EPI-326 / EpiBiologics - LARVOL DELTA

EPI-326: a clinical stage mutation-independent and normal tissue-sparing bispecific antibody that degrades EGFR for the treatment of EGFR-driven solid tumors (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Bispecific • Clinical • Oncology • Solid Tumor • EGFR

EPI-326: A Mutation-Independent and Normal Tissue-Sparing Bispecific Antibody That Degrades EGFR for the Treatment of EGFR-driven Solid Tumors (IASLC-WCLC 2026) - P1 | "EPI-326 represents a promising and differentiated novel therapeutic approach to address the limitations of current EGFR drugs. The first-in-human phase I study is enrolling to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of EPI-326 in patients with advanced/metastatic EGFR mutant NSCLC and HNSCC (NCT07462377)."

Bispecific • First-in-human • Colorectal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Targeted Protein Degradation • EGFR

EPI-326: A novel mutation-independent and normal tissue-sparing EGFR bispecific antibody that degrades EGFR for the treatment of EGFR-driven solid tumors (AACR 2026) - "EPI-326 represents a promising and differentiated novel therapeutic approach to address the limitations of current EGFR drugs. An IND was submitted in early 2026 and the first-in-human Phase I study is expected to start in the first half of 2026 to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of EPI-326 in patients with advanced/metastatic EGFR mutant NSCLC and HNSCC."

Bispecific • First-in-human • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

EpiBiologics Doses First Patient with EPI-326 Bispecific Antibody in Global Phase 1 Study for EGFR-Driven Solid Tumors (Businesswire) - "The Phase 1 study (NCT07462377) is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of EPI-326 as a monotherapy in patients with advanced NSCLC and HNSCC. The study is currently enrolling patients at sites in the U.S. and is planned to initiate sites in the Asia-Pacific region, including South Korea."

First-in-human • Trial status • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: EpiBiologics | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: EpiBiologics

First-in-human • New P1 trial • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

EpiBiologics Extracellular Protein Degraders Demonstrate Robust Preclinical Anti-tumor Activity and Survival Benefit (Businesswire) - "EpiBiologics...is presenting data today on its EpiTAC protein degraders in oncology demonstrating robust in vivo anti-tumor activity and survival benefit....These data are being presented this morning at the American Association for Cancer Research (AACR) Annual Meeting 2024....EpiTACs drove robust in vitro tumoricidal activity in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) models, independent of KRAS or EGFR mutational status. In vivo tumor models demonstrated EpiTACs degraded mutant EGFR and disrupts downstream signaling, suppressing tumor growth and increasing survival beyond osimertinib standard of care."

Preclinical • Non Small Cell Lung Cancer