Just days after announcing that investigators had red-flagged a high-profile Phase III study of the cancer vaccine MAGE-A3 after failing to hit two primary endpoints for non-small cell lung cancer, GlaxoSmithKline has decided to bring a last-stab effort to find a subpopulation of patients who could benefit from the therapy to a halt. GSK says it was not possible to find a genetically defined group of patients who responded.
Once a top Phase III program at the pharma giant, MAGE-A3 failed to hit a pair of primary endpoints for non-small cell lung cancer, its second failure since the melanoma flop that occurred in the first hurdle of the study reported last fall.
A new round of late-stage data on Amgen's cancer-fighting viral vaccine talimogene laherparepvec, better known as T-Vec, found that about two-thirds of the tumors injected with T-Vec shrank 50% or more. And the same effect was seen in about a third of all uninjected tumors in the skin and lymph nodes, providing an indication that the treatment is triggering the desired immune system effect.
Northwest Biotherapeutics announced that German health regulators have OK'd a special hospital exemption that allows the sale of its controversial--and unproven--dendritic vaccine for brain cancer for all glioma brain cancers.
After an interim analysis, NewLink Genetics is planning to keep on keeping on with a Phase III study of its cancer vaccine. But that news came as an apparent disappointment to investors, who hoped the drug's promise would result in an early trial termination, and the biotech's shares fell more than 12% on Friday morning.
Bethesda, MD's Northwest Biotherapeutics has watched as rivals Dendreon and ImmunoCellular have run into serious roadblocks with personalized cancer vaccines over the past year, but with a major Phase III study underway, the biotech believes it can change the narrative.
GlaxoSmithKline's MAGE-A3 cancer vaccine was viewed as a long shot by some analysts even before it missed its first co-primary endpoint last year. Yet while analysts lowered expectations in the wake of the weak data in melanoma patients, GSK is continuing to promote its prospects.
Germany's Medigene AG has nabbed a small cancer vaccine developer in a buyout which will add a team of investigators from one of the country's top research institutes. Medigene agreed to pay about 4 million euros in stock for Trianta Immunotherapies, with another 6 million euro chunk held aside for possible milestone payments.
ImmunoCellular Therapeutics put out the word Wednesday afternoon that its dendritic cell-based vaccine for brain cancer flunked the key overall survival test in Phase II, news that swiftly wiped out more than half of the small biotech's market cap as shares instantly cratered.
A few months after Jennerex and its partner Transgene reported that their oncolytic cancer vaccine Pexa-Vec flunked a Phase IIb endpoint on overall survival in liver cancer, the private South Korean CRO SillaJen has stepped in to buy the company in a deal worth up to $150 million at the high end.