“This is a tough business. It’s never a straight line from start to success.” Those words, from Exelixis Inc. CEO Michael Morrissey, during a presentation at the J.P. Morgan Healthcare Conference (JPM), could easily sum up any aspect of the biopharma industry. But with more biopharma firms than ever having reached commercial status, along with the introduction of new therapeutic modalities into the health care market, many are finding the toughest part comes after regulatory approval, whether it’s navigating a competitive landscape, getting payers and physicians on board, or satisfying regulators’ stringent postmarketing requirements. As industry players and observers head home after a busy week in San Francisco, BioWorld offers a brief glimpse at a few firms taking on those post-approval challenges in 2024.
Insilico Medicine Inc. struck an out-licensing deal with Exelixis Inc. for its small-molecule USP1-inhibitor candidate called ISM-3091, the company said on Sept. 12, standing to gain $80 million in up-front payments.
Ajinomoto Co. Inc.'s Ajinomoto Bio-Pharma Services has announced a license agreement with Exelixis Inc. to incorporate AJICAP, Ajinomoto's proprietary site-specific bioconjugation and linker technologies, in the development of certain of Exelixis' antibody-drug conjugate (ADC) programs for cancer.
Exelixis Inc. and Sairopa BV have entered into an exclusive clinical development and option agreement for ADU-1805, a potentially best-in-class monoclonal antibody that targets SIRPα.
Black Friday is still weeks away, but Exelixis Inc. has gone shopping and inked two deals that together are potentially worth more than $1 billion, bolstering its pipeline with cancer drugs from Cybrexa Inc. and Sairopa B.V. Both deals are eye-catching, not just because of their potential value but also because of the technologies involved. Cybrexa’s drug is a peptide-drug conjugate, a class where only one drug is FDA approved and established, and Sairopa is working on an antibody targeting SIRPα, a potential next-generation immunotherapy.
Bioinvent International AB is banking an up-front payment of $25 million as part of an option and license agreement with Exelixis Inc., which aims to discover antibodies acting on new immuno-oncology targets. Further financial details were not disclosed, but the alliance entails the discovery of three novel targets and their associated antibodies, identified through Bioinvent’s F.I.R.S.T. screening platform and its n-Coder antibody library.
Janssen Pharmaceutica NV and Exelixis Inc. are among the many companies releasing new data ahead of the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which runs Feb. 11-13.
Probably no one was surprised by the FDA’s recent nod for the combination of Alameda, Calif.-based Exelixis Inc.’s tyrosine kinase inhibitor, Cabometyx (cabozantinib), which targets MET, AXL and VEGF, and PD-1 drug Opdivo (nivolumab) from Bristol Myers Squibb Co. as a first-line treatment for advanced renal cell carcinoma (RCC), but investors may feel less confident about the odds for the pairing in a competitive space.
HONG KONG – Takeda Pharmaceutical Co. Ltd. received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for an additional indication for its tyrosine kinase inhibitor, Cabometyx (cabozantinib), clearing the firm to manufacture and market 20-mg and 60-mg tablets for patients with unresectable hepatocellular carcinoma that has progressed after prior systemic therapy.