Heat Biologics Provides Update on Its HS-410 Phase 2 Monotherapy Bladder Cancer Trial Arm
News Mar 02, 2016
Heat Biologics, Inc. has announced that the company will no longer enroll new patients in its Phase 2 monotherapy trial arm evaluating HS-410 alone for the treatment of non-muscle invasive bladder cancer (NMIBC). Heat added the monotherapy trial arm in response to the intermittent global shortage of standard of care Bacillus Calmette-Guérin (BCG) in early 2015.
The shortage has since then been resolved and as such, Heat will no longer enroll new patients in this trial arm based on discussions with the U.S. Food and Drug Administration (FDA). The decision does not relate to concerns regarding the safety profile of HS-410. The 16 patients currently enrolled, out of the anticipated 25 patients, can continue receiving HS-410 monotherapy per the study protocol. Heat anticipates reporting topline 6-month data from these 16 patients in the fourth quarter of 2016, contemporaneous with reporting data from the company’s BCG combination cohorts.
This decision does not impact the three additional randomized Phase 2 trial arms evaluating HS-410 in combination with BCG for the treatment of NMIBC. As previously announced, Heat completed enrollment of the 75 patients for these three combination trial arms in October 2015 and continues to expect to report one-year topline efficacy, immune-response and safety data in the fourth quarter of 2016.
HS-410 is an investigational product candidate for NMIBC based on Heat’s proprietary ImPACT immunotherapy platform, designed to generate CD8+ “killer” T cells that attack cancer cells. HS-410 is currently being evaluated in a Phase 2, placebo-controlled NMIBC trial at multiple centers and has been granted U.S. FDA Fast Track Designation for the treatment of NMIBC.
Tight junctions are multi-protein complexes that serve as barriers in epithelial tissues such as the skin or lining of the gut. Loss of a specific tight junction barrier protein, claudin 18, occurs in the majority of gastric cancer patients and is correlated with poor prognosis in patients with advanced gastric cancer.READ MORE
Policies, economic systems, and marketing practices that promote the consumption of energy-dense, nutrient-poor food, changing behavioral patterns that couple high total energy intake with insufficient physical activity, and human-built environments that amplify these factors are driving a worldwide rise in excess body weight, according to a new report.READ MORE
A widely used diabetes medication combined with an antihypertensive drug specifically inhibits tumor growth – this was discovered by researchers two years ago. In a follow-up study, recently published in “Cell Reports”, the scientists report that this drug cocktail induces cancer cell death by switching off their energy supply.READ MORE
18th International Conference on Pharmaceutics & Novel Drug Delivery Systems
May 27 - May 28, 2019