NIAID Awards $212 Million to Advance Biodefense Therapeutics
The National Institute of Allergy and Infectious Diseases (NIAID) is making a major investment in furthering the development of new drugs to treat potential agents of bioterror. NIAID has awarded six product development contracts totaling more than $212 million to advance therapeutics against NIAID Category A-C Priority Pathogens, microbes and toxins considered the most significant threats to the nation’s biodefense.
Current treatments for these conditions are either nonexistent, of limited utility, or threatened by the emergence of antimicrobial resistance or intentional engineering to increase virulence or decrease drug susceptibility. Thus, the need for new medicines that use novel approaches has intensified. At the same time, companies have had fewer incentives to invest in antimicrobials because of limited returns on investment, regulatory hurdles, and extensive clinical trial requirements. Establishing a market for biodefense therapeutics is even more challenging since at present, the main reason for purchasing most of these medicines is for government stockpiling.
In recent years, NIAID has held several forums in which participants discussed supply and demand as well as opportunities, challenges, barriers, and risks to drug discovery and development. Representatives from industry, academia, small business, and government identified key areas in which NIAID could play a significant role. In response, NIAID is supporting unique partnerships between government, industry, and academia. The contracts described below are examples of the Institute’s most recent efforts to move promising products through the pipeline to generate new therapeutics that will address some of the most pressing microbial threats.
Services for the Preclinical Development of Therapeutic Agents, SRI International, Menlo Park, CA
NIAID has awarded a five-year, $56.9-million contract to SRI International to support preclinical services for the development of drugs and antibodies aimed at a broad range of viral, bacterial, and parasitic agents, including pathogens and toxins that could be used as agents of bioterrorism. SRI will serve as a resource for the scientific community by performing medicinal and analytical chemistry, custom drug synthesis, formulation, clinical manufacturing, microbiology and virology screening, pharmacokinetics, and safety testing.
NDA-Enabling Development for SIGA-246: A Smallpox Antiviral Drug, SIGA Technologies, Inc., Corvallis, OR
Smallpox is considered one of the most significant threats for use as a bioterrorist agent due to the fact that people in the United States have not been vaccinated against it since 1972, it is easily transmitted between people, and it has high morbidity and mortality rates. Currently, there is no approved drug to prevent or treat smallpox, and available vaccines may cause complications. To advance a promising smallpox therapeutic, NIAID has awarded a three-year, $16.5-million contract to SIGA Technologies, Inc. for further development of SIGA-246. This antipoxvirus compound inactivates a smallpox protein required to produce the virus.
Development of a Final Drug Product for a Mixture of mAbs for Type A Botulinum Neurotoxin, XOMA, LLC, Berkeley, CA
NIAID has awarded a $16-million contract to XOMA, LLC to produce monoclonal antibodies for the treatment of botulism. Under the new three-year contract, XOMA will create and produce an injectable product composed of three monoclonal antibodies against type A botulinum neurotoxin. The product will be developed for testing in clinical trials.
Broad-spectrum RNAi Antiviral Against Hemorrhagic Fever Virus (Ebola), Alnylam Pharmaceuticals, Cambridge, MA
Viral hemorrhagic fevers can cause severe, often fatal infections, and pose a potential bioterrorism threat. NIAID has awarded a 4-year, $23-million contract to advance the development of an antiviral drug against Ebola. This drug selectively silences specific viral genes, leading to inhibition of viral replication. This technique could eventually be applied to a variety of viral diseases.
Humanized Anti-West Nile Virus Monoclonal Antibody, MacroGenics, Inc., Rockville, MD
This five-year, $50-million contract will support development of a monoclonal antibody to West Nile virus, and advancement of the antibody through manufacturing and clinical trials. There currently are no approved treatments for disease caused by West Nile virus, and there is no evidence that this disease is abating since its introduction in the United States in 1999.
Development of DAS 181 (Fludase®) as a Broad Spectrum Therapeutic Agent for All Annual and Pandemic Variations of Influenza, NexBio, Inc., San Diego, CA
Fludase is a broad-spectrum anti-influenza agent with potential for prophylactic and therapeutic use. This recombinant protein targets the host receptor for influenza rather than the virus. The novel mechanism may overcome the problem of antiviral resistance, an issue with currently licensed antivirals. Fludase targets all strains and subtypes of influenza, including H5N1. NIAID has awarded a $49.8 million contract to NexBio to develop and test this product over five years.
For more information on recent NIAID biodefense awards, please see the FY 2006 Biodefense Grants and Contracts
back to top