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EpiVax Phase II SBIR: Preclinical studies of Tregitope Delivery and Mechanism of

Award Number: R44DK081261
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2008
PERIOD OF PERFORMANCE END DATE: 03/31/2017

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EpiVax Phase II SBIR: Preclinical studies of Tregitope Delivery and Mechanism of - DESCRIPTION (provided by applicant): The goal of this Phase II project is to advance the development of novel tolerance-inducing peptides (Tregitopes) to prevent and/or treat Type 1 diabetes (T1D) by optimizing the clinical delivery vehicle and treatment protocol, and by identifying correlates of efficacy in preparation for Phase 1 clinical trials. More than 13,000 children in the U.S. are diagnosed with Type 1 Diabetes (T1D) each year. T1D results from destruction of insulin-producing pancreatic islet cells by auto-reactive T cells, eventually leading to glucose intolerance. Induction of antigen (Ag)-specific tolerance is the key to effective immunotherapy for T1D. EpiVax discovered a new biologic intervention for T1D called Tregitopes, which are administered along with insulin peptides in order to reprogram the autoimmune responses and induce islet cell Ag-specific tolerance. On the basis of excellent Phase I results, and parallel collaborative studies demonstrating the induction of Ag- specific tolerance in gene therapy and transplant models, this Phase II project will advance a form of Tregitope therapy called T1D-Ag-Specific Adaptive Tolerance Induction (T1D-ASATI) toward preclinical development. Successful translation of T1D-ASATI to the clinic will have a radical impact on the field of diabetes therapy, potentially abrogating the need for insulin therapy in T1D. Studies in Phase I of this project demonstrated that Tregitopes can both prevent and successfully treat diabetes in NOD mice, when delivered prior to, or at the onset of diabetes, however, the delivery vehicles tested in Phase I are not FDA-approvable. The primary objective of this Phase II project is, therefore, to select a clinically feasible delivery vehicle and regimen; the secondary objective is to define biomarkers or correlates of Tregitope efficacy to support clinical development. Aim 1 will identify a suitable delivery vehicle therapeutic administration route, administration frequency protocol, and dose range for Tregitope therapy in the genetically susceptible non-obese diabetic (NOD) mouse model of T1D. Delivery of either peptides or concatamers composed of the Tregitope and PPI epitopes will be tested in clinically proven vehicles: liposomes, glucan particles, and as a conjugate with recombinant human albumin. Pharmacokinetic and toxicity testing of the final formulation have been included in this revised application, per the review. Aim 2 is devoted to defining key correlates of efficacy associated with the induction of tolerance by Tregitopes in NOD mice, and adaptive tolerance induction in NOD GFP and DO11.10 FoxP3:knock-in mice. Induction of Ag-specific aTregs is an innovative feature of this approach. The long-term goal of this research program is to develop, define, validate and commercialize a novel, first-in-class, safe and effective biological therapy to prevent or treat T1D. We have secured the enthusiastic participation of a regulatory expert (Cavagnaro) and two experienced drug developers (CardioVax, Novozyme) that will support our program. Upon successful completion of the Phase II project, we will be well equipped to enter into pre-INDA discussions with the FDA in preparation for T1D-ASATI Phase I clinical trials.


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: 2018 ( Subtotal = $0 )
2018	2013	EPIVAX, INC.	188 VALLEY ST STE 424	PROVIDENCE	RI	02909	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	9/30/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2013	EPIVAX, INC.	146 CLIFFORD ST STE 3	PROVIDENCE	RI	02903	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/7/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2013	EPIVAX, INC	146 CLIFFORD STREET	PROVIDENCE	RI	02903	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	9/15/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $0 )
2015	2013	EPIVAX, INC	146 CLIFFORD STREET	PROVIDENCE	RI	02903	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	3/4/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2013 ( Subtotal = $727,574 )
2013	2013	EPIVAX, INC	146 CLIFFORD STREET	PROVIDENCE	RI	02903	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	3/20/2013	NON-COMPETING CONTINUATION	$727,574
														Subtotal = $727,574

Issue Date FY: 2012 ( Subtotal = $746,662 )
2012	2012	EPIVAX, INC	146 CLIFFORD STREET	PROVIDENCE	RI	02903	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	3/27/2012	COMPETING CONTINUATION	$746,662
														Subtotal = $746,662

Grand Total All Awards = $1,474,236

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EpiVax Phase II SBIR: Preclinical studies of Tregitope Delivery and Mechanism of

Award Number: R44DK081261

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2008

PERIOD OF PERFORMANCE END DATE: 03/31/2017

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