Pharma Focus Asia

Hanmi Enters Clinical Trial Collaboration and Supply Pact with MSD to Assess BH3120 with KEYTRUDA®

Wednesday, April 24, 2024

Hanmi Pharmaceutical, a leading biopharmaceutical company headquartered in Korea with a focus on oncology, obesity/metabolism, and rare diseases, has recently announced a significant collaboration. They've entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD (Merck & Co., Inc., Rahway, NJ, USA).

Under this agreement, Hanmi Pharmaceutical will initiate a phase 1 clinical trial to assess the safety and efficacy of their immuno-oncology drug, 'BH3120', alongside MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with progressive or metastatic solid tumors. Hanmi Pharmaceutical will lead the trial, with MSD providing the supply of KEYTRUDA.

'BH3120' represents a next-generation immunotherapy drug utilizing 'Pentambody', a bispecific antibody platform technology developed jointly by Hanmi Pharmaceutical and its Chinese subsidiary, BJHM (Beijing Hanmi Pharmaceutical).

Pentambody is a cutting-edge technology allowing one antibody to target two different sites simultaneously, facilitating both immuno-oncology therapy and targeted therapy.

Specifically, BH3120 is an IgG-like bivalent bispecific antibody targeting PD-L1 and 4-1BB, designed to have biased binding affinities towards PD-L1.

This design aims to trigger potent antitumor activities, particularly in tumor tissues overexpressing PD-L1 within the tumor microenvironment (TME), while minimizing unnecessary immune activation in normal tissues.

While many existing antibody candidates targeting 4-1BB have safety limitations, BH3120 has shown promising results in various preclinical studies, demonstrating a clear separation of immune activity between TME and normal tissue, suggesting its potential as an effective and safe anticancer agent.

Dr. Kim Dong-wan, director of the Seoul National University Hospital Clinical Trials Center (Hemato-Oncology Department), serving as the Principal Investigator of the phase 1 clinical trial of BH3120 in Korea and the US, commented, “Through collaboration with MSD, we anticipate that BH3120 in combination with KEYTRUDA could enhance outcomes for patients with relapsed or refractory disease.”

A representative from Hanmi stated, "BH3120 marks our inaugural global clinical research endeavor utilizing the next-generation bispecific antibody platform technology 'Pentambody' in immuno-oncology therapy, potentially revolutionizing the paradigm of anticancer treatment." They further added, “We are committed to overcoming the limitations of current therapies and innovatively enhancing therapeutic efficacy through our next-generation immune-oncology therapy.”

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

BH3120 is a heterodimeric bispecific antibody (PENTAMBODY) designed to target 4-1BB and PD-L1 simultaneously to stimulate anti-tumor immune response either by inhibition of an immune checkpoint mechanism and by activation of a co-stimulatory signal in tumor microenvironment (TME) focused manner. Non-clinical observations with BH3120, either as a monotherapy or in combination settings, consistently explain strong anti-tumor T cell activities in tumor tissue-specific manner with clear dose dependency, while systemic immune response is minimally modulated. These properties support further evaluation of the immune-modulating bispecific antibody, and BH3120 will be studied as a therapeutic candidate with multiple types of solid tumors.



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