Nano cap Heat Biologics Inc(NASDAQ:HTBX) gets dropped on double normal volume in anticipation to its report that main product candidate ‘HS-410’ failed to surpass placebo in a Phase II in non-muscle invasive bladder cancer. This report was shown at the Society of Urologic Oncology yearly meeting in San Antonio, TX.
Heat Biologics reported that HS-410 posted a strong antigen-specific immune response to numerous tumor-associated peptides compared to none for placebo but the responses failed to translate into clinical outcomes. The company noted no statistically noteworthy difference in the primary objective of percentage of recurrence-free survival at year one between the cure and placebo arms.
To better evaluate the durability of the affirmative immunological responses, and in going with clinical study guidance recently released by International Bladder Cancer Group recommending a 2-year trial duration for NMIBC studies, Heat Biologics will continue to track all patients registered in the trial for an additional one year. At that time, the company will make a final call whether to advance its bladder cancer plan into a Phase 3 study.
CEO Jeff Wolf said that they are actively pursuing new plans to complement their current platforms, which they project to report in early 2017. Moreover, they look forward to assessing the additional top-line report that will be posted in coming period for their combination study of ‘HS-410’ with Bristol-Myers Squibb’s Opdivo in lung cancer.
HS-410, dependent on the firm’s proprietary ImPACTimmunotherapy platform, is developed to generate specific immune cells that attack cancer cells. Gary Steinberg, M.D., the Principal Investigator, said that the capability of ‘HS-410’ to prime T-cells indicates a strong indication that the medication is having an impact, and an opportunity to enhance responses, in this deadly disease.
Historically, NMIBC has been extremely tough to cure, with BCG being the sole approved therapy in the last 40 years. They were surprised to witness that all arms of this study fared much better than old control, which is an evidence to enhancements in standard of care, and authenticates company’s choice to manage a controlled clinical study.