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CLAREMONT, Calif.--(BUSINESS WIRE)--Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced a partnership valued at up to $119 million over a six-year period with the Biomedical Advanced Research and Development Authority (BARDA), a center within the Administration for Strategic Preparedness and Response, part of the U.S.
加利福尼亚州克莱蒙特(商业新闻短讯)--Synedgen,Inc.,一家针对人类糖生物学治疗胃肠道疾病的生物技术公司,今天宣布与生物医学高级研究与发展局(BARDA)在六年内建立价值高达1.19亿美元的合作伙伴关系,BARDA是美国政府战略准备和应对中心的一部分。
Department of Health and Human Services. This contract aims to develop Synedgen’s lead therapeutic, MIIST305, to address Gastrointestinal Acute Radiation Syndrome (GI-ARS) arising from acute exposure to ionizing radiation. The initial phase of the award provides up to $17 million for proof-of-concept studies in two animal models.
卫生与公众服务部。该合同旨在开发Synedgen的主要治疗药物MIIST305,以解决急性电离辐射引起的胃肠道急性辐射综合征(GI-ARS)。该奖项的初始阶段为两种动物模型的概念验证研究提供了高达1700万美元的资金。
If all options are exercised, this BARDA contract will advance MIIST305 development through U.S. Food and Drug Administration (FDA) approval and contribute to the field of medical countermeasures research by optimizing a new nonclinical GI-ARS model for FDA acceptance..
如果行使所有选择权,该BARDA合同将通过美国食品和药物管理局(FDA)的批准推进MIIST305的发展,并通过优化新的非临床GI-ARS模型以供FDA接受,从而为医疗对策研究领域做出贡献。。
“We are delighted to be partnering with BARDA to develop MIIST305 as a therapeutic to address GI-ARS,” said Shenda Baker, Ph.D., President and CEO of Synedgen. “No currently available FDA-approved therapeutic exists to provide protection to major gastrointestinal organs against acute exposure to ionizing radiation.
Synedgen总裁兼首席执行官ShendaBaker博士表示:“我们很高兴与BARDA合作,开发MIIST305作为治疗GI-ARS的药物。”。“目前没有FDA批准的治疗方法可以保护主要胃肠器官免受电离辐射的急性暴露。
Importantly, this program leverages Synedgen’s MIIST305 program to address gastrointestinal inflammation and damage from radiation, chemical or physiological sources, thus potentially meeting this unmet need.”.
重要的是,该计划利用Synedgen的MIIST305计划来解决胃肠道炎症和辐射,化学或生理来源的损害,从而有可能满足这一未满足的需求。”。
Synedgen has developed a drug design platform called Multivalent Innate Immune Signaling Target (MIIST) to identify and synthesize an innovative class of glycomedicines. MIIST305, derived from this platform, is a non-systemic therapeutic that modulates innate immune receptor responses and targets the anionic glycocalyx at the gastrointestinal cell surface to repair and restore the gut mucosal barrier.
。源自该平台的MIIST305是一种非全身性治疗剂,可调节先天性免疫受体反应,并靶向胃肠道细胞表面的阴离子糖萼,以修复和恢复肠粘膜屏障。
By doing so, MIIST305 is designed to mitigate the systemic hyperinflammation and dysbiosis that are characteristic of the gastrointestinal injury caused by acute radiation exposure. MIIST305 is shelf-stable and orally administered, obviating the need for specialized administration in an emergent scenario.
通过这样做,MIIST305旨在减轻全身性过度炎症和生态失调,这是急性辐射暴露引起的胃肠道损伤的特征。。
In a Phase 1-ready program established independently of the partnership with BARDA, MIIST305 is also being developed as a therapy for ulcerative colitis (UC)..
在独立于与BARDA合作建立的1期就绪计划中,MIIST305也被开发为溃疡性结肠炎(UC)的治疗方法。。
GI-ARS occurs when patients are exposed to a high level of radiation by sources which may be accidental or malicious in nature. ARS and UC are marked by similarities in disease pathophysiology, including mucosal barrier disruption, enterocyte death, activation of hyperinflammatory pathways, and dysbiosis.
GI-ARS发生在患者暴露于高水平辐射源时,这些辐射源可能是偶然的或恶意的。ARS和UC在疾病病理生理学上具有相似性,包括粘膜屏障破坏,肠细胞死亡,过度炎症途径的激活和生态失调。
GI-ARS is a major radiation toxicity that can lead to sepsis and death. While there are four FDA approved products for hematopoietic acute radiation syndrome (H-ARS), there remains an unmet need for therapies that address GI-ARS. Together with BARDA, Synedgen is meeting this critical gap in national defense preparedness..
GI-ARS是一种主要的辐射毒性,可导致败血症和死亡。虽然有四种FDA批准的造血急性放射综合征(H-ARS)产品,但针对GI-ARS的治疗需求仍未得到满足。Synedgen与BARDA一起,正在填补国防准备方面的这一关键空白。。
“Today’s announcement marks an important step in moving forward Synedgen’s innovative MIIST platform to produce therapies at the leading edge of medicine,” said LTC (retd.) Mark Bohannon, former Chief of the Medical Branch for the Joint Requirements Office for Chemical, Biological, Radiological, and Nuclear Defense (JRO-CBRND).
LTC(retd。)化学、生物、放射和核防御联合需求办公室(JRO-CBRND)前医学部门负责人马克·博哈农(Mark Bohannon)表示:“今天的宣布标志着推进Synedgen创新MIIST平台在医学前沿生产疗法的重要一步。”。
“The development of MIIST305 as an FDA-approved GI-ARS therapeutic, in addition to its development as a UC drug, would be a major step forward in our efforts to improve not just civilian health but also provide a necessary option for furthering U.S. medical countermeasures against radiation threats.”.
“MIIST305作为FDA批准的GI-ARS治疗药物的开发,除了作为UC药物的开发外,将是我们努力改善平民健康的重要一步,也是进一步加强美国医疗对抗辐射威胁的必要选择。”。
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The views and opinions presented herein are those of the contributing parties and do not necessarily represent the views of DoD or the Army. Appearance of, or reference to, any commercial products or services does not constitute DoD or Army endorsement of those products or services. The appearance of external hyperlinks does not constitute DoD or Army endorsement of the linked websites, or the information, products or services therein..
本文所述观点和意见均为派遣方的观点和意见,不一定代表国防部或陆军的观点。任何商业产品或服务的出现或提及并不构成国防部或陆军对这些产品或服务的认可。。。
About Synedgen, Inc.
关于Synedgen,Inc。
Synedgen, Inc. (Claremont, CA) is a biotechnology company developing Multivalent Innate Immune Signaling Target (MIIST) therapeutics that modulate and enhance the innate immune system. The company’s lead development candidate is MIIST305, an oral, glycocalyx-targeted therapy for ulcerative colitis (UC) and a medical countermeasure for gastrointestinal acute radiation syndrome (GI-ARS).
Synedgen,Inc.(加利福尼亚州克莱蒙特)是一家开发调节和增强先天免疫系统的多价先天免疫信号靶标(MIIST)疗法的生物技术公司。该公司的主要开发候选人是MIIST305,这是一种针对溃疡性结肠炎(UC)的口服糖萼靶向疗法,也是胃肠道急性放射综合征(GI-ARS)的医学对策。
MIIST technology has been validated with clinical trials in partnered programs and extensively peer-reviewed through National Institutes of Health grants and Department of Defense contracts. Synedgen’s GI-ARS program is funded in whole or in part with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority, under Contract No.
MIIST技术已通过合作项目的临床试验进行了验证,并通过美国国立卫生研究院拨款和国防部合同进行了广泛的同行评审。Synedgen的GI-ARS计划全部或部分由卫生与公众服务部的联邦资金资助;战略准备和应对管理局(ASPR);生物医学高级研究与发展局,合同号:。
75A50124C00047. For more information, please visit www.synedgen.com..
75A50124C00047。有关更多信息,请访问www.synedgen.com。。