APG-157

Global Phase 3 study of first oral immunotherapy designed to work independent of PD-L1 across “hot” and “cold” tumors in locally advanced head and neck cancer BEDFORD, MA, UNITED STATES, March 24, 2026 / EINPresswire.com / -- Aveta Biomics, a clinical stage biotechnology company developing first-in-class therapies designed to reprogram the immune system to fight cancer, today announced that its Trial-in-Progress abstract for the registrational Phase 3 study of APG-157 in head and neck squamous cell carcinoma (HNSCC) has been selected for a podium presentation at the American Head and Neck Society (AHNS) 12th International Conference, to be held July 18–22, 2026 in Boston, Massachusetts. The study, titled “A Multicenter Phase III Study Assessing Neoadjuvant APG-157 in Resectable HNSCC and Induction plus Maintenance APG-157 in Unresectable HNSCC,” will be presented by Jonathan D. Schoenfeld, MD, MPhil, MPH , Professor of Radiation Oncology at Harvard Medical School and Director of Head & Neck and Melanoma Radiation Oncology at Dana-Farber Brigham Cancer Center. The AHNS International Conference , the largest and the most prominent global meeting in head and neck cancer, draws approximately 2,000 specialists. Podium presentations are reserved for abstracts selected by an independent scientific review committee as particularly important to the field. Selection at this level, typically associated with more established pharmaceutical programs, reflects recognition of this novel therapy, the study’s clinical relevance and potential to influence the standard of care. APG-157 is an oral immunomodulatory therapy designed to reprogram the tumor microenvironment. Unlike current immunotherapies that rely on pre-existing immune activation and PD-L1 expression, APG-157 acts upstream to enable immune engagement independent of PD-L1 status and across both immunologically “cold” and “hot” tumors. This approach is particularly relevant in HNSCC where many patients remain underserved due to biologic resistance and limited response to existing therapies. The registrational, randomized Phase 3 trial builds on Phase 2 findings previously presented at ASCO and ESMO, where APG-157 monotherapy demonstrated encouraging signals in event-free survival, disease control, ctDNA clearance, tumor reduction, and a favorable safety profile with no Grade ≥3 treatment-related adverse events. This study will evaluate APG-157 as a neoadjuvant therapy in surgically resectable patients and as induction plus maintenance therapy in surgery-ineligible patients. More than 50 clinical centers have confirmed participation with additional centers expected to join this global trial. The study addresses areas of substantial unmet need, including patients who are not eligible for PD-1–based therapies and treatment settings in which no approved induction immunotherapy currently exists. “In head and neck cancer, outcomes depend not only on tumor control, but also on preserving function and quality of life,” said Selda Samakoglu, MD, PhD, Chief Medical Officer of Aveta Biomics. “APG-157 modulates the tumor microenvironment to broaden immune engagement beyond patients who benefit from current therapies. This Phase 3 trial will evaluate how an oral immunotherapy approach can improve disease control and survival in curative-intent settings while maintaining a favorable safety profile in a population with significant unmet need.” Head and neck cancer is associated with substantial morbidity and mortality due to lack of durable benefit, biological resistance or treatment-related toxicity. New approaches such as APG-157 that enhance curative-intent therapy while preserving tolerability are a priority for patients and clinicians. PRESENTATION DETAILS • Session Name: Proffered Papers 44 – Novel Diagnostics and Systemic / Immunotherapy • Date: Tuesday, July 21, 2026 • Time: 3:30 PM – 5:00 PM • Location: Boston Convention and Exhibition Center, Boston, MA ABOUT AVETA BIOMICS Aveta Biomics is a clinical-stage biotechnology company developing a new class of oral immunomodulatory therapies designed to reprogram the tumor microenvironment and improve outcomes across multiple cancers. Its lead program, APG-157, is being evaluated in a global Phase 3 trial for head and neck cancer. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those regarding the impact of the Fast Track Designation, the progress of our clinical trials, potential regulatory approvals, the development and commercial success of our drug candidates, and our strategic goals, reflect our current expectations and involve risks and uncertainties. Actual results may differ materially due to factors such as our ability to advance drug candidates through development and regulatory approval, clinical trial outcomes, competition, and economic conditions. Words like “may,” “will,” “could,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. We caution you not to place undue reliance on these statements, which speak only as of the date they are made. As a private company, we are under no obligation to publicly update or revise any forward-looking statements to reflect new information or future events, except as required by applicable law. Hema Gandhi Aveta Biomics, Inc. email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

ESMO data illuminate APG-157’s immune-modulating mechanism in Head and Neck Cancer ahead of the upcoming Phase 3 trial and its broad therapeutic potential BEDFORD, MA, UNITED STATES, October 13, 2025 / EINPresswire.com / -- Aveta Biomics, a clinical-stage biotechnology company developing first-in-class drugs that reprogram the immune system to fight cancer, today announced 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) Congress, taking place October 17–21, 2025, in Berlin, Germany. 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 immune-cold 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. ABOUT AVETA BIOMICS, INC Aveta Biomics is a clinical-stage biotechnology company committed to developing multi-targeted oral immunotherapies that reprogram the immune system for safe and durable cancer control based on mimicking the functions of the body’s endogenous metabolites and processes. The company’s lead candidate, APG-157, is advancing toward registrational development in head and neck squamous cell carcinoma and is being evaluated across additional immune-cold tumor types, including high-grade adult glioma, such as Glioblastoma , with preclinical studies also underway in pediatric glioma. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those regarding the impact of the Fast Track Designation, the progress of our clinical trials, potential regulatory approvals, the development and commercial success of our drug candidates, and our strategic goals, reflect our current expectations and involve risks and uncertainties. Actual results may differ materially due to factors such as our ability to advance drug candidates through development and regulatory approval, clinical trial outcomes, competition, and economic conditions. Words like “may,” “will,” “could,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. We caution you not to place undue reliance on these statements, which speak only as of the date they are made. As a private company, we are under no obligation to publicly update or revise any forward-looking statements to reflect new information or future events, except as required by applicable law. Hema Gandhi Aveta Biomics, Inc betterhealth@avetabiomics.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.