Voronoi announced on the 20th that it has applied for approval from the U.S. Food and Drug Administration (FDA) for the Phase 1 clinical trial plan of VRN11, a treatment for non-small cell lung cancer.
VRN11 has already received approval for Phase 1 clinical trial plans from the Korea Ministry of Food and Drug Safety and the Taiwan Food and Drug Administration (TFDA). Voronoi originally planned to start the U.S. clinical trials from Phase 1b (dose expansion study) scheduled for the second half of this year, but changed the plan after the FDA recommended conducting the trials from Phase 1a (dose escalation study) in the U.S.
Through this multinational clinical trial, Voronoi plans to verify the efficacy of VRN11 in patients with EGFR C797S mutation cancer, which arises due to drug resistance to existing epidermal growth factor receptor (EGFR) mutation non-small cell lung cancer treatments such as Tagrisso. In preclinical trials, VRN11 demonstrated excellent efficacy and low toxicity related to various EGFR mutations, including primary cancers such as EGFR C797S, L858R, and Del19, as well as a brain penetration rate reaching 100%.
Daegwon Kim, Head of Research at Voronoi, said, “Following the FDA’s recommendation, we plan to start U.S. clinical trials from Phase 1a,” adding, “We will do our best to proceed with the clinical development of VRN11, which surpasses the limitations of existing treatments, so that lung cancer patients and their families worldwide can be relieved from pain and burden as soon as possible.”
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