DM919, a Novel MICA/B Antibody for Treating Patients with Advanced Solid Tumors

DM919，一种用于治疗晚期实体瘤患者的新型MICA/B抗体

NATICK, Mass., April 18, 2024 /PRNewswire/ -- 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. .

NATICK，Mass。，2024年4月18日/PRNewswire/--D2M Biotherapeutics，Inc.（D2M），一家专注于开发治疗免疫炎症性疾病和癌症的创新疗法的临床阶段生物技术公司，今天宣布，第一名患者已在DM919的第一阶段开放标签剂量递增和扩展研究中服用，DM919是一种靶向MICA/B的新型单克隆抗体，可恢复和促进T细胞和自然杀伤（NK）细胞的抗肿瘤反应，用于治疗晚期实体瘤。。

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.   .

第一阶段，首次在人体内，多中心，剂量递增和扩展试验（NCT06328673）将评估DM919单独和联合抗PD1治疗晚期或转移性实体瘤患者的安全性，耐受性，药代动力学，药效学和临床活性。。

'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.

“这项临床研究的启动代表了D2M的一个重要里程碑，”D2M的联合创始人兼首席执行官南斌博士说。“MICA/B靶向治疗是一种新型的癌症治疗方式，它通过其独特的作用模式来解决MICA/B介导的免疫逃逸在许多类型的肿瘤中的表现。

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.'.

它还具有针对MHC-I低表达的某些肿瘤的有效治疗的潜力，这些肿瘤通常对当前的免疫检查抑制剂具有抗性。我们很高兴与我们的首席研究员Shiraj Sen博士在Next Oncology合作，在这项Ph1研究中评估DM919的安全性和临床活动。”。

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'.

森博士评论道：“DM919具有独特的生物学特性，有可能恢复患者对癌症的先天性和适应性免疫力。我们渴望研究DM919作为单一治疗剂并与抗PD1治疗相结合。

About DM919

关于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..

DM919是一种人源化MICA/B特异性IgG1单克隆抗体，旨在阻止癌细胞中MICA和MICB蛋白的脱落。MICA/B在癌细胞中高度表达，是先天性和适应性免疫细胞通过NKG2D受体识别的应激诱导配体。通过脱落MICA/B，肿瘤细胞发生免疫逃逸。DM919恢复并增强肿瘤微环境中T细胞和NK细胞的NKG2D依赖性激活，从而促进癌症患者的抗肿瘤活性。。

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.

D2M生物治疗学表明，DM919可防止MICA/B脱落，稳定表面MICA/B，并呈现脱落的MICA/B，以激活NK或T细胞上的NKG2D，并介导肿瘤细胞的抗体依赖性细胞毒性（ADCC）。在临床前研究中，DM919在各种肿瘤模型中作为单一药物显示出显着的抗肿瘤活性。

Furthermore, substantial synergistic anti-tumor effects have been demonstrated when DM919 is combined with anti-PD1 agent.  .

此外，当DM919与抗PD1剂组合时，已经证明了显着的协同抗肿瘤作用。。

About D2M Biotherapeutics, Inc.

关于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..

D2M Biotherapeutics是一家临床阶段的生物制药公司，专注于发现和开发创新药物，以帮助肿瘤和自身免疫性疾病中未满足医疗需求的患者。D2M通过我们专有的INGENUITI（用于靶标识别的集成遗传学和多组学）平台，正在彻底改变基于免疫学的药物开发。通过INGENUITI，我们利用机器学习和专有生物信息学算法的强大功能，通过深度挖掘整合的疾病和功能基因组数据，系统地识别出具有重要价值的新型疾病靶标。。

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..

在INGENUITI的支持下，D2M基于具有独特作用模式和强大人类遗传学支持的新型靶标，建立了多样化的药物资产管道。通过专注于具有FIC或BIC潜力的高可信度目标，我们努力应用我们的人类遗传学数据驱动方法，并为有需要的患者带来变革性药物。有关更多信息，请访问www.d2mbio.com。。

Contact

联系人

info@d2mbio.com

info@d2mbio.com

D2M Biotherapeutics, Inc.

D2M生物治疗公司。

22 Strathmore Road,

Strathmore路22号，

Natick, MA 01760, USA

纳蒂克，MA 01760，美国

View original content to download multimedia:https://www.prnewswire.com/news-releases/d2m-biotherapeutics-announces-first-patient-dosed-in-a-phase-1-study-evaluating-302120400.html

查看原始内容以下载多媒体：https://www.prnewswire.com/news-releases/d2m-biotherapeutics-announces-first-patient-dosed-in-a-phase-1-study-evaluating-302120400.html

SOURCE D2M Biotherapeutics, Inc.

来源：D2M Biotherapeutics，Inc。