- From GlobeNewswire News Room
(“Heat”) (Nasdaq:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, announced the latest results of its ongoing Phase 2 clinical trial of HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo®), for the treatment of non-small cell lung cancer (NSCLC).
Researchers also reported that the safety profile continues to be favorable in the HS-110/nivolumab combination, with no evidence of additional toxicities seen as compared to existing data on nivolumab alone.
Furthermore, if ELISPOT assay results continue to correlate with clinical results, the combination of HS-110 and nivolumab may become an attractive therapeutic approach for the approximately 80% of patients that do not respond well to nivolumab alone, particularly with the positive safety profile of this combination seen to-date.” About Heat Biologics, Inc.
These statements are based upon current beliefs, expectations and assumptions and include statements regarding the ELISPOT results suggesting that HS-110 plays an integral role in tumor reduction and may enhance efficacy of checkpoint inhibitors in lung cancer patients, continued indication that patients are mounting a vaccine-mediated immune response to the vaccine lysate, as well as peptides derived from cancer-specific immune response, the suggestion that HS-110 vaccine is making a measurable contribution to the desired cancer-specific immune response, the suggestion that the 5 tumor reductions seen thus far in the 15 evaluated patients are the result of synergistic activity between HS-110 and anti-PD-1 therapy, the results appearing to further validate the expected mechanism of action of Heat’s approach in combination with checkpoint inhibitors, with a continuing trend towards early and sustained T cell activation in the peripheral blood cells, the combination of HS-110 and nivolumab may become an attractive therapeutic approach for the approximately 80% of patients that do not respond well to nivolumab alone if ELISPOT assay results continue to correlate with clinical results, and the potential of Heat’s ImPACT and ComPACT therapies.
These statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements, including the ability of Heat to develop its product candidates and prove them safe and efficacious, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, the company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the company’s ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, the company’s ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and its ability to retain its key scientists or management personnel and the other factors described in the company’s annual report on Form 10-K for the year ended December 31, 2015 and other filings with the SEC.