Abion revealed on November 6 that it received the phase 1 Clinical Study Report (CSR) for ‘Vabametkib (ABN401)’ conducted in Korea, the U.S., and Australia. The trial targeted patients with advanced solid tumors and non-small cell lung cancer (NSCLC).
This phase 1 clinical trial was split into two cohorts: a dose-escalation cohort involving 16 patients with advanced solid tumors and a pilot expansion cohort with 8 patients suffering from NSCLC. The results showed no cases of dose-limiting toxicity (DLT) or death, and there were no instances of peripheral edema of grade 3 or higher, which is commonly associated with c-MET inhibitors. In addition, laboratory tests revealed no specific factors that could jeopardize the safety of the subjects, confirming the safety profile of Vabametkib.
“We met the objectives of the phase 1 clinical trial by confirming Vabametkib’s excellent safety and tolerability,” an Abion official explained. “We also secured efficacy data for c-MET mutant NSCLC and pharmacodynamic analysis results, which provide the necessary information for designing the phase 2 clinical trial.”
Currently, Vabametkib is progressing smoothly in phase 2 clinical trials, with positive safety evaluations due to the relatively low incidence of serious adverse events compared to other competing drugs.
“We expect to continue treatment without dose reductions or interruptions, which will improve patient compliance and treatment continuity,” the official further commented. “We plan to conduct a study on combination therapy with ‘Lazertinib,’ a third-generation EGFR TKI, in an additional cohort during phase 2 clinical trials. We plan to expand the indications to other solid cancers beyond NSCLC. We will focus on clinical trials to further increase its potential as a best-in-class novel drug.”
Conversely, Abion has signed a supply agreement with Janssen, a Johnson & Johnson (J&J) affiliate, for a clinical trial of Lazertinib in combination with Vabametkib and is preparing to submit an investigational new drug (IND) application.
Published by: www.thebionews.net/news/articleView.html?idxno=10283
