Yuhan Corporation Receives Domestic Clinical Approval for Immune Checkpoint Dual Antibody 'YH32367'

Technology Import from ABL Bio in 2018
"Plan to Fully Enter Clinical Trials in the Second Half of the Year"

Exterior view of Yuhan Corporation headquarters building

[Asia Economy Reporter Chunhee Lee] Yuhan Corporation's immune-oncology bispecific antibody candidate 'YH32367 (ABL105)', licensed from ABL Bio, is entering full-scale clinical trials.

According to industry sources on the 22nd, the Ministry of Food and Drug Safety approved the clinical trial plan for phases 1 and 2 of YH32367 in South Korea the day before.

This clinical trial will be conducted to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of YH32367 in patients with HER2-positive locally advanced or metastatic solid tumors. The trials will take place at four institutions: Samsung Medical Center, Asan Medical Center, Severance Hospital, and Seoul National University Hospital. A Yuhan Corporation official stated, "We plan to start recruiting clinical trial patients in the second half of this year and proceed with the trials. We intend to conduct phase 1 first, followed sequentially by phase 2."

YH32367 is an anticancer agent that specifically binds to HER2-expressing tumor cells and increases the anticancer activity of immune cells by stimulating 4-1BB, an activation receptor on T immune cells. It is expected to be effective for patients resistant to existing anticancer treatments in various solid tumors such as breast, stomach, and lung cancers by enhancing tumor-specific immune activation while inhibiting tumor cell growth.

Thus, Yuhan Corporation is entering human clinical trials four years after licensing YH32367 from ABL Bio in 2018. Yuhan introduced YH32367 through a technology transfer contract with a total value of 29.5 billion KRW from ABL Bio. The two companies agreed to jointly conduct cell line development, process development, and nonclinical trials, while Yuhan Corporation will take charge of the full-scale clinical stages. Yuhan also holds the exclusive global sales rights.

Earlier, Yuhan Corporation presented preclinical research results of YH32367 in a poster session at the American Association for Cancer Research (AACR 2022) in April. According to the data, YH32367 demonstrated significantly superior anticancer efficacy compared to control antibodies in various HER2-expressing tumor preclinical experiments. Safety was also confirmed in preclinical toxicity tests.