Natick, Mass., April 1st, 2024 -- D2M Biotherapeutics Inc (D2M), a clinical stage biotech company focused on developing innovative therapies in treating Immunological-Inflammatory diseases and cancers, today announced that China National Medical Products Administration (NMPA) 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 T cells and natural killer (NK) and, for the treatment of solid tumors.
This phase 1, first-in-human, multicenter, dose-escalation and expansion trial (CXSL2400035) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of DM919 in patients with advanced or metastatic solid tumors.
“Following the IND approval of DM919 by FDA in December 2023, we are pleased to receive the clearance of DM919 IND from NMPA” said Nan Bing, MD., Ph.D., co-founder and CEO of D2M. “It underscores D2M’s commitment and capabilities in executing our corporate and clinical development strategies. With the INDs approved by both FDA and NMPA, we are well positioned to accelerate the phase 1 clinical development of DM919. We look forward to working closely with Principal Investigators to bring this innovative drug candidate into clinical development to benefit the cancer patients in needs”.
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 T and NK 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 T or NK 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
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D2M Biotherapeutics, Inc.
22 Strathmore Road,
Natick, MA 01760, USA