Ongoing Projects

HOME > R&D Pipeline > Current status > Ongoing Projects

KDDF-201809-12 IND filing for development of HER2 CAR (Chimeric Antigen Receptor) expressing NK cells for phase I clinical study against gastric cancer(Oncology, Genetics) [2019-10-25]

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

Development and Market Objectives

Assessment of anti-cancer efficacy and Phase I clinical trial IND submission for HER2 CAR expressing NK cells targeting HER2-positive gastric cancer

Unmet Medical Need & Target Patients

Target patients: HER2-positive gastric cancer patients

Unmet medical needs: HER2-positive gastric cancer patients comprise 10 ~ 23% of the entire gastric cancer patient population. Despite diverse treatment options, the reported survival rate is low. Hence, development of a novel anti-cancer drug is needed to improve the survival period and to provide benefits to patients with HER2-positive gastric cancer. The immunotherapeutic drug such as HER2 CAR expressing NK cells with enhanced targeting function could be an attractive alternative.

Status

Completion of generating HER2 CAR expressing NK cells

Evaluation on the in vivo efficacy of HER2 CAR expressing NK cells in process

Establishment of large scale production in process

Establishment of analysis methods on efficacy and potency in process

Intellectual Property

1. NK specific CAR domain: We have discovered the most optimal co-stimulatory domain for NK cell activation and potency. The patent for this specific CAR domain is in pending in Korea and international patent applications will be filed in key countries including the US.

 

2. Feeder Cell: We have developed the feeder cell system necessary for large scale expansion of NK cells. The patent has been registered in Korea and international patent application under the PCT has been filed. Additionally, each patent application will be filed in key countries including the US.

 

3. Medium composition for NK cell cryopreservation: We have established the medium composition for NK cell cryopreservation, enabling long-term storage for off-the-shelf- products. The patent is in pending in Korea and international patent application under the PCT has been filed. Additionally, each patent application will be filed in key countries including the US.

 

4. Large scale production of NK cells using bio-reactor system: We have established the process development system for large scale production of primary immune cells. The patent is in pending in Korea and international patent applications will be filed in key countries including the US.

Competitive Advantages

- CAR-T is a novel immunotherapeutic drug recognized for its target specificity towards tumor cells and long term existence after infusion. However, it also harbors adverse effects such as instigation of cytokine storm. Also, the fact that it is tailored to the individual patient may limit its commercialization. As CAR-NK shows similar level of effectiveness and minimal side effects in comparison with CAR-T, we are focused on developing CAR-NK as a commercially available off-the shelf drug.

 

- We are competent with various technologies required for NK cell culture and gene editing. We can implement commercialization based on our techniques for large scale culture of NK cells and long term cryopreservation.


- Successful development of HER2-CAR-NK cells expressing her2 gene (overexpressed in various cancers) and NK specific domain from a small amount of mononuclear cells will serve as a basis for establishing an industry-leading gene therapy platform applicable to different kinds of cancers.

Contact & Company Overview

Related Project

Related Project
list
Update to 2013 © KOREA DRUG DEVELOPMENT FUND. ALL RIGHTS RESERVED. QR Code