Drug Development

Agenus’ lead cancer vaccine flops, investigators read last rites over glioblastoma PhII

Just days after handing over the reins on a big antibody collaboration to Incyte, Agenus is now slamming the brakes on its top cancer vaccine trial, conceding a flop.

The Lexington, MA-based biotech $AGEN says an independent data monitoring committee overseeing the Phase II combination study of its cancer vaccine Prophage with Avastin (bevacizumab) found no encouragement that the vaccine — made of heat shock protein-peptide complexes taken from a patient’s tumor tissue — was any better than bevacizumab alone in prolonging survival among brain cancer patients.

The study was launched in 2013 and intended to recruit 165 patients. Agenus quietly noted the failure in a filing with the SEC on Tuesday.

The bottom line in the 8-K:

The interim analysis suggested that the trial is unlikely to demonstrate that the vaccine in combination with bevacizumab will lead to a better survival than bevacizumab as a monotherapy. Therefore, upon the DSMB’s recommendation, the accrual for the trial has been closed.

The biotech’s shares were down 5.5% in premarket trading Wednesday.

A spokesperson for the biotech says that while that Phase II has been closed, the program for Prophage is definitely continuing. Just a few weeks ago Agenus announced plans to combine Prophage and the PD-1 drug Keytruda in a new trial. The failed study was in late-stage patients and this next study will be for newly diagnosed glioblastoma patients.

“The rationale for synergy between Prophage and a checkpoint inhibitor is much greater,” she adds. “This, along with earlier stage patients being studied in the trial, leads to expectations of better outcomes.”

Like a long lineup of cancer vaccines in recent years, Agenus’ attempt to kickstart an immune system attack appeared safe but ineffective in the most recent setback, too weak to make a significant difference. The biotech also has a slate of checkpoints in the clinic, looking to follow up on a new approach to removing cancer cells’ natural defenses so that they can be eliminated by the immune system.

A few days ago Agenus backed away from a 50/50 deal split arrangement that it had with Incyte on antibody development, triggering some speculation that the company was too weak financially to keep up its end of the bargain. Agenus settled for an $80 million cash infusion and a royalty stream on any products that hit the market.



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