D2M Biotherapeutics Announces FDA Clearance of Investigational New Drug (IND)
Application for DM919, a Novel MICA/B Antibody for Treating Patients with Solid Tumors
- D2M will initiate a multicenter Ph 1 study to evaluate DM919 as monotherapy and in combination with an anti-PD1 agent
Natick, Mass., December 21, 2023 — D2M Biotherapeutics, Inc. (D2M), an immune therapy company, today announced that the U.S. Food and Drug Administration (FDA) has cleared company’s Investigational New Drug (IND) for DM919, a novel monoclonal antibody targeting MICA/B to restore and promote anti-tumor response by natural killer (NK) and T cells, for the treatment of solid tumors.
The Phase 1, multicenter, dose-escalation and expansion trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DM919 alone and in combination with anti-PD1 therapy.
“The FDA IND clearance of DM919 represents a major milestone for D2M,” said Nan Bing, MD., Ph.D., co-founder and CEO of D2M. “We are excited to bring DM919 into clinical development. The MICA/B targeted therapy represents a novel modality in cancer treatment through its unique mode-of-action by addressing MICA/B mediated immune escape with many types of tumors. In addition, DM919 has potential to bring effective therapy to patients with MHC-I low expression tumor types, which are typically resistant to the current immune check inhibitor agents. We look forward to exploring multiple opportunities for DM919 as a monotherapy and in combination with anti-PD1 therapy”.
About DM919
DM919 is a humanized MICA/B-specific IgG1 monoclonal antibody designed to block the shedding of MICA and MICB proteins from cancer cells. Highly expressed in cancer cells, MICA/B are stress-induced ligands recognized by both innate and adaptive immune cells via NKG2D receptors. Through shedding MICA/B, tumor cells develop immune escape. DM919 restores and enhances NKG2D-dependent activation of NK and T cells in the TME, and therefore promotes anti-tumor activity in cancer patients.
D2M Biotherapeutics have shown that DM919 prevents MICA/B shedding, stabilizes surface MICA/B and presents shed MICA/B to activate NKG2D on NK or T cells and mediates antibody-dependent cytotoxicity (ADCC) of tumor cells. In preclinical studies, DM919 has demonstrated significant antitumor activity as a single agent in a variety of tumor models. Furthermore, substantial synergistic anti-tumor effects have been demonstrated when DM919 is combined with anti-PD1 agent.
About D2M Biotherapeutics, Inc.
D2M Biotherapeutics is a clinical stage biopharmaceutical company focused on discovery and development of innovative medicines to help patients with unmet medical needs in oncology and autoimmune diseases. D2M is revolutionizing immunological-based drug development empowered by our proprietary INGENUITI (INtegrated GENetics and mUlti-omIcs for Target Identification) platform. Through INGENUITI, we systematically identify novel disease targets of significant value by deep mining integrated disease and functional genomic data with the power of machine learning and proprietary bioinformatics algorithms.
Anchored by INGENUITI, D2M has built a diversified pipeline of drug assets based on novel targets with unique modes of action and strong human genetics support. By focusing on the high-confidence targets with either FIC or BIC potential, we strive to apply our human genetics data-driven approach and bring transformative medicines to patients in need. For more information, please visit www.d2mbio.com.
Contact
[email protected]
D2M Biotherapeutics, Inc.
22 Strathmore Road,
Natick, MA 01760, USA