NATICK, MA, USA I April 18, 2024 I D2M Biotherapeutics, Inc. (D2M), a clinical stage biotech company focused on developing innovative therapies in treating Immunological-Inflammatory diseases and cancers, today announced that the first patient had been dosed in a phase 1, open-label, dose escalation and expansion study of DM919, a novel monoclonal antibody targeting MICA/B to restore and promote anti-tumor response by T and natural killer (NK) cells for the treatment of advanced solid tumors.
This phase 1, first-in-human, multicenter, dose-escalation and expansion trial (NCT06328673) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of DM919 alone and in combination with anti-PD1 therapy in patients with advanced or metastatic solid tumors.
“The initiation of this clinical study represents a major milestone for D2M,” said Nan Bing, MD., Ph.D., co-founder and CEO of 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 tumors. It also has potential to bring effective treatment against certain tumors with MHC-I low expression, which are typically resistant to the current immune check inhibitor agents. We are thrilled to work with our Principal Investigator, Dr. Shiraj Sen at Next Oncology to assess DM919’s safety and clinical activities in this Ph1 study.”
Dr. Sen commented “DM919 has unique biological properties to potentially restore a patient’s innate and adaptive immunity against cancers. We are eager to investigate DM919 as a monotherapy agent 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 T and NK cells in the tumor micro-environment, 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.
SOURCE: D2M Biotherapeutics
Post Views: 1,274
NATICK, MA, USA I April 18, 2024 I D2M Biotherapeutics, Inc. (D2M), a clinical stage biotech company focused on developing innovative therapies in treating Immunological-Inflammatory diseases and cancers, today announced that the first patient had been dosed in a phase 1, open-label, dose escalation and expansion study of DM919, a novel monoclonal antibody targeting MICA/B to restore and promote anti-tumor response by T and natural killer (NK) cells for the treatment of advanced solid tumors.
This phase 1, first-in-human, multicenter, dose-escalation and expansion trial (NCT06328673) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of DM919 alone and in combination with anti-PD1 therapy in patients with advanced or metastatic solid tumors.
“The initiation of this clinical study represents a major milestone for D2M,” said Nan Bing, MD., Ph.D., co-founder and CEO of 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 tumors. It also has potential to bring effective treatment against certain tumors with MHC-I low expression, which are typically resistant to the current immune check inhibitor agents. We are thrilled to work with our Principal Investigator, Dr. Shiraj Sen at Next Oncology to assess DM919’s safety and clinical activities in this Ph1 study.”
Dr. Sen commented “DM919 has unique biological properties to potentially restore a patient’s innate and adaptive immunity against cancers. We are eager to investigate DM919 as a monotherapy agent 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 T and NK cells in the tumor micro-environment, 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.
SOURCE: D2M Biotherapeutics
Post Views: 1,274
