Y-Biologics has signed a government-wide life-cycle new drug development project agreement with the Government-wide New Drug Development Project Group to develop ACE-05, an anti-cancer dual antibody with increased T cell activity.

 

According to the agreement, Y-Biologics will be carrying out research on the efficacy and mechanism of ACE-05, an anticancer drug candidate, with the support of the project group. ACE-05 is a PD-L1/CD3 bispecific antibody that inhibits immune checkpoint molecules and binds to T cells and cancer cells simultaneously.

 

ACE-05 is a bispecific antibody candidate based on ALiCE (Antibody-Like Cell Engager), the company’s new bispecific T cell engager platform. It has shown to exhibit powerful efficacy even at low doses compared to the existing PD-L1 antibodies in tumor models.

 

The ALiCE platform developed by Y-Biologics recognizes the CD3 of T cells and a target antigen on the surface of cancer cells at the same time. Compared to Amgen’s BiTE, it was designed to bind more strongly to cancer cells by optimizing the cancer cell-immune cell distance. The results of animal testing showed that the toxicity was lower, and it demonstrated substantially improved stability in the bloodstream, with more than double the molecular weight of BiTE (50 kDa), as well as enhanced productivity and efficacy.

 

Although the PD-1/PD-L1 type immune checkpoint inhibitors currently on the market exhibit excellent efficacy, only 20-30% of cancer patients respond to them. On the other hand, CAR T cell therapy has a high response rate of over 80% in blood cancer patients, but its use is limited, as it must be tailored to each patient and it is expensive. Y-Biologics explained, “It is expected to provide an alternative to CAR-T cell therapy, which is costly, by addressing the shortcomings of the existing immunotherapy with an increased response rate and activating immune cells through antibodies."

 

Young Woo Park, CEO of Y-Biologics, said, “I hope this research project agreement will serve as an impetus for our company’s technological prowess to be recognized. [...] All our executives and employees will make an effort for the ALiCE platform technology to gain recognition in the global market through this agreement.”

 

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