Ernexa Therapeutics (NASDAQ: ERNA) will present groundbreaking preclinical data for its lead cell therapy candidate ERNA-101 at the inaugural AACR Special Conference in Cancer Research: Advances in Ovarian Cancer Research on September 20, 2025, in Denver. The oral presentation, titled "Gene-modified iPS-derived MSC restore a 'Hot' immune microenvironment in high-grade serous ovarian cancer," represents a significant milestone for the company's innovative approach to cancer treatment.
Revolutionary Cell Therapy Technology
ERNA-101 is a synthetic, off-the-shelf cell therapy designed to activate and regulate the immune system to recognize and attack cancer cells. The therapy is built on Ernexa's core technology platform that engineers induced pluripotent stem cells (iPSCs) and transforms them into induced mesenchymal stem cells (iMSCs). iPSCs are stem cells that can be reprogrammed from adult cells to become nearly any cell type in the body, while iMSCs are specialized stem cells with a unique ability to migrate toward tumors.
"This research underscores the promise of engineered iPSC-derived MSCs to fundamentally reshape the tumor microenvironment in ovarian cancer," said Dr. Michael Andreeff, M.D., Ph.D., professor at The University of Texas MD Anderson Cancer Center and the trial's lead investigator. "By restoring immune activity in these difficult-to-treat tumors, ERNA-101 has the potential to open new therapeutic avenues where current options remain limited."
Addressing Critical Unmet Medical Need
The preclinical findings highlight ERNA-101's potential to reprogram the ovarian tumor microenvironment, transforming "cold" tumors with limited immune activity into "hot" tumors that can be effectively targeted by the immune system. This approach addresses a critical challenge in ovarian cancer treatment, where current therapeutic options remain limited for patients with advanced disease.
Ernexa's allogeneic synthetic iMSCs provide a scalable treatment solution without requiring patient-specific cell harvesting, potentially making the therapy more accessible and cost-effective compared to personalized cell therapies.
Clinical Development Pathway
The data being presented supports the continued advancement of ERNA-101 toward clinical evaluation in ovarian cancer. According to Sanjeev Luther, President and CEO of Ernexa Therapeutics, the company's recent operational excellence initiatives have enabled strategic resource allocation to advance ERNA-101 into clinical trials.
"This opportunity to share our ERNA-101 data on an international stage is an important milestone for Ernexa, and we are honored to partner with Dr. Andreeff, a leading pioneer in cell therapy, and specifically in MSCs," Luther stated. "AACR is a premier organization for scientific exchange, and we are proud to demonstrate the potential of our engineered cell therapies to expand treatment options for patients with ovarian cancer and beyond."
Presentation Details
The oral presentation will take place during the "Spotlight on Proffered Talks" session on Saturday, September 20 at 10:10 a.m. in the Colorado Ballroom at the Grand Hyatt Denver Hotel. Ernexa is also scheduled to deliver a poster presentation on the same topic during the conference.
Broader Pipeline Development
Beyond ERNA-101, Ernexa is developing ERNA-201, a cell therapy product designed to target inflammation and treat autoimmune diseases. The company's initial focus remains on developing ERNA-101 for ovarian cancer treatment, with the preclinical data representing critical validation as the therapy progresses toward clinical trials.
