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Ebola Virus: Orphan Drug ZMapp And Vaccine Developments

October 19, 2014

With the Ebola Virus crisis escalating, the US Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), is accelerating the development of treatments. Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) “ … develops and procures medical countermeasures – vaccines, medicines, diagnostics, and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.”

I – 3 US Labs Asked For ZMapp Ebola Manufacturing Plans

The experimental Ebola orphan drug ZMapp is made up of 3 humanized monoclonal antibodies manufactured in plants, specifically Nicotiana. It is an optimized cocktail that is first identified as a drug candidate in January 2014. ZMapp has shown efficacy in a monkey model of Ebola, but has not yet been evaluated for safety in humans. Because ZMapp is an experimental product, only limited supplies were manufactured for testing in animals. ZMapp’s supply ran out in August 2014.

Reuters reports that BARDA asked three advanced biological laboratories to submit plans for producing ZMapp. BARDA issues a task order on October 16th that detailed plans are to be submitted for the mass production of ZMapp by November 10th. The three advanced labs are established by the US government in 2012 with $440 million in seed money, and are required to “develop flexible manufacturing capabilities to allow them to produce countermeasures against chemical, biological, and other threats.” Once the proposals are submitted, BARDA will pick one or more labs to produce ZMapp. ZMapp has been manufactured in tobacco plants by Kentucky Bioprocessing, a unit of Reynolds American Inc.

The three advanced biological laboratories are:

•   Texas A&M Health Science Center in partnership with Britain’s GlaxoSmithKline Plc

•   Emergent Biosolutions (Baltimore)

•   Lab located in Holly Springs, North Carolina led by Novartis AG.

II – Profectus BioSciences Vaccine

HHS announces on October 16th, that under a 1-year contract, BARDA will provide about $5.8 million in funding along with expertise and technical assistance to Profectus BioSciences (PBS), to further develop an experimental Ebola vaccine. The contract can be extended to a total of 13 months and $8.6 million.

PBS is a Baltimore, Maryland, clinical-stage biotechnology company, that develops preventive and therapeutic vaccines. PBS will manufacture the experimental Ebola vaccine for use in animal studies, future clinical trials, and will conduct animal studies to test safety. Once PBS completes this work, an investigational FDA New Drug Application (NDA) is to be submitted. Once the NDA is accepted, the vaccine can start the first clinical trials for safety in humans.

Per the HHS News Release, BARDA Director Robin Robinson, Ph.D., says:

 “We are pushing hard to advance the development of multiple products as quickly as possible for clinical evaluation and future use in preventing or treating this deadly disease … Our goal is to close the global gap in vaccines and therapeutics needed to protect the public health from Ebola as highlighted by the epidemic in West Africa.”

In March 2014, PBS along with the University of Texas Medical Branch at Galveston, Vanderbilt University Medical Center, and Tekmira Pharmaceuticals are awarded up to $26 million by the National Institutes of Health (NIH) to develop and test vaccines for both the Ebola and Marburg viruses.  

III – Other Ebola Vaccines

•   cAD3_EBOV (cAd3) vaccine, from GlaxoSmithKline and the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), in Phase I clinical trials

•   Vaccine in Phase I clinical trials being tested by the Public Health Agency of Canada (PHAC) and NewLink Genetics Corporation (Iowa).

Please Note: “Ebola Virus Particles” courtesy of NIH/NIAID [CC-BY-2.0 Generic].

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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