Looking to Opdivo combo trial, Heat ends cancer vaccine PhII

Cancer vaccine/checkpoint inhibitor partnerships just keep rolling in. On Tuesday, oncology company Heat Biologics announced that it's the most recent to get involved, though it'll be applying the method to a cancer that so far others haven't.

NC-based Heat ($HTBX) announced that it's discontinuing a single-agent Phase II trial of cancer vaccine candidate HS-110 in non-small cell lung cancer (NSCLC) and that it's instead shifting focus to checkpoint inhibitor pairings. In doing so, the biotech began a Phase Ib trial combining the candidate with the Bristol-Myers Squibb ($BMY) checkpoint inhibitor Opdivo in NSCLC, the first such combo trial in that cancer.

The company's stock dropped about 18% Tuesday on the news. Enrolling 18 patients, the new trial's primary and secondary endpoints include safety and tolerability, immune response, overall response rate and progression-free survival (PFS). Heat expects to release top-line objective response rate and 6-month PFS data by the end of next year. That schedule will enable the company to "reach a clinical readout for HS-110 with a checkpoint-focused clinical trial, on the same schedule that we had forecasted for our previous trial," Melissa Price, VP of product development, said in a statement.

Heat Biologics CEO Jeffrey Wolf

In a statement, Heat CEO Jeffrey Wolf called checkpoint inhibitors the "standard of care" for NSCLC, adding that the trial will enable the company to "more fully evaluate this combination with other checkpoint inhibitors, such as Merck's pembrolizumab, as they become available."

Heat's pairing is just the most recent example of cancer vaccine makers trying their candidates with checkpoint inhibitors to seek out the potential benefits. Combinations such as BMS' and Bavarian Nordic's $1 billion Prostvac deal announced in March, an AstraZeneca ($AZN)/Inovio ($INO) partnership and two Aduro ($ADRO) deals utilizing GVAX--with BMS and Johnson & Johnson ($JNJ)--are a driver in the cancer vaccines market expected to grow at a CAGR of 27.24% through 2019, a recent report said.

Heat, which went public in 2013, saw its market cap fall to about $40 million following Tuesday's stock drop. In addition to NSCLC, it's also working on a bladder cancer vaccine candidate, HS-410.

- here's the release

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