八大胜

Scientific Research
Research Project

Currently, CAR-T therapy has achieved significant efficacy in hematological neoplasms, and 9 products have been launched. However, there are still many challenges in the treatment of solid tumors. We are committed to developing CAR-T technology for solid tumors and currently has three technology platforms with independent intellectual property rights: Trans-CAR®, Boost-CAR®, and R-Star. Clinical trials of solid tumor CAR-T targeting CLDN18.2, GUCY2C and other targets have been carried out in a number of Grade A tertiary hospitals, and relevant data have initially shown controllable safety and good clinical efficacy.

NK cells can quickly and directly kill tumor cells without recognizing tumor-specific antigens, and have a broad-spectrum and efficient anti-tumor effect, which shows a broad prospect in tumor immunotherapy. The CAR-NK cells, as modified by the CAR structure, have a stronger ability to target and kill tumor cells, and show excellent anti-tumor activity whether it is against hematological tumors or solid tumors.

CAR-NK therapy has good anti-tumor activity, high safety and can be produced on a large scale . It is a general-purpose, ready-to-use product and a new hope for tumor treatment. Clinical studies have shown that it has significant clinical advantages. On the one hand, CAR-NK cells can be used allogeneously, making it possible to become a off-the-shelf generic product; on the other hand, CAR-NK cells have a low incidence of cytokine release syndrome (CRS) and higher safety; third, CAR-NK cells have low sensitivity to the inhibitory effect of the tumor microenvironment.

The company's research and development of CAR-NK technology aims to develop universal off-the-shelf immune cell innovative drugs for solid tumors, greatly reduce the production cost of cell products and benefit more patients. At present, the company has built a lentiviral transfection platform for NK cells, which solves the problem of low efficiency of lentiviral transfection into NK cells, and the transfection rate reaches more than 70% while MOI=3 and VCN5. At the same time, in response to the problem that NK cells do not survive for a long time in the body, the company has developed the candidate product iCAR-NK.

The project won the first prize in the final of the 2020 Harbin Institute of Technology Global Alumni Innovation and Entrepreneurship Competition, which used in vitro-induced chondrogenic stem cells to treat degenerative osteoarthritis.The mechanism of action is as follows:

1、1. Differentiate into chondrocytes, repair and regenerate cartilage tissue

2、2. Immune regulation, suppression of inflammation

3、3. Secrete a variety of cytokines to reduce the destruction of bone joints and synovium

4. Inhibit the expression of MMPs and promote the regeneration of articular cartilage

5. Regulate signaling pathways to reduce osteoarthritis progression

Due to the in vitro-induced chondrogenic stem cell technology, the efficiency of differentiation stem cells into chondroblasts is higher. Currently undergoing double filing for stem cell clinical research。

At present, the company has 11 research pipelines, covering mesenchymal stem cells, CAR-T cells, CAR-NK cells and other directions.



Technology platform

Product code

indication

preclinical study

Exploratory clinical

IND apply for

Clinical stage I

Clinical stage II

NDA report to a higher body

Trans-CAR

CT076

/

Boost-CAR

CT040

CT086

R-Star

/

/

2nd-CAR

CT023

Diffuse large B cell lymphoma (DLBCL)

CT007

CLDN18.2 Positive solid tumors

CT080

GUCY2C-positive solid tumor

CT173

/

CAR-NK

CK001

/

MSC

ST001

Knee osteoarthritis

Research Results
We have achieved fruitful research results in cell cryopreservation, cell medicine, regenerative medicine, cell derivatives, etc., and have applied for more than 100 invention patents, utility model patents and international patents (PCT). In addition, also the monograph "Clinical Research and Application of Stem Cells in the treatment of nine major systemic diseases" was also compiled.