Regen BioPharma to develop first universal donor immunotherapy


San Diego’s Regen BioPharma ($RGBP) has started a preclinical program aimed at creating the first cord blood-based cancer immunotherapeutic that will use the NR2F6 immunological checkpoint. 

In a provisional patent application, the tiny, early-stage biotech said it was seeking to create a generation of cord blood-derived killer cells whose anticancer activity was helped by gene silencing. 

The product in development, known as ucVax, will be a “universal donor” cellular immunotherapy--which can be shipped frozen to the site of use and does not involve complex cellular manipulations by the treating institution, as current versions of this type of therapy require.

David Koos, chairman and CEO of Regen BioPharma, said: “Developing a universal donor immunotherapy will substantially reduce costs of clinical implementation and allow for wide access to treatment including at institutions that do not possess cellular processing abilities. To our knowledge, universal donor cellular immunotherapies have not been developed to date. We believe ucVax will possess both therapeutic and commercial advantages as compared to other immunotherapies.”

Currently, cancer cellular immunotherapies involve extraction of patient blood cells, manipulation of the cells outside of the body, followed by subsequent re-infusion. This has proven a costly way of generating personalized cellular products given the processes involved, as well as the need for each institution to possess cell manipulation facilities. This is however very early-stage with many, many years of development and risk ahead of the publicly-traded company--which says it is only planning to take its studies from preclinical to midstage testing, when it will presumably need help/financing from a new partner. 

Harry Lander, president and CSO of Regen BioPharma, explained: “By using cord blood cells as the starting population for generation of ucVax, we overcome the problem of immune rejection by the patient receiving the therapy, thus potentially allowing the therapy to be used by everyone in need.”

The biotech is focused on regenerative medicine applications in the immunotherapy and stem cell space. It’s currently centering its leading research efforts on a gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.

Back in March, Regen submitted an IND with the FDA for preclinical candidate tCellVax, which aims to use siRNA to silence NR2F6 activity in human immune cells.

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.

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