Yuhan Corporation Presents Preclinical Results of Targeted and Immuno-Oncology Agents at AACR in the US

On April 29 (local time), Yuhan Corporation announced that it had presented preclinical research results for its anticancer drug pipeline?specifically, the targeted anticancer agent YH42946 (JIN-A04) and the immuno-oncology agent YH32364 (ABL104)?at the annual meeting of the American Association for Cancer Research (AACR 2025) held in Chicago, United States.

The results were disclosed in a poster presentation format at AACR 2025, which took place from April 25 to 30 (local time). The related abstract was previously published on the conference website on March 25.

YH42946 is an anticancer agent in the tyrosine kinase inhibitor (TKI) class that targets HER2 (Human Epidermal Growth Factor Receptor 2) and EGFR (Epidermal Growth Factor Receptor) mutations. It demonstrated strong antitumor activity against a variety of mutations, including HER2 exon 20 insertions, as well as HER2 amplification and expression, and also showed efficacy against EGFR exon 20 insertion mutations.

In particular, HER2 and EGFR (Epidermal Growth Factor Receptor) exon 20 insertion mutations in non-small cell lung cancer patients do not respond well to existing TKI therapies, which means the available treatment options for these patients are extremely limited.

At this conference, a research team led by Professor Cho Byoungcheol of Yonsei Cancer Center presented key preclinical results based on various cell experiments, including patient-derived cells (PDCs), demonstrating the anticancer effect of YH42946 on EGFR exon 20 insertion mutations in non-small cell lung cancer. The results confirmed that YH42946 not only exhibited activity against existing HER2 exon 20 insertion mutations but also showed broad inhibitory effects on EGFR exon 20 insertion mutations.

YH42946 is a novel drug candidate that Yuhan Corporation licensed in from J INTS BIO in 2023. Currently, a global phase 1/2 clinical trial is underway targeting patients with locally advanced or metastatic solid tumors harboring HER2 and EGFR gene mutations.

Meanwhile, YH32364 is a bispecific immuno-oncology agent jointly developed by Yuhan Corporation and ABL Bio. It specifically binds to tumor cells expressing EGFR, blocking growth signals, while simultaneously stimulating 4-1BB, a T-cell activating receptor, thereby enhancing the antitumor activity of immune cells.

In vitro cell-based studies showed that YH32364 exhibited potent antitumor effects, including T-cell activation superior to competing drugs, in lung and colorectal cancer cells expressing EGFR and harboring KRAS mutations. In head and neck cancer tumor cells, combination efficacy with an anti-PD1 antibody was observed. In animal models, YH32364 increased immune cell infiltration into tumors, improved the tumor microenvironment, provided long-term antitumor effects through immune memory, and demonstrated excellent tolerability and antitumor efficacy when combined with standard therapies. Based on these preclinical efficacy studies, Yuhan Corporation expects YH32364 to become a promising treatment option for patients with various EGFR-expressing solid tumors.

This candidate received Investigational New Drug (IND) approval for phase 1/2 clinical trials from the Ministry of Food and Drug Safety on April 7, 2025, and the company aims to initiate clinical trials within the first half of this year.