The US regulator will now decide whether the drug is safe to progress human trials.
Regen said preclinical data had indicated the gene silencing approach was “dramatically effective” at stimulating the body’s immune response.
"Because tCellVax is a personalized cell therapy product aimed at activating the immune system of patients with cancer, we are excited to potentially have a product to deliver to patients who at the moment have no other options," said David Koos Regen BioPharma’s chief executive.
“Using siRNA to silence NR2F6 activity in human immune cells is dramatically effective at stimulating the type of immune response associated with known checkpoint inhibitors.”
tCellVax comprises a patient’s own immune cells, which are then activated to attack cancerous cells.
“Regen and other groups have shown the cells in tCellVax are highly active and secrete the same cytokines that immune cells known to kill cancer cells do.”
The NR2F6 gene is clearly playing a role as a very potent immune checkpoint, he said, and tCellVax is designed to inhibit this protein.
Regen’s current focus is to use gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.