On February 9, 2021 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 positive interim data of the Company’s fully-enrolled Phase 2 trial of HS-110, in combination with Bristol-Myers Squibb’s (BMS) OPDIVO (nivolumab) in advanced non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, FEB 9, 2021, View Source [SID1234574771]). HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients’ immune system against multiple cancer testis antigens to elicit a diverse and robust immune response against tumor cells.

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Substantial survival benefit was observed in a cohort of previously treated, checkpoint inhibitor naïve patients with advanced NSCLC (Cohort A, N = 47). A median progression free survival (PFS) of 1.8 months and a median overall survival (OS) of 24.6 months was observed with a median follow-up time of 19.4 months. The one-year survival rate of Cohort A is 61.7%. The median OS data was 12.2 months and the 1-year survival rate was 50.7% in previously treated, advanced NSCLC patients who received nivolumab as a single agent, according to published data of the BMS CheckMate 057 study1. Our data suggests that addition of HS-110 to a checkpoint inhibitor has the potential to improve survival benefit for checkpoint inhibitor naïve NSCLC patients.

For NSCLC patients who had previously been treated with a checkpoint inhibitor and whose disease had subsequently progressed (Cohort B, N = 68), a median PFS of 2.8 months and median OS of 11.9 months was observed with a median follow-up time of 11.9 months. NSCLC patients whose disease progresses following checkpoint inhibitor therapy have limited treatment options2. Published data from other studies reported median OS of 6.8 to 9.0 months for NSCLC patients treated with chemotherapies after PD-(L)1 progression3,4. Our data of HS-110 in combination with nivolumab in Cohort B suggests potential treatment benefit for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy.

As of this data cut, 30% of the patients in Cohort A and 26% of the patients in Cohort B are still alive. HS-110 has a favorable safety profile and has been administered in approximately 200 patients to date. As of this data cut, there have been no treatment-related serious adverse reactions. A review of immune-related adverse events reported in the study raised no safety concerns. The data to date demonstrate that combination of HS-110 and nivolumab is well-tolerated.

"We are thrilled to report this latest positive survival data from our Phase 2 trial of HS-110, in combination with Bristol-Myers Squibb’s OPDIVO (nivolumab) in advanced non-small cell lung cancer demonstrating HS-110’s broad potential for providing multiple treatment options to NSCLC patients," stated Jeff Wolf, Chief Executive Officer of Heat Biologics. "HS-110 is the lead candidate in our portfolio of therapeutic products and vaccines utilizing Heat’s gp96 technology platform and showcases the broad utility of this platform for NSCLC and potentially other types of cancer. We are currently evaluating possible Phase 3 registration pathways for HS-110 in combination with a checkpoint inhibitor and intend to review these plans with the FDA as well as potential partners."