Voronoi Applies for Phase 1 Clinical Trial Approval for NSCLC Treatment
The innovative drug design company Voronoi, led by CEO Kim Dae-kwon and Kim Hyeon-tae, has submitted an application for approval of the phase 1 clinical trial design (IND) for VRN11, a potential treatment for non-small cell lung cancer (NSCLC), to the Food and Drug Safety Administration. This marks an important step forward in Voronoi’s mission to develop precision targeted therapies.
The objective of the phase 1 clinical trial is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of VRN11 in NSCLC patients with an epidermal growth factor receptor (EGFR) mutation. By conducting these trials, Voronoi aims to gain valuable insights into the therapeutic potential of VRN11 for those affected by this specific type of lung cancer.
The phase 1 clinical trials for VRN11 will be carried out at around 10 distinguished medical institutions in Korea, the United States, and Taiwan, involving approximately 50 NSCLC patients. In addition to evaluating safety parameters such as adverse patient events, this study will also assess key efficacy indicators including the objective response rate (ORR), progression-free survival (PFS), and intracranial response rate.
One of the major benefits anticipated from VRN11 clinical trials is the verification of its therapeutic effects on non-small cell lung cancer patients with an EGFR C797S mutation. This specific mutation often leads to resistance to existing drug treatments. Notably, VRN11 has demonstrated 100% brain permeability (Kp, uu, brain) in pre-clinical experiments, suggesting its potential effectiveness in treating metastatic brain cancer, a condition that affects nearly half of NSCLC patients with small EGFR.
“VRN11 exhibits strong activity not only against the EGFR C797S mutation but also against primary cancers with Del19, L858R, and specific mutations. Thus, it holds promise for expanded indications,” commented Voronoi Research Division’s CEO, Kim Dae-kwon. “With the successful clinical outcomes of VRN11, we hope to alleviate the suffering of EGFR mutated NSCLC patients as soon as possible.”
In the upcoming months, Voronoi plans to present the preclinical data for VRN11 at the prestigious World Society of Lung Cancer (IASLC WCLC 2023) conference.
Voronoi (CEO Kim Dae-kwon, Kim Hyeon-tae), a company specializing in drug design for precision targeted therapy, applied for phase 1 clinical trial design (IND) approval for VRN11 (development code name), a candidate for non-small cell lung cancer (NSCLC) treatment, to the Food and Drug Safety Administration Posted on the 28th.
Voronoi aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of VRN11 in non-small cell lung cancer patients with an epidermal growth factor receptor (EGFR) mutation through this phase 1 clinical trial.
Phase 1 clinical trials of VRN11 are scheduled to be conducted in approximately 50 non-small cell lung cancer patients at approximately 10 institutions in Korea, the United States, and Taiwan. In phase 1 clinical trials, efficacy indicators such as objective response rate (ORR), progression-free survival (PFS), and intracranial response rate are evaluated as well as safety, such as adverse patient events.
Through clinical trials, the company can confirm the therapeutic effect of VRN11 on patients with EGFR C797S mutant non-small cell lung cancer, which is caused by resistance to existing drug treatments. In particular, VRN11 confirmed 100% brain permeability (Kp, uu, brain) in pre-clinical experiments, and is expected to be effective in the treatment of metastatic brain cancer, which affects about half of non-small cell lung cancer patients. small EGFR.
“VRN11 has strong activity not only in EGFR C797S but also in primary cancers (Del19, L858R and specific mutations), so it is expected to expand the indications,” said Kim Dae-kwon, CEO of Voronoi Research Division. “With the clinical success of VRN11, EGFR mutated NSCLC We hope patients will be pain free as soon as possible.”
Meanwhile, the company plans to disclose VRN11 preclinical data at the World Society of Lung Cancer (IASLC WCLC 2023) in the second half of the year.
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