Shares of Heat Biologics, Inc. (HTBX) gained more than 8% to close the trading session on March 20 at $7.42 per share. The company’s shares surged after it submitted a revised protocol to the U.S. Food and Drug Administration (FDA) regarding its impending phase II study on pipeline candidate HS-110 in patients suffering from non-small cell lung cancer (NSCLC).
The submitted protocol for the multicenter, randomized study is designed to mimic expected future combinations with checkpoint inhibitors in preparation of next generation of therapy aimed at oncology. The biopharmaceutical company intends to commence the study (n~120) in the third quarter of this year. Patients will be enrolled from 20-30 sites and the enrollment process is expected to be over in the second quarter of 2016. Top-line efficacy data is expected in the third quarter of 2017and the phase III study is projected to commence in the following quarter. The impending study will evaluate among other things the overall survival rates of NSCLC patients on being treated with the candidate (as a combination therapy).
Apart from HS-110, Heat Biologics’ oncology pipeline also includes HS-410. Earlier in the month, the company announced the commencement of patient enrollment in a phase I/II study (n~93) on HS-410 in the bladder cancer indication. The study will evaluate whether vaccination with HS-410, post transurethral resection of bladder tumor (TURBT) and bacillus Calmette-Guérin (BCG), delays disease recurrence compared to placebo. Heat Biologics will further evaluate the safety profile of the candidate in patients suffering from bladder cancer.
Even though pleased with the company’s efforts to develop its pipeline, we remain concerned about its early stage nature.
Heat Biologics carries a Zacks Rank #3 (Hold). Better-ranked biopharma stocks include Alexion Pharmaceuticals, Inc. (ALXN), Alkermes (ALKS) and Gilead Sciences, Inc. (GILD). All three stocks carry a Zacks Rank #1 (Strong Buy).
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