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KDDF-201709-04 A Phase 1 study of ISU104 (anti-ErbB3 mAb) in patients with advanced solid tumors(Oncology, Protein) [2019-02-22]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

ErbB3 is well known for drug resistance. This study is the phase 1 clinical study of ISU104 (human anti-ErbB3 monoclonal antibody) in patients with advanced solid tumors.

Unmet Medical Need & Target Patients

1. Target Patients: The solid tumor patient who has recurred due to refractory or tolerance to standard treatment.

2. Unmet Medical Needs

To acquire alternative treatment for the nonresponse and resistant patient group of existing standard therapies that currently have no treatment alternatives.

To acquire a treatment that can prevent to develop a tolerance through combination therapy with conventional therapy.

Status

Clinical phase 1 trial

Intellectual Property

- The original technology of antibody (ISU104) specifically binding to ErbB3: The patent for ‘ANTIBODY SPECIFICALLY BINDING TO ERBB3 AND USE THEREOF’ secured exclusive rights until 2036.

- Patent registration: Republic of Korea (2017), Taiwan (2018)

- PCT application

- Under patent examination: US, China, Argentina

Competitive Advantages

- Competitive antibodies under development for ErbB3 have limited efficacy with only one of the ligand binding inhibitors or dimerization inhibitors. On the other hand, ISU104 is an antibody which has inhibition of ligand binding and dimerization. It has a broader efficacy range and comparative advantage potency.

- ErbB3 Target Drugs Not Approved (2018.01.30 Based on US FDA and EMA Approval Status)

Contact & Company Overview

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