Heat Biologics Stock Falls On Negative Bladder Cancer Data
Zacks Investment Research | Nov 30, 2016 10:23PM ET
Heat Biologics, Inc.’s (NASDAQ: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%.
HEAT BIOLOGICS Price
Zacks Investment Research
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.