A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals

Active
No
Status
Closed
Release Date
August 25th, 2023
Open Date
August 25th, 2023
Due Date(s)
November 14th, 2023
Close Date
November 14th, 2023
Topic No.
NIH/NIAID 124

Topic

Development of Next-Generation Devices and Materials-Based Platforms for the Administration of HIV1 Broadly Neutralizing Antibodies

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023

Summary

The National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) are seeking proposals for the development of next-generation devices and materials-based platforms for the administration of HIV1 broadly neutralizing antibodies. The goal is to improve the delivery of these antibodies for HIV prevention or other indications. The research aims to enhance potency, increase tissue levels, extend half-life, and target multiple sites of vulnerability on the HIV Envelope glycoprotein. The project duration for Phase I is up to 1 year with a budget of $300,000, while Phase II has a duration of up to 3 years with a budget of $2 million. The solicitation is closed, and 1-3 awards are anticipated. The research may involve the development of dermal patches, controlled-release hydrogels, nanoparticle carriers, vaginal rings, implantable devices, and nucleic acid delivery systems. The expected impacts include increased end-user acceptability, improved adherence, reduced administration-associated cost and time, and improved efficacy by maintaining sustained antibody titers. For more information, refer to the solicitation notice on grants.gov.

Description

Fast Track Proposals will be accepted. Direct-to-Phase II will not be accepted. Number of anticipated awards: 1-3 Budget (total costs): Phase I: $ 300,000 for up to 1 year. Phase II: $ 2 million for up to 3 years.

Background Passive immunization by antibody administration has been used to prevent and/or treat several infectious diseases, including RSV, hepatitis A and B, rabies, and COVID-19. The Antibody Mediated Prevention (AMP) trials established proof-of-concept that delivery of a broadly neutralizing antibody (bNAb), VRC01, can protect against acquisition of bNAbsensitive HIV-1 strains. VRC01 has an excellent safety profile, does not depend on daily adherence for efficacy, and lacks the side effects that can deter pre-exposure prophylaxis (PrEP) use. NIAID and its partners are building on the success of the AMP trials by engineering next-generation bNAb candidates to enhance potency, increase tissue levels, extend half-life, and contend with the ever-evolving global diversity of HIV-1. Effective antibody-based HIV prevention will require a more potent combination of bNAbs with greater neutralization breadth than VRC01 and must target multiple sites of vulnerability on the HIV Envelope (Env) glycoprotein. Developing bNAb cocktails presents additional challenges: complex pharmacokinetics, larger injection volumes, multi-product formulations, and complicated manufacturing. Currently, HIV-1 bNAb administration requires frequent injections. In the AMP trials, recipient acceptability of intravenous (IV) administration was high. However, high cost and logistical burdens slowed the early uptake of monoclonal antibodies for prevention and treatment of SARS-CoV-2, suggesting that IV administration can be challenging outside the context of a clinical trial. Subcutaneous (SC) administration has low recipient acceptability due to local reactogenicity. Improvements in bNAb delivery would benefit the field as NIAID and its partners develop the next generation of bNAbs for HIV-1 prevention or other indications. Examples of devices and materials include, but are not limited to, dermal patches, controlled-release hydrogels, nanoparticle carriers, vaginal rings, implantable devices, and nucleic acid delivery. New or improved delivery devices and materials have the potential to increase end-user acceptability, increase adherence, reduce administration-associated cost and time, and improve efficacy by maintaining sustained antibody titers.