On March 29, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of fibrosis and cancer, reported that it will report the results from its Phase 1 dose-finding trial with novel, tumor selective, anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC) AVID100 at the AACR (Free AACR Whitepaper) Annual Meeting 2019 (Press release, Forbius, MAR 29, 2019, View Source [SID1234534768]). An additional AACR (Free AACR Whitepaper) poster presentation will feature preclinical data confirming AVID100’s novel mechanism of action, which potently targets tumor cells while sparing EGFR-expressing non-tumor cells.
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Details and highlights of the presentations are as follows:
CT056 / 13 – A Phase Ia/IIa trial of AVID100, an anti-EGFR antibody-drug conjugate
Poster presentation: April 1, 8:00 AM – 12:00 PM EDT, Section 17
Author: N. Lakhani
(Abstract available here)
AVID100 was well-tolerated in a Phase 1 dose-escalation study in patients with advanced solid tumors of epithelial origin (any EGFR status)
Most common treatment-related adverse events (TRAEs, in > 25% patients) were rash (66.7%; grade 1 or 2), nausea (41.7%; grade 1 or 2), and fatigue (29.2%; grade 1 or 2)
Recommended Phase 2 dose (RP2D) of 220 mg/m2 (~6 mg/kg) confirmed, one of the highest RP2Ds reported for maytansinoid payload ADCs (Deslandes, 2014)
Phase 2 (AVID100-01; NCT03094169) enrollment ongoing to evaluate AVID100 efficacy, safety, and tolerability in patients with EGFR-overexpressing (IHC 3+) SCCHN and sqNSCLC
218 / 9 – AVID100 is an anti-EGFR ADC that promotes DM1-meditated cytotoxicity on cancer cells but not on normal cells
Poster presentation: March 31, 1:00 PM – 5:00 PM EDT, Section 9
Author: M. Thwaites
(Abstract available here)
AVID100 is highly potent and selectively cytotoxic against EGFR-expressing cancer cells, while sparing normal EGFR-positive keratinocytes
Protection of EGFR-expressing normal cells is shown to be a function of AVID100’s antibody moiety, which inhibits EGFR signaling and proliferation in normal cells
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 RP2D being grade 1 or 2 in severity.
AVID100-01 (NCT03094169) is an open label, multicenter, dose-escalation study to evaluate the safety and efficacy of AVID100 in patients with confirmed EGFR-overexpressing tumors.