Forbius initiates Phase 2a trial evaluating efficacy, safety of AVID100 in patients with squamous NSCLC

Forbius, a clinical stage company developing biotherapeutics targeting EGFR and TGF-β pathways, today announced that the first patient has been dosed in a Phase 2a trial evaluating the efficacy and safety of AVID100 in patients with squamous non-small cell lung cancer (sqNSCLC) whose tumors overexpress epidermal growth factor receptor (EGFR).

Approximately 25% of patients with sqNSCLC have tumors that highly overexpress EGFR. Currently, no therapy is approved for the treatment of EGFR-overexpressing sqNSCLC.

An initial safety Phase 1 study for AVID100 was completed mid 2018, having enrolled 24 patients, and established a recommended Phase 2 dose (RP2D) of AVID100 of 240 mg/m2 (~6 mg/kg). This is one of the highest RP2Ds reported for maytansinoid payload ADCs (Deslandes, MAbs. 2014 Jul 1; 6(4): 859-870) and is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events at RP2D were well-tolerated and grade 1 and 2 in severity. Of note, skin-related side-effects, that have been observed previously for therapeutic anti-EGFR antibodies, remained low grade and well tolerated.

"The sqNSCLC trial, along with additional soon-to-be launched Phase 2a trials, will provide us with important information about the efficacy of AVID100 in patients with confirmed EGFR overexpression. No therapy is approved for the treatment of EGFR-overexpressing malignancies, and AVID100 could be the first agent to address this significant unmet medical need," commented Paul Nadler, M.D., Chief Medical Officer of Forbius.

The primary goal of the Phase 2a trial is to evaluate efficacy, safety, and tolerability of AVID100 when administered to sqNSCLC patients with confirmed EGFR-overexpression. The study is being conducted at multiple sites across North America and will initially enroll approximately 15 sqNSCLC patients who failed all prior lines of treatment. The number of patients will be increased pending preliminary signs of AVID100 efficacy. This Phase 2a study is being supported by the previously announced $18.8M peer-reviewed grant from the Cancer Prevention Institute of Texas (CPRIT).