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Long-acting multi prevention implant for 2-year contraception and HIV PrEP

Award Number: R01AI167659
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: 04/01/2023
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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Long-acting multi prevention implant for 2-year contraception and HIV PrEP - PROJECT SUMMARY/ABSTRACT Maternal mortality and AIDS are among the leading causes of death in reproductive-age women globally due to unintended pregnancy and the disproportionate burden of HIV infection. While effective prevention methods exist, only 21% of women have access to modern contraceptives and adherence to HIV PrEP regimen is poor in many HIV-endemic regions. Multipurpose prevention technologies (MPT) aim to synchronize contraceptive delivery with HIV PrEP, offering a patient-centered approach to provide dual coverage to sexually active women in a single product. A long-acting unified delivery product that can be administered in a discreet manner could reduce stigma around contraceptives and HIV PrEP, thereby improving uptake and adherence to combination prevention products. Our goal is to develop a long-acting delivery implant of etonogestrel (ENG) and islatravir (ISL) drugamer with an unprecedented 2-year release duration for pregnancy and HIV prevention that eliminates further need of adherence. A new subcutaneous nanofluidic multipurpose implant (NanoMPI) will be brought together with a new polymeric prodrug technology termed “drugamer”, to achieve this innovative product candidate that delivers ultra-long acting ENG+ISL drug dosing durations. The NanoMPI leverages a nanofluidic membrane with nanochannels and a single drugamer reservoir to achieve zero-order release kinetics through passive diffusion without pumping mechanisms, permitting discreet, user-independent dosing. Key product attributes will include drug stabilization on the multi-year timeframe, minimized early- and late-stage burst release and pharmacokinetic (PK) tailing, zero-order drug release kinetics tailored to the individual drug PK/PD (pharmacodynamic) requirements, user-independent dosing, and retrievability. The project is structured around 3 specific aims: 1) to develop optimized ENG-ISL drugamer formulations that stabilize the drugs and exhibit the desired zero order release profiles, in concert with the optimization of the NanoMPI device for 2-year sustained release; 2) to assess pharmacokinetics, tolerability, and safety of the lead ENG-ISL NanoMPI device for 2 years in pigtail macaques; and 3) to evaluate contraception and HIV PrEP efficacy of ENG-ISL NanoMPI in pigtail macaques via repeated low-dose vaginal challenge and develop a PK/PD model. We will use a milestone-driven research approach to advance the ENG-ISL NanoMPI technology towards the ultimate goal of clinical translation, leveraging the interdisciplinary team’s experience in drugamer technology, drug delivery, pre-clinical and clinical HIV prevention studies, and hormonal contraceptive and antiretroviral pharmacology. Importantly, the NanoMPI addresses user preferences for a dual prevention product, discretion and longer dosing duration. Successful completion will generate a versatile MPT platform that could be adopted for other drug combinations and preventative strategies.


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: 2026 ( Subtotal = $798,886 )
2026	2026	THE METHODIST HOSPITAL RESEARCH INSTITUTE	6565 FANNIN ST STE D200	HOUSTON	TX	77030	HARRIS	USA	Allergy and Infectious Diseases Research	000	4	4/17/2026	NON-COMPETING CONTINUATION	$798,886
														Subtotal = $798,886

Issue Date FY: 2025 ( Subtotal = $817,162 )
2025	2025	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Allergy and Infectious Diseases Research	000	3	3/28/2025	NON-COMPETING CONTINUATION	$817,162
														Subtotal = $817,162

Issue Date FY: 2024 ( Subtotal = $816,407 )
2024	2024	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Allergy and Infectious Diseases Research	000	2	4/17/2024	NON-COMPETING CONTINUATION	$816,407
														Subtotal = $816,407

Issue Date FY: 2023 ( Subtotal = $830,671 )
2023	2023	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Allergy and Infectious Diseases Research	000	1	3/30/2023	NEW	$830,671
2023	2023	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Allergy and Infectious Diseases Research	001	1	6/2/2023	NEW	$0
2023	2023	METHODIST HOSPITAL, THE	6670 BERTNER AVE	HOUSTON	TX	77030	HARRIS	USA	Allergy and Infectious Diseases Research	002	1	6/14/2023	NEW	$0
														Subtotal = $830,671

Grand Total All Awards = $3,263,126

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Long-acting multi prevention implant for 2-year contraception and HIV PrEP

Award Number: R01AI167659

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: 04/01/2023

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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