Heat Biologics gains IRB approval to expand Phase I cancer vaccine study

US-based clinical-stage company Heat Biologics and The University of Miami Miller School of Medicine have reported that the University’s Institutional Review Board or IRB has approved an expansion and acceleration of the Phase I clinical trial of a novel vaccine to treat non-small cell lung cancer underway at the University’s Sylvester Comprehensive Cancer Center.

As part of an academic study, the University had been enrolling patients in the clinical trial on a limited basis to satisfy the IRB of its safety. The IRB’s approval means enrollment can now be expanded to accommodate simultaneous administration of the vaccine on three dosage schedules: twice a week, weekly and bi-weekly. Approximately 12 patients will be enrolled in each group at a rate of three patients every four weeks.

If successful, GP96-Ig is expected to fill a substantial need in the treatment of non-small cell lung cancer (NSCLC), which accounts for 85% of all lung cancers and has a five-year survival rate of just 15%.

Heat Biologics holds the exclusive license to develop and commercialize the GP96-Ig cell-based vaccine technology. Unlike conventional vaccines, which are used to prevent infectious diseases, the GP96-Ig vaccine stimulates the immune system to fight the disease once it is diagnosed.

Jeffrey Wolf, CEO of Heat Biologics, said: The impact the GP96-Ig vaccine will have on the lives of NSCLC patients is significant, but it is just the beginning. The potential this vaccine holds as a technology platform across which treatments for other cancers, as well as viral and other inflammatory and infectious diseases, can be delivered is staggering.