WuXi Biologics Congratulates OncoImmune on FDA Clearance of IND Application for Next Generation anti-CTLA-4 Antibody ONC-392
SHANGHAI, January 2, 2020 – WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, congratulates its partner OncoImmune on the U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) for ONC-392, a novel, next generation anti-CTLA-4 antibody.
As part of the collaboration, WuXi Biologics provided comprehensive and integrated services for the ONC-392 program, including CMC development and GMP manufacturing of the drug substance and drug product, through its world-class development and manufacturing capacities and capabilities.
“It has been our great pleasure working with WuXi Biologics on our ONC-392 program. The clearance of ONC-392 IND by the FDA is an important milestone for OncoImmune,” said Yang Liu, PhD, Founder and CEO of OncoImmune. “WuXi Biologics’ state-of-the-art and full-service biologics platform enabled us to complete a solid CMC package in support of our IND submission and clearance. We are excited about the potential of this next generation anti-CTLA-4 antibody with its novel and differentiated mechanism of action to improve therapeutic outcomes while significantly reducing toxicity.”
“Congratulations to OncoImmune on reaching this milestone for the ONC-392 program. We are glad to enable OncoImmune to accelerate the development of biologics from DNA to IND,” said Dr. Chris Chen, CEO of WuXi Biologics. “We wish the program a great success to benefit more patients suffering from cancers. WuXi Biologics will continue empowering global partners to provide more life-saving treatments to meet health challenges.”
About OncoImmune, Inc.
OncoImmune (www.oncoimmune.com) is a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel immunotherapies for cancer, inflammation and autoimmune diseases. OncoImmune is based in Rockville, Maryland.
ONC-392 is OncoImmune’s second biological product to reach clinical testing and a Phase 1A/1B clinical trial of ONC-392 that is designed to assess the safety, pharmacokinetics, and efficacy of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care in Non- Small Cell Lung Cancer is expected to begin in early 2020.
OncoImmune’s lead product, CD24Fc, is a novel therapeutic that regulates host inflammatory response to tissue injuries and which has broad implications in the pathogenesis of cancer, autoimmune disease, metabolic syndrome and graft-versus-host disease (GvHD). CD24Fc has completed a Phase IIa trial for the prophylactic treatment of acute Graft versus Host Disease (GvHD) in leukemia patients undergoing hematopoietic stem cell transplantation (HSCT) and resulted in a significant improvement in 180 Day Grade III-IV GVHD Free Survival, the Phase III primary endpoint. CD24Fc prophylaxis also resulted in a reduced relapse and, compared to match controls, CD24Fc demonstrated improvement in Overall Survival, Non-Relapse Mortality and Relapse-Free Survival. A dose-dependent reduction in severe (Grade > 3) mucositis was also observed. A 20 patient open label dose expansion cohort at the recommended clinical dose is fully enrolled and the drug continues to perform very well. A Phase III study is anticipated to start in early 2020.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of June 30, 2019, there were a total of 224 integrated projects, including 106 projects in pre-clinical development stage, 102 projects in early-phase (phase I and II) clinical development, 15 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, Singapore, and the U.S. exceeding 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.