Heat Biologics, Inc.
) 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
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.
Gilead Sciences, Inc.
). All three stocks carry a Zacks Rank #1 (Strong Buy).
ALKERMES INC (ALKS): Free Stock Analysis
ALEXION PHARMA (ALXN): Free Stock Analysis
GILEAD SCIENCES (GILD): Free Stock Analysis
HEAT BIOLOGICS (HTBX): Get Free Report
To read this article on Zacks.com click here.