INFEX-2313 Solid Form
Past New Requirement Updated
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- Total Small Business
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 forecasts a new Total Small Business requirement under NAICS 541715 for a solid-form development effort on INFEX-2313, with an estimated solicitation release date of 2026-08-01 and an estimated award date of 2026-10-01. The work develops a soluble and stable crystalline polymorph of the INFEX-2313 drug substance, a small molecule preclinical coronavirus candidate that Infex Therapeutics developed as a PLpro-targeting protease inhibitor, so the drug product can be used in FDA-required GLP toxicology studies. The source states that the program will be delayed or halted if the work is not funded.
The estimated award value range is $250,000 to $700,000. The source does not specify a period of performance or place of performance. Points of contact are Miranda Adams, Contracting Officer in NIH Legal, Contracts (miranda.adams@nih.gov, +1-240-669-5344), and Jeremy Starr, Project Officer (jeremy.starr@nih.gov, +1-240-268-4711).
Forecast text
INFEX-2313 is a small molecule preclinical candidate developed by Infex Therapeutics as a novel mechanism therapy for Coronaviruses. It selectively targets PLpro while the only approved protease inhibitors, such as Nirmatrelvir, target Mpro. Furthermore it will not require co-dosing with a Cytochrome P450 inhibitor (as paxlovid does) and INFEX-2313 will be advantageous in combination with existing therapies, or where resistance has developed. Further progressing INFEX-2313 to the clinic requires a formulated drug product with a soluble and stable crystalline polymorph of the drug substance. The proposed work would develop the physical form of the API to enable its use in FDA required GLP toxicology studies. If the work is not funded, development of this important 2nd generation Coronavirus treatment will be delayed or halted.
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