Heat Biologics, Inc.’s HTBX shares plunged 56.1% during yesterday’s after-hours trading after the company presented disappointing top-line data from a phase II study on its lead pipeline candidate, HS-410 (vesigenurtacel-L), for the treatment of non-muscle invasive bladder cancer (NMIBC). The data was presented at the annual meeting of the Society of Urologic Oncology.

The randomized, blinded study evaluated HS-410 in combination with standard of care, bacillus Calmette-Guérin (BCG), or as monotherapy in patients with NMIBC.

Data from the study showed signs of encouraging anti-tumor activity with HS-410, producing vigorous antigen-specific immune response to multiple tumor-associated peptides in treated patients. No immune responses of this type were observed in the placebo arm. However, these responses did not lead to clinical outcomes, and there was no statistically significant difference in the primary endpoint (proportion of recurrence-free survival at one year) between the vaccine and placebo arms of the study.

Heat Biologics plans to continue monitoring the patients in the study for an additional 12 months in order to further evaluate the durability of positive immunological responses and in accordance with the clinical trial guidance recently issued by International Bladder Cancer Group recommending 2-year duration for the NMIBC studies.

Thereafter, the company will decide on whether or not to move the bladder cancer program into phase III.

However, considering that HS-410 is the lead candidate in the company’s pipeline, the latest phase II study results are far from encouraging.

We remind investors that Heat Biologics’ shares had taken a beating earlier this year when the FDA put a phase II study on HS-410 on partial clinical hold, even though the hold was lifted within a week.

Nevertheless, Heat Biologics has outperformed the Zacks categorized Medical-Drugs industry year to date with the stock gaining 17.6% compared to the industry’s 24% decline. Moreover, the stock has surged 102.1% in the past month compared to the industry’s 7.8%.

—The 18th China(Guangzhou)Int’l Heat Treatment, Industrial Furnace Exhibition