Oncoimmune new generation CTLA-4 antibody is approved by FDA for clinical trials

Shanghai, China, January 2, 2020 / Meitong news agency / -- oncoimmune, a partner of the world's leading open biopharmaceutical technology platform company, recently announced that its new generation of CTLA-4 antibody onc-392 has been approved by the US Food and Drug Administration (FDA) to conduct clinical trials of new drugs (ind), which was congratulated by the company Yaoming bio has the world-class capacity of R & D and production services for biological drugs Through the comprehensive and integrated biological pharmaceutical technology platform, it provides services for the onc-392 project, such as CMC development, GMP production of biological drug stock solution and preparation, etc "This onc-392 project has been approved by FDA to carry out clinical trials, which is undoubtedly an important milestone for oncoimmune We are very happy to cooperate with Yaoming biology to promote the development process of this project," said Dr Liu Yang, founder, chairman and CEO of oncoimmune "Yaoming biology's excellent integrated biopharmaceutical platform helps the company successfully complete all clinical applications for ind application The former CMC research work provided strong support for us to submit the ind application and successfully obtain the approval of FDA to carry out clinical trials We very much hope that this new generation of CTLA-4 antibody with a new mechanism of action can improve the therapeutic effect and significantly reduce the toxicity " "Congratulations on the significant progress of the onc-392 project of our partner oncoimmune We are very pleased to empower oncoimmune to accelerate the development process of biological drugs from DNA to ind, and wish the clinical research of this project a smooth progress and benefit cancer patients as soon as possible " "The company will continue to empower global partners to develop more life-saving and innovative treatments to meet health challenges," said Dr Chen Zhisheng, CEO of YaoMing bio About oncoimmune oncoimmune (www.oncoimmune Com), a clinical stage biopharmaceutical international private holding company headquartered in Rockwell, Maryland, USA, is dedicated to the research and development of new immunotherapies for cancer, inflammation, metabolic syndrome and autoimmune diseases The onc-392 project is oncoimmune's second biological product to enter clinical trials A phase 1A / 1b clinical trial to be launched in early 2020 aims to evaluate the safety, pharmacokinetics and efficacy of onc-392 as a single drug in the treatment of advanced solid tumors and in combination with anti-PD - (L) 1 standard therapy in patients with non-small cell lung cancer The main product of oncoimmune, cd24fc, is a new type of therapy that can regulate the inflammatory response of the host to tissue damage It has a wide range of significance for the study of the pathogenesis of cancer, autoimmune diseases, metabolic syndrome and graft-versus-host disease (GVHD) Cd24fc has completed phase IIa clinical trial, aiming at the prophylactic treatment of acute graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation (HSCT) in leukemia patients The results show that the main study end point for phase III clinical trial-- The 180 day disease-free survival rate of grade III-IV graft-versus-host disease was significantly improved Compared with the control group, the cd24fc preventive therapy could also reduce the relapse rate of leukemia The total survival rate, non relapse mortality rate and non relapse survival rate were all increased, and the dose-dependent reduction of severe mucositis (above grade 3) was observed An open label dose extension cohort study of 20 patients with clinically recommended doses was completed and the drug continued to perform well Phase III clinical trials are expected to start in early 2020 About Guangzhou onc immune Biotechnology Co., Ltd Guangzhou onc immune Biotechnology Co., Ltd is a R & D center in China built by the US onc immune company It was registered and settled in the beautiful International Biological Island of Guangzhou in 2018 Guangzhou onc immune Biotechnology Co., Ltd owns the rights and interests of the products under research in Greater China of the US onc immune company, and undertakes many pre clinical development work of the products under research, including the research required for the clinical approval of onc-392 Since its establishment, Guangzhou onco immune Biotechnology Co., Ltd has been strongly supported by Guangzhou Development Zone, Guangdong Provincial Laboratory of regenerative medicine and health As a Hong Kong listed company, Yaoming bio (Stock Code: 2269 HK) is the world's leading open, integrated bio pharmaceutical capability and technology enabling platform The company provides a full range of end-to-end R & D services for global biopharmaceutical companies and biotechnology companies, helps anyone and any company to discover, develop and produce biopharmaceuticals, realizes the whole process from concept to commercial production, accelerates the global R & D process of biopharmaceuticals, reduces the cost of research and development, and benefits patients As of June 30, 2019, there are 224 comprehensive projects developed on the platform, including 106 in the preclinical research stage, 102 in the early clinical (phase I, phase II), 15 in the late clinical (phase III) and 1 in the commercial production stage It is estimated that by 2022, the total capacity of the company's planned biopharmaceutical production bases in China, Ireland, Singapore and the United States will exceed 280000 liters, which will effectively ensure that the company will provide customers with biopharmaceuticals that meet global quality standards through a sound and strong global supply chain network For more information, please visit www.wuxibiologics.com.cn Adorable adorable