VRN11 / Voronoi - LARVOL DELTA

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

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 • P1 data • PK/PD data • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

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

Voronoi, core pipeline VRN11 finally takes off… Anticipation ‘soothing’ [Google translation] (Money Today) - "Last October, the Phase 1 clinical trial plan (IND) was approved by the Ministry of Food and Drug Safety (MFDS), effectively entering clinical development....Voronoi...is conducting a clinical trial on about 50 non-small cell lung cancer patients at home and abroad to confirm the effect of VRN11 on EGFR (epithelial growth factor receptor) C797S mutation cancer patients. It was announced on the 17th....It is planned to be developed as a drug to treat Tagrisso-resistant patients and brain metastatic non-small cell lung cancer patients."

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

Voronoi, the reason why we are paying attention to the VRN11 clinical trial with ‘100% brain penetration’ [Google translation] (Money Today) - "Voronoi announced on the 26th that it has received approval for a phase 1 clinical trial (IND) for VRN11 from the Ministry of Food and Drug Safety (MFDS)....Voronoi will begin a global phase 1 clinical trial of VRN11 targeting approximately 50 EGFR-mutated non-small cell lung cancer patients at 10 institutions in Korea, Taiwan, and the United States. Through this, the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor effects of VRN11 are evaluated. This multicenter clinical trial will be conducted in two parts: a dose escalation test and a dose expansion test."

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

Voronoi participates in Amgen Networking Day…“High interest from global big pharma companies such as VRN11” (Sedaily) - "Voronoi announced on the 18th that he was invited to a networking event hosted by the Ministry of Health and Welfare and co-hosted by the Korea Health Industry Development Institute and Amgen Korea and held at the Seoul Health Industry Promotion Agency Innovation and Startup Center on the 14th. At the event attended by Amgen's R&D and business development (BD) senior executives, Voronoi announced the development of new drugs based on artificial intelligence (AI) along with core pipelines such as VRN11, an EGFR mutation inhibitor for non-small cell lung cancer, and VRN10, a breast cancer HER2-positive protein inhibitor."

Clinical • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Voronoi paid-in capital increase success…KRW 61.3 billion will be spent on clinical trials for new lung cancer drugs [Google translation] (News1 Korea) - "Voronoi (310210)'s paid-in capital increase through shareholder allocation was a box office success, achieving better-than-expected results. The amount of financing increased from KRW 45 billion to KRW 61.3 billion as the issuance price of new shares increased...With funding secured, the development of 'VRN11', a new drug candidate for EGFR C797S mutated non-small cell lung cancer, and 'VRN10', a new drug candidate for HER2 mutated breast cancer, is expected to proceed until 2025...Voronoi plans to conduct phase 1 clinical trials of VRN11 in the second half of this year....The VRN10 phase 1a clinical trial is expected to be conducted on a total of 21 people in Korea."

Financing • New P1 trial • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

VRN110755, A New Therapeutic Option for EGFR Mutation-Driven NSCLC with Brain Metastasis or 1st-line Osimertinib-Resistant EGFR Mutations (IASLC-WCLC 2023) - "Afatinib has been treated for these uncommon mutations, but it has tolerability limitations due to a low margin against wild-type EGFR...Lastly, although osimertinib has shown promising results in patients with brain metastases (BM), BM patients with intrinsic and acquired osimertinib-resistant EGFR mutations are left with no treatment options.Here, we report nonclinical data of VRN10755, a brain permeable and EGFR mutant selective inhibitor that can overcome these limitations. VRN110755 kinase selectivity was confirmed by KINOMEscan... Nonclinical data of VRN110755 showed anti-tumor efficacy against EGFR common mutations (Del19 and L858R), uncommon, and resistance mutants for 1st-line osimertinib (C797S) in both subcutaneous and intracranial in vivo models, with enough therapeutic window. Therefore, VRN110755 can be considered a potential treatment option for EGFR mutation-driven NSCLC patients with brain metastasis or 1st-line osimertinib-resistant EGFR mutations..."

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

Voronoi unveils ’VRN11’, a new non-small cell lung cancer treatment drug, at the World Lung Cancer Society for the first time [Google transition] (HIT News) - "Voronoi...will unveil its non-small cell lung cancer treatment candidate 'VRN11 (development code name)' for the first time at the World Congress on Lung Cancer (WCLC 2023), which will be held in Singapore from the 9th to the 12th of next month (local time) 30 the day said....At this World Lung Cancer Society, preclinical data including the excellent efficacy of VRN11 in relation to various EGFR mutations, including primary cancers such as C797S and Del19, and brain permeability reaching 100% level will be released."

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

Voronoi, non-small cell lung cancer treatment VRN11 phase 1 IND application [Google translation] (PRESS9) - "Voronoi announced on the 28th that it had applied for approval of a clinical trial plan (IND) for VRN11, a non-small cell lung cancer (NSCLC) treatment, to the Ministry of Food and Drug Safety. Voronoi has applied for approval of a phase 1 clinical trial plan to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of VRN11 in epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer patients.... Voronoi plans to disclose VRN11's preclinical data at the World Lung Cancer Society (IASLC WCLC 2023) in the second half of the year."

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

VRN11, Brain Permeable EGFR inhibitor with High Efficacy against Activating Mutations and Osimertinib-Resistant Mutations (AACR-NCI-EORTC 2022) - No abstract available

Clinical • Oncology

Voronoi's NSCLC drug candidate to get state financial support (Korea Biomedical Review) - "Voronoi said Friday that its next-generation non-small cell lung cancer (NSCLC) drug candidate, VRN11, has been selected as a new non-clinical support project by the Korea Drug Development Fund (KDDF). Voronoi will receive 1.2 billion won ($920,000) in full-time research and development expenses for VRN11 over the next two years....Voronoi plans to disclose its VRN11 preclinical research data for the first time at the American Association for Cancer Research (AACR) in October."

Financing • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology