On May 28, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that it has obtained approval from Health Canada to conduct Phase 2 clinical trials evaluating AVID100, a novel anti-EGFR antibody drug conjugate (ADC), in EGFR-overexpressing squamous cell carcinoma of the head and neck (SCCHN), squamous non-small cell lung cancer (sqNSCLC) and triple negative breast cancer (TNBC) (Press release, Forbius, MAY 28, 2019, View Source [SID1234536623]).

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AVID100-01 (NCT03094169) is a Phase 2, open label, multicenter study to evaluate the safety and efficacy of AVID100 in up to 100 SCCHN, sqNSCLC and TNBC patients with confirmed EGFR-overexpression. The trial is currently enrolling patients at centers in the U.S. and will be expanding to additional clinical sites in Canada.

Preclinical data demonstrated AVID100 to be highly potent and selectively cytotoxic against EGFR-expressing cancer cells while sparing normal keratinocytes. A Phase 1 dose-escalation study in patients with advanced solid tumors of epithelial origin confirmed that AVID100 was well tolerated and established an RP2D of 220 mg/m2 (~6 mg/kg), which is expected to be in the therapeutically active range and is one of the highest RP2Ds reported for ADCs with maytansinoid payload.

Approximately 20–25% of patients with SCCHN, sqNSCLC and TNBC have tumors that highly overexpress EGFR. No targeted therapy is approved for these indications with confirmed EGFR-overexpression.

About AVID100 and the AVID100-01 Trial
AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and 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.

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).