• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » HHS contracts with Mapp Biopharmaceutical to develop ZMapp for Ebola

HHS contracts with Mapp Biopharmaceutical to develop ZMapp for Ebola

September 4, 2014
CenterWatch Staff

The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide funding as well as access to subject matter expertise and technical support for manufacturing, regulatory and nonclinical activities through a $24.9 million, 18-month contract with Mapp Biopharmaceutical, of San Diego, Calif. ASPR can extend the contract up to a total of $42.3 million.

Work under the contract supports the development and manufacturing of the medication ZMapp, toward the goal of FDA approval.

“While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy,” said Dr. Nicole Lurie, assistant secretary for preparedness and response. “Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. government, and today’s agreement represents an important step forward.”

The Defense Threat Reduction Agency (DTRA) within the Department of Defense and the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH supported initial work on this product. To speed the development of ZMapp, BARDA will work closely with those agencies. BARDA also will work with the company to optimize and accelerate the manufacturing of ZMapp so testing can be done as soon as possible.

Mapp Biopharmaceutical will manufacture a small amount of the drug for early stage clinical safety studies and nonclinical studies needed to demonstrate the drug’s safety and efficacy in people. Mapp Biopharmaceuticals also will work with BARDA on the manufacturing process, increasing production yields and the scale of manufacturing. 

As an experimental drug, ZMapp currently is available only in very limited quantities and these steps will contribute to increasing the amount of product potentially available to treat patients with Ebola.

ZMapp is a combination of three monoclonal antibodies manufactured in tobacco plants. Monoclonal antibodies bind certain virus proteins and neutralize the virus, decreasing the amount of the virus in the body that the patient's immune system has to fight. ZMapp has been shown to reduce mortality in mice and nonhuman primates exposed to Ebola viruses.

The project with Mapp Biopharmaceutical is the first BARDA program supporting the development of a product against viruses that cause viral hemorrhagic fever.

Even the most advanced potential therapeutics and vaccines for Ebola are entering early clinical trials. BARDA is working with other federal agencies to accelerate the development of Ebola therapeutics and vaccines and to identify ways to optimize and expand their production. BARDA is exploring whether its Centers for Innovation in Advanced Development and Manufacturing, its Fill Finish Manufacturing Network, or other measures can accelerate the manufacturing time.

BARDA is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever.

HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.

Within ASPR, 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.

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing