YBL-013, the first new drug candidate material to be discovered on ALiCE, gets licensed out for exclusive development and commercialization rights in China​

Y-Biologics has successfully completed the global technology transfer of the first new drug candidate discovered by applying its proprietary CD3-based bispecific T cell engager bispecific platform called Antibody-Like Cell Engager (ALiCE).

 

 

The company announced that it had signed a licensing agreement to 3D Medicines in China for the exclusive rights to CD3xPD-L1 bispecific antibody, YBL-013, in China.

 

 

Y-Biologics will receive a total of USD 85 million (approx. KRW 95.2 billion), including an upfront payment of USD 2 million (approx. KRW 2.2 billion) and milestone fees for clinical development approval, commercialization, and sales in China. Additionally, royalties at a double-digit percentage of the sales will be paid in phases.

 

 

3D Medicines, on the other hand, has acquired exclusive rights to develop and commercialize YBL-013 for the Chinese market (incl. Hong Kong, Macau, and Taiwan). Y-Biologics is planning to pursue clinical development of YBL-013 in Korea and the United States based on the non-clinical research results in China and license out the technology for regions other than China.

 

 

YBL-013, a new anticancer drug candidate, is the first new drug substance to be produced based on ALiCE, a bispecific T cell engager platform independently developed by Y-Biologics. ALiCE, which has been patented in the United States, is a bispecific antibody with a unique structure where the ratio of cancer antigen and CD3 binding sites is 2:1. This format results in stronger binding affinity to tumor antigens and leads to the activation of T cells around the cancer cells. As a result, the toxicity is much lower than that of the existing bispecific T cell engagers.

 

 

3D Medicines is a Chinese biopharmaceutical company that pursues development of differentiated next-generation immuno-oncology drugs. To this end, it is building anticancer drug pipelines composed of biopharmaceuticals and low-molecular compounds and has built global clinical development and commercialization capabilities. The company, which plans to launch Envafolimab (KN 03), a subcutaneous (SC) PD-L1 antibody injection, in China as soon as possible, has attracted an investment of USD 140 million in October last year.

 

 

Y-Biologics CEO Young Woo Park said, “We have concentrated our efforts on the development of ALiCE, a bispecific T cell engager platform technology, and it brings us great joy that the outcome of such efforts has led to a licensing agreement. [...] Using ALiCE, we will strengthen our new drug portfolio by introducing a wide range of competitive candidates for the development of a CD3-based bispecific T cell engager, which is currently a major trend in the field of bispecific antibodies. We will do our best to demonstrate our technology in wider markets, starting with China.”

 

 

“The new structure of the next-generation CD3 antibody-based bispecific antibody, YBL-013, will bring about a paradigm shift in treatment for various types of cancer. [...] We will develop YBL-013 as a crucial therapeutic agent for cancer patients in China through close collaboration with Y-Biologics. The addition of the YBL-013 portfolio is an important strategic step to enhancing 3D Medicines’ competitiveness,” said John Gong, CEO of 3D Medicine.

 

 

Meanwhile, Y-Biologics licensed YBL-001, an antibody-drug conjugate (ADC) targeting DLK-1, jointly developed with LegoChem Biosciences, last month, to Pyxis Oncology for a total of USD 294 million, including an upfront payment of USD 9.5 million.

By Sung Min Kim, sungmin.kim@bios.co.kr