Process development for manufacturing ECD4-IG
Active Project Grant Awarded Last action
- Award ID
- R44AI170285
- Recipient
-
Emmune Inc. UEI N65ZDYUGWAH8
- Awarding agency
-
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Department of Health and Human Services
- Obligated
- $1,899,991
Award facts
- Assistance listing
- 93.855 Allergy and Infectious Diseases Research
- Completion date 68% complete
- Originally
- Place of performance
- West Palm Beach, FL 33408, USA
Award details come from USAspending.gov.
Description
- Abstract
- ECD4-IG is an antibody-like therapeutic for HIV that was constructed by fusing CD4 domains 1 and 2, and an HIV coreceptor-mimetic sulfopeptide, to the N- and C-termini of the constant FC region of an antibody. ECD4-IG will join an emerging class of long-acting therapeutics for treating and preventing HIV infection. As a consequence of being built from parts of HIV's receptors, ECD4-IG neutralizes 100% of HIV isolates, and even neutralizes simian immunodeficiency virus (SIV). Thus, ECD4-IG presents fundamental barriers to escape. This grant will fund the work that is needed in between cell line development and IND-enabling studies to bring ECD4-IG to the clinic. In phase I, we will validate assays for critical quality attributes (CQAS) including the sulfotyrosine content of the coreceptor-mimetic sulfopeptide, and then show that the ECD4-IG protein made by new cell lines meets pre-defined CQAS. In phase II, we will optimize our upstream process, downstream process, formulation buffers, and generate a GLP lot of ECD4-IG protein for IND-enabling studies. Features of the upstream process that will be optimized include media and feed selection, a temperature shift, and FED-batch versus perfusion culture. Our downstream process is based on convective chromatography, including for protein a affinity chromatography, anion exchange (AEX) chromatography, and hydrophobic interaction (HIC) chromatography. These processes efficiently remove poorly sulfated ECD4-IG, aggregates, and host cell protein (HCP). We will develop a formulation for intravenous injection, and a high-concentration formulation with acceptable viscosity for subcutaneous injection. Production of a GLP lot of protein for IND-enabling studies will be outsourced to a CMO after a technology transfer process. These are the essential next steps towards bringing ECD4-IG to the clinic.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $999,997 | |
| Amendment | $0 | |
| Amendment | $299,998 | |
| Amendment | $299,998 | |
| Original award | $299,998 |
Quick answers
Who received award R44AI170285?
R44AI170285 was awarded to Emmune Inc. by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on January 1, 2023.
How much is award R44AI170285 worth?
$1,899,991 has been obligated on R44AI170285.
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