Voronoi Demonstrates VRN11's Potential as a Next-Generation EGFR Lung Cancer Drug at ESMO Asia 2025
2025.12.08
■ VRN11 draws attention from the global oncology community for high target selectivity and outstanding CNS penetration
■ VRN11 set to enter clinical trials as a first-line treatment option
Voronoi announced on the 8th that VRN11, the next-generation EGFR lung cancer targeted therapy it is developing, is attracting strong interest in the global lung cancer drug development field, having demonstrated excellent target selectivity, outstanding CNS (central nervous system) penetration, and a favorable safety profile in recently presented clinical data.
Voronoi announced that it presented the Phase 1 results of VRN11 at the ESMO Asia Congress 2025, held in Singapore from December 5 to 7.
The congress was the first occasion at which the clinical potential of VRN11 was shared with oncology experts from Korea and abroad, and the drug's efficacy and safety drew attention from clinical investigators.
Professor Myung-Ju Ahn of the Division of Hematology-Oncology at Samsung Medical Center took the stage as the speaker at the oral presentation held on the 6th. Professor Ahn is an internationally recognized clinical investigator in the field of lung cancer who has played a leading role in numerous clinical trials of EGFR targeted therapies, including Tagrisso (osimertinib).
Photo caption: Professor Myung-Ju Ahn presenting VRN11 Phase 1 data at the ESMO Asia Congress 2025
Professor Ahn assessed that VRN11 at 320 mg shows four times higher target engagement than Tagrisso, the existing third-generation EGFR lung cancer targeted therapy, and therefore has ample potential as a first-line treatment option. She went on to state that, as the next stage of clinical development, the company plans to initiate a clinical trial in treatment-naïve patients.
Experts are paying particular attention to VRN11's CNS penetration. According to the Phase 1 data presented, not a single case of CNS metastasis progression was reported among patients dosed with VRN11 at 160 mg or higher. Considering that brain metastases commonly occur during treatment with existing EGFR targeted therapies, this is regarded as a highly encouraging result.
Professor James Chih-Hsin Yang of the Department of Oncology at National Taiwan University, who participated as a principal investigator in the global approval process for Tagrisso, commented, "VRN11 showed drug concentrations in the brain 1.7 to 2.6 times the blood concentration in a non-clinical monkey model, and CNS penetration at about twice the blood concentration was also confirmed in the Phase 1 trial."
Professor Yang added, "The fact that consistent data have been obtained across the cell, animal, and preclinical stages provides strong support for the future clinical development strategy of VRN11."
Meanwhile, Voronoi plans to enter a TKI-naïve clinical trial in patients with EGFR mutation lung cancer accompanied by CNS metastases, based on the Phase 1 data.
■ VRN11 set to enter clinical trials as a first-line treatment option
Voronoi announced on the 8th that VRN11, the next-generation EGFR lung cancer targeted therapy it is developing, is attracting strong interest in the global lung cancer drug development field, having demonstrated excellent target selectivity, outstanding CNS (central nervous system) penetration, and a favorable safety profile in recently presented clinical data.
Voronoi announced that it presented the Phase 1 results of VRN11 at the ESMO Asia Congress 2025, held in Singapore from December 5 to 7.
The congress was the first occasion at which the clinical potential of VRN11 was shared with oncology experts from Korea and abroad, and the drug's efficacy and safety drew attention from clinical investigators.
Professor Myung-Ju Ahn of the Division of Hematology-Oncology at Samsung Medical Center took the stage as the speaker at the oral presentation held on the 6th. Professor Ahn is an internationally recognized clinical investigator in the field of lung cancer who has played a leading role in numerous clinical trials of EGFR targeted therapies, including Tagrisso (osimertinib).
Photo caption: Professor Myung-Ju Ahn presenting VRN11 Phase 1 data at the ESMO Asia Congress 2025
Professor Ahn assessed that VRN11 at 320 mg shows four times higher target engagement than Tagrisso, the existing third-generation EGFR lung cancer targeted therapy, and therefore has ample potential as a first-line treatment option. She went on to state that, as the next stage of clinical development, the company plans to initiate a clinical trial in treatment-naïve patients.
Experts are paying particular attention to VRN11's CNS penetration. According to the Phase 1 data presented, not a single case of CNS metastasis progression was reported among patients dosed with VRN11 at 160 mg or higher. Considering that brain metastases commonly occur during treatment with existing EGFR targeted therapies, this is regarded as a highly encouraging result.
Professor James Chih-Hsin Yang of the Department of Oncology at National Taiwan University, who participated as a principal investigator in the global approval process for Tagrisso, commented, "VRN11 showed drug concentrations in the brain 1.7 to 2.6 times the blood concentration in a non-clinical monkey model, and CNS penetration at about twice the blood concentration was also confirmed in the Phase 1 trial."
Professor Yang added, "The fact that consistent data have been obtained across the cell, animal, and preclinical stages provides strong support for the future clinical development strategy of VRN11."
Meanwhile, Voronoi plans to enter a TKI-naïve clinical trial in patients with EGFR mutation lung cancer accompanied by CNS metastases, based on the Phase 1 data.