Data supports further evaluation of investigational antisense OT‑101 (trabedersen) as a TGFB2‑targeted approach in pancreatic ductal adenocarcinoma.

SAN DIEGO, Calif., July 17, 2025 (GLOBE NEWSWIRE) -- Sapu Biosciences, LLC (Sapu), a wholly owned subsidiary of GMP Biotechnology Limited (GMP Bio), in collaboration with Oncotelic Therapeutics, Inc. (OTCQB: OTLC) (Oncotelic), a clinical‑stage biopharmaceutical company developing RNA‑targeted and small‑molecule therapeutics for cancer and rare diseases, today highlighted the publication of new translational research evaluating TGFB2 expression and promoter methylation as potential prognostic markers in pancreatic ductal adenocarcinoma (PDAC). The article, “TGFB2 Expression and Methylation Predict Overall Survival in Pancreatic Ductal Adenocarcinoma Patients,” appears in the International Journal of Molecular Sciences (IJMS). The work involved investigators affiliated with Sapu.

Access the publication: DOI 10.3390/ijms26136357 (open access via IJMS).

Study Highlights

Clinical data from the OT‑101 P001 PDAC study suggest targeting TGFB2 merits additional evaluation in younger patients; in a treated subset characterized by low IL‑6, median OS was 12.7 months.†

Investigator Commentary

“These findings give clinicians a practical way to stratify patients and design more precise, age focused trials, an urgently needed step toward improving outcomes in this notoriously lethal disease. OT-101, TGFB2 targeted approach deserves testing in randomized clinical trials,” said Professor Wasif Saif, MD, co-author of the study and Director of Eisenberg Center for Translational Therapeutics and Co-director of gastro-enterology Oncology Program at Karmanos Cancer Institute. He further added. “Analysis shows that high TGFB2 expression was significantly associated with reduced overall survival (OS) in patients under 65 (TGFB2 high median vs. low median OS: 17.9 vs. 66.9 months) but not in older cohorts. Moreover, elevated TGFB2 methylation showed improved survival in younger patients (high methylation vs. low methylation median OS: 66.9 vs. 17.9 months). Also, our clinical data from a Pancreatic Ductal Adenocarcinoma trial using OT-101, an antisense oligonucleotide targeting TGFB2, supported these findings that young patients treated with OT-101 showed improved OS compared to untreated controls. TGFB2 is not just another biomarker; its expression clearly delineates a younger subset of pancreatic cancer patients experiencing far poorer survival, and a patient population challenging clinicials more commonly over the last few years.”

† Source: Company materials and the IJMS publication, TGFB2 Expression and Methylation Predict Overall Survival in Pancreatic Ductal Adenocarcinoma Patients (Saif et al. 2025).

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