Regen Developing Novel CAR Approach for Solid Tumors

Regen Biopharma is developing a novel immunotherapy approach using chimeric antigen receptor (CAR) natural killer (NK), macrophage (M), and T cells (T) for treating solid tumors.¹

The approach is supposed to address the difficulties with T cell exhaustion in current approaches that use CAR T-cell therapies. These therapies are hindered by the tumor microenvironment (TME) of blood vessels, immune cells, fibroblasts, signaling molecules and extracellular matrix. CAR T-cells are often currently prevented from entering the tumor or inactivated by the TME.

"The company believes that taking this 2-step approach – first softening up the target with CAR-M and CAR-NK cells and then bringing in the heavy artillery (CAR-T cells) will allow solid tumors to be successfully targeted by these cell therapies, thus greatly expanding the CAR-T market and ultimately saving people's lives," David Koos, chief executive officer and chairman, Regen, said in a statement.¹

Regen previously filed for a patent for the approach to combat T-cell exhaustion earlier in August, furthering its goal to create more durable and efficacious cell therapies in solid tumors. T cell exhaustion is an even greater issue with autologous therapies where patients’ T cells are already fatigued.

WATCH NOW: Kim A. Reiss Binder, MD, on the Potential of CAR Macrophages in Solid Tumors

The company believes their novel cell therapy will be 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.²

"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.”

Many patents have been granted in the recent past as more companies investigate novel approaches to treating cancers and rare diseases with cell and gene therapies. The European Patent Office has recently given an intent-to-grant notice to Longeveron for its methods of using vascular biomarkers to monitor the efficacy of its Lomecel-B cell therapy, which is being investigated in several indications, including hypoplastic left heart syndrome (HLHS).³

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).⁴

REFERENCES

1. Regen BioPharma develops novel means of using CAR-T cell immunotherapy to attack solid tumors. News release. Regen Biopharma. August 25, 2022. https://www.prnewswire.com/news-releases/regen-biopharma-develops-novel-means-of-using-car-t-cell-immunotherapy-to-attack-solid-tumors-301612726.html
2. 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
3. U.S. Food and Drug Administration (FDA) grants fast track designation for Longeveron’sLomecel-B™ product for treatment of hypoplastic left heart syndrome (HLHS) in infants. News release. Longeveron. August 31, 2022. https://www.globenewswire.com/news-release/2022/08/31/2507637/0/en/U-S-Food-and-Drug-Administration-FDA-Grants-Fast-Track-Designation-for-Longeveron-s-Lomecel-B-Product-for-Treatment-of-Hypoplastic-Left-Heart-Syndrome-HLHS-in-Infants.html
4. 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