On April 22, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that the first patient has been dosed in a Phase 2a triple negative breast cancer (TNBC) clinical trial with AVID100, a novel, tumor-selective anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC) (Press release, Forbius, APR 22, 2019, View Source [SID1234535316]).

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Approximately 20% of TNBC patients have tumors that highly overexpress EGFR. No targeted therapy is approved for EGFR-overexpressing TNBC.

The multicenter, dose-expansion Phase 2a trial (AVID100-01; NCT03094169) will evaluate the efficacy, safety, and tolerability of AVID100 in patients with advanced, EGFR-overexpressing TNBC (IHC 2+/3+). This is the third cohort that has been launched and follows the previously announced cohorts evaluating AVID100 in patients with advanced squamous non-small cell lung cancer (sqNSCLC) and squamous cell carcinoma of the head and neck (SCCHN). In total, approximately 100 patients will be evaluated across three EGFR-overexpressing tumor types: sqNSCLC, SCCHN, and TNBC.

About AVID100 and the AVID100-01 Trial
AVID100 is a highly potent EGFR-targeting ADC engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity in skin or other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity in EGFR-overexpressing tumor models resistant to marketed EGFR inhibitors. AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development and targets both wild-type and mutant forms of EGFR.

A recommended Phase 2 dose (RP2D) of 220 mg/m2 (~6mg/kg) was established for AVID100 in a completed Phase 1 study. This RP2D is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment-related adverse events in the Phase 1 trial at the RP2D were well-tolerated and grade 1 or 2 in severity.

AVID100-01 (NCT03094169) is an open-label, multicenter, dose-expansion study to evaluate the efficacy, safety, and tolerability of AVID100 in patients with confirmed EGFR-overexpressing sqNSCLC (IHC 3+), SCCHN (IHC 3+), and TNBC (IHC 2+/3+) (more than 50% of cells with EGFR 3+ or more than 75% of cells with EGFR 2+ staining).