(March 7, 2018) Formation Biologics, a clinical stage biopharmaceutical company, today announced that its anti-EGFR antibody-drug conjugate program, AVID100, had been selected for an oral presentation at the 16th Targeted Anticancer Therapies (TAT) International Congress. The conference is organized by ESMO and is a premier conference for presenting Phase 1 oncology trial data.
The presentation, entitled “A Phase 1a/2a trial of AVID100, an anti-EGFR antibody-drug conjugate”, highlighted the status of the ongoing AVID100 clinical trial. The study is currently evaluating patients in Cohort 7 (270 mg/m2). In Cohorts 1-6, AVID100 has been well-tolerated with no cycle 1 dose limiting toxicities (DLTs). PK results from these cohorts demonstrate that exposure levels of AVID100 have been reached that exceed therapeutic levels predicted from preclinical studies. In addition, the AVID100 exposure levels observed in the higher dose cohorts are similar or above those reported for ado-trastuzumab emtansine (T-DM1) on its FDA-approved schedule, exposures which were associated with significant anti-cancer activity for T-DM1. Efficacy of AVID100 will be evaluated in the Phase 2a portion of the study in EGFR-overexpressing patients with breast cancer, squamous carcinoma of head and neck, and other tumor types.
About AVID100 and the Phase 1a/2a Clinical Trial
AVID100 is an antibody-DM1 conjugate targeting the EGFR, a cell surface protein that is overexpressed by multiple cancer types. The conjugate is being evaluated in a Phase 1a/2a multicenter, open-label, dose-escalation, cohort study. The Phase 1a dose escalation portion enrolls patients with documented solid tumor malignancies of epithelial origin that are locally advanced or metastatic, and either refractory to standard therapy or for whom no standard therapy is available. The Phase 2a portion of the study will enroll patients with confirmed high expression of EGFR (IHC 3+) in cohorts of breast cancer, squamous carcinoma of head and neck, and other tumor types. See NCT03094169 for additional details.
About Formation Biologics
Formation Biologics is a clinical stage pharmaceutical company that engineers novel biotherapeutics. Our mission is to transform the lives of patients affected by life-threatening diseases. Based on a deep understanding of the biology of rare diseases, including molecularly-defined cancers, heritable disorders and pediatric diseases, Formation Biologics identifies therapeutic targets that are central to the disease process. Subsequently, our scientists apply advanced protein engineering methods to design biotherapeutics that are positioned to become the new standard of care.