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PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic

Award Number: R44AI197364
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2026
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $299,352 )
2026	2026	EMMUNE INC	620 MEMORIAL DR STE W-100	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	1	7/24/2026	NEW	$299,352
														Subtotal = $299,352

Grand Total All Awards = $299,352

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PK, tolerability, and toxicology studies for eCD4-Ig as a long-acting recombinant protein therapeutic

Award Number: R44AI197364

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2026

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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