Overview of Solicitation
The Biomedical Advanced Research and Development Authority (BARDA), partnered with the Vaccine Innovation and Therapeutics Accelerator Launchpad (VITAL), have announced a solicitation for proposals to address current limitations of monoclonal antibody (mAb) platforms used as pre-exposure prophylaxis (PrEP) for seasonal respiratory viruses. The solicitation focuses on advancing the development of mAb platforms that enhance the distribution of antibodies to the upper and lower respiratory tracts, improving their efficacy in preventing infections like influenza and other respiratory viruses.
Key Areas of Focus
This solicitation is aimed at refining and optimizing mAb platforms for PrEP, with specific emphasis on achieving long-lasting protection and improving delivery to the respiratory tract. Here are some of the key requirements and goals for offerors to consider: Platform must demonstrate improvements in targeted drug delivery to the upper and lower respiratory tracts.
- Long Lasting Protection
- The platform must support the development of long-acting mAbs that are dosed infrequently and that provide at least 6 months of protection from a single dose.
- Enhanced Delivery to Respiratory Tracts
- If the platform uses a parenteral route of administration, it should improve antibody delivery to the upper and lower respiratory tracts. This would help reduce overall dosing requirements while maintaining efficacy.
- If the platform utilizes an inhaled route of administration, the focus should be on improving retention time in the respiratory tract to enhance protection against respiratory viruses
- Safety Profile
- The platform should not introduce respiratory complications or other significant toxicities in individuals, including those with underlying comorbidities. Safety, particularly in vulnerable populations, remains a top priority.
Additional Considerations
- As a part of the proposal, offerors should provide clear, timed milestones and metrics that objectively measure the advancement of the platform. This can be illustrated through studies in small animal models and non-human primates (NHPs).
- This solicitation is target agnostic, but payloads targeting seasonal and pandemic influenza increase the strength of the proposal.
- While not required, future funding from the BARDA IEIDD Therapeutics Program for advanced development of a product would require activity against seasonal and pandemic influenza.
Important Deadlines
Pre-applications are due January 15th, 2025. Eligible proposers will receive full application invitations by mid-February. PrEP DEV awards can be used to fund development activities taking up to 3 years.
If your company has considered applying for BARDA funding, your federal funding journey starts here.
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