SAN FRANCISCO - A restructured global immuno-oncology deal between Regeneron Pharmaceuticals Inc. and Sanofi SA means "we're now pretty much in control of our entire pipeline of oncology agents," Regeneron's founder and CEO, Len Schleifer, told attendees at the J.P. Morgan Healthcare Conference on Monday. (See BioWorld, Oct. 2, 2018.)
Genentech Inc. is partnering with Seattle-based Adaptive Biotechnologies Corp. to develop a new type of cell therapy for solid cancers targeting individual's tumor-specific proteins, or neoantigens. Under terms of the cancer immunotherapy deal, which leverages Adaptive's TruTCR screening platform, Genentech will pay Adaptive $300 million up front as well as potential development, regulatory and commercial milestones valued at more than $2 billion, plus royalties. The deal is expected to close in the first quarter.
Johnson & Johnson's Janssen Pharmaceuticals Inc. has agreed to pay Locus Biosciences Inc. $20 million up front and up to $798 million in potential milestones plus royalties for exclusive rights to develop, manufacture and commercialize CRISPR/Cas3-enhanced bacteriophage products. The preclinical programs target two key bacterial pathogens for the treatment of respiratory tract and other infections. If proven safe and effective, they could "provide a turning point in the global battle against antibiotic-resistant infections," Locus said.
Cybrexa Therapeutics, a New Haven, Conn.-based company developing a solid tumor-targeting technology to work with an already-approved PARP inhibitor, said it plans to submit an investigational new drug application for its lead candidate, CBX-11, by the fourth quarter of 2019. A phase I trial evaluating the drug is expected to begin in the first quarter of 2020. If preclinical findings hold, the approach could potentially enhance the therapeutic index of the PARP inhibitor, improve overall survival and limit the toxicities associated with combining PARP inhibitors and DNA-damaging chemotherapy.
Abbvie Inc. has agreed to pay Lupin Ltd. $30 million up front and as much as $947 million in milestones for an exclusive license to a molecule designed to inhibit a protein involved in both T-cell and B-cell lymphocyte activation across a range of blood cancers. The deal gives Abbvie access to a relatively new class of drugs capable of inhibiting mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT-1), which may improve response to immunotherapy according to early research. If successful, Mumbai-based Lupin would be entitled to receive a double-digit royalty on sales of any product from the collaboration and will retain commercial rights to the program in India.
FDA approval for Stemline Therapeutics Inc.'s Elzonris (tagraxofusp) has made it the first drug ever approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive disease of the bone marrow and blood. The green light, which covers both adult and pediatric patients ages 2 and older, arrived two months ahead of the date by which the regulator was expected to release its decision.
Comments on a proposed rule requiring drug companies to disclose pricing information in direct-to-consumer (DTC) TV ads drew both qualified support and strong opposition from predictable quarters in responses posted by the U.S. CMS on Monday. Arguments against the rule from industry and advocates for free commercial speech made clear likely lines of attack while positive feedback suggested in some cases that the rule wouldn't go far enough to clarify true out-of-pocket costs in a complex market.
Taking advantage of what Amag Pharmaceuticals Inc. President and CEO Bill Heiden called a "significant growth opportunity," the company is acquiring anticoagulant reversal agent developer Perosphere Pharmaceuticals Inc. for $50 million up front and up to $365 million in potential milestone payments. Analysts lauded the intent of the deal, praising its potential to further diversify Amag's portfolio and complement its oral iron therapy, Feraheme (ferumoxytol). But differentiating the phase II candidate, ciraparantag, from already-approved reversal agents Praxbind (idarucizumab) and Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo), will be key to the program's success, they said.
