[ASCO 2025] What is Hanmi's next-gen onocology development strategy? 

CHICAGO, Ill. -- By Hong Sook, Korea Biomedical Review correspondent -- "We are focused on generating synergistic clinical data with Keytruda (pembrolizumab), while our preclinical pipeline targets anti-cancer therapies across various modalities, including antibody-drug conjugates (ADCs) and mRNA-based treatments."

Hanmi Pharmaceutical participated in the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO 2025), held in Chicago from May 30 to June 3, to refine and advance its clinical strategies for anticancer drug development. A regular attendee of ASCO for over a decade, Hanmi has consistently used the global forum to align its clinical direction with the latest oncology trends and to engage with key opinion leaders (KOLs) from around the world.

Korea Biomedical Review sat down with Noh Young-su, Director of Hanmi’s ONCO Clinical Team, during ASCO 2025 to discuss the company’s progress in anticancer drug development showcased at the conference, as well as its future strategies in oncology.

Question: What is your purpose for attending ASCO this year, and what areas are you particularly interested in?

Answer: This marks our 16th time attending ASCO. For us, it’s not just about presenting data -- it’s also a valuable opportunity to network and collaborate with global KOLs, pharmaceutical companies, CROs, and vendors. Recently, We’ve been especially focused on clinical acceleration through AI, biomarker-based patient selection strategies, and the development of next-generation anticancer therapies.

In particular, we are concentrating on developing therapies targeting HER2 mutations and overexpression. To this end, he has been conducting advisory board meetings (ABMs) with experts to explore potential indications and address unmet needs across various cancer types.

Q: You've had a difficult time developing poziotinib for HER2-mutant NSCLC. Is Hanmi planning to target this area again?

A: The market for HER2-mutant lung cancer is expected to grow further, especially with the recent launch of Boehringer Ingelheim’s HER2-targeted drug, zongertinib. We’ve also identified HM100714 in our pipeline as a candidate to re-enter this space. Based on insights from advisory board meetings, we’ve established a development strategy targeting multiple cancer types -- not only lung, but also breast, gastric, and pancreatic cancers. Our goal is to enter clinical trials within the year.

Q: ASCO is primarily focused on clinical pipelines. What were the key programs Hanmi discussed at ASCO 2025?

A: We mainly discussed the development strategies for BH3120, a bispecific antibody targeting 4-1BB and PD-L1, and HM16390, an IL-2 inhibitor. Recently, the bispecific antibody space -- particularly in China -- has become highly competitive. While speed is important, differentiation through smart and efficient clinical design is equally critical.

Given the known hepatotoxicity associated with existing 4-1BB-targeting agents, we’ve designed our clinical trial to mitigate liver toxicity while enhancing efficacy by combining BH3120 with pembrolizumab. So far, we’ve observed no safety concerns in the phase 1 dose-escalation stage.

Q: The IL-2 inhibitor class has yet to produce a blockbuster drug, and many late-stage trials have yielded disappointing results. What sets HM16390 apart?

A: The currently approved recombinant IL-2 therapy, Proleukin (aldesleukin), is recommended only for limited use due to its significant side effects. Most IL-2 analogs under development aim to modulate binding to the IL-2 beta receptor, but this approach has shown notable safety limitations.

Reducing beta receptor binding may lower the risk of side effects like vascular leak syndrome, but it also compromises anti-cancer efficacy. Conversely, increasing beta receptor binding while eliminating alpha receptor binding can enhance the anti-cancer effect—but this comes with a higher risk of serious adverse events, such as cytokine release syndrome.

To address these challenges, HM16390 was developed using a different strategy. Unlike other IL-2 candidates, it features precise modulation of IL-2 alpha receptor binding—a design intended to maximize therapeutic efficacy while ensuring safety. This balance is expected to reduce the risk of severe side effects without sacrificing anti-tumor activity.

Notably, HM16390 demonstrates the strongest beta receptor binding among IL-2 analogs currently in development, while maintaining optimal alpha receptor binding for immune regulation.

Q: What is the direction of your business development (BD) strategy?

A: Our primary strategy focuses on generating meaningful data in phase 1 and phase 2 trials to explore co-development or licensing collaborations with global partners. Our ultimate goal is to design combination therapies, leveraging existing immunotherapy like Keytruda as a backbone to accelerate global clinical development.

Also, we are actively developing several next-generation modalities internally, including antibody-drug conjugates (ADCs), targeted protein degraders (TPDs), and mRNAs. We anticipate several of these entering clinical trials within the next two to three years. In the mid- to long-term, we also plan to develop a cell and gene therapy platform.

Q: What is the direction of your business development (BD) strategy?

A: Our primary strategy focuses on generating meaningful data in Phase 1 and Phase 2 trials to explore co-development or licensing collaborations with global partners. Our ultimate goal is to design combination therapies, leveraging existing immuno-oncology drugs like Keytruda as a backbone to accelerate global clinical development.

Concurrently, we are actively developing several next-generation modalities internally, including Antibody-Drug Conjugates (ADCs), Targeted Proteolytic Drugs (TPDs), and mRNAs. We anticipate several of these entering clinical trials within the next two to three years. In the mid- to long-term, we also plan to develop a cell and gene therapy platform.

Q: What are the upcoming clinical data presentations and conferences?

A: While we did not make any official announcements at ASCO, we are preparing to present major clinical data at a lymphoma society and the European Society of Medical Oncology (ESMO) in the second half of the year. Specifically, data from our EZH1/2 drug pipeline will be presented at ESMO. Previously, various preclinical data were presented at the American Association for Cancer Research (AACR).