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news.Heat Biologics, a clinical stage biopharmaceutical company, has submitted its revised Phase II clinical trial protocol for its HS-110 product candidate to the US Food and Drug Administration for the treatment of patients with non-small cell lung cancer (NSCLC).
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HS-110 is Heat’s first product candidate in a series of its proprietary Immune Pan Antigen Cytotoxic Therapy ("ImPACT") based allogeneic cell lines designed to direct killer T cells to attack cancer.
HS-110 utilizes genetically modified lung cancer cells to stimulate a patient’s immune system to activate a robust cytotoxic T cell response against a wide array of lung cancer antigens.
Heat’s Phase II NSCLC clinical trial is a multicenter, randomized study of approximately 120 patients expected to be enrolled in 20-30 clinical trial centers. This Phase II study in the 3rd line setting will evaluate multiple efficacy endpoints including overall survival and response rates as well as immune response to HS-110 in combination with low dose cyclophosphamide versus chemotherapy alone.
The addition of low dose cyclophosphamide as an immune stimulator allows Heat to simulate the response to HS-110 that might occur if it is combined with other novel immune checkpoint inhibitors. The company’s lead investigator for this Phase II study is Dr Roger B. Cohen, Professor of Medicine at the University of Pennsylvania and Associate Director for Clinical Research for the Abramson Cancer Center.
Dr Cohen played a critical role in the design and development of this Phase II protocol. He is an active investigator on a number of clinical trials with research interests that focus on evaluation of novel therapies, including monoclonal antibodies, immune therapies, and small molecule cell-signaling pathway inhibitors. He primarily sees patients with lung and head and neck cancer.
Heat Clinical and Regulatory Affairs vice president Dr Melissa Price noted that in addition to evaluating the combination of HS-110 with low-dose cyclophosphamide, in this Phase II trial the company plans to evaluate the potential of this novel immune therapy to sensitize patient tumors to subsequent chemotherapy treatments.
"We will also obtain pre- and post-treatment biopsy specimens in order to correlate tumor infiltrating lymphocytes and T-cell receptor sequencing with patient outcomes, which we believe will lead to proof of concept and allow greater precision in patient selection for this therapy," Dr Price added.
Heat expects to begin patient enrollment and dosing of the Phase II NSCLC study in the third quarter of 2014.