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- vabametkib (ABN401) / Abion
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 (Hall A; Theater 1) - May 24, 2024 - Abstract #ASCO2024ASCO_7066;
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.
- vabametkib (ABN401) / Abion
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 (Hall A; Theater 1) - Apr 7, 2024 - Abstract #ASCO2024ASCO_709;
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. Sponsored by ABION Inc.
- interferon ? biobetter (ABN101) / Abion
Inhalable Interferon-beta Bio-better, ABN101 Dry Powder, Inhibits and Reduces the Infection of Respiratory Viruses in Non-human Primates (NHPs) (San Diego Convention Center, Area H (Hall H, Ground Level)) - Mar 17, 2024 - Abstract #ATS2024ATS_9290;
Interestingly, ABN101 DP pre-treated group showed the lowest virus titers for both viruses, which indicated that ABN101 DP can be utilized as prophylactic treatment for respiratory viruses. Conclusions In conclusion, ABN101 DP delivered through inhalation can reduce virus titers of IAV and SARS-CoV-2 in NHPs, which may prove ABN101 DP has the potential broad-spectrum anti-respiratory virus therapeutics for pandemic preparedness.
- ABN501 / Abion
?-ABN501, a novel antibody targeting claudin-3, demonstrates the potential to be a new therapeutic option for small cell lung cancer (Section 22) - Mar 5, 2024 - Abstract #AACR2024AACR_3925;
Present study data sets suggest that the ?-ABN501 can be a potential new therapeutic option for SCLC. In addition, the ?-ABN501 antibody is currently under way of development into new drug platforms for further applications.
- || babamekip (ABN401) / Abion
Trial completion: To Evaluate the Safety, Pharmacokinetic and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers (clinicaltrials.gov) - Feb 19, 2024
P1, N=25, Completed, Sponsor: Abion Inc
In addition, the ?-ABN501 antibody is currently under way of development into new drug platforms for further applications. Recruiting --> Completed
- || babamekip (ABN401) / Abion
Trial completion date, Trial primary completion date, Metastases: 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) - Feb 18, 2024
P1, N=78, Recruiting, Sponsor: Abion Inc
Recruiting --> Completed Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- | babamekip (ABN401) / Abion
Phase classification, Metastases: 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) - Nov 13, 2023
P1, N=78, Recruiting, Sponsor: Abion Inc
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 Phase classification: P1/2 --> P1
- ABN401 / Abion
Efficacy and Safety Outcomes of ABN401 in NSCLC Patients with MET Exon 14 Skipping: A Clinically Relevant Subgroup Analysis. (LEVEL 2, EXHIBIT HALL D) - Sep 16, 2023 - Abstract #AACRNCIEORTC2023AACR_NCI_EORTC_367;
- | babamekip (ABN401) / Abion
New P2 trial, Pan tumor, Metastases: A Phase II Study of ABN401 in Advanced Solid Tumors With c-MET Gene Aberration (clinicaltrials.gov) - May 31, 2023
P2, N=20, Not yet recruiting, Sponsor: Yonsei University
- ABN401 / Abion
ABN401 in patients with NSCLC with MET exon 14 (METex14) skipping: Result from the pilot expansion study. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6505;
P1/2, P2
Enrollment is currently ongoing. References National Comprehensive Cancer Network: Non-small cell lung cancer (version 2.2021).
- interferon ? biobetter (ABN101) / Abion
A Novel Dry Powder, ABN101 Broad-spectrum, Anti-viral Inhaler to Avoid and Treat Global Respiratory Virus Pandemics (Walter E. Washington Convention Center, Area C, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_8424;
Conclusions In conclusion, ABN101 DP can penetrate tertiary airways and remains available in the BALF up to 24H following IH treatment, whereas the effect was much shorter when delivered by IV, and not observed in the BALF. Abion is determining biomarkers to measure prophylactic and therapeutic efficacy through IH in AGMs.
- ABN401 / Abion
ABN401 demonstrates robust anti-tumor efficacy in orthotopic PDX models of MET-driven NSCLC brain metastases in a pre-clinical study (Section 19; Poster Board #23) - Mar 14, 2023 - Abstract #AACR2023AACR_7286;
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.
- ABN501 / Abion
ABN501, a novel anti-claudin-3 antibody, shows potent anti-cancer activity in vitro and in vivo (Section 13; Poster Board #21) - Mar 14, 2023 - Abstract #AACR2023AACR_4877;
In summary, we suggest that ABN501 can be used as promising tissue-agnostic drug candidates as therapeutics for various types of claudin-3-positive cancers. ABN501 is currently developed with various antibody engineering platforms.
- ABN401 / Abion
Synergistic anti-tumor effect of ABN401 in combination with KRAS inhibitor in a c-MET-altered KRASG12C non-small cell lung cancer model (Section 14; Poster Board #8) - Mar 14, 2023 - Abstract #AACR2023AACR_2485;
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.
- || vabametkib (ABN401) / Abion
Enrollment open, Metastases: To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation (clinicaltrials.gov) - Jan 13, 2023
P2, N=40, Recruiting, Sponsor: Abion Inc
Our results suggest that the combination of ABN401 and KRAS inhibitor could be an alternative treatment option for c-MET-altered KRASG12C NSCLC patients. Not yet recruiting --> Recruiting
- || vabametkib (ABN401) / Abion
New P2 trial, Metastases: To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation (clinicaltrials.gov) - Sep 15, 2022
P2, N=40, Not yet recruiting, Sponsor: Abion Inc
- ABN401 / Abion
A phase I-II multicenter, open-label, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of ABN401 in patients with advanced solid tumors and dose-expansion in patients with non-small cell lung cancer harboring c-MET dysregulation (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3061;
P1/2
We plan to open several cohorts to treat other types of cancers harboring MET alteration. In addition, combination therapies with different types of drugs are planned.
- ABN401 / Abion
The MET inhibitor ABN401 in combination with the third-generation EGFR-TKI is effective MET-amplified and EGFR-mutant NSCLC with acquired resistance to third-generation EGFR-TKI in preclinical models (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3054;
Notably, in MET gene amplification (PDX model YHIM-1035, gefitinib/Osimertinib resistant), ABN401 alone showed a potent therapeutic effect. Conclusions Our findings suggest that the clinical application of ABN401 in combination with a third-generation EGFR-TKI to NSCLC patients with MET gene amplification can provide a promising therapeutic strategy for overcoming acquired resistance to EGFR-TKIs.
- ABN401 / Abion
A phase 1 dose-escalation study of the ABN401 (c-MET inhibitor) in patients with solid tumors. (Available On Demand; 97) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5142;
P1/2
The extension (pilot expansion) for additional efficacy assessment is under way at 800 mg daily dose with c-MET altered NSCLC patients in South Korea and Australia. In addition, a phase 2 expansion study is to start in the United States and South Korea.
- | babamekip (ABN401) / Abion
Trial completion date, Trial primary completion date: To Evaluate the Safety, Pharmacokinetic and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers (clinicaltrials.gov) - Feb 25, 2022
P1, N=24, Recruiting, Sponsor: Abion Inc
In addition, a phase 2 expansion study is to start in the United States and South Korea. Trial completion date: Feb 2022 --> Dec 2023 | Trial primary completion date: Feb 2022 --> Dec 2023
- || babamekip (ABN401) / Abion
Trial primary completion date, Metastases: 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) - Feb 25, 2022
P1/2, N=78, Recruiting, Sponsor: Abion Inc
Trial completion date: Feb 2022 --> Dec 2023 | Trial primary completion date: Feb 2022 --> Dec 2023 Trial primary completion date: Mar 2021 --> Dec 2023
- || babamekip (ABN401) / Abion
New P1 trial: To Evaluate the Safety, Pharmacokinetic and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers (clinicaltrials.gov) - Feb 20, 2022
P1, N=24, Recruiting, Sponsor: Abion Inc
- | ABN401 / Abion
Journal: Solubility Determination of c-Met Inhibitor in Solvent Mixtures and Mathematical Modeling to Develop Nanosuspension Formulation. (Pubmed Central) - Sep 9, 2021
The mean particle size of nanosuspension decreased to 43.05 nm when the mole fraction of ABN401 in THP, and mole fraction of ABN401 in TWM mixture were decreased to 0.04 and 0.1. The ultrasonicated nanosuspension appeared to give comparatively higher dissolution than micronized nanosuspension and provide a candidate formulation for in vivo purposes.
- ABN401 / Abion
[VIRTUAL] Phase I dose-escalation study to evaluate safety and clinical activity of c-MET inhibitor ABN401 in patients with advanced solid tumor () - Jul 22, 2021 - Abstract #ESMO2021ESMO_2642;
P1/2
The safety profile and early signs of antitumor activity support further development of ABN401. Safety and efficacy of ABN401 as c-MET inhibitor will be assessed in planned future studies.
- ABN401 / Abion
[VIRTUAL] Trial in progress: A phase 1-2 multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of ABN401 in patients with advanced solid tumors. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_963;
P1/2
For the extension (pilot expansion) study, patients must have NSCLC with MET exon 14 skipping, MET amplification and/or c-MET overexpression . An exploratory study is being conducted for co-development of a companion diagnostic (CDx) system including a CTC device and ddPCR kit through liquid biopsy.
- || ABN401 / Abion
Biomarker, Clinical, Journal: Therapeutic Efficacy of ABN401, a Highly Potent and Selective MET Inhibitor, Based on Diagnostic Biomarker Test in MET-Addicted Cancer. (Pubmed Central) - Jun 19, 2020
The results show that the efficacy of ABN401 is associated with MET status and they highlight the importance of determining the cut-off values. The results suggest that clinical trials need to establish the characteristics of each sample and their correlations with the efficacy of MET inhibitors.
- | ABN401 / Abion, erlotinib / Generic mfg.
Preclinical, Journal: New Preclinical Development of a c-Met Inhibitor and Its Combined Anti-Tumor Effect in c-Met-Amplified NSCLC. (Pubmed Central) - Feb 8, 2020
The bioavailability is approximately 30% in dogs and it is highly efficient in the PDX model, achieving around 90% tumor growth inhibition in combination with erlotinib. These observations indicate that the compound is acceptable for the next phase of trials.
- ||| babamekip (ABN401) / Abion
Enrollment open, Metastases: 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) - Oct 31, 2019
P1/2, N=78, Recruiting, Sponsor: Abion Inc
These observations indicate that the compound is acceptable for the next phase of trials. Not yet recruiting --> Recruiting
- ABN401 / Abion
Preclinical pharmacokinetic/pharmacodynamic (PK/PD) relationship of ABN401, a highly selective met inhibitor, in gastric and non-small cell lung cancer models (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_1424;
Legal entity responsible for the study: The authors. Funding: Abion Inc.
- | babamekip (ABN401) / Abion
New P1/2 trial, Metastases: 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) - Aug 11, 2019
P1/2, N=78, Not yet recruiting, Sponsor: Abion Inc