vabametkib (ABN401) / Abion - LARVOL DELTA

Vabametkib in MET exon 14 skipping non-small-cell lung cancer: Efficacy and safety from the open-label, phase 2, cohort-1 trial. (ASCO 2025) - P2 | "Vabametkib demonstrates good antitumor activity in pts with METex14 NSCLC, and better toxicity profile with excellent tolerability, compared to FDA-approved MET inhibitors, supporting vabametkib continued clinical development for METex14 NSCLC pts."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Phase 2 cohort-2 trial in progress: Vabametkib plus lazertinib for patients with EGFR-mutant NSCLC who developed resistance to 1st-line, 3rd-gen-EGFR TKIs via C-Met dysregulation. (ASCO 2025) - P2 | "Recently, lazertinib, combined with amivantamab, has been approved as a potential first-line therapy for NSCLC. Key secondary endpoints include objective response rate (ORR), disease control rate (DCR), progression free survival (PFS) and duration of response (DOR). Additionally, safety and patient-reported outcome will be evaluated."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Next-gen Korean cancer fighters to showcase innovation at ASCO 2025 (Korea Biomedical Review) - P2 | N=178 | NCT05541822 | Sponsor: Abion Inc | "Abion will present results from a phase 2 study of ABN401, a MET-selective inhibitor under investigation in MET-altered non-small cell lung cancer. The drug showed an ORR of 43.2 percent and a disease control rate (DCR) of 97.3 percent in monotherapy."

P2 data • Non Small Cell Lung Cancer

[ASCO] Abion unveils Phase 2 trial results for 'vabametkib' monotherapy in cancer treatment (BioNews) - P2 | N=178 | NCT05541822 | Sponsor: Abion Inc | "In the trials, the vabametkib monotherapy group demonstrated an objective response rate (ORR) of 43.2% and a disease control rate (DCR) of 97.3%. Notably, 43% of patients exhibited a partial response (PR), underscoring the substantial therapeutic efficacy of vabametkib as a monotherapy....The company particularly noted the high partial response (PR) rate observed among patients who had previously received first-line treatment with 'Keytruda (pembrolizumab),' a PD-1/PD-L1-targeting immune oncology agent....'We will also present the 'Trial in Progress' data for the ongoing combination therapy cohort (Cohort 2) at ASCO'..."

P2 data • Trial status • Non Small Cell Lung Cancer

To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation (clinicaltrials.gov) - P2 | N=178 | Recruiting | Sponsor: Abion Inc | N=40 ➔ 178 | Trial completion date: Aug 2025 ➔ Feb 2029 | Trial primary completion date: Apr 2025 ➔ Feb 2029

Enrollment change • Trial completion date • Trial primary completion date • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor • MET

Abion Announces DDI Analysis of Vabametkib and Lazertinib Combination at AACR…Safety Proven [Google translation] (HIT News) - P=NA | N=NA | "Abion...announced on the 22nd that it will additionally disclose the results of the drug interaction (DDI) analysis of the combination of its MET inhibitor candidate 'Vabametkib (ABN401)' and the 3rd generation targeted therapy 'Lazertinib' targeting EGFR mutation at the '2025 American Association for Cancer Research (AACR 2025)' to be held in Chicago, USA from the 25th to the 30th....According to the DDI analysis results disclosed in this AACR presentation, the drug interaction between Vabametkib and lazertinib was minimal, and the possibility of changes in drug efficacy or unexpected adverse reactions when co-administered was low. This is the basis for supporting the high safety and convenience of drug management as a combination therapy, and is expected to increase the possibility of utilization in actual clinical settings in the future."

Clinical data • Non Small Cell Lung Cancer

Vabametkib plus lazertinib shows promising antitumor activity in advanced NSCLC with MET amplification resistant to 3rd-gen EGFR-TKIs (AACR 2025) - P1 | "The ABN401-003 trial, a phase-2 study comprising cohort-2, is an open-label, multicenter investigation aiming to assess the efficacy and safety in patients who have experienced progression on 1st line 3rd-Gen EGFR-TKIs. Cohort-2 consists of three parts: Part 1 (safety run-in), Part 2 (a randomized dose optimization), and Part 3 (a randomized clinical trial comparing the optimal dose of vabametkib in combination therapy with standard of care)."

Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Abion, Russian Pharmaceutical Company Signs Term Sheet for Babamekib Technology Export [Google translation] (HIT News) - "Abion announced on the 1st that it signed a term sheet (Memorandum of Understanding) for the technology export of its non-small cell lung cancer treatment drug 'Vabametkib (ABN401, Vabametkib)' with a global pharmaceutical company headquartered in Russia. The contract area is Russia and four Commonwealth of Independent States (CIS) countries....In addition, the term sheet includes not only Babameqib monotherapy but also combination therapy with Yuhan Corporation's Lazertinib, and various indications such as hepatocellular carcinoma (HCC), gastric cancer, and glioblastoma (GBM)."

Commercial • Gastric Cancer • Glioblastoma • Hepatocellular Cancer • Non Small Cell Lung Cancer

Abion files IND for phase 2 clinical trial of glioblastoma treatment [Google translation] (HIT News) - "Abion announced on the 6th that it submitted an Investigational New Drug (IND) phase 2 clinical trial plan for 'Vabametkib (ABN401), a treatment for glioblastoma (GBM), to the Ministry of Food and Drug Safety....The clinical subjects are 26 patients with high-grade glioma (HGG) with MET gene alterations, and the objective response rate (ORR) will be evaluated according to the Response Evaluation in Neuro-Oncology (RANO) 2.0 criteria."

IND • New P2 trial • Glioblastoma

Abion, approval for change in clinical plan [Google translation] (HIT News) - "On the 14th, the company announced that it received approval for a change in the phase 2 clinical trial of c-MET targeted anticancer drug vabametkib (ABN401) from the Ministry of Food and Drug Safety. The phase 2 clinical trial cohort 2 for which the change approval was applied is explained to be for patients who showed MET overexpression or amplification among patients who showed resistance to EGFR targeted anticancer drugs, and to confirm the safety, efficacy, and tolerability, etc. by co-administering the EGFR targeted anticancer drug lazertinib and the MET targeted anticancer drug vabametkib. It was added that the target number of subjects is 138, and the expected end date is December 31, 2027."

Trial completion date • Trial status • Solid Tumor

To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Harboring c-MET Dysregulation (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Abion Inc | Recruiting ➔ Completed | N=78 ➔ 24

Enrollment change • Trial completion • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • MET

c-MET Inhibitor in Advanced Solid Tumors With c-MET Gene Aberration (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Yonsei University | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment open • Metastases • Pan tumor • Trial completion date • Trial primary completion date • Endometrial Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • MET

Abion Announces Pipeline Performance at ’China Bio’ and Expands Global Partnership [Google translation] (Pharm News) - "Abion announced on the 9th that it will attend the global healthcare conference 'China Bio'. China Bio will be held in Shanghai, China on the 10th and 11th, and EDB Group, which hosts global conferences such as Bio Europe and Bio Asia, will be the host this time as well. Abion was selected as the Presenting Company for this conference. It will present its research and development results for major pipelines such as Vabametkib (ABN401)...to global pharmaceutical and bio industry officials and institutional investors. It also plans to hold business development (BD) partnering meetings with a number of multinational companies."

Clinical data • Oncology

[ESMO 2024] Abion "Vabametkib, Valid Patient Selection Biomarker Confirmed" [Google translation] (Hankyung) - P=NA | N=NA | "'We have confirmed that tracking circulating tumor cells (CTCs) in the blood to find patients with MET overexpression is a good tool for selecting patients for combination therapy with Babamekib and Leclaza'...Abion presented the results of a study that confirmed MET mutations using CTCs of patients with EGFR mutation non-small cell lung cancer....'This study confirmed that we can find MET mutation patients early because we confirmed that when the number of CTCs in the blood increases, the prognosis worsens and EGFR is no longer effective'."

Biomarker • Clinical data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Abion, 'Babamekip' combination clinical competitiveness strengthened liquid biopsy' ESMO abstract adopted [Google translation] (Yakup Shinmoon) - "Abion announced on the 2nd that the abstract of the liquid biopsy study to strengthen the clinical competitiveness of combination therapy with babamekip (ABN401) was accepted by the European Society for Medical Oncology (ESMO 2024)."

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

Abion is in the final stages of patient registration for the phase 2 clinical trial of vabametkib and is “promoting accelerated approval from the FDA” [Google translation] (Medipana) - "Abion announced on the 17th that it has entered the final stages of patient registration for the phase 2 clinical trial of vabametkib (ABN401)...The company said, 'After registering around 10 patients at the end of last year, the number of patients has increased rapidly over the past 6 months,' and added, 'Once we have recruited 40 patients and secured efficacy data, we plan to discuss with the Ministry of Food and Drug Safety for domestic conditional approval.'"

Trial status • Oncology • Solid Tumor

Abion unveils phase 2 cut-off results for vabametkib and combination strategy with lazertinib at ASCO 2024 (Korea Biomedical Review) - "In addition to vabametkib, Abion presented the clinical design for a combination therapy involving vabametkib and Johnson & Johnson’s lazertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The first patient enrollment is anticipated in the fourth quarter of this year....Abion also introduced ABN501, the only existing Claudin-3 protein antibody, currently in the preclinical stage and under a joint research partnership with the National Cancer Institute (NCI)...An investigational new drug (IND) application for ABN501 is planned for submission in the second half of next year. In addition, Abion showcased its novel antibody-cytokine fusion protein (ACFP) platform technology, ABN 202."

IND • New trial • Preclinical • Oncology • Solid Tumor

Abion unveils phase 2 cut-off results for vabametkib and combination strategy with lazertinib at ASCO 2024 (Korea Biomedical Review) - P2 | N=40 | NCT05541822 | Sponsor: Abion Inc | "Abion’s vabametkib demonstrated a favorable safety and response profile, positioning itself as a potential global best-in-class treatment. Notably, treatment-related adverse events (TRAE) greater than Grade 3 were reported in only 10 percent of patients...The phase 2 trial data revealed an objective response rate (ORR) of 54 percent and a median progression-free survival (mPFS) of 11.6 months....Vabametkib's promising results were further underscored by a case where tumor size was reduced by approximately 90 percent within 16 days of administration under the Expanded Access Program (EAP) granted by the Ministry of Food and Drug Safety."

P2 data • Oncology • Solid Tumor

Industry Expert Theater: Vabametkib (ABN401): An Overview of Phase 2 Clinical Efficacy and Safety in Non-Small Cell Lung Cancer (NSCLC) Patients with MET Exon 14 (METex14) Skipping (ASCO 2024) - "Join us for an overview of ABION's NSCLC pipeline, highlighting Vabametkib (ABN401), a MET-targeting TKI. This session will detail Vabametkib's antitumor activity and exceptional safety profile demonstrated in Phase 2 clinical trial for patients with MET Exon 14 skipping mutations."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Vabametkib (ABN401): An Overview of Phase 2 Clinical Efficacy and Safety in Non-Small Cell Lung Cancer (NSCLC) Patients with MET Exon 14 (METex14) Skipping (ASCO 2024) - "Sponsored by ABION Inc."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

[ET Lasciro] Telcon RF Pharmaceutical becomes Abion’s largest shareholder… Stock price rises together [Google translation] (ET news) - "Telcon RF Pharmaceuticals purchased additional Abion common stocks through a block deal (after-hours bulk trading) on ​​this day, and now holds a total of 4,486,274 shares (20.37% stake)...A Telcon RF Pharmaceutical official said, 'We decided to acquire additional shares because we judged that the possibility of a large-scale technology transfer contract for ABN401 (c-MET targeting anticancer drug), Abion’s main pipeline, was becoming visible,'....'In addition to ABN401, we will secure various technologies and maximize synergies, including the next-generation platform technology ‘ABN202’, which is being developed based on ACFP (antibody-cytokine fusion protein) platform technology.'"

Licensing / partnership • Oncology • Solid Tumor

Abion announces phase 2 clinical trial cutoff for ‘Babamekip’ at ASCO [Google translation] (HIT News) - "Abion...announced on the 8th that it will announce the phase 2 clinical cutoff results of 'Babamekip (development code name ABN401)' at the American Society of Clinical Oncology (ASCO 2024)...Abion plans to attend the 'IET (Industry expert theater)', a presentation session by corporate experts, and make an 'oral presentation' on the results of Babamekip's phase 2 clinical trial. IET is a presentation program where global pharmaceutical companies disclose their research and development (R&D) pipelines and clinical results....ASCO plans to release the updated phase 2 clinical trial results."

P2 data • Oncology • Solid Tumor

Abion “Non-small cell lung cancer treatment ‘Babamekip’, two additional Phase 2 clinical centers added” [Google translation] (HIT News) - "Abion...announced on the 28th that two clinical implementation institutions have been added for the phase 2 clinical trial of 'Babamekip (development code name ABN401)', a non-small cell lung cancer treatment drug. The added clinical institutions are Yonsei University Severance Hospital and Seoul Boramae Hospital. With the addition of this clinical institution, Abion will conduct phase 2 clinical trials at 20 global institutions, including a total of 11 in Korea, 6 in Taiwan, and 3 in the United States. In the United States, the first patient registration for phase 2 clinical trials was completed at the MD Anderson cancer center last year. The strategy is to speed up global patient registration and clinical trials and also actively pursue licensing out (L/O)."

Trial status • Non Small Cell Lung Cancer

To Evaluate the Safety, Pharmacokinetic and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Abion Inc | Recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Harboring c-MET Dysregulation (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Abion Inc | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • MET