Pharma Focus Europe

D2M Biotherapeutics Initiates Phase 1 Study of DM919, a Novel MICA/B Antibody for Advanced Solid Tumors, with First Patient Dosed

Friday, April 19, 2024

D2M Biotherapeutics, Inc. (D2M), a clinical stage biotech company, announced today that it has initiated dosing the first patient in a phase 1 study of DM919. DM919 is a novel monoclonal antibody targeting MICA/B, aiming to enhance the anti-tumor response by T and natural killer (NK) cells, particularly for advanced solid tumors.

This phase 1 trial, designated as a first-in-human study, will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical efficacy of DM919. It will assess DM919 both as a standalone treatment and in combination with anti-PD1 therapy in patients with advanced or metastatic solid tumors (NCT06328673).

Nan Bing, MD., Ph.D., co-founder, and CEO of D2M, highlighted the significance of this milestone, emphasizing the unique approach of MICA/B targeted therapy in cancer treatment. Dr. Bing also expressed gratitude for collaborating with Dr. Shiraj Sen at Next Oncology, the Principal Investigator overseeing the assessment of DM919's safety and efficacy in this phase 1 study.

Dr. Sen, the Principal Investigator, underscored DM919's unique biological properties, suggesting its potential to enhance a patient's immune response against cancers. Dr. Sen expressed eagerness to explore DM919's efficacy both as a monotherapy and in combination with anti-PD1 therapy.

DM919 is a humanized MICA/B-specific IgG1 monoclonal antibody designed to inhibit the shedding of MICA and MICB proteins from cancer cells. These proteins are recognized by both innate and adaptive immune cells through NKG2D receptors. By preventing MICA/B shedding, DM919 aims to enhance NKG2D-dependent activation of T and NK cells within the tumor microenvironment, thereby promoting anti-tumor activity.

Preclinical studies conducted by D2M Biotherapeutics have shown that DM919 effectively prevents MICA/B shedding, stabilizes surface MICA/B, and facilitates the presentation of shed MICA/B to activate NKG2D on NK or T cells, thereby mediating antibody-dependent cytotoxicity (ADCC) of tumor cells. Additionally, DM919 has demonstrated significant anti-tumor activity as a standalone agent across various tumor models, and it has shown synergistic effects when combined with anti-PD1 agents.



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