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Antibody-hyaluronic acid bioconjugates for localized treatment of chronic non-infectious uveitis

Award Number: R43EY032414
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2021
PERIOD OF PERFORMANCE END DATE: 06/30/2023

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Antibody-hyaluronic acid bioconjugates for localized treatment of chronic non-infectious uveitis - Project Summary Uveitis is a group of diseases characterized by sight-threatening intraocular inflammation and responsible for roughly 5-10% of blindness cases worldwide. Uveitis flare-ups can be caused by either an active infection or, in in the case of non-infectious uveitis (NIU), a dysregulated immune response including altered cytokine expression and processing. Thus, there is an urgent and unmet need for more effective treatments. The standard first line therapies for chronic NIU are corticosteroids delivered either topically, systemically, or locally through intravitreal injections or implants. However, long-term use of these treatments is associated with serious side effects. Alternative anti-inflammatory therapeutics are often used to minimize these side-effects and inhibition of the pro-inflammatory cytokine, TNFα has become a key approach. Systemic delivery of TNFα inhibitors is effective but costly and carries a risk of side-effects from long-term use. Valitor, Inc. is developing protein-polymer therapeutics to overcome the vision-threatening effects of chronic ocular inflammation with substantially fewer systemic side effects by enabling intravitreal delivery of a biologic anti-TNFα therapy. We have conjugated single-domain anti-TNFα antibodies (VHH) to linear chains of the natural biopolymer hyaluronic acid to generate multivalent anti-TNFα conjugates (Anti-TNFα MVP) that are substantially larger than any other drugs currently delivered by intravitreal injection. In our previous studies, we verified that the large sizes of our MVPs are sufficient to substantially reduce their clearance rate out of the vitreous, thereby providing a sustained treatment effect to inhibit intraocular TNFα. Thus, our strategy for sustained anti-TNFα therapy has the potential to improve the long-term efficacy, safety, and cost efficacy of anti-TNFα treatment. The overall objective of this Phase I SBIR project is to verify that our Anti-TNFα MVPs exhibit a rapid onset and durable anti-inflammatory treatment for chronic non-infections uveitis. In Specific Aim #1, we will evaluate the ability of an Anti-TNFα MVP to generate a rapid anti-inflammatory response compared to that of a corticosteroid. In Specific Aim #2, we will verify the anti-inflammatory durability of our Anti-TNFα MVP to that of a clinically available TNFα inhibitor. The results of this project will be used to continue the development of our Anti-TNFα MVP drug product and contribute to a productive pre-IND meeting to confirm the additional testing that required for our IND submission.


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 = -$1,525 )
2024	2021	VALITOR, INC.	2956 SAN PABLO AVE	BERKELEY	CA	94702	ALAMEDA	USA	Vision Research	000	1	4/9/2024	NEW	-$1,525
														Subtotal = -$1,525

Issue Date FY: 2021 ( Subtotal = $299,284 )
2021	2021	VALITOR, INC.	820 HEINZ AVE	BERKELEY	CA	94710	ALAMEDA	USA	Vision Research	000	1	6/11/2021	NEW	$299,284
														Subtotal = $299,284

Grand Total All Awards = $297,759

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Antibody-hyaluronic acid bioconjugates for localized treatment of chronic non-infectious uveitis

Award Number: R43EY032414

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2021

PERIOD OF PERFORMANCE END DATE: 06/30/2023

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