On January 26, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported that Taylor Schreiber, M.D. Ph.D., Heat’s Chief Scientific Officer, will discuss three-month interim data from the unblinded, monotherapy cohort of the company’s ongoing Phase 2 trial of HS-410 (vesigenurtacel-L) for the treatment of high risk, non-muscle invasive bladder cancer (NMIBC) at the Phacilitate Immunotherapy World Conference in Washington, D.C. on January 25-27, 2016 (Press release, Heat Biologics, JAN 26, 2016, View Source [SID:1234508862]). In the monotherapy arm of Heat’s Phase 2 trial, a series of weekly intradermal injections of HS-410 is being dosed as an alternative to intravesical standard of care, Bacillus Calmette-Guérin (BCG). Schedule your 30 min Free 1stOncology Demo! Dr. Schreiber will report that to-date HS-410 has been well-tolerated, with no serious adverse events. Six out of seven patients in the 25-patient arm, who have reached the 3-month timepoint after treatment with HS-410 alone, remain recurrence free. One of those patients had carcinoma in situ (CIS) – the patient population believed to be least responsive to BCG – and that patient experienced complete response. Images of the bladder taken from treated patients showed changes that resemble lymphoid (T cell rich) structures that we have observed in biopsy samples, indicating that HS-410 is generating an immune response as expected.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"These interim data are consistent with previous results from our Phase 1 trial, demonstrating that intradermal injections of HS-410 lead to a localized immune response within the urinary bladder," said Dr. Schreiber. "The fact that these localized immune responses are now being seen in the absence of standard of care, BCG, indicates that the response is due to HS-410. If the monotherapy arm of the trial demonstrates a trend toward low recurrence rates in the absence of BCG, that may extend options for subsequent pivotal study designs, and may potentially provide bladder cancer patients with an alternative to repeated BCG catheterization procedures. We look forward to presenting additional data from this trial in the future."
Heat continues to enroll the anticipated 25 patients who will receive HS-410 monotherapy and expects to complete enrollment in the first half of 2016. The three other blinded, randomized, placebo-controlled arms in the Phase 2 trial evaluating HS-410 in combination with BCG are fully enrolled with a total of 75 patients. Heat anticipates reporting topline efficacy, immune-response and safety data from those arms in the fourth quarter of 2016.
About HS-410 (vesigenurtacel-L)
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 an ongoing Phase 2, placebo-controlled, 100-patient NMIBC trial at multiple centers and has been granted U.S. FDA Fast Track Designation for the treatment of NMIBC.
About Bladder Cancer
According to the American Cancer Society, bladder cancer is the fifth most common cancer in the U.S., with approximately 75,000 new cases and 16,000 deaths in 2015. About 75% of the newly diagnosed patients have NMIBC. A key issue for bladder cancer is the high rate of recurrence, for which limited treatment options are available beyond complete bladder removal.