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Regen BioPharma, Inc. Submits IND Application to FDA on tCellVax, a Checkpoint Inhibitor for Cancer Therapy
New approach uses siRNA to silence NR2F6 activity in human immune cells
PR Newswire Regen BioPharma Inc.
2 minutes ago
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SAN DIEGO, March 23, 2016 /PRNewswire/ --

Regen BioPharma, Inc., (RGBP) and (RGBP) announced today submission to the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application focused on using a novel method to unleash the body's innate ability to kill cancer (immunotherapy).

The application submitted contained preclinical experiments as well as details of the proposed clinical trial. Results of the studies clearly demonstrated that the approach outlined, 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.

"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, PhD, Chairman & CEO of Regen BioPharma.

tCellVax is comprised of cells extracted from the patient's own circulating immune cells and processed using a proprietary method so as to activate these immune cells in such a way that they can attack cancer cells. Studies in animal and human immune cells by 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. Thus, we are optimistic this treatment will be useful in patients with cancer.

"The NR2F6 gene is clearly playing a role as a very potent immune checkpoint. tCellVax is one of the programs we are developing to inhibit this protein. Immune modulation, both inhibitory and stimulatory, is unlocking many novel ways to have the human body heal itself. tCellVax 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 Harry Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen BioPharma.