VRN11 / Voronoi - LARVOL DELTA

Safety, Pharmacokinetics, and Preliminary Antitumor Activity of VRN110755 in EGFR-Mutated NSCLC (IASLC-WCLC 2026) - "VRN110755 demonstrated dose-proportional PK, and at 320 mg, C trough /IC 50 -based target engagement against common EGFR mutations was approximately 4-fold higher than that observed with osimertinib 80 mg. Particularly, a notable tumor response was observed in the C797S-positive subgroup after prior 3rd-generation EGFR TKI treatment. These data support dose optimization and expansion to define the RP2D and assess POC in groups including C797S-positive patients after third-generation TKI or treatment-naive EGFR-mutated NSCLC with/without brain metastasis."

Clinical • PK/PD data • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR

Early Clinical Evidence of VRN110755: A Novel Brain-Penetrant EGFR TKI Active Across Common, Uncommon, and Resistance EGFR Mutations (ESMO 2026) - No abstract available

Clinical • Oncology

Quantitative Prediction of Progression-Free Survival (PFS) From Early Tumor Response in Non-Small Cell Lung Cancer (IASLC-WCLC 2026) - "When applied to VRN110755, preclinical xenograft data at human-equivalent exposures showed deeper and more durable tumor regression than Osimertinib, with lower residual disease by luciferase imaging. Model-based simulations also support its potential to predict the clinical benefit of VRN110755, a mutant-selective, CNS-penetrant EGFR TKI, and to improve outcomes in resistance-defined subgroups, as well as enhance overall efficacy when incorporated into sequential treatment strategies. These findings highlight its promise as a differentiated therapeutic option in the evolving EGFR TKI landscape."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Voronoi...voluntarily withdrew its application for clinical trial application (CTA) approval in Canada for the Non-small cell lung cancer (NSCLC) treatment candidate “VRN110755“ about a month after filing. (Chosun Biz) - "The move followed a request from Canadian health authorities during the review process to update the investigator's brochure (IB)....Voronoi plans to resubmit the clinical trial plan to Health Canada after supplementing the related materials. This withdrawal is limited to the Canadian CTA application....Voronoi previously obtained approvals for protocol amendments from the Taiwan Food and Drug Administration (TFDA), the Human Research Ethics Committee (HREC) in Australia, the Department of Health (DOH) in Hong Kong, the Health Sciences Authority (HSA) in Singapore, and the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia."

Clinical protocol • New P1/2 trial • Non Small Cell Lung Cancer

A Phase 1/2 Study of VRN110755 in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC) (IASLC-WCLC 2026) - "Introduction : Third-generation EGFR tyrosine kinase inhibitors (TKIs), such as osimertinib, have established a new standard of care for EGFR-mutant non-small cell lung cancer (NSCLC). The primary endpoints are the incidence of DLTs and the overall safety profile. Secondary endpoints include objective response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS), and intracranial efficacy endpoints in patients with brain metastases."

Clinical • First-in-human • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

VRN110755, a Mutant-Selective CNS-Penetrant EGFR TKI, Demonstrates Superior Antitumor Activity Over Osimertinib in EGFR-Mutant NSCLC Models (IASLC-WCLC 2026) - "Its enhanced intracranial efficacy in BM and LM models, combined with deeper tumor responses in SC xenografts, positions VRN110755 as a promising candidate for EGFR-mutant NSCLC, particularly for patients with CNS disease. These findings provide the preclinical rationale for the ongoing and future clinical evaluation of VRN110755."

CNS Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

REACH-EGFR: A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=315 | Recruiting | Sponsor: Voronoi, Inc

First-in-human • New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety and antitumor activity of VRN110755, a brain-penetrant, selective EGFR inhibitor, in patients with EGFR-driven non–small cell lung cancer. (ASCO 2026) - "At 320 mg, target engagement (Ctrough/IC50) against common EGFR mutations exceeded that of osimertinib 80 mg by approximately four-fold. VRN110755 demonstrated favorable PK, a manageable safety profile, and encouraging systemic and CNS antitumor activity in heavily pretreated EGFR-mutant NSCLC, including C797S-positive disease, supporting continued clinical development."

Clinical • CNS Tumor • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755 (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Voronoi, Inc | Recruiting ➔ Completed

Trial completion

VRN110755: A next-generation non-covalent EGFR tyrosine kinase inhibitor for EGFR-mutated NSCLC (AACR 2026) - "VRN110755 demonstrated a favorable safety profile relative to the established safety profile of approved-dose osimertinib. VRN110755 demonstrates promising clinical activity and a favorable safety profile in patients with EGFR-mutated NSCLC, including those harboring resistance-associated EGFR alterations. By targeting key resistance mechanisms while maintaining high potency against activating EGFR mutations, VRN110755 represents a promising next-generation EGFR inhibitor. These findings support further clinical evaluation of VRN110755 both following failure of third-generation EGFR TKIs and in earlier lines of therapy."

Late-breaking abstract • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Voronoi recently presented phase 1 results for VRN11 at the American Association for Cancer Research (AACR2026) meeting in San Diego. (Chosun Biz) - "Partial response (PR), defined as at least a 30% reduction in tumor size, was confirmed in 7 of 8 patients with the EGFRC797S mutation in Non-small cell lung cancer (NSCLC), and the company said every patient dosed at 160 mg or higher achieved PR. Consistent clinical benefit was also observed in patients unresponsive to existing targeted therapies. Based on patients who received an effective dose, the disease control rate (DCR) was 96.8%, and some patients were confirmed to have maintained long-term treatment for more than one year."

P1 data • Non Small Cell Lung Cancer

First-in-human studies of VRN110755 in NSCLC patients with EGFR mutations: Safety, pharmacokinetics, and early efficacy assessment (AACR 2025) - "Tumor assessments showed >40% tumor shrinkage in a patient with a C797S mutation, who had progressed after dacomitinib and osimertinib, after 4 weeks of 40 mg treatment. Additionally, another patient with a Del19 mutation, who had progressed after afatinib and platimum chemotherapy, demonstrated >20 % tumor shrinkage after 3 weeks of 80 mg treatment.These findings strongly support the translation of preclinical data into early clinical outcomes for VRN110755. In conclusion, the preclinical and early clinical outcomes of VRN110755 highlight its potential as a promising therapeutic option that can address unmet medical needs in advanced EGFR mutated NSCLC, including resistance to current standard-of-care therapies and progression with BM/LM."

Clinical • First-in-human • P1 data • PK/PD data • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Voronoi's 4th-gen EGFR candidate VRN11 shows distinct signal beyond Tagrisso (Korea Biomedical Review) - "As of Oct. 2, a total of 53 patients had received doses ranging from 10 mg to 400 mg. Pharmacokinetic analysis showed dose-proportional exposure. Treatment-related adverse events were mostly Grade 1 or 2, with no Grade 3 or higher adverse events or dose-limiting toxicities reported. The most common adverse event was Grade 1 rash (13 percent). No serious toxicities, such as diarrhea, interstitial lung disease, or QTc prolongation, were observed."

P1/2 data • Non Small Cell Lung Cancer

Safety profile and anti-tumor efficacy of VRN110755, a highly selective, brain penetrant EGFR inhibitor for patients with EGFR-driven non-small cell lung cancer (ESMO Asia 2025) - "The target engagement (Ctrough/IC50) of 320mg VRN110755 against EGFR common mutations was 4 times higher than that of 80 mg Osimertinib. In phase 1a study, VRN110755 demonstrates favorable PK, CNS penetration, and a differentiated safety profile. Robust antitumor activity in heavily pretreated, C797S-positive, and/or BM patients, supporting the potential of VRN110755 as a promising best-in-class EGFR inhibitor."

Clinical • Late-breaking abstract • CNS Tumor • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thoracic Cancer

A Phase 1/2 Study of VRN110755 in Patients with Epidermal Growth Factor Receptor (EGFR) Mutant Non‑small Cell Lung Cancer (NSCLC) (AACR-NCI-EORTC 2025) - "The standard of care for patients with EGFR-mutated NSCLC is the use of tyrosine kinase inhibitors (TKIs), such as gefitinib and osimertinib.‎ TKIs block the activity of the mutated EGFR protein, slowing the growth of the cancer cells. Phase 1b/2 will comprise more than three cohorts for patients with advanced NSCLC, including a safety run-in (Phase 1b) for the platinum combination and a dose expansion phase targeting specific patient groups. These groups include second-line treatment patients with the C797S mutation after prior 3rd generation EGFR TKI and treatment- or TKI-naïve patients with atypical EGFR mutations."

Clinical • Late-breaking abstract • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • EGFR

VRN110755 Shows Promise with Improved Efficacy in EGFR mutation NSCLC: Highlighting CNS activity, Potency Against Resistant EGFR Mutations, and a Favorable Safety Profile (AACR-NCI-EORTC 2025) - "Encouragingly, a patient who had progressed with a C797S mutation after osimertinib treatment showed a 51% tumor reduction with 40 mg of VRN110755. VRN110755 demonstrated clinically meaningful antitumor activity and was well-tolerated in patients, even with heavily pre-treated NSCLC harboring EGFR mutations. VRN110755 is anticipated to offer significant advantages over first-, second-, and third-generation EGFR TKIs due to its potential for improved efficacy through high CNS activity, potency against intrinsic/acquired resistant EGFR mutations, and a more favorable safety profile."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • TP53

A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755 (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Voronoi, Inc | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755 (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Voronoi, Inc

New P1 trial

Voronoi, lung cancer new drug 'VRN11' phase 1a presented at AACR [Google translation] (docdocdoc.co.kr) - "Voronoi announced on the 10th that it will present the interim results of the phase 1a clinical trial of 'VRN11', an EGFR non-small cell lung cancer targeted therapy candidate, at the American Association for Cancer Research Annual Meeting (AACR 2025) in April...The presentation will be in poster format at the AACR 2025 Annual Meeting, Chicago, April 25-30."

P1 data • Non Small Cell Lung Cancer

Voronoi withdraws from US phase 1 trial for NSCLC drug (Korea Biomedical Review) - "Voronoi has voluntarily withdrawn its phase 1a/b Investigational New Drug (IND) application for VRN110755 for non-small cell lung cancer (NSCLC) with the U.S. Food and Drug Administration, drawing the industry’s attention. In a public filing on Monday, Voronoi said it voluntarily withdrew its U.S. phase 1a/b IND for VRN110755 last Friday. This comes less than one month after the company filed the IND on June 20....Voronoi explained that the company planned to conduct clinical trials in Korea, Taiwan, and the U.S. simultaneously. Still, the FDA-recommended phase 1a dose groups were larger than in Korea and Taiwan, leading to the voluntary withdrawal of the U.S. clinical application to speed up the trial."

IND • Non Small Cell Lung Cancer

Voronoi “Applies to the U.S. FDA for a clinical plan for lung cancer treatment ‘VRN11’” [Google translation] (Money Today) - "Voronoi...announced on the 20th that it had applied for approval of an IND (clinical trial designation) for non-small cell lung cancer (NSCLC) treatment 'VRN11' from the U.S. Food and Drug Administration (FDA)...Voronoi originally planned to involve U.S. hospitals in phase 1b clinical trials in the second half of this year. However, as the FDA recommended that the 1a clinical trial begin in the United States, the 1a dose-escalation trial is scheduled to be conducted on non-small cell lung cancer patients at a large U.S. hospital sooner than expected."

IND • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Voronoi, will VRN07 receive accelerated approval in 2026? “Aggressive expansion of U.S. clinical trials” [Google translation] (Nate) - "In addition, Oric posted the expected clinical completion date for ORIC-114 as March 2026. In fact, the target date for accelerated approval of ORIC-114 by the U.S. Food and Drug Administration (FDA) is 2026....According to Canter Fitzgerald, an American biotechnology research center, global sales of ORIC-114 (excluding Greater China) are estimated to be up to 900 billion won....On this day, Yuanta Securities suggested a target stock price of 80,000 won for Voronoi, saying that clinical studies of VRN07 and VRN11, two of Voronoi's non-small cell lung cancer treatment candidates, are progressing without problems. In particular, it was explained that the Voronoi target price of 80,000 won only reflected the values ​​of VRN07 and VRN11."

NDA • PDUFA • Sales projection • Stock price • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Voronoi “Non-small cell lung cancer treatment ‘VRN11’ clinical trial underway” [Google translation] (eDaily) - "Voronoi...recently disclosed the clinical status of its main pipeline, 4th generation non-small cell lung cancer (NSCLC) treatment 'VRN11', to correct misinformation...According to Voronoi on the 8th, the VRN11 clinical trial is progressing without a hitch. Voronoi completed its first administration last month along with the registration of patients participating in phase 1 clinical trials targeting patients with advanced or metastatic solid tumors at a domestic clinical site. In Korea, VRN11 clinical trials are being conducted at four hospitals, including Samsung Seoul Hospital, Seoul National University Bundang Hospital, Catholic University St. Vincent's Hospital, and Chungbuk National University Hospital....In the case of clinical trials in Taiwan, the goal is to administer the drug in the first half of the year, and the clinical site is being expanded from 2 hospitals to 4 hospitals. The U.S. clinical trial is in discussion with four hospitals with the..."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Voronoi, a new lung cancer drug candidate, cruises through clinical trials side by side… Expectations rise in a virtuous cycle [Google translation] (Nate) - "According to Voronoi on the 18th, the company is preparing to administer patients in the phase 1 clinical trial of 'VRN11', a candidate for the treatment of non-small cell lung cancer (NSCLC)...The clinical trial will begin at four domestic institutions, including Samsung Seoul Hospital, and will be conducted on approximately 50 patients in Taiwan and the United States. In particular, we plan to obtain the results of Phase 1a within the year and apply for a US IND to join the Phase 1b phase in the second half of the year."

IND • New P1 trial • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Voronoi approves phase 1 clinical trial plan for lung cancer new drug candidate in Taiwan [Google translation] (HIT News) - "Voronoi...has approved an clinical trial designation (IND) for the non-small cell lung cancer (NSCLC) new drug candidate 'VRN11 (development code name)' currently under development from the Taiwan Food and Drug Administration (TFDA), following Korea last year. It was announced on the 31st that it had been received...'VRN07 (ORIC-114)', a treatment for EGFR Exon20 INS mutant non-small cell lung cancer....Positive interim results from phase 1 clinical trials have been announced. Oric plans to expand the number of patients to 280 and begin phase 2b clinical trials to apply for accelerated approval next year."

Enrollment status • New P1 trial • Regulatory • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor