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KDDF-201904-18 Nonclinical development of CD19-targeting CAR-T therapeutics(Oncology, Genetics) [2019-07-31]

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

Development and Market Objectives

The final objective is development of CD19-CART therapeutics with novel CD19 antibody which is bind to unique epitope for treatment of B-cell malignancies.

The candidate of CD19-CART will be developed through pre-clinical studies and the clinical trial protocol will be defined.

Unmet Medical Need & Target Patients

The 1-year survival rate of patients with refractory acute lymphoblastic leukemia is less than 40%. The recently approved chimeric T (CAR-T) therapy has a high response rate and approximately 80% of 1-year survival rate. However, two approved CD19-targeting CAR-T, Kymriah® and Yescarta®, in US are developed with mouse anti-CD19 antibody, FMC63, and it causes immunogenicity issue and lack of binding capacity to some CD19 isoforms. There is urgent need for novel CD19-CART with antibody which is bind to distinct epitope compared to FMC63 and could address the limitations of current CD19-CART therapies.

Status

· Novel CD19-targeting antibody was developed and it shows distinct epitope from previously used FMC63 antibody.

· The CD19-CART with novel antibody showed CD19-specific activation and cytotoxicity.

· The CD19-CART with novel antibody showed In vivo efficacy.

· Optimization of CAR-T manufacturing process is going on.

Intellectual Property

· National patent application (B Cell Malignancy Recognizing Antibody or Antigen Binding Fragment Thereof, Chimeric Antigen Receptor Comprising The Same and Uses Thereof)

· PCT patent application (B Cell Malignancy Recognizing Antibody or Antigen Binding Fragment Thereof, Chimeric Antigen Receptor Comprising The Same and Uses Thereof)

Competitive Advantages

· Novel antibody binds to distinct epitope from FMC63 which is used for Kymriah® and Yescarta®

· Equivalent CAR-T activation compared to FMC63-based CAR-T

· Optimized binding activity and immunogenicity mitigation

Contact & Company Overview

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