Abpro Corp. and Celltrion Healthcare Inc. entered a global partnership for ABP-102, a T-cell engager targeting HER2-positive breast, gastric and pancreatic cancers. Under the terms, Celltrion picks up worldwide rights to the preclinical-stage program, taking over development following the completion of in vitro studies. In exchange, Abpro will receive up to $1.75 billion in payments, including an equity investment, milestones and profit-sharing agreements.

Sesen, Carisma to merge in all-stock deal; phase I cell therapy in the works

Sesen Bio Inc. and privately held cell therapy specialist Carisma Therapeutics Inc. disclosed an all-stock merger plan under which Sesen stockholders are expected to own about 41.7% of the combined firm, and Carisma the remainder. At the same time, Carisma has also secured commitments from a syndicate of investors for a $30 million financing. The new company will have about $180 million in the bank, enough to last through 2024. Ahead from Carisma are additional phase I data with CT-0508, a macrophage-based candidate for advanced HER2-positive solid tumors. Shares of Sesen (NASDAQ:SESN) were trading midday at 46 cents, down 21 cents, or 31.3%.

Fennec finally finds FDA approval for Pedmark

It took resolving issues from two complete response letters (CRLs) for Fennec Pharmaceuticals Inc. to finally land U.S. FDA approval of Pedmark. The injectable formulation of sodium thiosulfate is for reducing the risk of platinum-induced ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors. Approval of the NDA arrived Sept. 20, three days before its Sept. 23 PDUFA date. The FDA issued a CRL in August 2020 and another in November 2021, both citing manufacturing deficiencies. The FDA granted the application priority review and orphan drug status in 2004. Company shares (NASDAQ:FENC) rose 24.9% to $8.18 by midday.

Merck KGaA strikes option deal for Nerviano’s brain tumor-targeting PARP drug

Merck KGaA has struck a collaboration and option-to-license deal with Nerviano Medical Sciences Srl centered around NMS-293, a next-generation PARP-1 selective inhibitor cancer drug already in early clinical development for brain tumors. Merck is making a play for the poly (ADP-ribose) polymerase (PARP) inhibitor market, first opened up in December 2014 by Astrazeneca plc, when Lynparza (olaparib) was first approved in advanced ovarian cancer, going on to become a blockbuster through a partnership with Merck & Co Inc.

Biden’s remarks regarding pandemic prompts Congress to revisit funding

U.S. President Joseph Biden’s recent statement that the COVID-19 pandemic is over may or may not reflect popular fatigue with the associated public health emergency (PHE), but the statement struck a different tone in some quarters on Capitol Hill. Sen. Richard Burr (R-N.C.) was one of several who argued that the need for the PHE had thus necessarily run its course, with Burr specifically calling into question the need for additional funding for COVID-related federal health efforts.

Also in the news

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