Date: 2015-09-01
Type of information: Recruitment of the first patient
phase: 1b
Announcement: recruitment of the first patient
Company: Heat Biologics (USA - NC)
Product: HS-110 (viagenpumatucel-L) and nivolumab
Action mechanism: monoclonal antibody/immunotherapy product/cell therapy. HS-110 is Heat Biologics' first product candidate in a series of proprietary ImPACT™ based immunotherapies designed to stimulate patient\'s own T-cells to attack cancer. Nivolumab is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: USA
Trial details: This study will test whether vaccination with viagenpumatucel-L combined with strategies to modulate the immune response is safe for patients with non-small cell lung adenocarcinoma who have failed at least one prior line of therapy for incurable or metastatic disease. These methods collectively use the body\'s immune system to target the patient\'s own tumor. Immunosuppression hinders than response, and may develop in NSCLC patients in a variety of ways, such as activation of checkpoint pathways in the tumor microenvironment. Drugs that disrupt checkpoint molecule signaling like anti-PD-1 monoclonal antibodies nivolumab, may release this brake on the immune system. Tumor expression of PD-L1 plays an important role in patient response to checkpoint inhibitors; in general, clinical response to checkpoint inhibitors requires tumor expression of PD-L1 and presence of Tumor Infiltrating Lymphocytes (TIL). Combining viagenpumatucel-L with anti-PD-1 agents may enhance the vaccine\'s anti-tumor activity while prolonging or increasing the efficacy of the checkpoint inhibitor.(NCT02439450)
Latest news: * On September 1, 2015, Heat Biologics, a clinical stage cancer immunotherapy company, announced that it has enrolled the first patient in a Phase 1b clinical trial investigating the combination of its HS-110 therapeutic vaccine and the PD-1 inhibitor nivolumab (Opdivo®) in non-small cell lung cancer (NSCLC). Additionally, as the FDA approval of nivolumab and anticipated approval of other checkpoint inhibitors is dramatically changing the standard of care in lung cancer treatment, Heat is winding down its ongoing Phase 2 trial with HS-110, which does not include a checkpoint inhibitor combination, to instead focus on combinations with checkpoint inhibitors. This multicenter trial is evaluating the safety and efficacy of HS-110 in combination with nivolumab in patients with NSCLC whose cancers have progressed after first-line therapy. Primary and secondary trial endpoints include safety and tolerability, immune response, overall response rate and progression-free survival. The trial is expected to initially enroll 18 patients, and is designed to accommodate rapid cohort expansion as positive clinical data emerge. The company expects to release top-line objective response rate and 6-month progression free survival (PFS) data on these first 18 patients by the end of 2016.
