On October 13, 2025 Aveta Biomics, a clinicalstage biotechnology company developing first-in-class drugs that reprogram the immune system to fight cancer, reported the poster presentation of new clinical and translational findings from its Phase IIa study of APG-157 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place October 17–21, 2025, in Berlin, Germany (Press release, Aveta Biomics, OCT 13, 2025, View Source [SID1234656579]).
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The company’s poster will highlight data from patients with head and neck squamous cell carcinoma (HNSCC) treated with oral APG-157 as neoadjuvant or induction monotherapy. The results provide the first detailed mechanistic evidence of how APG-157 reshapes the immunecold tumor microenvironment (TME) into an immune-engaged, "hot" state correlating with the observed Event-Free Survival (EFS) outcomes.
"These translational data provide unprecedented insight into APG-157’s multi-axis immune reprogramming in head and neck cancer," said Selda Samakoglu, M.D., Ph.D., Chief Medical Officer of Aveta Biomics. "They reveal how APG-157 orchestrates effector and helper T-cell coordination, collapses PD-L1⁺ epithelial barriers, and repolarizes suppressive macrophages. This mechanism appears to drive the durable responses observed in our Phase IIa study and reinforces the rationale for advancing APG-157 as a monotherapy into our registrational Phase III trial next year."
"The implications of these findings extend well beyond head and neck cancer," added Luis Avila, Ph.D., Chief Scientific Officer of Aveta Biomics. "The broad immune remodeling coupled with the excellent safety profile observed in Phase IIa defines a new therapeutic paradigm. These results support APG-157’s potential as a PD-1–independent, oral immunotherapy capable of producing durable responses across multiple tumor types and enhancing the effectiveness of existing immunotherapies."
PRESENTATION DETAILS:
TITLE: Spatial Profiling of Immune Architecture Reveals APG-157-Induced Anti-Tumor Immune Remodeling in Locally Advanced Head and Neck Cancer
ABSTRACT NUMBER: 1401P
SESSION TITLE: Head and Neck Cancer, excluding Thyroid
LOCATION: Messe Berlin, Poster Area, Hall 25
SESSION DATE AND TIME: Monday, October 20, 2025, 9:00 AM – 12:45 PM
PRESENTERS: • Daniel S. Shin, MD, PhD, Associate Professor, Hematology-Oncology, Baylor College of Medicine, Houston, Texas • Selda Samakoglu, MD, PhD, Chief Medical Officer, Aveta Biomics, Inc.