Hanmi Pharmaceutical (KOSPI: 128940, CEO: Jae-Hyun Park), a leading biopharma company in Korea that focuses on research areas such as oncology, obesity/metabolism, and rare diseases, announced it has entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA).

Upon the execution of the agreement, Hanmi Pharmaceutical will conduct a phase 1 clinical trial to evaluate the safety and efficacy of its immuno-oncology drug, 'BH3120', in combination with MSD's anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), in patients with progressive or metastatic solid tumors. Hanmi Pharmaceutical will sponsor the clinical trial, and MSD will supply KEYTRUDA.

'BH3120' is a next-generation immunotherapy drug that applies 'Pentambody', a bispecific antibody platform technology, currently under joint development by Hanmi Pharmaceutical and its Chinese subsidiary, BJHM (Beijing Hanmi Pharmaceutical).

Pentambody is a technology that combines one antibody to two different targets simultaneously, facilitating both immuno-oncology therapy and targeted therapy.

More specifically, BH3120 is an lgG-like bivalent bispecific antibody targeting PD-L1 and 4-1BB with biased binding affinities towards PD-L1.

This design aims to induce strong anti-tumor activities, particularly in PD-L1 overexpressed tumor tissues within the tumor microenvironment (TME), while minimizing undue immune activation in normal tissues.

Most of the existing antibody candidates targeting 4-1BB have limitations in terms of safety. However, BH3120 has been shown through various non-clinical studies to exhibit a clear decoupling of immune activity between TME and normal tissue, confirming its potential as an effective and safe anticancer agent.

Dr. Kim Dong-wan, the director of the Seoul National University Hospital Clinical Trials Center (Hemato-Oncology Department), is the Principal Investigator of the phase 1 clinical trial of BH3120 in Korea and the US. He said, "Through the collaboration with MSD, we expect BH3120 in combination with KEYTRUDA could improve outcomes for patients with relapsed or refractory disease."

A Hanmi representative stated, "BH3120 is our first global clinical research project using the next-generation bispecific antibody platform technology 'Pentambody' in the field of immuno-oncology therapy, potentially changing the paradigm of anticancer treatment," and added, "We are dedicated to surpassing the constraints of current therapies and innovatively boosting 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