Genmab A/S is paying $8 billion to acquire Merus NV, gaining rights to the latter’s phase III-stage petosemtamab, a bispecific antibody initially in development for head and neck cancer, and continuing the firm’s strategy to transition from a royalty-based operation to a fully integrated biopharma.
Investor hopes rose sharply for Merus NV’s phase III trials – data should roll out next year – with bispecific antibody petosemtamab after mid-stage results impressed Wall Street in head and neck squamous cell carcinoma. Shares of Utrecht, the Netherlands-based Merus (NASDAQ:MRUS) jumped, too, closing May 23 at $55.14, up $13.54, or 33%, on interim data as of the Feb. 27 cutoff date.
Intriguing scientific data continue to roll out in the head and neck cancer space, where the need for therapies has spurred a number of drug firms to try new approaches, which BioWorld examines in part two of a series that began in the Dec. 30 issue.
Merus NV gained accelerated U.S. FDA approval of Bizengri (zenocutuzumab) as the first and only targeted therapy indicated for NRG1-positive pancreatic adenocarcinoma and non-small-cell lung cancer patients with advanced unresectable or metastatic disease. The approval came about seven months after the FDA accepted the BLA for filing under priority review, and two months ahead of the PDUFA goal date of Feb. 4, 2025, which had been extended by three months in November as the agency reviewed CMC information submitted in response to its request.
After shares climbed 36% on May 24 following the release of an American Society of Clinical Oncology abstract detailing an impressive phase II overall response rate in first-line head and neck cancer with bispecific antibody petosemtamab in combination with pembrolizumab, Merus NV is raising $400.2 million in an upsized follow-on offering.
Merus NV added Gilead Sciences Inc. to its collaboration roster, entering a deal potentially worth more than $1.5 billion. While its previous agreements have focused primarily on bispecific antibodies, the Gilead alliance takes aim at trispecifics, antibodies capable of binding three targets at once. In other news, shares of Biomx Inc. (NYSE:PHGE) jumped 194% March 6, ending the day at 68 cents, up 45 cents, on news that it was merging with fellow phage-focused company Adaptive Phage Therapeutics Inc. and raised $50 million in a concurrent private placement.
Could Merus NV be on course to get the fourth “tumor agnostic” drug approved, a groundbreaking approach to cancer that focuses on mutations rather than location of the disease? According to a trial update revealed at the American Society of Clinical Oncology (ASCO) conference the biotech from Utrecht, the Netherlands, could join Merck & Co Inc., Bayer AG/Eli Lilly and Co. and Roche Holding AG with its early-to-mid stage candidate, zenocutuzumab.
DUBLIN – The latest update from Merus NV’s phase I/II trial of zenocutuzumab (MCLA-128) – and its early access program – in patients with solid tumors harboring an NRG1-fusion offered a slight improvement on the data disclosed in an abstract released last month, in the run-up to the 2021 American Society of Clinical Oncology meeting.
DUBLIN – Merus NV is banking $40 million up front, plus an equity investment of $20 million, under a research collaboration and license agreement with Eli Lilly and Co.’s Loxo Oncology arm to develop up to three CD3-directed bispecific T-cell engager antibodies. Each program also has up to $540 million attached in development and commercialization milestones, taking the total potential value of the deal to $1.68 billion. Merus would also receive tiered royalties on any product sales, ranging, in percentage terms, from mid-single-digits to low-double-digits.
BOSTON Researchers from Memorial Sloan-Kettering Cancer Center presented encouraging, though very early, data on Merus NV's bispecific antibody MCLA-128 for the treatment of patients with NRG-1 gene fusions at the AACR-NCI-EORTC Molecular Targets meeting on Sunday.