On April 9, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that Dr. Maureen O’Connor-McCourt, Chief Scientific Officer of Forbius, will be presenting an overview of AVID100, a novel, tumor-selective, anti-EGFR antibody-drug conjugate (ADC), at PEGS Boston’s 9th Annual Clinical Progress of Antibody-Drug Conjugates (Press release, Forbius, APR 9, 2019, View Source [SID1234535091]).
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Details and highlights of Dr. O’Connor-McCourt’s presentation:
Discovery of Next-Generation ADCs: Preclinical and Clinical Development of AVID100, an EGFR-Targeting ADC
Presentation Friday, April 12th at 11:35 AM ET, Harborview 1 & 2
AVID100 is highly potent and selectively cytotoxic against EGFR-expressing cancer cells, while sparing normal EGFR-positive keratinocytes
AVID100 was well-tolerated in a Phase 1 dose-escalation study in patients with advanced solid tumors of epithelial origin (any EGFR status)
Only modest skin toxicity observed, in line with preclinical findings
Phase 2 trial (AVID100-01; NCT03094169) ongoing to evaluate AVID100 efficacy, safety, and tolerability in patients with EGFR-overexpressing (IHC 3+) SCCHN and sqNSCLC
About AVID100 and the AVID100-01 Trial
AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) that was 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, including in EGFR-overexpressing tumor models that are resistant to marketed EGFR inhibitors. AVID100 is the only anti-EGFR ADC in clinical development that targets both wild-type and mutant forms of EGFR.
In a successfully completed Phase 1 study, AVID100 reported a recommended Phase 2 dose (RP2D) of 220 mg/m2 (~6mg/kg), which is expected to be in the therapeutically active range based on preclinical efficacy studies. Treatment was generally well-tolerated, with the majority of treatment-related adverse events in the Phase 1 trial at the RP2D being grade 1 or 2 in severity.
AVID100-01 (NCT03094169) is an open label, multicenter study to evaluate the efficacy, safety, and tolerability of AVID100 in patients with confirmed EGFR-overexpressing tumors (more than 50% of cells with EGFR 3+ or more than 75% of cells with EGFR 2+ staining by a validated immunohistochemistry assay).