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Hanmi, Merck Enter Clinical Collaboration & Supply Agreement

To evaluate BH3120 in combination with Merck's KEYTRUDA in progressive or metastatic solid tumors.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Hanmi Pharmaceutical, a biopharma company in Korea that focuses on oncology, obesity/metabolism, and rare diseases, has entered into a Clinical Trial Collaboration and Supply Agreement with MSD (Merck & Co., Inc.)
 
Under 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-gen immunotherapy drug that applies Pentambody, a bispecific antibody platform technology, currently under joint development by Hanmi Pharmaceutical and its Chinese subsidiary, Beijing Hanmi Pharmaceutical.
 
Pentambody is a technology that combines one antibody to two different targets simultaneously, facilitating both immuno-oncology therapy and targeted therapy. 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, 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.

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