DAT-2645, the world's first PARG inhibitor approved by the NMPA for clinical trials

2024 August 23, 2024, Beijing, China & Boston, USA— Danatlas Pharmaceuticals today announced that the IND application for DAT-2645, its independently developed PARG inhibitor with complete intellectual property rights, has been approved by the National Medical Products Administration (“NMPA”). This is the first PARG inhibitor globally to be approved by the NMPA for clinical trials and the first in China to be approved by the FDA for clinical trials.

A multi-center, open-label, dose-escalation and dose-expansion Phase I clinical trial is underway in China and the United States to evaluate the safety and efficacy of DAT-2645 monotherapy in patients with advanced or metastatic solid tumors harboring BRCA1/2 loss-of-function mutations and/or homologous recombination deficiency (HRD).

        Dr. Zhou Wenlai, Founder and CEO of Danatlas, stated: “The NMPA’s approval of Danatlas’ PARG inhibitor DAT-2645 for clinical trials marks a significant milestone for the company in its commitment to ‘being rooted in China and facing the world’ It is believed that DAT-2645 can become a revolutionary therapy, providing more effective treatment options for cancer patients worldwide. Danatlas will continue to contribute innovative and high-quality products, upholding its corporate mission of ‘becoming a pillar of support for patients’ lives and health.’ About DAT-2645

DAT-2645 is a novel, highly selective, orally administered small molecule poly (ADP-ribose) glycohydrolase (PARG) inhibitor independently developed by Danatlas.

   DAT-2645 PARG and poly (ADP-ribose) polymerase (PARP) act on the same signaling pathway and play a key role in DNA damage repair response and DNA replication. DAT-2645 specifically kills tumor cells with specific DNA damage repair defects through a synthetic lethality mechanism. Its indications include various common cancers such as breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, uterine cancer, gastric cancer, and colorectal cancer. It will effectively expand indications where PARP inhibitors are ineffective and address the pain point of PARP inhibitor resistance, with the potential for broad-spectrum therapeutic clinical applications. To date, no PARG inhibitor has been marketed globally. About Danatlas

Danatlas is an innovation-driven company dedicated to the research of DNA damage repair mechanisms and the development of novel precision oncology targeted therapies for patients.

  Our team has established a strong pipeline of ‘First-in-Class & Best-in-Class’ precision oncology drug development and advanced technology platforms, possessing high-level professional capabilities in target identification, validation and drug discovery, translational medicine, and clinical research. We are discussing extensive cooperation intentions and establishing strategic partnerships with professional institutions focusing on tackling solid tumors in the global areas of breast cancer, digestive tract tumors, and urinary system tumors, with the aim of bringing these transformative products and therapies to patients as soon as possible. The company's R&D center is located in Beijing, with a branch center in Boston, USA. 。我们团队已经建立了强大的“First-in-Class & Best-in-Class”肿瘤精准药物研发管线和先进的技术平台，拥有靶点识别、验证和药物发现、转化医学、临床研究等高水平专业功能。我们正在与专注攻克全球乳腺癌、消化道肿瘤，泌尿系统肿瘤等实体瘤领域的专业机构讨论广泛合作意向，建立战略合作伙伴关系，以期尽早将这些变革性的产品及疗法惠及患者。公司研发中心位于北京，在美国波士顿设有分中心。