Health Canada Clears Forbius’ AVID100 to Commence Phase 2 Clinical Trials

Jennifer Schram Portfolio News, Forbius

Austin, TX and Montreal, QC (May 28, 2019) – Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, announced today 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).

  • Expansion of ongoing AVID100 Phase 2 trials in patients with SCCHN, sqNSCLC and TNBC who overexpress EGFR to include clinical sites in Canada
  • AVID100 is the most advanced and broadly active anti-EGFR ADC in clinical development, targeting both wild-type and mutant forms of EGFR
  • Recommended Phase 2 dose (RP2D) of 220 mg/m(~6 mg/kg) q3w, one of the highest amongst ADCs in development and predicted to be in therapeutic range

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.

Related Article: Forbius’ AVID200, a Novel TGF-beta 1 & 3 Inhibitor, Cleared by Health Canada to Commence Phase 1 Clinical Trial in Solid Tumors

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/m(~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).

About Forbius: Targeting TGF-beta and EGFR Pathways in Fibrosis and Cancer

Forbius is a clinical-stage protein engineering company that designs and develops novel biologics for the treatment of fibrosis and cancer. Our current focus is the development of agents targeting the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

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