Combos, Drug Development

Bristol-Myers preps second checkpoint/cancer vax combo study under its $1B Bavarian Nordic pact

Paul Chaplin, Bavarian Nordic

Bristol-Myers Squibb is ready to launch its second combination trial using Bavarian Nordic’s cancer vaccine Prostvac.

Operating under a 2015 deal worth up to about a billion dollars, investigators will combine Prostvac with Yervoy and Opdivo in 10 patients with castration-resistant prostate cancer. Then they’ll push enrollment to 55 and divvy up the patients into three cohorts, studying T cell infiltration in tumors with one-on-one combos or the triple.

The first trial in the partnership was begun last fall, testing a combination of Prostvac and Yervoy in early prostate cancer.

The theory here is simple enough. Bristol-Myers checkpoint drugs are designed to take the brakes off an immune system attack on cancer cells while Prostvac is designed to hit the gas. Cancer vaccines have proven to be largely too mild to generate much of a clinical response in patients, but researchers have theorized that an enhanced attack with checkpoint drugs could provide a significant benefit.

The step forward in the pact is a plus for Bavarian Nordic, which had to scrap plans for an IPO while fending off an open short attack by Kerrisdale Capital, which ridiculed Prostvac and claimed that the Phase II data it had touted was largely an illusion due to a strikingly bad placebo response.

We’ll know more later this year when Bavarian Nordic releases top-line data from its Phase III prostate cancer study.

The move also underscores that Bristol-Myers’ commitment to its checkpoint program, led by the CTLA-4 and PD-1 drugs, remains as strong as ever as the company looks to get its groove back following a bitter setback on non-small cell lung cancer, which saw its rivals at Merck leapfrog ahead with Keytruda.

All the key checkpoint players, including Genentech and Pfizer/Merck KGaA, have been barreling ahead with hundreds of combination studies, looking to grab the lead in various niche cancer markets. That’s a multibillion-dollar opportunity no one wants to lose.

“There are now eleven ongoing studies of Prostvac across various stages of prostate cancer. In recent years, there has been a growing interest in the evaluation of the immunotherapy candidate in earlier disease stages, where the cancer has not yet spread beyond the prostate. We are excited to learn more about the potential of Prostvac for treating this population, and to evaluate the potential synergistic effects of combining the vaccine with checkpoint inhibitors, as we believe Prostvac may enhance the clinical activity of these drugs,” said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.

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