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.
Reversing an Unstoppable Cancer Cascade with ProteomicsNews
Mutations in genes that produce RAS proteins turn a normally benign process, essential for cellular growth, into a cancer stimulant that is currently undruggable. Now, cutting-edge protein analysis may help treat cancers caused by these mutations.READ MORE
A New, Streamlined Approach to Diagnosing and Treating Bowel CancerNews
Researchers at the South Australian Health and Medical Research Institute (SAHMRI) and the University of Adelaide have discovered a faster, more cost-effective way to determine which DNA mutations cause human bowel cancer.READ MORE
Protein "Shield" Affects Responses to Breast Cancer DrugNews
BRCA-positive breast cancers arise from a cell's failure to accurately repair its DNA. A study analyzing the complex network of DNA repair molecules has discovered a new group of proteins which affect response to some first-line breast cancer drugs.READ MORE
Comments | 0 ADD COMMENT
World Congress on Advanced Biomaterials and Tissue Engineering
Jun 20 - Jun 21, 2018
29th International Conference on Public Mental Health and Neuroscience
Jul 16 - Jul 18, 2018
International Conference on Epigenetics and Epitranscriptomics
Sep 17 - Sep 18, 2018