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Development of a multimeric CD40 ligand vaccine adjuvant

Award Number: R43AI098246
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: 08/06/2013
PERIOD OF PERFORMANCE END DATE: 07/31/2016

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Development of a multimeric CD40 ligand vaccine adjuvant - DESCRIPTION (provided by applicant): CD40 ligand (CD40L or CD154) is widely recognized as one of the most important endogenous activators of the immune system. In particular, CD40L stimulates dendritic cells (DCs) to initiate strong CD8+ T cell responses. However, despite several attempts, no form of CD40L has been licensed for clinical use. To solve this problem, this project will advance the development of a highly active, soluble form of CD40L. This novel protein is made by fusing the body of Acrp30 (a natural serum protein) with the extracellular domain of CD40L. The final protein, Acrp30-CD40L or "MegaCD40L," has been validated as a highly effective adjuvant for vaccine-induced CD8+ T cell responses. In this SBIR Phase 1 project, MegaCD40L will be advanced toward the clinic by developing research cell banks of cGMP CHO cells that produce human and murine MegaCD40L. The resulting proteins will be purified to homogeneity using methods that can be scaled up to industrial production. To prove the utility of this new adjuvant, MegaCD40L will be tested in a mouse vaccination system called "cross-prime-short interval boost" as developed by Dr. John Harty (University of Iowa), a Consultant to the project. In this vaccination protocol, mice are first vaccinated with PLGA microspheres coated with antigen followed 7 days later by boosting with antigen plus MegaCD40L plus poly(I:C). This is anticipated to generate a truly enormous antigen-specific CD8+ T cell response that would be important for vaccines against influenza, malaria, and infections caused by biodefense agents. At the conclusion of this project, MegaCD40L will be ready for BLA-enabling cGMP protein manufacturing and formal toxicity testing as the next steps toward a human trial with this exciting new vaccine adjuvant.


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: 2017 ( Subtotal = $0 )
2017	2014	MULTIMERIC BIOTHERAPEUTICS, INC.	5580 LA JOLLA BLVD STE 76	LA JOLLA	CA	92037	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	2	1/11/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $293,401 )
2014	2014	MULTIMERIC BIOTHERAPEUTICS INC	5580 LA JOLLA BOULEVARD	LA JOLLA	CA	92037	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	2	7/15/2014	NON-COMPETING CONTINUATION	$293,401
														Subtotal = $293,401

Issue Date FY: 2013 ( Subtotal = $300,000 )
2013	2013	MULTIMERIC BIOTHERAPEUTICS INC	5580 LA JOLLA BOULEVARD	LA JOLLA	CA	92037	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	1	8/6/2013	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $593,401

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Development of a multimeric CD40 ligand vaccine adjuvant

Award Number: R43AI098246

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: 08/06/2013

PERIOD OF PERFORMANCE END DATE: 07/31/2016

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