Though cancer vaccines have seen limited success and late-stage clinical failures in recent years, a new report by Infiniti Research suggests they're here to stay and will begin taking off in a big way.
A couple of years ago, as Vical struggled to overcome a Phase III flop for its cancer vaccine, the biotech said it would hustle ahead with a Phase I/II study of a herpes vaccine as part of its strategy to calm jittery investors. But after the markets closed Monday, the San Diego-based company was forced to concede that their herpes strategy had misfired as well, with their vaccine failing to perform as well as a placebo.
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.
Celldex has added another round of positive data demonstrating that its brain cancer vaccine rindopepimut--more formally called Rintega and less formally "rindo"--provided a clear though relatively modest average survival benefit for recurrent glioblastoma patients in a Phase II study. And with the initial data set from Phase III looming later in the year, the biotech is carefully moving forward with its ongoing dialogue with regulators to gauge just how receptive they may be to speeding up an approval.
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.
Cancer vaccines have had a long and troubled history in the clinic, often proving safe but relatively ineffective in killing cancer cells. Now a team at Houston Methodist says that a tiny porous silicon microparticle could prove a key tool in amping up the efficacy of cancer vaccines.
An internal FDA review of Amgen's study of its cancer-killing virus talimogene laherparepvec (T-Vec), released Monday morning, raises red flags for this drug, presenting some thorny questions for the company's regulatory team to answer.
The stomach and the gut are difficult places for DNA to survive and eventually pass into the bloodstream intact. Now researchers have developed nanoparticle-coated bacteria that can someday be used to create effective DNA vaccines.
Bristol-Myers Squibb has swooped in with $60 million upfront to gain an option on Bavarian Nordic's Phase III therapeutic prostate cancer vaccine Prostvac, ready to shell out an additional $915 million-plus in milestones if it takes the next step to license and ultimately commercialize the therapy.