Ernexa Therapeutics Inc. (NASDAQ:ERNA) on Wednesday said an independently conducted preclinical study validated the anti-tumor activity of its lead cell therapy candidate, ERNA-101, when combined with PD-1 checkpoint inhibition, reinforcing earlier findings.
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The cell therapy company prepares for an Investigational New Drug application later this year.
According to the company, the independent study reproduced previous research conducted at The University of Texas Anderson Cancer Center in a larger cohort, demonstrating complete tumor clearance and durable long-term survival.
Ernexa said the findings provide third-party support for ERNA-101’s mechanism of action, as it targets an IND submission in the third quarter of 2026 and plans to begin a first-in-human phase one clinical trial in the fourth quarter.
Combination Therapy Outperformed Other Treatment Groups
In the study, ERNA-101 combined with anti-PD-1 therapy produced complete tumor clearance and long-term survival in 10 of 15 treated animals, representing a 67% response rate.
The company said none of the remaining 45 animals treated with ERNA-101 alone, anti-PD-1 therapy alone, or left untreated achieved complete tumor clearance or durable survival, suggesting the anti-tumor effect was unique to the combination therapy.
Earlier Research Supports Mechanism of Action
The company said earlier studies at The University of Texas Anderson Cancer Center showed that ERNA-101 selectively homes to ovarian tumors and delivers its engineered IL-7/IL-15 fusion cytokine directly into the tumor microenvironment.
According to Ernexa, the localized immune response increased infiltration of cancer-fighting T cells into tumors that typically evade immune detection, providing the rationale for pairing ERNA-101 with PD-1 checkpoint inhibitors.
The newly completed independent study reproduced those findings and again showed that complete tumor clearance and durable long-term survival occurred only in the combination therapy group, further supporting the proposed synergy between ERNA-101 and PD-1 blockade.
ERNA Stock Price Activity: Ernexa Therapeutics shares were up 7.43% at $6.51 at the time of publication on Wednesday, according to Benzinga Pro data.
Image via Shutterstock/ K_E_N
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