SAN DIEGO – Although "it's going to be a bit of a bumpy road" and the process "won't be as pretty as we would like it to be," clinicians have reached "a point where I think we can start to mix and match the appropriate mechanisms" of immuno-oncology drugs to fit individual patient needs, said Tim Reilly, head of early asset development in oncology for Bristol-Myers Squibb Co. (BMS), of New York.
SAN DIEGO – After reporting upbeat data from the first part of an experiment with omaveloxolone for Friedreich's ataxia (FA), Reata Pharmaceuticals Inc. has adjusted the second part for better chances of continued victory, vice president of strategy Vineet Jindal told BioWorld at the BIO International Convention.
Aveo Oncology Inc. CEO Michael Bailey told BioWorld that the positive opinion from the EMA's Committee for Medicinal Products for Human Use on approval of Fotivda (tivozanib) in advanced renal cell carcinoma is "really just the beginning" of the drug's revival. "It's a great first chapter," he said, to be followed by efforts for approval in North America and combination-drug experiments.
SAN DIEGO – When it comes to big-pharma strategic corporate venture capital (CVC), biotech entrepreneurs should cast a wide net and be unafraid of multiple funders, but beware build-to-buy arrangements if the first money isn't plenty.
SAN DIEGO – "I think we have a real shot," Axovant Sciences Ltd. CEO David Hung told a rapt audience, speaking about the phase III MINDSET trial in more than 1,300 patients with Alzheimer's disease (AD). Eagerly awaited results with the 5HT6 therapy RVT-101 (intepirdine) are due in September, and hopes are that the positive phase II data from a 684-patient experiment will be duplicated.
SAN DIEGO – How to approach angel investors and whether startups ought to consider that route at all became two topics among many during a panel at the Redefining Early Stage Investments (RESI) conference, where Bernard Rudnick told attendees that "when you look at a company and you interview the CEO and he wants to grow something of substance over a lengthy period of time, it may not be an angel deal."
Melinta Therapeutics Inc. won approval from the FDA for Baxdela (delafloxacin), in adults for the treatment of acute bacterial skin and skin structure infection (ABSSSI) caused by susceptible bacteria, and CEO Eugene Sun told BioWorld that the treatment will be made available as soon as possible.
After a spate of upbeat news, Basilea Pharmaceutica International Ltd. is not slowing down, CEO Ronald Scott said, and the company is “very active in talking to potential partners for our assets at all stages.”
Aldeyra Therapeutics Inc. CEO Todd Brady told BioWorld that the missed phase IIb primary endpoint with aldehyde trapper ADX-102 in allergic conjunctivitis (AC) was “retrofitted for another class of drugs [i.e., antihistamines], which is inactive after five to 10 minutes. We would have been viewed as having three eyes if we had picked something else as the main goal,” he said, adding that the outlook is likely “to change after the end-of-the phase II meeting” with the FDA.
