NIDDK in vivo efficacy of Fc-bispecifics study
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The National Institute of Diabetes and Digestive and Kidney Diseases within the National Institutes of Health is seeking to advance its long-term research into novel antibody-protein conjugates designed to provide durable protection against HIV infection. This effort, funded by the Office of AIDS Research, focuses on evaluating the in vivo antiviral and immune-recruiting activity of a specific panel of conjugates known as APCs, which have previously demonstrated promising results in preventing HIV infection in cell-based and animal models. The current study will expand on a pilot investigation using humanized CD34+ mice, testing six groups of six mice each to assess five different APC formulations alongside a vehicle control. The research will measure viral load through PCR and flow cytometry of T-cells, with blood samples collected at designated timepoints leading to a terminal collection on day 56, followed by serum preparation and analytical processing to determine efficacy in both prophylactic and therapeutic settings. The work is based on earlier findings that highlighted the plasma stability and favorable pharmacokinetic profile of a glycosylated Fc-containing conjugate, mGRFT-Fc(glyc), which triggered strong immune and cytotoxic antiviral responses. This new phase aims to validate and build upon those results by conducting comprehensive in vivo efficacy assessments under controlled conditions at the Laboratory of Bioorganic Chemistry’s Natural Products Chemistry Section in Bethesda, Maryland. The solicitation, issued under the number 75N98026Q00898TACONICBIOSCIENCESINC, is a presolicitation notice with a response deadline in August 2026, and is open to entities capable of supporting complex preclinical research involving animal models, immunological assays, and advanced molecular diagnostics. The project is part of a broader, sustained initiative to develop next-generation biologics for HIV prevention and immune modulation, with all testing and analysis to be conducted in alignment with NIH’s intramural research mission and regulatory standards.
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Bethesda, MD, 20892, USASet-Aside
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As part of the statutorily required functions of the National Institute of Health (NIH), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports a wide range of biomedical research directly through intramural research within NIH laboratories, and externally through grants to universities and other medical research institutions across the country. In addition, NIDDK supports research training for students and scientists at various stages of their careers and a range of education and outreach programs to bring science-based information to patients and their families, health care professionals, and the public.
Within the Laboratory of Bioorganic Chemistry, NIDDK, the Natural Products Chemistry Section (NPCS) requires studies to determine the in vivo anti- human immunodeficiency virus (HIV) and immune-recruiting activity of a novel panel of antibody or Fc-lectin/nanobody conjugates (termed antibody-protein conjugates or APC’s). These studies are being performed with optimized APCs that have been shown to prevent HIV infection in cell-based and vivo studies. The research study is needed to expand a recent pilot study in humanized CD34+ mice (strain NOD- Prkdcem26Cd52Il2rgem26Cd22 /NjuCrl). The protocols used will measure antiviral efficacy of the APCs in both pre-infection and post-infection studies. Viral infection will be measured by polymerase chain reaction (PCR) and flow cytometry of T-cells in infected and control mice. In-life blood collections will be conducted on study dates every 2 weeks (W#): -1 day (W0), W2, W4, S6 and W8 (end-point) or +1 day (W0), W2, W4, S6 and W8 (end-point). A terminal blood collection will be conducted on day 56 for all mice. Blood processing and serum preparations will be conducted on all samples. Additionally, PCR and flow cytometry will be conducted. A total of six study groups comprising six CD34+ mice per group will be used for testing of five APCs plus vehicle control.
The NPCS carries out research aimed at developing antiviral antibody-protein conjugates with an emphasis on anti-HIV conjugates that offer durable protection. This is a long-term project that has been funded by the Office of AIDS Research. Previous studies tested plasma stability and toxicity (pharmacokinetics) of conjugate mGRFT-Fc(glyc). Favorable results showing protection and recruitment of immune/cytotoxic antiviral responses in APCs containing a glycosylated Fc region indicate the need for expanded testing.
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