Y-Biologics, a domestic bio company, is planning to commence a Phase 1 clinical trial for YBL-020, a new bispecific antibody drug for cancer treatment, in 2020.

Y-Biologics Vice President (Director of Research) Young Gyu Cho announced the plan while introducing the company at the Bio Korea held at COEX in Samseong-dong, Gangnam-gu, Seoul. 

YBL-020 is an immune checkpoint inhibitor that inhibits the proteins PD-L1 and LAG-3 with two antibodies. Cancer cells can evade the attacks from T cells by secreting a protein called PD-L1. This is possible because when PD-L1 binds to the PD-1 receptor on the surface of a T cell, the immune cell fails to recognize it. This means that by inhibiting PD-L1 or PD-1, immune cells will be able to maintain their function and attack cancer cells. Similarly, inhibiting LAG-3 increases the activity of immune cells under similar principles.

Among the immune checkpoint inhibitors currently on the global market, Keytruda from a multinational pharmaceutical company and Opdivo from Bristol Myers Squibb are ranked first and second in terms of sales. Both of these are monospecific antibodies that inhibit a single type of protein, i.e., PD-1. Y-Biologics is planning to increase the therapeutic effectiveness by more than a double by developing a bispecific antibody consisting of two antibodies.

There are only two comparable drugs with the same mechanism of action as YBL-020, and they have been developed by F-STAR and MacroGenics. All of them are currently being examined in Phase 1 clinical trials.

Y-Biologics is armed with several new bispecific antibody drugs with slightly different mechanisms of action from YBL-020. All of them are in the non-clinical phase (animal testing).

Among them, YBL-008 normalizes microvessels or prevents fibrosis thereof, thereby increasing the ability of immune cells to penetrate into tumors. It inhibits the proteins, PD-L1 and VEGF-a.

Thee company is also examining a bispecific antibody that can inhibit PD-L1, while boosting the activity of OX-40 and CD-137, thereby enhancing the ability of T cells to attack cancer cells.

Five new bispecific antibody drug substances, i.e., YBL-013, YBL-017, YBL-018, YBL-031 and YBL-032, developed through the proprietary bispecific antibody platform technology, ALiCE, are currently in the non-clinical stage. Y-Biologics plans to select one of these substances and begin a Phase 1 clinical trial around 2021.

Y-Biologics is also planning to kick off a Phase 1 clinical trial for YBL-006, a monospecific antibody and an immune checkpoint inhibitor, at the end of this year. Since an immune checkpoint inhibitor has yet to be developed in Korea, this can be seen as the first step toward localization.

Y-Biologics has a total of 20 pipelines, including 10 bispecific antibody drug substances, 5 monospecific antibodies, 2 antibody-drug conjugates (ADCs), and 3 autoimmune disease antibody substances.