document that signals what could be an uphill meeting for the sponsor. At that Thursday meeting, the Oncologic Drugs Advisory Committee (ODAC) will discuss whether the risk-benefit data for Spectrum’s non-small-cell lung cancer drug, Pozenveo (poziotinib), warrants accelerated approval, especially since the confirmatory trial hasn’t started enrollment yet. Shares of Spectrum (NASDAQ-GS:SPPI) traded as low as 71 cents this morning, down 33% from yesterday’s close of $1.06. The Pozenveo discussion will lead an ODAC triple-header, with the committee also considering whether the current indications for Oncopeptides AB’s Pepaxto (melphalan flufenamide) and Secura Bio Inc.’s Copiktra (duvelisib) are appropriate, given a potential detriment in overall survival with both drugs and other safety issues.

Basilea sells dual-kinase inhibitor rights to Sillajen in $334M deal

Basilea Pharmaceutica Ltd., having advanced a first-in-class cancer drug through preclinical studies, is selling some rights and sublicensing others for the dual-kinase inhibitor to Sillajen Inc. Sillajen pledged to pay Basilea $14 million in up-front and near-term milestone payments, plus further milestones of up to $320 million. Tiered royalties on net sales are also on offer, should the program succeed. The deal, for BAL-0891, is part of a larger plan at Basilea to monetize its cancer portfolio as it builds its anti-infectives business. It's Basilea's second recent oncology asset sale after a deal with Nodus Oncology Ltd.

Renovacor grabbed by cardiomyopathy-focused Rocket in $53M all-stock deal 

Shares of Renovacor Inc. (NYSE:RCOR) were trading midday at $2.16, up 26 cents, or 13%, on word that Rocket Pharmaceuticals Inc. is acquiring the firm in an all-stock transaction valued at $53 million. Rocket said “compelling” preclinical data generated by Renovacor validates an AAV-based transgene replacement strategy for BAG-3 dilated cardiomyopathy. Shares of Rocket (NASDAQ:RCKT) were trading midday at $13.54, down 43 cents.

LPAM strategy in IBD draws more players after Entyvio success

In the wake of the May 2014 approval of Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab), an infused therapy for inflammatory bowel disease, efforts march on to come up with an even better, potentially oral drug. Of special interest is pathway involving the alpha-4 beta-7 integrin, also known as the lymphocyte Peyer patch adhesion molecule, or LPAM, exploited by Entyvio. Those working in the area include Protagonist Therapeutics Inc. and Morphic Holding AG.

Newco news: Avelos raises $8M series A funding to develop biomarker-driven oncology pipeline 

Biotech startup Avelos Therapeutics Inc. raised $8 million in series A funding that will launch the company’s biomarker-driven cancer therapy pipeline using its synthetic lethality platform. Participating in the series A funding were SV Investment, UTC Investment, Quad Investment Management, Timepolio Asset Management, Mirae Asset Venture Investment and Mirae Asset Capital. Founded in September 2021, Avelos plans on developing next-generation, targeted, biomarker-driven cancer drugs focused in the areas of cell cycle regulation, DNA damage response and undruggable cancer targets, primarily based on the concept of synthetic lethality.

Also in the news

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