A Phase 2 Multicenter, Open-Label, Parallel Cohort Expansion Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-Mesenchymal-epithelial Transition Factor (c-MET) Dysregulation

ABN401-003 is a Phase 2 clinical study to assess efficacy, safety, tolerability and pharmacokinetic profile of ABN401 in specific populations of advance solid tumors with c-MET alterations as monotherapy.

开始日期2023-01-17

申办/合作机构

ABION, Inc.

NCT05248074

/ Completed临床1期

An Open-label, Randomized, Crossover Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers

This randomized open-label, two-way crossover study is designed to evaluate the safety and pharmacokinetic characteristics of ABN401, and the effect of high-fat meal on the pharmacokinetic profiles of ABN401 and its metabolites in healthy adult volunteers.

开始日期2022-01-04

申办/合作机构

ABION, Inc.

NCT04052971

/ Completed临床1期

A Phase 1 Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Pilot Expansion in Patients With Non-Small Cell Lung Cancer Harboring c-MET Dysregulation

This is a dose escalation, Phase 1 study of ABN401 in patients with advanced solid tumors, refractory metastatic disease, or refractory locally advanced disease not amenable to local therapy.

开始日期2019-08-01

申办/合作机构

ABION, Inc.

[+1]

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项与 ABION, Inc. 相关的文献（医药）

2025-04-21·Cancer Research

Abstract 5831: ABN202 (αTROP2), a sacituzumab-interferon-beta mutein fusion protein: a novel approach beyond antibody-drug conjugate therapeutics in ADC-naïve and ADC-refractory cancers

作者: Kim, Na Young ; Lee, Chan Gyu ; Lee, Sae Hyung ; Hong, Sungyoul ; Choi, Jun Young ; Shin, Young Kee ; Jeong, Hae Min ; Lee, Hyun Kyung ; Seo, Myeung Ryun ; Ryu, Soo Jin ; Park, Hee Geon

AbstractTrophoblast cell surface antigen 2 (TROP2) is a cell-surface glycoprotein overexpressed in various solid tumors, including triple-negative breast cancer (TNBC), hormone receptor-positive breast cancer (HR+ BC), and non-small cell lung cancer (NSCLC). TROP2-targeting antibody-drug conjugates (ADCs) such as Sacituzumab-govitecan (SG) and Datopotamab deruxtecan (Dato-DXd) demonstrated promising clinical efficacy in patients with TROP2-positive cancers. However, TROP2-targeting ADCs exhibit a high incidence of adverse events, a short duration of response, and frequent recurrence. Therefore, there is an unmet medical need for treatments beyond ADC therapeutics, particularly for ADC-naïve and ADC-refractory patients.ABN202 is an antibody-cytokine fusion protein platform that fuses a potent cytotoxic and immune-modulating cytokine, interferon-beta mutein (IFN-β mutein), with an antibody via flexible protein linker. In previous studies, ABN202 utilizing the TROP2-targeting antibody, Sacituzumab (ABN202, αTROP2), demonstrated potent anti-tumor efficacy by inhibiting cancer cell growth and activating anti-tumor immunity within the tumor microenvironment. In this study, we compared the in vitro and in vivo anti-cancer efficacy of ABN202 (αTROP2) with those of SG and Dato-DXd in ADC-resistant preclinical models, as well as in xenograft and human IFNAR knock-in (hIFNAR KI) mouse models. The preclinical toxicity profiles of SG, Dato-DXd, and ABN202 (αTROP2) were evaluated using human immune cells and hIFNAR KI mouse models.In conclusion, ABN202 (αTROP2) demonstrated potent anti-cancer efficacy and a tolerable safety profile compared to SG and Dato-DXd. Our findings suggest that ABN202 (αTROP2) represents a novel therapeutic approach beyond ADCs for both ADC-naïve and ADC-refractory cancers.Citation Format:Hee Geon Park, Hyun Kyung Lee, Myeung Ryun Seo, Soo Jin Ryu, Sungyoul Hong, Chan Gyu Lee, Hae Min Jeong, Sae Hyung Lee, Na Young Kim, Young Kee Shin, Jun Young Choi. ABN202 (αTROP2), a sacituzumab-interferon-beta mutein fusion protein: a novel approach beyond antibody-drug conjugate therapeutics in ADC-naïve and ADC-refractory cancers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 5831.

2025-04-21·Cancer Research

Abstract 2118: ABN501: A CLDN3-targeted monoclonal antibody with proven safety, pharmacokinetics, and synergistic anti-tumor efficacy

作者: Kim, Jaemun ; Seo, Myeung Ryun ; Shin, Young Kee ; Jung, Seung Hwa ; Kim, Na Young ; Hong, Sunghyun ; Yang, Hobin ; Choi, Jae ; Lee, Sangin ; Hong, Sungyoul ; Choi, Jun Young ; Park, Ha Yeon ; Lee, Ho Jin ; Lee, Saehyung

AbstractABN501 is an afucosylated monoclonal antibody specifically designed to target claudin-3 (CLDN3), a protein frequently overexpressed in various solid tumors, including small-cell lung cancer (SCLC). Given the critical role of CLDN3 in cancer cell proliferation and tumorigenesis, it is recognized as a promising therapeutic target. In this study, we evaluated the preclinical safety and efficacy of ABN501, focusing on its potential for clinical development as a targeted cancer therapy. To identify suitable animal models for toxicity assessment, we investigated the cross-species reactivity of ABN501 with CLDN3. Our results confirmed that ABN501 binds to CLDN3 across human, mouse, rat, and cynomolgus monkey species. Based on these findings, rats and cynomolgus monkeys were selected for comprehensive toxicity evaluations, including single-dose and repeated-dose studies. Notably, even at the highest administered doses, ABN501 exhibited no significant changes in key toxicity markers, demonstrating its exceptional safety profile. We further assessed the therapeutic potential of ABN501 as both monotherapy and in combination with chemotherapy. Chemotherapy was shown to upregulate CLDN3 expression in lung cancer cell lines, thereby enhancing the antitumor activity of ABN501 and confirming a synergistic effect. In conclusion, our preclinical studies demonstrate that ABN501 is a safe and effective CLDN3-targeting monoclonal antibody for treating CLDN3-overexpressing cancers. Its excellent safety profile and synergistic effects in combination with chemotherapy present a promising strategy for improving treatment outcomes, particularly in cancers with limited targeted treatment options. These findings pave the way for further clinical investigation, particularly in lung cancer and other CLDN3-expressing malignancies.Citation Format:Saehyung Lee, Jae Choi, Sunghyun Hong, Ha Yeon Park, Ho Jin Lee, Jaemun Kim, Sangin Lee, Seung Hwa Jung, Myeung Ryun Seo, Hobin Yang, Sungyoul Hong, Jun Young Choi, Na Young Kim, Young Kee Shin. ABN501: A CLDN3-targeted monoclonal antibody with proven safety, pharmacokinetics, and synergistic anti-tumor efficacy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 2118.

2025-04-21·Cancer Research

Abstract 6010: Evaluation of BsABN501: A novel T cell engager targeting CLDN3-positive solid tumors

作者: Choi, Jae ; Kim, Jaemun ; Hong, Sungyoul ; Kim, Na Young ; Lee, Sangin ; Choi, Jun Young ; Yang, Hobin ; Shin, Young Kee ; Hong, Sunghyun ; Lee, Saehyung

Claudin 3 (CLDN3) plays a critical role in tumor initiation, progression, and metastasis and is overexpressed in multiple solid tumors, including breast, ovarian, and small cell lung cancers. Previously, ABN501 was developed as a fully human monoclonal antibody targeting CLDN3, demonstrating strong anti-tumor activity and a favorable safety profile. In this study, we established the proof of concept for BsABN501, a CD3 T cell engager, utilizing the anti-CLDN3 sequence derived from the novel antibody ABN501. BsABN501 specifically binds to CLDN3 while concurrently targeting CD3 on T cells, thereby initiating T cell-mediated cytotoxicity (TDCC) against tumor cells. In vitro assays demonstrated that BsABN501 effectively activates peripheral blood mononuclear cells, resulting in potent TDCC against CLDN3-positive cancer cell lines. Notably, BsABN501 exhibited robust cytotoxic activity against CLDN3-expressing tumor cell lines compared to controls. Cytokine release assays further confirmed tumor-specific activation of T cells. Additionally, in vivo studies using xenograft mouse models bearing CLDN3-expressing tumors showed that BsABN501 induced significant tumor regression, highlighting its robust anti-tumor activity. In summary, BsABN501 represents a novel and promising therapeutic strategy for the treatment of CLDN3-positivie solid tumors by effectively recruiting and activating T cells to enhance TDCC. Moving forward, we aim to optimize the CD3 sequence and format of BsABN501 to further improve its anti-cancer efficacy and safety, paving the way for its development as a targeted immunotherapeutic for CLDN3-expressing malignancies.Citation Format:Saehyung Lee, Sangin Lee, Sunghyun Hong, Jaemun Kim, Jae Choi, Hobin Yang, Sungyoul Hong, Na Young Kim, Jun Young Choi, Young Kee Shin. Evaluation of BsABN501: A novel T cell engager targeting CLDN3-positive solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 6010.

项与 ABION, Inc. 相关的新闻（医药）

2023-10-13

·Endpoints

Harmony Biosciences' Wakix fails PhIII hypersomnia study; Florida gene therapy startup downsizes

Plus Phase II data on ABION’s MET tyrosine kinase inhibitor, and 60 Degrees Pharmaceuticals giving up on repurposing its antimalarial drug for Covid-19. Harmony Biosciences’ drug failed the primary goal in a Phase III study and investors reacted by shedding the biotech’s share price $HRMY by about 30% Friday morning. The Pennsylvania drugmaker said its treatment candidate pitolisant did not achieve statistical significance on excessive daytime sleepiness in the randomized withdrawal phase of the INTUNE study, which includes patients with the rare and chronic disease idiopathic hypersomnia. The FDA approved the tablets, sold as Wakix, in 2019 to treat excessive daytime sleepiness in adults with narcolepsy. — Kyle LaHucik

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