SEOUL, South Korea & BOSTON--(BUSINESS WIRE)--ABION (KOSDAQ: 203400) today released data from an ongoing Phase 2 trial of ABN401, the company’s wholly owned tyrosine kinase inhibitor intended to treat adult patients with advanced non-small cell lung cancer that exhibit the MET Exon 14 skipping mutation. In eight treatment-naïve patients, the objective response rate was 75% (6/8), and in the evaluable population of 17 patients, the objective response rate was 52.9% (9/17).
Patients were dosed 800 mg QD and the median duration of response was 5.4 months as of the data cut-off on July 25, 2023. The data are not mature enough to measure progression-free survival and duration of response. All patients are MET inhibitor naïve. Overall efficacy was comparable to currently marketed drugs and demonstrate superior efficacy in treatment-naïve patients.
The cut-off data reaffirm ABN401’s excellent safety profile as shown in an earlier Phase 1 trial. A total of 24 patients received ABN401 800 mg QD, including 17 METex14 NSCLC patients. Of 24 patients evaluable for safety, 2 (8.3%) experienced grades ≥3 treatment-related adverse events (TRAE). The most common treatment-related adverse events were nausea (70.8%), vomiting (29.2%), and diarrhea (33.3%). Grade ≥3 treatment-emergent adverse events occurred in 20.8% (5/24) patients. Treatment-related adverse events leading to permanent discontinuation occurred in none of the patients (0/24). Peripheral edema was observed in 29.2% (grade 1-2) and there was no grade 3 or greater event in all safety-evaluable populations, and 17.6% (grade 1-2) and 0% (grade 3) in METex14 NSCLC population. None of the patients discontinued treatment due to SAE or TRAE.
For the 17 METex14 NSCLC patients, one was not evaluable because the patient had not had the first tumor assessment at the time of the data cut-off. The median age is 69 (41-81) and 70.6% were male, with 1 (0-3) as the median prior lines of treatment. 41.2% of 17 patients were non-smokers and 58.8% were smokers. ABN401 continued to demonstrate outstanding safety compared to the currently marketed drugs.
The results were presented in a poster session at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, and at a separate company event nearby.
“We are delighted to see the outstanding data from the global Phase 2 clinical trial to evaluate this potential best-in-class treatment, which continues to exhibit an outstanding safety profile,” said Young Kee Shin, M.D., Ph.D., CEO of ABION. “Notably, these results follow and further expand the potential of ABN401 combination therapy with other treatment regiments. “The excellent safety enables the potential combination of ABN401 with EGFR treatment, chemotherapy, or KRAS or immuno-oncology treatments. Our goal is to increase options for patients with c-MET positive NSCLC.”
Based on these results, ABION plans to initiate a Phase 2 combination trial with a multiple drug regimen. The c-MET mutation is the most common mutation shown by NSCLC patients after treatment with EGFR TKIs.
ABION (KS 203400) is the Korean biopharma that brings a pioneering spirit to targeted cancer therapeutics and infectious diseases. ABION’s lead candidate, ABN401, is a MET tyrosine kinase inhibitor in a Phase 2 clinical trial for patients with c-MET positive non-small cell lung cancer. The company has 12 drug candidates in its R&D pipeline, including ABN501, the novel antibody therapeutics for solid tumor and ABN101, a prophylactic anti-viral in delivered via inhaler for broad-spectrum protection against respiratory viruses. With offices in Seoul, Korea, and San Diego, ABION intends to bring more treatment options to patients with life-threatening disease. Learn more here.
ABN401 is the small molecule which specifically inhibit the phosphorylation site of c-MET tyrosine kinase. In Phase 1 clinical trial, ABN401 demonstrate 0 patients with G3 or higher treatment-related adverse events and no dose-limiting toxicity. 2 partial responses confirmed NSCLC MET overexpression in patients in a dose escalation study, and 2 partial responses confirmed in NSCLC MET exon 14 skipping patients in an expansion study. ABN401 is currently in a Phase 2 trial. Recently released cut-off data from the Phase 2 study, which target the MET exon 14 skipping patients, confirmed ABN401’s superior safety profile.
About ABION’s Phase 2 clinical trial of ABN401 (NCT05541822)
ABION’s Phase 2 clinical trial of ABN401 is a Multicenter, Open-Label, Parallel Cohort Expansion Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients with Advanced Solid Tumors Harboring c-Mesenchymal-epithelial Transition Factor (c-MET) Dysregulation. Patients were treated with ABN401 800mg once daily oral tablets. The trial was enrolled in 13 centers in South Korea, Taiwan and the U.S.