Drug Development

Protocols: Infinity hunts up a buyer for its disappointing cancer drug duvelisib; Is Northwest Bio finally broke?

AbbVie’s decision to abruptly pull out of its partnership with Infinity on duvelisib largely wrecked the company’s hopes to finally make it big after repeated setbacks over the years. But Infinity CEO Adelene Perkins isn’t giving up. She tells BioWorld that the company is pushing ahead in search of an accelerated approval – the drug hit its endpoint but looked commercially feeble – while scouting for another company willing to buy it. “We have several parties who are interested [in duvelisib] and we’re in discussions,” Perkins told the news group.

Is Northwest Biotherapeutics $NWBO broke? Longtime critic Adam Feuerstein broke down the numbers, and concluded that with only $5.4 million on hand at the beginning of last month, the biotech barely had enough money to make it through July. This isn’t the first cash crunch that CEO Linda Powers has faced, though the company’s shares trade now as a battered penny stock. But the company had been able to raise cash in the past, even as short sellers hammered it for self-dealing and more. We’ll keep you posted.

Princeton, NJ-based Advaxis says that its live attenuated Listeria monocytogenes bacteria-based cancer vaccine has passed the first hurdle in a Phase II study. The first step involved tracking evidence of a response to the immunotherapy. The second hurdle in the study will involve 13 patients.

How does it feel to be the journalist who exposed key details in the Valeant Pharmaceuticals saga, whose work directly led to yesterday’s Wall Street Journal report Valeant Under Criminal Investigation? Getting a movie deal like Theranos-buster John Carreyrou? Well, not quite. Actually, not even a mention. Endpoints asked Roddy Boyd, proprietor of the donor-funded Southern Investigative Reporting Foundation, if he felt vindicated by yesterday’s report. “The question of vindication is complex,” Boyd remarked. “On the one hand it is certainly evidence that independent newsrooms can compete with MSM–and outcompete them–given half a chance. It’s the “half a chance” where things are hard because you need money to do investigative reporting. I’d have done 50% more on the story if I could have afforded it.”


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RAPS Regulatory Convergence 2017