Simcha Therapeutics Presents Preclinical Data Demonstrating Potential for Decoy-Resistant IL-18 to Enhance Efficacy of Bi-specific T-cell Engagers

Findings presented at European Society for Medical Oncology include models in solid tumors and hematologic malignancies

SOUTH SAN FRANCISCO, Calif., and NEW HAVEN, Conn., Oct. 21, 2025 (GLOBE NEWSWIRE) — Simcha Therapeutics (“Simcha”), a clinical-stage immunobiology company pioneering first-in-class cytokine treatments for cancer, today announced the presentation of preclinical results which demonstrate enhanced efficacy from combining decoy-resistant IL-18 (DR-18), ST-067, with bispecific T-cell engagers (BiTEs) in multiple solid and hematologic cancer models. The presentation, titled “Decoy-resistant IL-18 combination with bispecific T-cell engager enhances anti-tumor efficacy,” was delivered at the European Society for Medical Oncology (ESMO) Congress.

Data presented at the conference showed that adding ST-067 to treatment with BiTEs enhanced tumor growth inhibition without observed weight loss, compared to treatment with BiTEs alone. Positive results were observed across models of solid and hematologic malignancies, including melanoma and humanized models of colorectal cancer and B-cell acute lymphoblastic leukemia. ST-067 also demonstrated potential to induce immunological memory that inhibited tumor growth upon re-challenge, compared with an untreated control group.

“The findings presented at ESMO further strengthen our confidence that decoy-resistant IL-18 has the unique potential to act as a universal T-cell enhancer across treatment modalities,” said Sanuj Ravindran, M.D., chief executive officer of Simcha Therapeutics. “We look forward to advancing collaborations to evaluate ST-067 in combination with bispecific therapies, while also continuing our development efforts integrating ST-067 with additional forms of T-cell mediated therapeutics.”

ST-067 is the first decoy-resistant variant of IL-18, designed to be impervious to the decoy receptor IL-18BP, which prevents IL-18 from binding to its receptor. As the most clinically advanced engineered IL-18 agonist, ST-067 is currently being evaluated in multiple clinical studies, as monotherapy post hematopoietic stem cell transplant, and in combination with CAR-T cell therapy.

About Simcha Therapeutics
Simcha Therapeutics is a clinical-stage immunobiology company pioneering the development of first-in-class engineered cytokine therapeutics with transformational promise for patients. The company is built on a foundation of scientific rigor to overcome biological challenges in clinically translatable pathways, exemplified by the first decoy-resistant interleukin-18 (IL-18). By unlocking the potential of IL-18, Simcha is focused on advancing therapeutic approaches that enhance efficacy of T-cell mediated therapies. Its lead program, ST-067 is currently being evaluated in multiple clinical studies in solid tumors and hematologic malignancies. Simcha is partnered with Janssen Biotech for development of CAR-T cell therapies armored with decoy-resistant IL-18, while exploring additional T-cell enhancement modalities for IL-18-based therapeutics to capture the full potential of this best-in-class cytokine. For more information, please visit www.simchatherapeutics.com.

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