Sign up for the Info Session: Pre-exposure Prophylaxis (PrEP) Funding Opportunities

Innovations in Pre-exposure Prophylaxis (PrEP)
for Respiratory Viruses

Non-dilutive funding to advance innovations in delivery, distribution and half-life extension for monoclonal antibody and/or nucleic acid platforms for pre-exposure prophylaxis (PrEP) for seasonal and pandemic influenza and other respiratory viruses.

Non-Dilutive Funding to Advance Your Platform Approaches for Pre-Exposure Prophylaxis (PrEP)

VITAL and BARDA are seeking innovations to improve delivery, biodistribution, and durability of long-acting monoclonal antibody and/or nucleic acid-based platforms for PrEP for seasonal and pandemic influenza and other respiratory viruses.

The Approach

Monoclonal antibodies (mAbs) and long-acting mAbs have been successfully developed to treat and provide protection against viral infections. Pre-exposure prophylaxis (PrEP) using long-acting mAbs was demonstrated recently during the COVID-19 pandemic. However, it is evident that further refinement is necessary to allow broader adoption of long-acting mAbs for use as PrEP for respiratory viral diseases.

Similarly, the recent success of mRNA-based vaccines has opened the door for further development of nucleic acid-based therapies. With their specificity and functional diversity, therapeutic nucleic acids hold enormous promise. However, challenges for applying nucleic acid therapeutic technologies to acute infectious diseases include organ-targeted delivery and short half-life.

With this funding opportunity, VITAL and BARDA are seeking transformative approaches that would address the current limitations with long-acting mAbs and nucleic acid-based platforms for use as PrEP for seasonal and pandemic influenza and other respiratory viruses.

Key Focus Areas

Long-Acting Monoclonal Antibody Platform Approaches for Pre-Exposure Prophylaxis (PrEP): Targeting Delivery to the Upper and Lower Respiratory Tracts

Nucleic Acid Platform Approaches for Pre-Exposure Prophylaxis (PrEP): Targeting Delivery to the Upper and Lower Respiratory Tracts and Extending Half-Life

Eligibility

We are accepting applications from academic innovators, non-profit entities, and for-profit startups and companies globally.

Funding Guidelines & Duration

  • Up to $4M in total costs for pre-clinical work
  • Up to $7.5M in total costs if the proposal includes clinical studies including Phase 1 Clinical Trials
  • Awards are anticipated to be structured with milestone-based deliverables
  • The PrEP DEV awards are multi-year awards for development activities taking up to 3 years

Pre-applications are now open. Pre-applications will be reviewed on a rolling basis through January 31, with invitations to apply for the full-applications sent out on a rolling basis by mid-February.

VITAL Insights On-Demand:
Watch Our Webinar Info Session

Watch our info session to gain insights into the VITAL Non-Dilutive Funding Opportunities to Advance Your Platform Approaches for Pre-Exposure Prophylaxis (PrEP)

Join one of our live webinars by signing up to a session here.

Teaming Opportunity

If you or your organization would like to explore collaborations with other potential applicants, please visit our Teaming Page.

FAQs

Applications will be reviewed in whole based on responses to the questions in the application and all information submitted, with focus on alignment to the program requirements and program strategy, innovation and quality of data presented, technical approach and milestones to be achieved with the proposal, team and resources available, ability to transition and commercialize the product, and cost/price reasonableness for the proposed use of funds.

The PrEP awards are anticipated to be multi-year awards for development activities taking up to 3 years. It is required that project milestones be completed within the timeframe indicated by the applicant. Project management and mentor support will be provided during the project period. VITAL and BARDA also understand that unforeseen and unpredicted events happen during development, evaluation and validation activities.

There will be reporting requirements on a monthly or quarterly basis, annual reports, and final reports. The applicant and VITAL will agree during negotiations and before final award which standard reporting requirements and other deliverables are necessary as determined by the final, mutually agreed-upon Statement of Work, project deliverables.

The Influenza & Emerging Infectious Diseases (EID) Therapeutics Program within BARDA focuses on development of 1) novel antivirals to treat seasonal and pandemic influenza in outpatient settings; 2) immune modulators and other host-directed therapeutics promoting lung repair to treat and improve clinical outcomes of acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) caused by pandemic and seasonal influenza and other viral pathogens of pandemic potential; and 3) long-acting antivirals to provide pre-exposure prophylaxis (PrEP) options against pandemic and seasonal influenza before vaccine availability and for people whose immune systems may not generate a sufficient response to available vaccines.