Hanmi Unveils Its Dual Action ‘EZH1/2’ Inhibitor Targeting Epignetic Regulation
Hanmi Unveils Its Dual Action ‘EZH1/2’ Inhibitor Targeting Epignetic Regulation
Hanmi presented clinical posters consecutively at ESMO Congress in Spain and ISSX conference in the US
at the ISSX conference.
The clinical progress for Hanmi's next-generation EZH1/2 dual inhibitor (HM97662), an innovative targeted anticancer agent, has garnered significant attention following presentations at globally renowned oncology conferences.
On September 19, Hanmi announced that it exhibited poster presentations on research results for HM97662 at the European Society for Medical Oncology (ESMO Congress 2024) held in Barcelona, Spain, from September 13 to 17 and at the International Society for the Study of Xenobiotics (ISSX) conference held in Honolulu, USA from September 15 to 18 (local time).
The Enhancer of Zeste Homolog (EZH) proteins, commonly referred to as 'genetic control switches', play a pivotal role in regulating cell growth and differentiation by activating or repressing specific gene expressions. The simultaneous inhibition of EZH1 and EZH2, critical components of the 'Polycomb Repressive Complex 2 (PRC2)', is expected to more effectively suppress PRC2 function, resulting in a stronger anticancer effect.
Selectively inhibiting only EZH2 can lead to compensatory activation of EZH1, causing drug resistance. Therefore, dual inhibition of both EZH2 and EZH1 has emerged as a more effective strategy to block PRC2 function and enhance anticancer efficacy. This highlights why Hanmi's HM97662, recognized for its greater efficacy compared to single-mechanism anticancer drugs and its ability to overcome resistance mechanisms, is attracting significant attention.
Hanmi has already demonstrated the powerful anticancer activity of HM97662 in preclinical studies. At this year's ESMO, Hanmi presented the background, design, and progress of the clinical study for HM97662. A global Phase 1 clinical trial is underway in South Korea and Australia, to assess the safety and tolerability of HM97662 as a monotherapy in patients with advanced or metastatic solid tumors.
To date, a total of 19 patients have been enrolled in the dose-escalation part of the Phase 1 trial, and no dose-limiting toxicities (DLTs) have been observed.
Dr. Bhumsuk Keam of the Department of Internal Medicine at Seoul National University Hospital, the coordinating investigator of the Phase 1 trial for HM97662, stated, "The Phase 1 clinical trial of HM97662 is a crucial step in verifying the innovative potential of EZH1/2 dual inhibitors. The trial is ongoing, and we anticipate positive results." He added, "We look forward to establishing HM97662 as an effective treatment option across various cancer types through ongoing research."
At the ISSX conference, Hanmi presented pharmacokinetic (PK) / pharmacodynamic(PD) modeling and simulation data for HM97662. The results highlighted the high predictive accuracy of pharmacokinetic models compared to clinical data (HM-EZHI-101) at first in human dose. Hanmi aims to develop a more precise model for predicting clinical effective dose and efficacy outcomes through a transitional approach, leveraging the correlation between the pharmacokinetic and pharmacodynamic profiles. Additionally, Hanmi expects to verify additional models at the efficacy level of the ongoing Phase 1 clinical trial to contribute to understand the clinical pharmacokinetic (PK) and pharmacodynamic (PD) relations to therapeutic efficacy.
Dr. Jae-Hyun Park, CEO of Hanmi, stated, "We are actively sharing the progress of HM97662 at international forums, including global academic conferences in the second half of the year. Experts worldwide are recognizing the potential of this drug." He added, "We will continue to challenge ourselves to fulfill our core mission as a pharmaceutical company by offering new hope to cancer patients and contributing to a healthier future for humanity."
HM97662 was selected in 2021 for the government-funded New Drug Development Program, aimed at developing anticancer agents for areas with unmet medical needs. Dr. In Young Choi, Head of Hanmi's R&D Center, said, "Thanks to this government-wide R&D initiative, Hanmi was able to enter clinical trial more quickly with HM97662. We will concentrate our research capabilities to commercialize this drug as a 'best-in-class' therapy for various cancer types where effective treatments are lacking."
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Official Websites: www.hanmipharm.com
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