vabametkib (ABN401) / Abion - LARVOL DELTA

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

Abion applies for orphan drug designation for lung cancer targeted therapy 'Babamekip' to the U.S. FDA [Google translation] (HIT News) - "Abion...announced on the 25th that it had submitted an orphan drug designation (ODD) application for 'Babamekip (development code name ABN401)' to the U.S. Food and Drug Administration (FDA)...Babamekip is a hepatocyte growth factor receptor (c-MET) mutation targeting treatment for non-small cell lung cancer."

Orphan drug • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A new trial activated at MDACC https://classic.clinicaltrials.gov/ct2/show/NCT05541822?term=abion&draw=2&rank=1 A novel MET TKI (ABN401) for METex14 NSCLC pts. Preliminary efficacy ORR 75% in TKI-naive pts and very favorable toxicity profile. @LaurenByersMD @esinghimd @metcrusaders @Exon20Group

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 | Phase classification: P1/2 ➔ P1

Metastases • Phase classification • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • MET

Abion selected as a global phase 2 clinical research support project for ‘ABN401’ worth 7 billion won [Google translation] (Pharm News) - "Abion...has been selected for a new support project while conducting a global phase 2 clinical trial for 'ABN401', a non-small cell lung cancer treatment drug. According to Abion, the company was finally selected for the '2023 3rd National New Drug Development Project New Drug Clinical Development New Support Project' hosted by the Korea New Drug Development Foundation (KDDF). This project will be supported for a total of 7 billion won over two years, and the company aims to obtain approval or technology transfer for the follow-up phase 2b clinical trial plan (IND) for 'ABN401'."

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

ABION Presents New Efficacy Data for ABN401, a Novel MET TKI for Advanced Non-Small Cell Lung Cancer (Businesswire) - P1/2 | N=78 | NCT04052971 | Sponsor: Abion Inc | "ABION...released data from an ongoing Phase 2 trial of ABN401, the company’s wholly owned tyrosine kinase inhibitor intended to treat adult patients with advanced non-small cell lung cancer that exhibit the MET Exon 14 skipping mutation. In eight treatment-naïve patients, the objective response rate was 75% (6/8), and in the evaluable population of 17 patients, the objective response rate was 52.9% (9/17)....The cut-off data reaffirm ABN401’s excellent safety profile as shown in an earlier Phase 1 trial....Based on these results, ABION plans to initiate a Phase 2 combination trial with a multiple drug regimen."

New P2 trial • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and Safety Outcomes of ABN401 in NSCLC Patients with MET Exon 14 Skipping: A Clinically Relevant Subgroup Analysis. (AACR-NCI-EORTC 2023) - No abstract available

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

Abion reveals interim results of global clinical phase 2 for lung cancer treatment at an international conference [Google translation] (HIT News) - "Abion (CEO Shin Young-ki) will present a poster presentation on the interim results of phase 2 clinical trials of 'ABN401 (development code name)' at the '2023 AACR-NCI-EORTC', an international clinical academic conference to be held in Boston, USA on October 11. It was announced on the 23rd....Abion announces the interim results of the global phase 2 clinical trial of ABN401, an ongoing non-small cell lung cancer c-MET mutation-targeting treatment." "

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

[Report Briefing] Abion, 'ABN401 Competitive Drug Clinical Comments (WCLC 2023)' Not Rated [Google translation] (Nate) - "Daishin Securities issued a new report on Abion (203400) on the 17th, saying 'ABN401 Competitive Drug Clinical Comments (WCLC 2023)', and presented an investment opinion as 'Not Rated'....The excellent safety of ABN401 is expected to draw great attention when used in combination therapy. The results of the phase 2 trial will be presented at the American Cancer Society in October."

P2 data • Oncology • Solid Tumor

ABN401 in patients with NSCLC with MET exon 14 (METex14) skipping: Result from the pilot expansion study. (ASCO 2023) - P1/2, P2 | "The ABN401 pilot expansion part of phase 1 demonstrated promising anti-tumor effects and safety in NSCLC pts with c-MET dysregulation, providing support for further evaluation of ABN401 in the METex14 skipping cohort (cohort-1) of the global phase 2 study (NCT05541822). Enrollment is currently ongoing. References National Comprehensive Cancer Network: Non-small cell lung cancer (version 2.2021)."

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

A Phase II Study of ABN401 in Advanced Solid Tumors With c-MET Gene Aberration (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Yonsei University

Metastases • New P2 trial • Pan tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • MET

Abion, American Society of Clinical Oncology 'ABN401' Pilot Expansion Cohort Study Abstract Disclosure [Google translation] (Pharm News) - "Abion...will conduct a pilot expansion cohort of 'ABN401' at the '2023 American Society of Clinical Oncology (ASCO)' held in Chicago, USA from June 2nd to 6th. Publish research abstracts. According to the company on the 11th, the pilot expansion clinical study abstract of 'ABN401', a non-small cell lung cancer treatment, was adopted in 'ASCO 2023' in April, and the ABN401 efficacy and safety results in the 'ABN401' pilot cohort were disclosed."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ABN401 demonstrates robust anti-tumor efficacy in orthotopic PDX models of MET-driven NSCLC brain metastases in a pre-clinical study (AACR 2023) - "ABN401 also showed a desirable PK and safety profile with no significant changes in body weight.Conclusions ABN401 treatment showed robust anti-tumor efficacy in PDX models of MET-driven NSCLC brain metastases. Our findings suggest that ABN401 has excellent potential for treating NSCLC patients with BM and supports its ongoing clinical development."

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

Synergistic anti-tumor effect of ABN401 in combination with KRAS inhibitor in a c-MET-altered KRASG12C non-small cell lung cancer model (AACR 2023) - "We have performed several in vitro and in vivo efficacy studies for the combination of ABN401, c-MET inhibitor, and sotorasib, KRASG12C variant inhibitor, including a PDX model of c-MET-altered KRASG12C NSCLC. Our results suggest that the combination of ABN401 and KRAS inhibitor could be an alternative treatment option for c-MET-altered KRASG12C NSCLC patients."

Combination therapy • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • KRAS • MET • NTRK • ROS1

K-Bio, a large number of AACR launches… active search for new drug candidates [Google translation] (Medical Observer) - "Genome & Company will disclose three preclinical study results of 'GENA-104', a new immuno-oncology drug candidate....For Abion, a total of five research results, including ABN401, were adopted as official presentation topics at AACR....Abion will unveil the results of non-clinical brain metastasis studies at this AACR....As a result of observation, ABN401 was found to be competitive in anticancer efficacy and safety compared to existing approved drugs for non-small cell lung cancer patients. In addition, non-clinical results of the combination of ABN401 and KRAS-targeted therapy will be disclosed."

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