Regen BioPharma, Inc (OTC:RGBP) has responded to the US Food and Drug Administration (FDA) with a revised data package supporting its breast cancer immunotherapy.
The revised Investigational New Drug application contained preclinical experiments as well as details of the proposed clinical trial.
Regen said the results of the studies clearly demonstrated that its enzyme silencing approach was effective at stimulating the type of immune response associated with known checkpoint inhibitors.
Checkpoint inhibitors are the process through which cancer manages to evade detection by the body’s defences.
The proposed dCellVax clinical trial involves generation of patient-specific immune stimulatory cells that are modified to lose expression of a particular immune checkpoint gene.
Ten patients with advanced breast cancer will be treated in the proposed clinical trial.
“dCellVax is only one of our immune modulatory products that we expect to bring to market in the future. The data package we sent to the FDA is an important step in this process," said Regen’s chief scientific officer Harry Lander.