Delving into the Latest Updates on ISU Abxis Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Isu Abxis is a biotechnology company that specializes in developing innovative treatment methods to enhance the quality of life for patients with cancer and rare diseases.

Tags

Nervous System Diseases

Congenital Disorders

Endocrinology and Metabolic Disease

Biosimilar

Enzyme

Monoclonal antibody

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Nervous System Diseases	5
Endocrinology and Metabolic Disease	3
Immune System Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

Biosimilar	4
Monoclonal antibody	2
Enzyme	2
Small molecule drug	1
Fab fragment	1

Top 5 Target	Count

GBA1(Beta-glucocerebrosidase)	1
GP IIb/IIIa(Integrin alpha-IIb/beta-3)	1
GALA(α-Galactosidase)	1
SMPD1(sphingomyelin phosphodiesterase 1)	1
HDACs(Histone deacetylase)	1

Primary Objective:
To compare the pharmacokinetics of Abcertin to the reference product, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.
Secondary Objective:
To compare the safety, tolerability and immunogenicity of Abcertin to the reference formulation, EU-sourced Cerezyme, after single intravenous administration of 60 IU/kg.

Start Date29 Jan 2020

Sponsor / Collaborator

ISU Abxis Co., Ltd.

100 Clinical Results associated with ISU Abxis Co., Ltd.

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0 Patents (Medical) associated with ISU Abxis Co., Ltd.

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13

Literatures (Medical) associated with ISU Abxis Co., Ltd.

15 Oct 2023·International journal of cancer

A phase Ia/Ib study of novel anti-ErbB3 monoclonal antibody, barecetamab (ISU104) in refractory solid cancers and monotherapy or in combination with cetuximab in recurrent or metastatic head and neck cancer.

Article

Author: Chae, Yee Soo ; Kim, Sung-Bae ; Keam, Bhumsuk ; Hong, Seung-Beom ; Kim, Tae Min ; Park, Lee Chun ; Shin, Seong Hoon ; Seo, Seyoung ; Ahn, Myung-Ju

We evaluated the safety, tolerability, pharmacokinetics and antitumor activity of barecetamab monotherapy and combination cetuximab therapy in patients with advanced solid cancers, especially head and neck cancer (HNC). Part 1 was a 3 + 3 dose-escalation study in which 15 patients received barecetamab at 1, 3, 5, 10 and 20 mg/kg intravenously (IV) on days 1 and 28 and weekly in patients with advanced solid cancer. Part 2 was a dose-expansion study including two patient groups with advanced HNC, including six patients receiving barecetamab at 20 mg/kg IV every 3 weeks and 12 patients receiving barecetamab and cetuximab (400 mg/m² on day 1 followed by 250 mg/m² every week). No dose-limiting toxicities (DLTs) were observed. Maximum serum target engagement was reached with trough levels of doses ≥3 mg/kg IV weekly. Common adverse drug reactions were diarrhea, stomatitis, dermatitis acneiform and decreased appetite. One durable complete response of more than 17 months was observed, and the overall response and disease control rates were 36.4% (4/11) and 81.1% (9/11), respectively, in the combination therapy group. In conclusion, DLT was not observed in barecetamab at 1 to 20 mg/kg. The recommended phase II dose was determined to be 20 mg/kg triweekly. Barecetamab and in cetuximab combination was well tolerated and demonstrated meaningful antitumor effects.

01 Jun 2021·Molecular Cancer TherapeuticsQ2 · MEDICINE

A Novel Therapeutic Anti-ErbB3, ISU104 Exhibits Potent Antitumorigenic Activity by Inhibiting Ligand Binding and ErbB3 Heterodimerization

Q2 · MEDICINE

Article

Author: Hong, Mirim ; Kim, Ju Yeon ; Kim, Kyungyong ; Kim, Uijin ; Yoo, Youngki ; Sohn, Youngsoo ; Cha, Jeong Seok ; Cho, Hyun-Soo ; Bae, Donggoo ; Choi, Myung Kyung ; Hong, Seung-Beom ; Kim, Miyoung

AbstractErbB3, a member of the ErbB receptor family, is a potent mediator in the development and progression of cancer, and its activation plays pivotal roles in acquired resistance against anti-EGFR therapies and other standard-of-care therapies. Upon ligand (NRG1) binding, ErbB3 forms heterodimers with other ErbB proteins (i.e., EGFR and ErbB2), which allows activation of downstream PI3K/Akt signaling. In this study, we developed a fully human anti-ErbB3 antibody, named ISU104, as an anticancer agent. ISU104 binds potently and specifically to the domain 3 of ErbB3. The complex structure of ErbB3-domain 3::ISU104-Fab revealed that ISU104 binds to the NRG1 binding region of domain 3. The elucidated structure suggested that the binding of ISU104 to ErbB3 would hinder not only ligand binding but also the structural changes required for heterodimerization. Biochemical studies confirmed these predictions. ISU104 inhibited ligand binding, ligand-dependent heterodimerization and phosphorylation, and induced the internalization of ErbB3. As a result, downstream Akt phosphorylation and cell proliferation were inhibited. The anticancer efficacy of ISU104 was demonstrated in xenograft models of various cancers. In summary, a highly potent ErbB3 targeting antibody, ISU104, is suitable for clinical development.

15 Aug 2020·Cancer Research

Abstract 3042: Anti-cancer efficacy of an anti-ErbB3 antibody, ISU104, against the cancers with NRG1-overexpression, NRG1-fusion, or oncogenic ErbB3 mutations

Author: Kim, Ju Yeon ; Shin, Bongseok ; Kim, Jung Won ; Cho, Jeongin ; Kim, Tae-Eun ; Hong, Mirim ; Bae, Donggoo ; Hong, Seung-Beom

AbstractErbB3, a heterodimeric partner of EGFR or ErbB2, plays important roles in the survival and growth of cancer cells through activation of PI3K/AKT pathway. ErbB3 can be activated by NRG1 expressed either by cancer cells or adjacent mesenchymal cells, or NRG1-fusion proteins produced by genetic alterations in cancer cells. Oncogenic driver mutations in ErbB3 also induce its activation. Previously, we have demonstrated preclinical anti-cancer efficacy of a monoclonal anti-ErbB3 antibody, ISU104 as a monotherapy or in combination with anti-EGFR antibody in various preclinical models. Biomarker analysis of the models demonstrated that there is a significant positive correlation between tumor growth inhibition by ISU104 and NRG1 mRNA/pERBB3 protein expression levels. Based on this analysis, anti-cancer efficacy of ISU104 was further explored in cancer cells and cell line- or patient-derived xenograft cancer models with high NRG1 expression, NRG1-fusion or oncogenic ErbB3 mutations. ISU104 potently inhibited phosphorylation of ERBB3 and AKT, cell proliferation and tumor growth of such models. Potential impacts of other genetic alterations on the anti-cancer efficacy of ISU104 were also investigated. Overall, the presented data suggest that ISU104, an anti-ErbB3 agent in the early stage of clinical development, can be applied for the treatment of the solid tumors expressing high level of NRG1 or harboring genetic alterations such as NRG1-fusion or oncogenic ErbB3 mutations.Citation Format: Seung-Beom Hong, Mirim Hong, Tae-Eun Kim, Ju Yeon Kim, Jung Won Kim, Jeongin Cho, Bongseok Shin, Donggoo Bae. Anti-cancer efficacy of an anti-ErbB3 antibody, ISU104, against the cancers with NRG1-overexpression, NRG1-fusion, or oncogenic ErbB3 mutations [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 3042.

100 Deals associated with ISU Abxis Co., Ltd.

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100 Translational Medicine associated with ISU Abxis Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

1

2

Preclinical

Approved

4

6

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Agalsidase beta biosimilar(ISU Abxis Co., Ltd.) ( GALA )	Fabry Disease More	Approved
Abciximab biosimilar(ISU Abxis Co., Ltd.) ( GP IIb/IIIa )	Myocardial Infarction More	Approved
Sodium Phenylbutyrate ( HDACs )	Urea Cycle Disorders, Inborn More	Approved
Imiglucerase biosimilar(ISU Abxis Co., Ltd.) ( GBA1 )	Gaucher Disease More	Approved
Adalimumab Biosimilar (ISU Abxis) ( TNF-α )	Rheumatoid Arthritis More	Preclinical