Heat Biologics Inc. on Tuesday announced it enrolled the first patient in a Phase 1b clinical trial that examines the combination of its HS-110 therapeutic vaccine and the Bristol-Myers Squibb PD-1 inhibitor nivolumab (Opdivo) in non-small cell lung cancer.
HS-110 is Heat’s first product candidate in a series of proprietary ImPACT based immunotherapies designed to stimulate patient's T-cells to attack cancer.
“Checkpoint inhibitors such as nivolumab are rapidly becoming standard of care in the treatment of NSCLC and many other types of cancer," Heat Biologics CEO Jeff Wolf said. "Substantial evidence is emerging regarding the benefits of combining checkpoint inhibitors and therapeutic vaccines. Heat had previously reported synergy between ImPACT and anti-PD-1 therapy. This important clinical study is among the first trials to explore the combination of a checkpoint inhibitor and therapeutic vaccine in NSCLC and will enable us to more fully evaluate this combination with other checkpoint inhibitors, such as Merck's pembrolizumab, as they become available."
The trial is expected to enroll 18 patients and accommodate fast-group expansion as positive clinical data emerges. Heat will be working with Yale Cancer Center's Translational Immuno-Oncology Laboratory on the analysis of the TILs biomarker data for patient selection.
The company expects to release the positive objective response rate and six-month progression free survival data on the first 18 patients by the end of 2016.