Manufacturing a Glycopeptide Antibiotic
Past New Requirement Updated
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $1,500,000 to $3,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Points of contact
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The National Institutes of Health is forecasting a new task order to optimize the synthetic route of EVG7, a semi-synthetic guanidino lipoglycopeptide derivative of vancomycin, and to produce large quantities of EVG7 for advanced development studies supporting an Investigational New Drug (IND) submission. The task order supports Valient Therapeutics' program to develop a new vancomycin analog for infections caused by antibiotic-resistant Gram-positive bacteria, and Valient needs the optimized route and material to begin IND-enabling preclinical studies in 2027. The estimated solicitation release date is July 1, 2026, and the estimated award date is August 1, 2026.
The estimated award value range is $1.5 million to $3 million under NAICS 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), with no set-aside used. Contracting Officer Miranda Adams (miranda.adams@nih.gov, +1-240-669-5344) and Project Officer Jeremy Starr (jeremy.starr@nih.gov, +1-240-268-4711) are the listed points of contact.
Forecast text
This request is for a new task order supporting Valient Therapeutics product EVG7. EVG7 is a semi-synthetic guanidino lipoglycopeptide derivative of vancomycin. This task order will optimize the synthetic route of EVG7, paving the road for scale up and providing large quantities of EVG7 for advanced development studies to enable Investigational New Drug (IND) submission. The rise of antibacterial resistance in bacteria means that fewer drugs can kill these pathogens, which means that we cannot easily treat certain kinds of infections. In the United States, more than 2.8 million antimicrobial-resistant infections occur each year. More than 35,000 people die as a result, according to CDC's 2019 AR Threats Report. Gram-positive bacterial infections are a major clinical challenge. Vancomycin is an effective antibiotic, but its use is at risk due to rising vancomycin resistance as well as poor solubility and kidney toxicity concerns. Multiple reviews of clinical viability of current agents and the diminishing drug development pipeline for antibacterials, emphasize the critical need for new agents, including new approaches to established drugs like vancomycin. It is imperative that NIAID continue to support the development of novel antibacterials throughout the product development pipeline. The objective of Valient's program is to develop a new analog of vancomycin to treat infections caused by antibiotic-resistant Gram-positive bacteria. They will need the optimized synthetic route and the material provided by this task order to move into IND-enabling preclinical studies in 2027.
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