PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic
NIAID - National Institute of Allergy and Infectious Diseases
About This Grant
ABSTRACT This FastTrack SBIR grant will support pre-clinical IND-enabling studies for recombinant eCD4-Ig protein, ahead of a first-in-human (FIH) Phase 1 clinical trial. eCD4-Ig is an antibody-like therapeutic for HIV consisting of parts of HIV’s receptor and coreceptors fused to the constant Fc region of an antibody. Due to being comprised of parts of HIV’s receptor and coreceptors, eCD4-Ig recognizes 100% of HIV isolates and cannot be escaped without HIV sacrificing its ability to bind its receptor and coreceptors. The eCD4-Ig protein we are developing has its effector function enhanced through afucosylation. Our Target Product Profile (TPP) for eCD4-Ig is a long-acting recombinant protein therapeutic that can be dosed quarterly (i.e., every 3 months) by subcutaneous injection as part of a long-acting combination regimen. Prior to a Phase 1 clinical trial, a necessary milestone is the submission of an Investigational New Drug (IND) application to the FDA. Here, we propose the preclinical IND-enabling studies that will support that Phase 1 clinical trial. In Phase I of this SBIR grant, we will conduct a pharmacokinetic (PK) and tolerability study in macaques with re-dosing. In Phase II of this grant, we will conduct a definitive GLP toxicology study in macaques. The GLP toxicology study will assess changes in leukocyte and lymphocyte populations, body weight, food consumption, clinical signs, clinical chemistries, coagulation, urinalysis, toxicokinetics, anti-drug antibodies (ADAs), and histopathology. Safety pharmacology endpoints will include cardiotoxicity, respiratory toxicity, and central nervous system (CNS) toxicity. Doses for the study will be set to provide a 10x safety margin. This definitive GLP toxicology study is critical to proceed with a Phase 1 clinical trial. Completion of these studies will allow us to submit an IND application and bring eCD4-Ig into the clinic.
Grant Summary
PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic is a NIAID - National Institute of Allergy and Infectious Diseases grant providing up to $299K for university, nonprofit, healthcare org. Applications are due 2027-01-31 (open). Check eligibility and apply with FindGrants.
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Eligibility
How to Apply
Up to $299K
2027-01-31
- 1Confirm your organization is eligible for PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic from NIAID - National Institute of Allergy and Infectious Diseases, checking organization type, location, and any population or project requirements.
- 2Gather the required documents and information, including your organization details, project plan, and budget figures.
- 3Draft your application narrative and budget addressing the funder's priorities and review criteria. FindGrants can draft each section for you to review and edit.
- 4Review every section against the requirements checklist, then export a submission-ready application pack and submit it to NIAID - National Institute of Allergy and Infectious Diseases before the deadline.
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PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic: Frequently Asked Questions
Who is eligible for the PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic?
PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic is offered by NIAID - National Institute of Allergy and Infectious Diseases and is generally open to university, nonprofit, healthcare org. It is open to organizations nationwide unless the funder specifies otherwise. Review the specific eligibility terms before applying, since funders set their own requirements around organization type, location, and the population or project being served.
How much funding does the PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic provide?
PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic provides up to $299K per award from NIAID - National Institute of Allergy and Infectious Diseases. Actual award sizes depend on the scope of your project, available program funds, and the number of applicants, so build a budget that reflects realistic, allowable costs rather than the maximum figure.
When is the PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic deadline?
Applications for PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic are due 2027-01-31 (open). Because deadlines can change, verify the date with the funder, NIAID - National Institute of Allergy and Infectious Diseases, and give yourself enough time to prepare a complete, competitive application before the close date.
How do you apply for the PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic?
To apply for PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic, confirm your eligibility, gather the required documents, and prepare a narrative and budget that address the funder's priorities. FindGrants guides you step by step and can draft each section, then exports a submission-ready application pack for this grant from NIAID - National Institute of Allergy and Infectious Diseases.