Long-acting eCD4-Ig therapy for HIV prevention and treatment
Official title: PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic
Funded at Emmune, INC · NIH-11312912 · Data updated 2026-11-12
A FastTrack SBIR grant funds early non-human and IND-enabling tests to develop a long-acting eCD4-Ig protein that could be given every three months to help prevent or treat HIV.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Emmune, INC NIH-funded |
| Lab location | 1 site (Juno Beach, UNITED STATES) |
| Project start | August 1, 2026 |
| Project end | January 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $299,352 |
| NIH project number | 1R44AI197364-01 |
| Project ID | NIH-11312912 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates include individuals at risk for HIV infection or people with HIV who could potentially benefit from a long-acting therapeutic option.
✕Less likely to help
Patients with HIV for whom a different treatment modality is more appropriate or who cannot tolerate biologics may not benefit from this approach.
What this research studies
This grant supports pre-clinical work to prepare an Investigational New Drug (IND) filing for the eCD4-Ig protein, an antibody-like therapy designed to block HIV infection. Researchers will study pharmacokinetics, tolerability, and toxicity in macaques and aim to develop a long-acting subcutaneous formulation that can be dosed quarterly. Phase I focuses on PK and tolerability with re-dosing in animals, followed by a GLP toxicology study in Phase II to assess safety and potential immune effects. The goal is to enable a first-in-human trial with a therapy that targets HIV using a novel protein built from parts of the HIV receptor coreceptors fused to an antibody Fc region.
Why it matters
Potential benefit: If successful, this therapy could provide a long-acting HIV prevention or treatment option that reduces dosing frequency and may improve adherence.
How similar studies have gone: Similar strategies using long-acting antibody-like proteins have shown promise in preclinical models, supporting continued development.
Where this research is happening
-
Emmune, INC
Juno Beach, United States Active
Researchers
- Principal investigator: Alpert, Michael David — Emmune, INC
- Study coordinator: Alpert, Michael David
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.