On May 29, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported its latest data at the ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, Heat Biologics, MAY 29, 2020, View Source [SID1234558694]). The poster presentation can be viewed on the ASCO (Free ASCO Whitepaper) meeting website at: View Source and on Heat Biologics’ website at: View Source
Schedule your 30 min Free 1stOncology Demo!
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!
HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients’ immune system against multiple cancer testis antigens (CTAs) to elicit a diverse and robust T-cell attack against tumor cells. A Phase 2 trial of HS-110 in combination with Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) for multiple treatment settings in advanced non-small cell lung cancer (NSCLC) is ongoing, with enrollment of this trial completed in July 2019.
This data demonstrated that significant survival benefit was observed in a cohort of previously treated, checkpoint inhibitor (CPI) naïve patients with advanced NSCLC; with a median overall survival (mOS) of 28.7 months for the intent-to-treat (ITT) patients (N = 47). This data compares favorably with published data of Checkmate 057, which reported a mOS of 12.2 months in patients who received nivolumab as single agent in a similar treatment setting. Notably, a statistically significant survival benefit with mOS of 42.1 months was observed in patients with injection site reaction (p = 0.0001). Exploratory biomarker analyses showed that overlapping CTA expression in patients’ tumors at baseline with HS-110, as well as the expression of a specific CTA were both associated with statistically significant improved overall survival (p = 0.028 and 0.008, respectively).
"Our exploratory biomarker analysis solidly establishes additional clinical evidence for the HS-110 mechanism of action," said Jeff Hutchins, Chief Scientific and Operating Officer of Heat. "This extended mOS also suggests that HS-110 treatment in combination with a CPI should be considered for any solid tumor type with sufficient CTA overlap with HS-110."
This study has completed enrollment, and 21 of the 47 patients enrolled (45%) are still alive as of this data cut. HS-110 now has a positive safety profile in over 200 patients, and combination of HS-110 and nivolumab appears to be safe and well-tolerated.
"This updated data demonstrates the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC", said Jeff Wolf, Chief Executive Officer of Heat. "Heat is planning an end-of-phase 2 meeting with the FDA to discuss registration trial design."