Preclinical data demonstrate deep and durable tumor regressions with lead product candidate ERNA-101 in combination with PD-1 Blockade in ovarian cancer

IND submission for ERNA-101 expected in Q3 2026 with first-in-human study planned for Q4 2026 for the treatment of platinum-resistant ovarian cancer

Multiple regulatory and clinical milestones expected to drive significant value creation over the next 12-18 months

CAMBRIDGE, Mass., March 31, 2026 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (NASDAQ:ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today provided a business update highlighting the Company's accelerating transition toward clinical development and a series of upcoming milestones expected to serve as key value-inflection points over the next 12-18 months.

Following significant scientific, regulatory and operational progress, Ernexa is entering a pivotal execution phase as it advances its lead program, ERNA-101, toward a first-in-human clinical trial expected to begin in Q4 2026 for the treatment of platinum-resistant ovarian cancer. The Company is currently completing the final steps required to support an Investigational New Drug (IND) submission in Q3 2026.

ERNA-101 is an engineered synthetic induced-mesenchymal stem cell (iMSC) therapy designed to deliver immune-activating cytokines directly to the tumor microenvironment, with the goal of converting immunologically "cold" tumors into immune-responsive tumors. Recent preclinical data further strengthen the rationale for ERNA-101 as a potential treatment for ovarian cancer. In a syngeneic ovarian cancer model, the combination of an anti-PD-1 mAb plus ERNA-101 demonstrated durable antitumor activity, including high rates of complete tumor regressions, significantly prolonged survival. When combined with PD-1 blockade, ERNA-101 produced markedly enhanced responses compared with either agent alone, supporting its potential to convert immunologically "cold" tumors into responsive tumors and reinforcing the Company's confidence as the program advances toward first-in-human clinical studies.

  • Key Highlights
    • Combination drives high rates of complete tumor regressions and significantly extended survival in aggressive ovarian cancer model, supporting ERNA-101 as a potential foundational immunotherapy platform
    • Company on track to commence first-in-human clinical trials of ERNA-101 in ovarian cancer in Q4 2026