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Tuesday, July 06, 2021 10:51:38 AM
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in development of dCellVax, a "therapeutic cancer vaccine" which stimulates the immune system of patients to selectively kill tumors.
Thomas Ichim, PhD, Chief Scientific Officer of Regen BioPharma, stated, "We are pleased to announce that Regen BioPharma has successfully achieved silencing of the IDO gene in human dendritic cells, which is a major step forward in development of our Investigational New Drug (IND) application to the FDA." He further noted that "Not only is this a significant milestone, but this provides additional trade secrets in our production methodology with the possibility of filing new patents on the optimized methodology and reagents we have developed."
The scientific foundation of dCellVax was developed by Dr. Wei-Ping Min, Professor at the University of Western Ontario. The patent related to this therapy, US patent # 8,389,708, was previously assigned to the company by Dr. Min. Dr. Min effectively used dendritic cells (DC) that are "gene silenced" to induce regression of breast cancer in animal models. The company also entered into a license agreement with Benitec Biopharma covering specific uses of their platform gene silencing technology for use in dCellVax. Dr. Min's animal efficacy data was previously published in peer-reviewed journal articles (1, 2).
The dCellVax therapeutic product is based on extracting blood from patients, growing a specialized type of immune cell from the blood called the "dendritic cell" and then subsequently genetically modifying the dendritic cell to become resistant to cancer's immune suppressive activity. It is known that cancer modifies the immune system by producing proteins which result in immune suppression. One such protein which cancer stimulates is an enzyme, indolamine 2,3 deoxygenase (IDO), which cancer turns on in dendritic cells. While dendritic cells are usually immune stimulators, dendritic cells found in cancer patients suppress the immune system as a result of expressing IDO. By administering dendritic cells that are silenced for IDO, it has been demonstrated that substantially enhanced antitumor responses may be stimulated.
Although Regen BioPharma and Dr. Wei-Ping Min have previously published in the area of gene silencing, all work has been performed in animal studies. These are the first experiments in which human cells were utilized in a manner similar to which will be filed with the FDA. "We are optimistic that this data will lead to advancement of dCellVax into clinical trials," said David Koos, PhD, Chairman and CEO of Regen BioPharma. "The smooth translation of this university acquired intellectual property into a commercial setting further supports the Regen BioPharma model of rapidly advancing patents that are sitting un-noticed in the technology transfer offices of universities."
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