Seattle Genetics Inc. shared progress on two key development programs Tuesday, dosing the first patient in a registrational phase II study of enfortumab vedotin (EV) for locally advanced or metastatic urothelial cancer and initiating a new phase II study of tisotumab vedotin (TV) in patients with advanced cervical cancer.
Harmony Biosciences LLC, a new company created by entrepreneur Jeff Aronin's Paragon Biosciences, has acquired exclusive U.S. rights to a drug already EMA-approved for adults with narcolepsy, from France's Bioprojet Societe Civile de Recherche. Harmony is fueling the deal with a $270 million equity financing that it said will also help accelerate its ability to advance other treatments for central nervous system disorders. Meanwhile, it intends to establish an expanded access program for the medicine, called pitolisant, in the U.S. in early 2018 and to submit an FDA new drug application for it during the first half of 2018.
Windmil Therapeutics Inc., a startup harnessing the power of bone marrow-infiltrating lymphocytes, or MILs, for cancer immunotherapy, has nearly completed enrollment of patients in a phase IIb trial testing its approach in high-risk myeloma.
Amgen Inc. agreed to pay $40 million up front and as much as $455 million in milestones to access as many as four T-cell engaging bispecific antibodies developed by Cytomx Therapeutics Inc. Built with Cytomx’s Probody technology, each carries the potential to localize cytotoxic activity within the tumor microenvironment, limiting off-target effects. The agreement, which starts with a preclinical bispecific targeting EGFR/CD3, also includes a $20 million equity investment.
Recursion Pharmaceuticals Inc., a biotech company leveraging artificial intelligence to discover new therapies, has raised a $60 million series B financing led by the Silicon Valley-based venture firm Data Collective.
Biohaven Pharmaceutical Holding Co. Ltd.'s trigriluzole, the most advanced candidate from its glutamate modulation platform, failed to outperform a placebo in the treatment of spinocerebellar ataxia (SCA) during a phase II/III study, the largest trial conducted in the rare disorder to date.
Positive new pivotal data has shown that ZX-008, Zogenix Inc.'s re-imagining of a key component of the ill-fated obesity drug Fen-Phen, can significantly reduce seizure frequency in children with the rare genetic epilepsy, Dravet syndrome.
PTC Therapeutics Inc.'s bid to convince members of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee that it should recommend approval of the Duchenne muscular dystrophy (DMD) drug Translarna (ataluren) failed on Thursday, with 10 out of 11 members agreeing that, although it's possible the drug may be effective, the data are inconclusive and more work needs to be done.
Preliminary data on three additional patients enrolled in a small open-label study of Immune Pharmaceuticals Inc.'s bertilimumab, an experimental treatment for the rare blistering disease bullous pemphigoid (BP), continued to suggest it may offer an effective alternative to systemic corticosteroids, a standard but imperfect therapy for the condition. Immune, which is seeking an FDA orphan designation for the candidate, expects to complete the proof-of-concept study and report final results in early 2018. Company shares (NASDAQ:IMNP) rose 16.7 percent to $1.40 by Wednesday's close.
Yet to find a partner ready to commit to carrying its herpes immunotherapy, GEN-003, through phase III, Cambridge, Mass.-based Genocea Biosciences Inc. is putting the program on hold as it refocuses its energies on a neoantigen cancer vaccine for which it expects to file an investigational new drug application by early 2018.
