Heat Biologics Inc (NASDAQ:HTBX) closed Tuesday’s trading session at $1.25 and seemed to be tanking after announcing interim data from its HS-110 + Nivolumab Phase 2 clinical trial at the ASCO-SITC Clinical Immuno-Oncology event.
The company has been running a Phase 2 clinical study to evaluate HS-110’s ability to combat advanced non-small cell lung cancer (NSCLC). However, the clinical trial has been evaluating the pipeline drug as a combination treatment with nivolumab, an anti-PD-1 checkpoint inhibitor developed by Bristol-Myers Squibb Co (NYSE: BMY).
Dr. Daniel Morgensztern, the lead investigator in HS-110’s clinical trial and Medicine professor at Washington University School of Medicine, presented the results at the ASCO-SITC Clinical Immuno-Oncology Symposium. The data presented was for two clinical study cohorts where one group never reached checkpoint inhibitors despite previous treatment while the second group achieved checkpoint inhibitors in previous treatment.
“The treatment landscape for NSCLC has fundamentally changed as the number of patients who receive first line checkpoint inhibitor therapy is rapidly increasing,” stated Heat’s Chief Medical Advisor, COL(ret) George E Peoples.
Peoples also noted that the preliminary data collected from Cohort B has been growing more relevant. This is because it indicates that an HS-110 and nivolumab combo can arouse anti-tumor activity even when patients’ condition progresses after a CPI treatment.
The enrollment process continues, and Heat expects to release more data later this year
Heat’s Chief Scientific and Operating Officer Jeff Hutchins stated that the disease stabilization and response rates observed in the clinical trial support the company’s mechanistic hypothesis. The latter suggests that HS-110 activates T-cell immune responses that might improve patient survival especially when the treatment is combined with a CPI.
Data collected from Cohort B indicates that HS-110 may promote better patient outcomes, especially where treatment benefits with a checkpoint inhibitor have been lost. Hutchins also stated that the company is working on finalizing the enrollment process in the current clinical trial within the second quarter of 2019. Heat also plans to release more data before the end of the year as more data is observed in the clinical trial.