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Therapeutic D-peptide Inhibitor of HIV Entry

Award Number: SB1AI095172
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: 08/10/2011
PERIOD OF PERFORMANCE END DATE: 04/24/2020

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Therapeutic D-peptide Inhibitor of HIV Entry - PROJECT SUMMARY While modern HIV combination therapy has transformed HIV into a manageable chronic infection for many patients, HIV/AIDS remains a formidable global epidemic. Despite the effectiveness of combining drugs from different classes, side effects and drug resistance remain serious concerns for these life-long therapies. Thus, there is an enduring need for novel HIV inhibitors with new mechanisms of action and stronger barriers to resistance. Furthermore, it is recognized that lack of patient compliance is a major factor leading to treatment failure. For this reason, HIV specialists are excited by the prospect of long-acting therapies, and a combination of such therapies would provide a revolutionary new treatment option for many HIV patients. Navigen is a small pharmaceutical company targeting infectious diseases through an innovative discovery and design process. We have identified a novel HIV entry inhibitor, cholesterol-PIE12-trimer (CPT31), that is a protease-resistant D-peptide (peptide made from D-amino acids) that targets HIV’s conserved entry machinery. With highly potent activity against all major HIV subtypes, designed barriers to resistance, and in vivo animal efficacy, our anti-HIV D-peptide overcomes the current limitations of the entry inhibitor treatment class. Additionally, CPT31 is ideal for pre-exposure prophylaxis (PrEP) since it blocks the first stage of the viral lifecycle prior to infection of target cells. Navigen has advanced CPT31 to late preclinical development via a recently completed Phase II SBIR award. In this three-year SB1 application we will complete 1) GMP manufacturing of drug substance, 2) GMP formulation of drug product including stability testing and aseptic packaging, 3) IND-enabling animal toxicology, and 4) our IND package. These studies will exclusively advance a daily-dosing formulation that will be used to establish the safety of our D-peptide therapeutic in animals and humans. However, CPT31’s high potency, protease resistance, and favorable pharmacokinetic (PK) and physicochemical properties make it an ideal candidate for extended-release depot formulation. In parallel with the studies proposed here, we are working with extended-release formulation experts to develop a long-acting formulation of CPT31 (CPT31-LA) suitable for once-monthly (or less frequent) injection. Many patients prefer long-acting injectables to daily oral pills. Therefore, CPT31-LA will likely achieve broad market penetration. Achieving IND status will greatly facilitate the early investment needed to demonstrate human efficacy with CPT31 and, ultimately, a licensing agreement with a large pharmaceutical company who can bring CPT31-LA to market as a potentially transformative new option for the prevention and treatment of HIV.


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: 2022 ( Subtotal = $0 )
2022	2019	NAVIGEN INC	675 S ARAPEEN DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	7	11/5/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	NAVIGEN, INC.	675 S ARAPEEN DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	7	4/16/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $1,000,000 )
2019	2019	NAVIGEN, INC.	383 COLOROW DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	7	7/31/2019	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2018 ( Subtotal = $1,000,000 )
2018	2018	NAVIGEN PHARMACEUTICALS, INC.	383 COLOROW DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	6	8/3/2018	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2017 ( Subtotal = $1,000,000 )
2017	2017	NAVIGEN PHARMACEUTICALS, INC.	383 COLOROW DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	5	9/18/2017	COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $3,000,000

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Therapeutic D-peptide Inhibitor of HIV Entry

Award Number: SB1AI095172

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: 08/10/2011

PERIOD OF PERFORMANCE END DATE: 04/24/2020

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