DM919 has shown antitumor activity in various tumour models in preclinical studies. Credit: Kateryna Kon / Shutterstock.com.

D2M Biotherapeutics has dosed the first subject in a Phase I clinical trial of DM919 for the potential treatment of advanced solid tumours.

A new monoclonal antibody, DM919 is designed to act on and hinder the major histocompatibility complex class I chain-related protein A / B (MICA/B) proteins. It is claimed to restore and enhance the anti-tumour response offered by T and natural killer (NK) cells.

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The first-in-human, multicentre, open-label, dose-escalation and expansion study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of DM919.

In the trial, the antibody will be assessed both as a standalone therapy and in combination with anti-PD1 therapy in patients with advanced or metastatic solid tumours.

Trial participants will receive intravenous infusions of DM919 or in combination with pembrolizumab.

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DM919 has shown antitumor activity as a monotherapy in a variety of tumour models and synergistic anti-tumour effects when combined with anti-PD1 agents in preclinical studies.

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D2M co-founder and CEO Nan Bing said: “The initiation of this clinical study represents a major milestone for D2M.

“The MICA/B targeted therapy is a novel modality in cancer treatment through its unique mode-of-action by addressing MICA/B mediated immune escape presented in many types of tumours.

“It also has potential to bring effective treatment against certain tumours with MHC-I low expression, which are typically resistant to the current immune check inhibitor agents.”

The China National Medical Products Administration (NMPA) recently granted clearance for an investigational new drug (IND) application for DM919 for solid tumours.

This development follows the US Food and Drug Administration’s (FDA) clearance of the IND application for DM919 to treat solid tumours in December 2023.