US-based Heat Biologics has started dosing in its Phase II trial of Viagenpumatucel-L (HS-110) to treat patients with non-small cell lung cancer (NSCLC).
HS-110 is the company's advanced product candidate in a series of proprietary Immune Pan Antigen Cytotoxic Therapy (ImPACT) based allogeneic cell lines designed to direct killer T cells to attack cancer.
University of Pennsylvania professor of medicine and Abramson Cancer Center associate director for clinical research Roger Cohen is the lead investigator of the trial.
Cohen said: "NSCLC is still the most common lethal cancer. The unmet need in this disease is huge.
"Recent encouraging data with various immune checkpoint inhibitors suggest that NSCLC may, in fact, be susceptible to an immune therapy approach.
"Heat's biologic immuno-oncology product candidate, HS-110, has a novel composition and mechanism of action that builds on decades of immunotherapy research. I look forward to seeing the effects of HS-110 on immune response and outcome in my patients."
A total of 123 patients with NSCLC who have failed two or three prior lines of therapy will be enrolled in this multicentre, randomised Phase II trial, which is designed to evaluate the safety and efficacy of HS-110 in combination with low-dose cyclophosphamide.
The Phase II protocol is specifically designed using low-dose cyclophosphamide as a modulator of immunosuppression, which is expected to improve the encouraging signals of efficacy observed in the Phase I trial of HS-110 as a monotherapy.
An interim analysis of the immune response data will be conducted after 14 patients have been treated for nine weeks with Viagenpumatucel-L and cyclophosphamide.
The company intends to report these interim immune response results in the first half of 2015.
Heat chief executive officer Jeff Wolf said: "Dosing the first patients with HS-110 in our NSCLC Phase II study is an exciting and significant milestone for the company.
"Our Phase II lung cancer study is designed to gauge the effectiveness of our approach in late stage NSCLC patients in a controlled setting, allowing us to design pivotal trials more effectively."