Project Grant R44AI170285

Award Date 1/1/23
Completion Date 6/30/23
Dollars Obligated $900K
Federal Grant Program
93.855
Assistance Type
Project Grant
Place of Performance
Florida, USA
Similar Awards
This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $300,000 to Emmune Inc. to conduct pre-clinical IND-enabling studies for ECD4-IG, a long-acting recombinant protein therapeutic for HIV. The award will support in vitro assays, a pre-IND meeting with the FDA, and a definitive GLP toxicology study in macaques to assess safety and toxicity, in preparation for a Phase 1...
This Project Grant awarded by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) provides $919,501 to Emmune Inc., a small business located in Cambridge, Massachusetts, to develop a non-viral gene therapy platform using ECD4-IG as a practical approach for suppressing HIV replication long-term after a single intramuscular injection. The funded research aims to establish a "functional cure" for HIV by...
This Project Grant award for $1,314,572.00, provided by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), supports research aimed at developing a cure strategy for HIV-1 using CD4-mimetic compounds (CD4MCs) and CD4-induced antibodies (CD4I Abs). The research, conducted by Yale University, leverages the recent discovery of a new class of indoline CD4MCs that display improved antiviral potency and breadth...
This Project Grant award, totaling $859,597, was provided by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855). The award aims to develop a vaccine that can elicit broadly neutralizing antibodies (bNAbs) against the HIV-1 fusion peptide epitope, a major vulnerable site on the viral envelope protein. The key product being developed is a recombinant fusion immunogen combining the HIV-1 fusion peptide with...
This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), will support the development of a novel universal rapid test for HIV diagnosis. IGE Immunodiagnostics & Therapeutics, LLC, a minority-owned small business, will receive $294,948 to adapt their existing HIV ELISA test into a 5th generation antigen/antibody combination rapid test format. The goal is to create a simple, rapid,...
This federal Project Grant award, provided by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), supports the development of a hematopoietic stem/progenitor cell-based chimeric antigen receptor (CAR) gene therapy approach to functionally cure HIV infection. The University of California, Los Angeles (UCLA) received $343,744 to work towards Investigational New Drug (IND) development and clinical implementation...
This Project Grant award, funded by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), aims to develop a novel HIV cure strategy by targeting CD127-expressing tissue reservoir cells. The total funding amount is $250,791.00, with an award date of August 6, 2024 and an ultimate completion date of July 31, 2026. The key products and services to be delivered under this grant include: Utilizing an ex vivo...
This Project Grant award, funded by the National Institute of Child Health and Human Development (NICHD) under the Child Health and Human Development Extramural Research program (CFDA 93.865), aims to develop ultra-long-acting antiretroviral drug formulations for the treatment of HIV-1 infection in pediatric populations. The $2,207,322 award, effective January 17, 2025 through December 31, 2026, supports an innovative approach to transform established oral pediatric therapies, such as...
The National Institutes of Health's National Institute of Allergy and Infectious Diseases awarded a $2.3 million Project Grant to the University of California, Davis to fund research targeting CD4 T follicular helper cells for enhancing HIV vaccine-induced humoral immunity. The two-year award, issued on May 12, 2021 under the Allergy and Infectious Diseases Research program (CFDA 93.855), will support preclinical studies in rhesus macaques to better understand the immunological mechanisms...
The federal Project Grant award R01AI187016 for $737,761.00, awarded on August 1, 2024 by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), aims to enhance HIV prevention through a vaccine approach that promotes durable immunity. The key objectives are to induce robust CD4 T follicular helper (TFH) cells, which are essential for vigorous B cell activity within germinal centers, to facilitate the...

PROCESS DEVELOPMENT FOR MANUFACTURING ECD4-IG - 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.

Posted 12/22/22, 12:00 AM