Voronoi announced on the 31st that its 'VRN11', being developed as a treatment for non-small cell lung cancer (NSCLC), received IND approval from the Taiwan Food and Drug Administration (TFDA) on the 29th, following the approval of the clinical phase 1 trial plan (IND) from the Korea Food and Drug Administration last October.
The phase 1 clinical trial of VRN11 is divided into two stages. First, through the dose-escalation study 1a phase, the maximum tolerated dose and dose-limiting toxicity of the drug will be confirmed. Patient dosing will soon begin at four institutions in Korea, including Samsung Seoul Hospital, and clinical trials will also be conducted at two institutions in Taiwan.
Next, through the dose-expansion study 1b phase, the optimal therapeutic dose ensuring efficacy, safety, and tolerability will be determined. During this stage, an IND will be submitted to the U.S. Food and Drug Administration (FDA) in the second half of the year to conduct clinical trials in the U.S. as well.
In preclinical trials, VRN11 demonstrated high activity against various EGFR mutations, including primary and rare mutations such as EGFR C797S mutation, L858R, and Del19. It was also explained that the brain penetration rate reaches 100%, suggesting excellent efficacy in patients with brain metastases.
Daegwon Kim, Head of Research at Voronoi, said, “We are striving to proceed with the clinical schedule without delay to alleviate the suffering of patients' families as soon as possible,” and added, “In addition to clinical drugs, we are preparing new pipelines in various fields.”
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