On April 9, 2026 Aveta Biomics, together with researchers from the VA Greater Los Angeles Healthcare System (VAGLAHS), reported new Phase 2A subpopulation data for APG-157 in head and neck squamous cell carcinoma (HNSCC) from patients at one of the clinical trial sites, which will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.
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HNSCC is a disease with limited durable treatment options, driven by multiple biological mechanisms, including persistent HPV16 infection in a growing subset of patients and chronic NF-κB-mediated immune suppression across the broader population. APG-157, an oral immunotherapy, is designed to address these drivers simultaneously.
The new analysis reveals distinct yet complementary effects across patient subpopulations. In HPV-positive patients, APG-157 reduces HPV16 expression in both tumor tissue and saliva, supporting antiviral activity. Across the broader population, treatment is associated with activation of systemic immune responses, including expansion of B and T cells.
These preliminary translational findings contain TWO CLINICALLY SIGNIFICANT observations that, to our knowledge, no therapy in HNSCC has previously reported. First, it showed a reduction in HPV viral load, addressing the root viral driver of disease in HPV-positive patients. Second, activation of gigaxonin and its downstream modulation of Snail and E-cadherin, pointing to a novel mechanism for reducing metastatic potential. While the confirmation in larger studies is the next step, these findings point to mechanisms of real clinical significance.
"The multiple mechanisms of action of APG-157 demonstrate strong potential, particularly in head and neck cancers that respond poorly to currently available chemotherapy and immunotherapy agents," said Dr. Marilene Wang, Professor of Head and Neck Surgery at the David Geffen School of Medicine at UCLA and lead investigator.
"APG-157 appears to activate gigaxonin, a novel regulator linked to NF-κB degradation, and modulates EMT markers with decreased Snail and increased E-cadherin, consistent with a less invasive, lower-metastatic-risk phenotype," added Dr. Eri S. Srivatsan, professor of surgery and senior Author at the David Geffen School of Medicine at UCLA and VAGLAHS.
These findings build on data previously presented at ASCO (Free ASCO Whitepaper) 2025 and ESMO (Free ESMO Whitepaper) 2025, adding further mechanistic depth to the emerging clinical profile.
The implications of these early observations may extend beyond HNSCC. HPV16 is a key driver of multiple anogenital cancers globally, and NF-κB activation is a hallmark across many solid tumors.
"These early findings of reduced HPV viral load may extend to other HPV-driven cancers, including cervical cancer. The observed shift toward a less invasive phenotype also suggests broader potential across solid tumors where reducing metastatic risk remains a key unmet need," said Dr. Selda Samakoglu, Chief Medical Officer of Aveta Biomics.
PRESENTATION DETAILS
• Title: Downregulation of HPV 16 and NF-κB and upregulation of gigaxonin and immune markers in APG-157 treated head and neck cancer: A phase 2A clinical investigation
• Presenter: Dr. Saroj Basak, Research Scientist, VAGLAHS
• Session: Biomarkers Predictive of Therapeutic Benefit
• Date: April 21, 2026
• Time: 9:00 AM – 12:00 PM
• Location: Section 42
(Press release, Aveta Biomics, APR 9, 2026, View Source [SID1234664535])