#South Korea #Seoul #Hanmi Pharmaceutical #BH3120 #Immunotherapy

Hanmi Pharmaceutical and Beijing Hanmi: A Leap Forward in Cancer Treatment

In a significant advancement in the field of cancer immunotherapy, Hanmi Pharmaceutical and Beijing Hanmi have made substantial progress in the clinical trials of their jointly developed drug, BH3120. This innovative therapy, designed to combat cancer using a novel approach, has garnered considerable attention in both research and medical communities.

On November 25, 2024, Hanmi announced that it had presented clinical research and developments for BH3120 at the Society for Immunotherapy of Cancer (SITC) conference held in Houston, Texas, from November 6 to 10. The findings highlighted the drug’s potential in treating various forms of advanced cancer and its unique mechanism of action.

BH3120 is based on Hanmi's proprietary Pentambody platform, which allows a single antibody to simultaneously bind to two distinct targets. This dual-targeting capability enables the immunotherapy to selectively attack cancer cells while simultaneously activating immune cells, enhancing the overall efficacy of the treatment. The drug specifically targets PD-L1, a protein found on many cancer cells that suppresses immune responses, as well as 4-1BB, a costimulatory molecule present on T cells.

Preclinical studies have shown that BH3120 exhibits strong anti-cancer activity without significant safety issues, overcoming challenges faced by other therapeutics targeting 4-1BB. The distinct mechanism by which BH3120 operates allows for a better decoupling of immune activity between the tumor microenvironment and normal tissues, suggesting a safer profile and increased potential for effectiveness.

During the SITC, Hanmi elaborated on the history and clinical progress of BH3120, revealing that a global Phase 1 clinical trial is currently underway in South Korea and the United States. This trial is evaluating the safety and tolerability of BH3120 administered as a monotherapy to patients with advanced or metastatic solid tumors.

The trial has progressed smoothly into the third dose cohort (1 mg/kg) without encountering any dose-limiting toxicities (DLT) or grade 3 adverse reactions to date. Dr. Dong-wan Kim, the principal investigator for the BH3120 trial and director at Seoul National University Hospital, emphasized the trial's critical role in assessing this next-generation immunotherapy's potential. He expressed optimism for positive results and the prospect of BH3120 serving as an effective treatment option that minimizes side effects often associated with current immunotherapy practices.

In addition to the standalone evaluation, Hanmi is also exploring the safety and efficacy of BH3120 in conjunction with PD-1 therapy, specifically using Keytruda (pembrolizumab), a well-known cancer immunotherapy developed by Merck. This combination trial was recently approved by regulatory bodies in both South Korea and the U.S., with the objective of beginning large-scale clinical development early next year. Hanmi will lead the trial as the main sponsor, with MSD providing Keytruda for the study.

Young Su Noh, head of the ONCO clinical team at Hanmi, remarked on the importance of the BH3120 trial. He noted that it represents the company's first global clinical research project employing the Pentambody platform in the oncology space, a cutting-edge field aimed at enhancing cancer treatment strategies. Noh expressed a commitment to advancing this next-generation immunotherapy to exceed the limitations of existing treatments and improve therapeutic efficacy.

As the clinical studies proceed, the scientific community watches closely, eager for outcomes that could reshape the landscape of cancer therapies and offer hope to patients worldwide.

For further details about Hanmi Pharmaceutical and its innovations, please visit Hanmi's official website.