While the FDA deliberates whether to approve Amgen's melanoma-fighting vaccine, T-Vec, as a monotherapy, the California biotech is partnering with Merck to test T-Vec in combination with the PD-1 drug, Keytruda, in patients with head and neck cancer.
Not only is Hampton, NJ-based Celldex Therapeutics operating in the challenging cancer vaccines field, but it's working on a treatment for one of the most difficult-to-treat cancers. But with positive new Phase II survival data in hand, the company could eventually have a winner.
Riding momentum from an FDA advisory committee recommendation last month, Amgen rolled out its data from a pivotal study of its cancer vaccine talimogene laherparepvec (T-Vec) on Tuesday as it awaits the agency's final decision, expected later this year.
Australian biotech Regeneus is set to become the latest company to brave moving a personalized cancer vaccine into the clinic. The company picked up clearance from an ethics committee this week, clearing the last remaining obstacle between it and the start of an early-phase study.
Oxford-based PsiOxus closed a Series C financing round, scoring £25 million ($39 million) to advance its lead candidate, enadenotucirev, an oncolytic virus aimed at fighting colorectal tumors. The funding came from GlaxoSmithKline's VC unit and U.K. heavyweight investor Neil Woodford's new $1.2 billion fund.
Without convincing data to prove a win for NewLink Genetics' late-stage cancer vaccine, it will go full steam ahead on its Phase III trial, the company announced Monday. The IMPRESS trial for algenpantucel-L--or HyperAcute pancreas--will continue with no changes following the second planned interim analysis for the trial.
Aduro Biotech is picking up in 2015 where it left off last year, riding momentum into an upsized $119 million IPO to fund its breakthrough pancreatic cancer immunotherapy combo CRS-207 and GVAX.
Back in November, U.K. heavyweight investor Neil Woodford invested $25 million in Northwest Biotherapeutics in the hope that its brain cancer candidate would turn up good Phase III results. Now, Woodford has thrown another $40 million behind the Bethesda, MD-based biotech as it continues to work through Phase III.
In January, Germany's cost watchdog decided that Dendreon's--now Valeant's--Provenge had no added benefit for men with metastatic prostate cancer. But now, it's changing its tune.
Aduro Biotech is the latest to try its hand at an IPO, and it laid out its case for an $86 million IPO last week.