Today, Heat Biologics Inc (NASDAQ:HTBX) presented randomized Phase II data from the HS-410 bladder cancer study. The primary endpoint of the study, one year recurrence-free survival (RFS), showed no statistical differences between the HS-410+BCG arms vs. BCG alone. The company was clear in that the one-year RFS endpoint was a “swing for the fences” approach from a potential accelerated approval standpoint. The potential clinical efficacy and durability of immune responses will be assessed to the two year mark based on NMIBC guidance from the International Bladder Cancer Group, which recommends two year studies for “regular” approval.
HTBX shares reacted to the news, crashing nearly 55% to $1.28 in early trading Thursday.
“The ability of HS-410 to prime T-cells suggests a strong signal that the vaccine is having an impact, as well as an opportunity to improve responses, in this challenging disease,” said study principal investigator, Gary Steinberg, M.D., The Bruce and Beth White Family Professor of Surgery and Director of Urologic Oncology at the University of Chicago. “Historically, NMIBC has been very difficult to treat, with BCG being the only approved therapy in the past 40 years. We were surprised to see that all arms of this trial performed much better than historical control, which is a testament to improvements in standard of care, and validates our choice to run a controlled clinical trial. We look forward to continuing to monitor patients in this trial, per IBCG recommendations. and would like to thank the many patients and their families for the commitment to this trial and advancement of the treatment of bladder cancer.”
“We were pleased to see a robust antigen-specific immune response, reinforcing our earlier clinical data,” Jeff Wolf, CEO of Heat Biologics, commented. “Even though we did not achieve our desired clinical outcomes, we are encouraged by the results and believe this, and other combination therapies, have the potential to improve long-term outcomes. In particular, Heat’s ComPACT technology, combining a therapeutic vaccine with an immune co-stimulator in a single product, was designed to substantially improve immune response durability. We are actively pursuing new programs to complement our existing platforms, which we expect to announce in early 2017. Moreover, we look forward to examining the additional top-line data that will be reported next week for our combination trial of HS-110 in with Bristol-Myers Squibb’s Opdivo® (nivolumab) in lung cancer.”
“HS-410 stimulated antigen-specific immune responses to multiple tumor-associated peptides,” commented Taylor Schreiber, M.D., Ph.D., Chief Scientific Officer. “The kinetics of these responses indicate efficient priming of CD8+ T cells, consistent with results seen in other Heat Biologics clinical trials. Remaining analyses are in progress to inform future development of other agents and/or combinations aimed at improving immune response durability. Further understanding of the secondary and exploratory endpoints will advise future development steps.”
“We conducted a cost-efficient trial and will continue to gather important data with minimal ongoing costs,” Mr. Wolf added. “We have maintained a solid balance sheet and intend to continue to be very prudent in managing our expenses as we generate additional clinical data and progress our programs and platforms.”
On the ratings front, HTBX stock has been the subject of a number of recent research reports. In a report issued on August 17, Noble Financial analyst Kumaraguru Raja maintained a Buy rating on HTBX, with a price target of $8.00, which implies an upside of 590% from current levels. Separately, on August 16, Roth Capital’s Joseph Pantginis maintained a Buy rating on the stock and has a price target of $2.75.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Kumaraguru Raja and Joseph Pantginis have a yearly average return of 10.5% and a loss of 12.5% respectively. Raja has a success rate of 71% and is ranked #1577 out of 4243 analysts, while Pantginis has a success rate of 34% and is ranked #4152.
Heat Biologics, Inc. operates as a clinical-stage biopharmaceutical company, with interest in the development of novel allergenic drugs. The company focuses on the commercialization of ImPact Therapy, a platform technology that offers a novel approach to treat cancer and other infectious diseases, including HIV, HCV and malaria by using live, genetically-modified, and irradiated human cells to activate the immune system against specific defined targets.