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).<\/p>\n
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.<\/p>\n
“We met the objectives of the phase 1 clinical trial by confirming Vabametkib\u2019s 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.”<\/p>\n
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.<\/p>\n
“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.”<\/p>\n
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.<\/p>\n