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Therapeutic Development of RNAi-based inhibitors against the Hepatitis Delta Virus

Award Number: R44AI104007
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: 09/01/2014
PERIOD OF PERFORMANCE END DATE: 03/31/2022

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Therapeutic Development of RNAi-based inhibitors against the Hepatitis Delta Virus - Abstract Hepatitis D virus (HDV) infection is the most severe type of viral hepatitis, often causing accelerated liver damage that leads to end-stage liver disease. About 15–20 million individuals are infected by HDV worldwide. The absence of an effective treatment for acute forms of the disease and the limited efficacy of current treatments for the chronic infection justify novel strategies towards the development of anti-HDV therapeutics. The lack of HDV-encoded “druggable” targets that are suitable for conventional therapeutic modalities such as small molecules and antibodies makes RNA interference an attractive alternative approach to target this virus. However, the highly structured, GC- rich circular genome of this smallest of RNA viruses make it a challenging target for RNA-targeting approaches such as RNAi. In Phase I of this project, we were able to identify inhibitors of HDV using SomaGenics' sshRNA® (synthetic small shRNAs) platform. These sshRNAs potently inhibit viral replication at multiple target sites in a cell culture infection model. The sshRNAs were then chemically modified to improve their drug-like properties. In Phase 2, we plan to move the program forward into preclinical studies using a transgenic mouse model that supports HDV infection. We will pursue dual approaches to delivery of our therapeutic sshRNAs to liver: formulation with lipid nanoparticles and use of a targeting ligand. Patterns of chemical modification will be optimized for each candidate delivery method to permit a careful comparison, and the most promising approach will be selected. Finally, combinations of sshRNAs will be assessed for ability to provide increased efficacy and forestall the development of resistance to therapy. By the end of Phase II, we expect to have established a cocktail of inhibitors ready for IND-enabling safety studies and then commencement of clinical studies.


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: 2024 ( Subtotal = -$2,691 )
2024	2020	SOMAGENICS INC	2161 DELAWARE AVE STE E	SANTA CRUZ	CA	95060	SANTA CRUZ	USA	Allergy and Infectious Diseases Research	000	4	10/12/2023	NON-COMPETING CONTINUATION	-$2,691
														Subtotal = -$2,691

Issue Date FY: 2020 ( Subtotal = $965,488 )
2020	2020	SOMAGENICS, INC.	2161 DELAWARE ST STE E	SANTA CRUZ	CA	95060	SANTA CRUZ	USA	Allergy and Infectious Diseases Research	000	4	3/17/2020	NON-COMPETING CONTINUATION	$965,488
														Subtotal = $965,488

Issue Date FY: 2019 ( Subtotal = $982,529 )
2019	2019	SOMAGENICS, INC.	2161 DELAWARE ST STE E	SANTA CRUZ	CA	95060	SANTA CRUZ	USA	Allergy and Infectious Diseases Research	001	3	4/1/2019	NON-COMPETING CONTINUATION	$1,000,000
2019	2018	SOMAGENICS, INC.	2161 DELAWARE ST STE E	SANTA CRUZ	CA	95060	SANTA CRUZ	USA	Allergy and Infectious Diseases Research	000	2	3/13/2019	COMPETING CONTINUATION	-$17,471
														Subtotal = $982,529

Issue Date FY: 2018 ( Subtotal = $920,413 )
2018	2018	SOMAGENICS, INC.	2161 DELAWARE ST STE E	SANTA CRUZ	CA	95060	SANTA CRUZ	USA	Allergy and Infectious Diseases Research	000	2	4/20/2018	COMPETING CONTINUATION	$920,413
														Subtotal = $920,413

Grand Total All Awards = $2,865,739

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Therapeutic Development of RNAi-based inhibitors against the Hepatitis Delta Virus

Award Number: R44AI104007

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: 09/01/2014

PERIOD OF PERFORMANCE END DATE: 03/31/2022

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