South Korea-based Hanmi Pharmaceutical has signed a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., to advance the clinical research of the former’s BH3120 immuno-oncology drug.

Hanmi will conduct a Phase I clinical trial to assess the safety and efficacy of BH3120 in combination with Keytruda (pembrolizumab), MSD’s anti-PD-1 therapy.

BH3120 is a next-generation immunotherapy drug. It uses ‘Pentambody’, a bispecific antibody platform technology that is under development by Hanmi and its Chinese subsidiary Beijing Hanmi Pharmaceutical (BJHM).

The Phase I clinical trial will focus on the combined effects of BH3120 and Keytruda in treating solid tumours.

The trial, which will be sponsored by Hanmi, will target patients with progressive or metastatic solid tumours while MSD will provide Keytruda.

Developed by Hanmi and its subsidiary BJHM, BH3120 is designed to target PD-L1 and 4-1BB, aiming to enhance the antitumour activities within the tumour microenvironment and reduce immune activation in normal tissues.

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Non-clinical studies have highlighted BH3120’s potential as a safe and effective cancer treatment.

Seoul National University Hospital Clinical Trials Center (Hemato-Oncology Department) director Dr Kim Dong-wan is serving as the principal investigator of the Phase I clinical trial of BH3120 in South Korea and the US.

Dong-wan said: “Through the collaboration with MSD, we expect that BH3120, in combination with Keytruda, could improve outcomes for patients with relapsed or refractory disease.”

A Hanmi representative said: “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.”

Last October, MSD secured approval from the US Food and Drug Administration (FDA) for Keytruda anti-PD-1 therapy for the treatment of resectable non-small cell lung cancer, in combination with platinum-containing chemotherapy as a neoadjuvant treatment.