Hanmi Pharmaceutical has unveiled another pillar of its new anticancer pipeline at the ESMO Congress 2025 (European Society for Medical Oncology).

The company presented Phase 1 clinical trial results of 'EZH1/2 dual inhibitor (HM97662),' suggesting possibilities for a new anticancer mechanism that could overcome drug resistance.

DailyPharm met with Young Su Noh, Director of Hanmi's Oncology Clinical Team, and heard about the clincal significance of HM97662 and the company's future development strategy.


"Evidence confirmed for resistance inhibition and maintained response… proving the value of EZH1 co-inhibition"

According to the poster presentation, HM97662 secured safety and tolerability and confirmed initial anti-tumor responses in a Phase 1 clinical trial involving patients with advanced or metastatic solid tumors.

A total of 28 patients received treatment across seven dose cohorts (50 to 350mg QD). Partial response (PR) and long-term stable disease (SD) were observed in some patients.

Director Noh said, "HM97662 was developed based on a mechanism that simultaneously inhibits both EZH1 and EZH2, showing superiority over single inhibition in terms of resistance suppression and response durability." He explained, "Since EZH1 is compensatorily activated, leading to resistance when EZH2 is inhibited alone, the approach of targeting both is favorable."

Noh also stated, "Long-term SD was also confirmed in the clinical trial, which shows the possibility that EZH1 co-inhibition contributes to maintaining the response," and added, "Although we are still in the early stages, we plan to continue establishing clinical evidence."

The presentation highlighted a PR observed in a patient with SMARCA4 deficiency.

Noh said, "The observation of PR in a patient with a SMARCA4 mutation is highly significant," and explained, "This patient group is high-risk with typically low response rates to existing treatments, and the results suggest that the EZH1/2 dual inhibition strategy has the potential to show therapeutic activity even in patients with molecular mutations."

He added, "In solid tumors, PRC2 (Polycomb Repressive Complex 2) complex abnormalities are often involved, while EZH2 mutations are directly implicated in blood cancers. HM97662 is a candidate that reflects these molecular characteristics and can expand treatment possibilities even in solid tumors."

Hanmi Pharmaceutical is currently conducting the Phase 1 trial of HM97662 in Korea and Australia and is considering expanding to the U.S.

Noh said, "Hanmi Pharmaceutical is focusing on small cell carcinoma, ovarian cancer, and prostate cancer as cancer types where EZH1/2 dual inhibition may be particularly effective. Although we started with a broad scope of metastatic solid tumors, we will gradually narrow down to cancer types with clearer responses."

"Combining global collaboration and in-house development… building the Hanmi oncology portfolio"

Although Hanmi Pharmaceutical's presentation at ESMO Congress 2025 focused on HM97662, the company is building a diverse portfolio of other anti-cancer pipelines.

Noh said, "Out-licensing (L/O) is an important process, but it is not the only goal." He added, "We are also considering a strategy of simultaneously pursuing in-house development and commercialization to target areas where patient access is limited in Korea and Asia."

Noh stated, "Global pharmaceutical companies are showing interest, and we are preparing for combination clinical trials," and added, "We have confirmed the possibility of synergy in preclinical studies when combining with immunotherapies, targeted therapies, or chemotherapy, and we plan to expand this into clinical trials."

Hanmi plans to strengthen the clinical evidence for the EZH1/2 mechanism based on these results while also entering combination clinical trials with immunotherapies.

Noh said, "We plan to secure dose and tolerability with monotherapy first, and then expand to combination strategies." He explained, "We are securing preclinical data that suggests the possibility of synergy when used in combination with chemotherapy and immunotherapy."

Noh particularly mentioned Hanmi Pharmaceutical's ongoing oncology research efforts, noting that the company is pursuing a long-term, sustainable commercialization strategy.

"Hanmi Pharmaceutical is known for obesity and metabolic diseases, but we also have long-standing research experience and accumulated capabilities in the oncology field," he said. "Our past clinical and research experience is driving our current anti-cancer pipeline."

Noh also expressed confidence, stating, "Hanmi has already had multiple global technology transfer experiences, and we are developing returned projects in-house. We are building the foundation to complete new drugs with proprietary capacity, such as the EZH1/2 dual inhibitor."

Following this trend, Hanmi is also accelerating its expansion into next-generation research areas.

Noh commented, "In addition to immunotherapy combinations, we are also conducting research on next-generation platforms like mRNA and TPD (Targeted Protein Degradation)," and added, "Even after ESMO, we will continue to make subsequent presentations at major conferences like SITC to bring our oncology portfolio into public view.