Home Hanmi Pharma and MSD Enter Clinical Trial Collaboration to Evaluate BH3120 in Combination with Keytruda® (pembrolizumab) for Advanced or Metastatic Solid Tumors

Hanmi Pharma and MSD Enter Clinical Trial Collaboration to Evaluate BH3120 in Combination with Keytruda® (pembrolizumab) for Advanced or Metastatic Solid Tumors

Apr 28, 2024 16:10 CST Updated 16:10
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Hanmi Pharmaceuticals Announces Collaboration with MSD to Conduct a Phase 1 Clinical Trial Evaluating BH3120 in Combination with Keytruda for Patients with Advanced or Metastatic Solid Tumors

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Beijing Hanmi Pharmaceutical Co., Ltd.2023YearAACRDisplay in ChinaBH3120Mechanism of Action

Hanmi Pharmaceuticals (KOSPI stock code: 128940, CEO: Jae-Hyun Park) announced that it has signed a Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD (Merck & Co., Inc., located in Rahway, New Jersey, USA). Hanmi Pharmaceuticals is a leading biopharmaceutical company in Korea, focusing on research areas such as oncology, obesity/metabolism, and rare diseases.

After the agreement is signed, Hanmi Pharmaceuticals will initiate 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) for the treatment of patients with advanced or metastatic solid tumors. Hanmi Pharmaceuticals will sponsor the clinical trial, and MSD will provide Keytruda.

BH3120 is a next-generation immunotherapy drug developed using the bispecific antibody platform technology Pentambody. It is currently jointly developed by Hanmi Pharmaceuticals and its Chinese subsidiary, Beijing Hanmi Pharmaceutical Co., Ltd.

Pentambody is a bispecific antibody technology that simultaneously targets two different antigens, enhancing the effectiveness of tumor treatment.

More specifically, BH3120 is a bispecific antibody targeting both PD-L1 and 4-1BBA lgG-like bivalent bispecific antibody with a binding affinity biased towards PD-L1.

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

Currently, most targeted 4-1BBThe candidate antibody has limitations in terms of safety. However, various non-clinical studies have shown that BH3120 exhibits significant immune activity decoupling in the TME compared to normal tissues, confirming its potential as a safe and effective anticancer drug.

Dr. Kim Dong-wan, Director of the Clinical Trials Center (Hematology-Oncology) at Seoul National University Hospital, is the principal investigator for the Phase 1 clinical trial of BH3120 in Korea and the United States. He said, "Through collaboration with MSD, we expect that the combination therapy of BH3120 and Keytruda can improve outcomes for patients with relapsed or refractory disease."

A representative of Hanmi Pharmaceuticals stated, "BH3120 is our first global clinical research project in the field of immuno-oncology treatment utilizing the next-generation bispecific antibody platform technology 'Pentambody,' which has the potential to change the paradigm of cancer treatment." They added, "We will focus on breaking through the limitations of existing therapies with next-generation immuno-oncology treatments and innovatively improving therapeutic outcomes."

Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., located in Rahway, New Jersey, USA.