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Heat Biologics Stock Falls on Negative Bladder Cancer Data


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%.


Meanwhile, Heat Biologics will present top-line data from a phase Ib study on its other pipeline candidate, HS-110, in combination with Bristol-Myers Squibb’s BMY Opdivo, for the treatment of non-small cell lung cancer at the annual meeting of the International Association for the Study of Lung Cancer next week.

Zacks Rank & Key Picks

Heat Biologics currently carries a Zacks Rank #2 (Buy). A couple of other favorably placed stocks in the health care sector include Sucampo Pharmaceuticals, Inc. SCMP and Vanda Pharmaceuticals, Inc. VNDA. Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.

Vanda’s loss estimates narrowed from 68 cents to 52 cents for 2016, while its earnings estimates increased from 16 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 77% year to date.

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