GLP Rabbit Vaginal Irritation Study of Innovene Topical Antiviral Against Human Papillomavirus (HPV)
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
- 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
-
- Miranda Adams miranda.adams@nih.gov (240) 669-5344
- Catherine Bigger catherine.bigger@nih.gov
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 requirement, issued as a revised Preclinical Services Request for Task Order, for a GLP rabbit vaginal irritation study of the Innovene topical antiviral, with estimated solicitation release and award both on September 1, 2026. The revision, posted November 14, 2026, addresses a cost variance in the proposed work. The study generates pivotal safety data for topical antiviral cream TW-1:5, a first-in-class therapeutic under development for persistent human papillomavirus (HPV) infection, and is a critical-path, FDA-required prerequisite for an IND submission and Phase 1 clinical trials.
Estimated award value falls between $250,000 and $700,000 under NAICS 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), with no set-aside used. Miranda Adams, Contracting Officer in Legal - Contracts at the National Institutes of Health, can be reached at miranda.adams@nih.gov or +12406695344, and Catherine Bigger is listed at catherine.bigger@nih.gov.
Forecast text
This is a revised Preclinical Services (PCS) Request for Task Order because of a cost variance in the proposed work The original study request is for supporting a vaginal irritation study required by the FDA for a topical antiviral cream (TW-1:5). TW-1:5 is under development for treatment of persistent human papillomavirus (HPV) infection, a chronic viral infection responsible for most cervical cancers, which are the 4th most common cancer in women worldwide. TW-1:5 will be delivered to the site of infection as a cream and targets the viral proteins that are important for tumor cell development. As a first-in-class HPV therapeutic, TW-1:5 has the potential to eliminate virus infection altogether thereby preventing pre-cancerous lesions prior to the development of cervical cancer. The proposed rabbit toxicology study is critical path, regulatory requirement for generating pivotal safety data needed for an IND (Investigational New Drug) submission and Phase 1 clinical trials.
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