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Regen Files for Patent on CAR T-Cell Exhaustion Prevention Technology

Multiple cell and gene therapy companies have been granted patents for novel technology in 2022.

Regen BioPharma is filing for a patent for its technique of preventing T cell exhaustion to create more durable and efficacious chimeric antigen receptor (CAR) T-cell therapies against solid tumors.1

"CAR-T cells have been in the clinic for 6 years but they have hardly made a dent in treating solid tumors," David Koos, chairman and chief executive officer, Regen BioPharma, said in a statement.1 "We hope that through the diligent work of our scientists and collaborators that advancements such as what we announced today will pave the way to bring this incredible cellular immunotherapy to patients suffering from solid tumors such as lung, colon, prostate and others.”

T cell exhaustion is a common issue with CAR T-cell therapies in solid tumors, especially with autologous therapies where T cells are already fatigued. Regen BioPharma is patenting a novel T cell type that is resistant to immunosuppression of tumors to prevent exhaustion. These cells are created with a technology that induces an intracellular program in the cells to give them characteristics of younger cells. Therefore, the cells will exhibit enhanced activity against solid tumors in the lungs, skin, breast, and brain. Part of this technology focuses inhibiting the T cell checkpoint NR2F6. Regen BioPharma has additional patents covering cord blood derived immunotherapy, cancer-killing Th17 cells, and mRNA vaccines.

READ MORE: Ovarian Cancer CAR-T Clinical Trial Doses First Patient

As more companies investigate novel approaches to treating cancers and rare diseases with cell and gene therapies, more patents are being granted to support these new technologies. Earlier in August, the US Patent and Trademark Office (PTO) granted a patent to Israeli cell therapy company Kadimastem for AstroRx, a cell therapy consisting of astrocytes derived from human embryonic stem cells intended for the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS).2

Other companies have found themselves fighting over patents to similar technologies, such as CRISPR therapies, a subject of conflict between the Broad Institute of Harvard University and the Massachusetts Institute of Technology and the group known collectively as CVC, which includes the University of California (UC), University of Vienna, and Emmanuelle Charpentier, PhD. The US PTO Patent Trial Appeal Board ruled in March 2022 that the Broad Institute was the first to invent CRISPR/Cas9 editing in eukaryotic cells, not the CVC, which had developed the technology in prokaryotic cells.3

“While scientists in both groups made important scientific contributions to the field, this proceeding was to determine who invented the use of CRISPR/Cas9 for editing the DNA in eukaryotic cells, including human cells. We are pleased with the USPTO’s decision, ending the interference, and determining the Broad Institute’s innovative work to discover and use the CRISPR/Cas9 technology in human cells,” James C. Mullen, chairman, president, and chief executive officer, Editas Medicine, said in a statement at that time.4 “The decision reaffirms the strength of our foundational intellectual property as we continue our work to develop life-changing medicines for people living with serious diseases.”

1. Regen BioPharma, Inc. develops novel dedifferentiation approach for increasing efficacy of CAR-T cells to treat solid tumors. News release. Regen BioPharma. News release. August 11, 2022. https://firstwordpharma.com/story/5635201
2. Kadimastem receives US patent for amyotrophic lateral sclerosis (ALS) treatment. News release. Kadimastem Ltd. August 9, 2022. https://www.kadimastem.com/post/kadimastem-receives-us-patent-for-a-treatment-of-amyotrophic-lateral-sclerosis-als
3. Patent Interference No. 106,115 (DK): Decision on Priority 37 C.F.R. § 41.125(a). USPTO. February 28, 2022. Accessed March 3, 2022. https://drive.google.com/file/d/1-NxaE-FqWz1spjckk-Q6I_-LuKSzvMg3/view
4. Editas Medicine announces favorable decision from U.S. Patent and Trademark Office In CRISPR patent interference. News release. February 28, 2022. https://ir.editasmedicine.com/news-releases/news-release-details/editas-medicine-announces-favorable-decision-us-patent-and