Out-licensing agreement for commercial use of RetroNectin® into Daiichi Sankyo

Kusatsu/Shiga Japan – September 3, 2018 – Takara Bio Inc. (Takara Bio), announced today that it has entered into a License and Supply Agreement, under which Takara Bio grants Daiichi Sankyo Co., Ltd, (Daiichi Sankyo) a commercial license to use applicable patents relating to RetroNectin*1 and supplies RetroNectin products. Takara Bio now has eleven licensees permitted to use RetroNectin patents commercially.

 

Under the agreement signed with Takara Bio, Daiichi Sankyo is allowed to use the patents relating to RetroNectin for clinical trial and commercial production of axicabtagene ciloleucel*2 as a cellular and gene therapy product in Japan. Takara Bio provides Daiichi Sankyo with reliable supplies of RetroNectin. Takara Bio will receive payments in consideration of license and supply in addition to sales for RetroNectin.

 

Takara Bio’s proprietary patent technologies licensed to Daiichi Sankyo are as follows:

・RetroNectin method, which includes a technology enabling highly efficient gene transduction to cells by retrovirus vector*3

・RetroNectin expansion culture method, which includes a technology enabling highly efficient expansion culture of T cells in the presence of anti-CD3 antibody*4

 

With such advantages, it enables an expansion of gene-transduced cells for therapy with high efficiency. RetroNectin method and RetroNectin expansion culture method are now becoming increasingly standard in protocols utilized for Engineered T-cell Therapy, which includes promising CAR*5 and TCR*6 gene therapies recently raising higher expectation.

 

Takara Bio is promoting out-licensing and supply of RetroNectin to clinical development of Engineered T-cell Therapy*7 actively pursued worldwide in recent years, and expects higher sales growth in the future.

1. RetroNectin

RetroNectin is a recombinant protein derived from human fibronectin fragment. The RetroNectin method has been widely employed for retroviral- and lentiviral-vector-mediated gene transfer into mammalian cells. RetroNectin is a registered trademark of TAKARA BIO INC.

 

2. axicabtagene ciloleucel, cellular and gene therapy product

axicabtagene ciloleucel is an international nonproprietary name of cellular and gene therapy product being developed by Daiichi Sankyo. It targets diseases such as B-cell lymphomas, with the infusion of T cells engineered to express a CAR (chimeric antigen receptor) gene to recognize the cell surface protein (antigen) CD19 expressed on B cells.

 

3. Retroviral vector

Retrovirus is a group of viruses that have genome consisting of single-strand linear RNA. DNA synthesized from RNA genome is integrated into the host chromosome in cells infected with retrovirus. Utilizing the system, the modified retrovirus has been widely employed as a vector for gene transfer (viral vector) which is efficient for gene therapy.

 

4. Anti-CD3 antibody

Anti-CD3 antibody recognizes CD3, a cell surface molecule expressed on human T cell which is responsible for immune homeostasis. Anti-CD3 antibody binds with CD3 molecule expressed on T cells, enabling T cells to activate and proliferate.

 

5. CAR gene therapy

Chimeric Antigen Receptor (CAR) is receptor that is made by artificially combining parts derived from antibodies that specifically recognize certain cancer antigens with parts with cytotoxic functions derived from T-cell receptors. CAR gene is transduced ex-vivo to T cells of patients with cancer, and the gene-transduced lymphocytes are subject to the efficient expansion culture and infused back to the patients as a therapeutic product. This type is one of Engineered T-cell Therapy. It acquires the capability to specifically recognize and attack cancer cells and eliminate them.

 

6. TCR gene therapy

TCR is a glycoprotein expressed on T cells and acts at the time of recognizing of tumor antigen by T cells. TCR gene is transduced ex-vivo to T cells of patients with cancer, and the gene-transduced T cells are subject to the efficient expansion culture and infused back to the patients as a therapeutic product. This type is one of Engineered T-cell Therapy. It acquires the capability to specifically recognize and attack cancer cells and eliminate them.

 

7. Engineered T-cell Therapy

It is a therapy through selective recognition and attack cancer cells by therapeutic gene-transduced T cells.