https://www.hankyung.com/it/article/202305118801i
ABION, a precision oncology drug development company (CEO Shin Young Khee, KRX 203400), announced its participation in the “2023 American Society of Clinical Oncology (ASCO)” conference, which will be held in Chicago, USA from June 2nd to 6th.
In April, ABION’s non-small cell lung cancer drug ‘ABN401’ pilot expansion clinical study abstract was accepted for ASCO 2023. Last year, ABION presented the CSR of the phase 1 dose escalation cohort of ‘ABN401’ at ASCO. This year, the company released the efficacy and safety results of ‘ABN401’ from the pilot cohort.
The pilot expansion cohort for ‘ABN401’ is a clinical study designed to predict the trends of phase 2. After confirming safety and determining the dosage in the phase 1 dose escalation cohort, ‘ABN401’ demonstrated excellent safety and efficacy with two partial responses (PR). Subsequently, in the pilot expansion cohort, ‘ABN401’ at the same dosage as phase 2 was administered to non-small cell lung cancer patients with c-MET exon 14 mutation to predict the trends of phase 2. As a result, the company obtained data confirming efficacy, safety, and tolerability from the same patient population as phase 2.
Currently, the company is conducting global phase 2 clinical trials of ‘ABN401’ as a targeted therapy for c-MET exon 14 gene skipping mutation in non-small cell lung cancer in the United States and Korea. Based on the outstanding efficacy results confirmed in the pilot expansion cohort, the company is accelerating patient recruitment for phase 2. In particular, the company reported cases of partial response (PR) observed in early-treated patients in phase 2, with no grade 3 or higher adverse events reported. Considering that grade 3 or higher adverse events occur on average in 10-20% of approved c-Met drugs, the company’s therapy has been evaluated to have secured competitiveness.
An ABION representative stated, “Last year, we received a positive response at ASCO based on the excellent safety results from the global phase 1 trial of ‘ABN401.’ With the announcement of the pilot expansion cohort results, we anticipate a favorable response and high expectations for the success of global phase 2.” They further added, “Since the ongoing global phase 2 trial maintains the trends observed in the pilot expansion cohort, we are confident in the competitiveness of ‘ABN401’ in technology transfer discussions.”
