Celdara Medical, a clinical-stage biotechnology company focused on delivering products to patients, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and The Geneva Foundation, 501(c)3 non-profit organization that advances military medical research. This collaboration is focused on the development of a therapeutic antibody cocktail candidate for the treatment of Sudan virus, using established animal models to test efficacy against viral infection. There are currently no available therapeutic countermeasures as a part of the U.S. Strategic National Stockpile for Sudan virus. “The advancement of this product will increase preparedness for an emerging infectious disease of global concern,” said John M. Dye, Ph.D., Chief of Viral Immunology at USAMRIID, whose research is supported by The Geneva Foundation.
The development of therapeutics targeting Ebolavirus and other filoviruses is an urgent health priority. Prior to 2014, Sudan virus was responsible for the largest recorded ebolavirus outbreak with greater than 400 cases in Gulu, Sudan in 2000. According to the Centers for Disease Control and Prevention (CDC), the aggregate human fatality rate for Sudan virus from all previous outbreaks is 52 percent. The unpredictable nature of filovirus outbreaks requires the development of a rapidly deployable therapeutic strategy that is both safe and protective against each of the disease-causing viral species. USAMRIID, in collaboration with Albert Einstein College of Medicine and The Geneva Foundation, discovered an antibody cocktail CM-JLD, to combat this potentially pandemic virus. It is a much needed therapeutic candidate that is undergoing development to ensure global protection in the event of an outbreak of Sudan virus. Highlighted by Jonathan Lai, Ph.D., Professor of Biochemistry at Albert Einstein College of Medicine, “Sudan virus does not receive as much attention as its bigger brother, Ebola virus, but it still has the potential to cause large and deadly outbreaks.”
Celdara Medical, LLC is an experienced biopharma developer focused on launching promising products to the patients who need it the most. Celdara has a robust pipeline in medical countermeasures and is proud to partner with USAMRIID and The Geneva Foundation to develop CM-JLD. Brandy Houser, Ph.D., site head in New York, NY and the development lead for the program at Celdara Medical commented, “In parallel with ongoing efficacy studies, additional development is underway in order to ensure regulatory compliance and manufacturing capacity in order to best serve the Strategic National Stockpile and Americans as a whole.”
This work was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under award number R44AI136273.
Disclosure: Dr. Jonathan Lai is a Scientific Founder of the Sudan virus countermeasure project at Celdara Medical, the company that is advancing CM-JLD for clinical application.
[The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.]
About Celdara Medical, LLC
Celdara Medical gives hope and health to patients by transforming academic innovations into medicines with the potential to cure the world’s most challenging diseases. Celdara Medical is a recognized leader with a rich stable of discoveries, developed in concert with premiere research institutions in the US, EU, and beyond. We secure lasting partnerships with inventors and their institutions, and provide the developmental, financial, and business acumen to bridge the gaps between discovery and clinical impact. With robust funding options, operations in greater Boston, NYC, and Washington, DC, growing affiliates in Seattle and Indianapolis, a wealth of opportunities in our pipeline, and partnerships with industry leaders worldwide, Celdara Medical navigates the path from science to medicine, accelerating innovation to improve human health.