Non-dilutive funding to advance innovations in delivery, biodistribution and half-life extension for protein- and peptide-based therapeutic platforms for pre-exposure prophylaxis (PrEP) for seasonal and pandemic influenza and other respiratory viruses. Schedule a call to find out more about future opportunities.
VITAL and BARDA are seeking protein-, including mAbs, and peptide-based therapeutic platforms for prevention of infection with influenza and other respiratory viruses.
In particular, we are interested in transformative approaches that result in enhanced distribution of long-acting therapeutics to the upper and lower respiratory tracts.
VITAL and BARDA are seeking protein-, including mAbs, and peptide-based therapeutic platforms for prevention of infection with influenza and other respiratory viruses.
In particular, we are interested in transformative approaches that result in enhanced distribution of long-acting therapeutics to the upper and lower respiratory tracts.
Context and Background
Protein- and peptide-based therapeutics have been successfully developed to treat a variety of diseases.
However, pre-exposure prophylaxis (PrEP) is a more challenging indication for proteins and peptides due to their relatively short half-life. When considering platform approaches for PrEP, long-acting monoclonal antibodies (mAbs) have offered significant advantages in terms of speed of response, treatment duration, and safety profile. However, mAbs have inherent limitations due to their minimal biodistribution to the upper and lower respiratory tracts.
Similarly, while peptide- and protein-based therapeutics offer many advantages over mAbs.
Advantages such as targeting otherwise obscure viral epitopes, higher yield, and flexible manufacturing platforms, they are not considered to be effective for use in a pandemic response due to limited half-life.
With this funding opportunity, VITAL and BARDA are seeking transformative approaches that would address the current limitations with protein- and peptide-based therapeutics for use as PrEP for seasonal and pandemic influenza and other respiratory viruses.
Protein or Peptide Platform Approaches for Pre-Exposure Prophylaxis (PrEP): Targeted Delivery to the Upper and Lower Respiratory Tracts with Extended Half-Life
By publishing the teaming profiles list, neither VITAL nor BARDA is endorsing, sponsoring, or otherwise evaluating the qualifications of the individuals or organizations included. Additionally, completing the form does not constitute an application for the PrEP funding opportunity, but rather, provides you an opportunity to partner and collaborate with other potential applicants to strengthen the quality of the submission. Submissions to the teaming profiles list are reviewed and updated periodically.
CHO Plus has developed technologies for engineering cells toward increasing and improving biologicals productivity such as monoclonal antibodies and viral vectors. We have demonstrated the ability to produce monoclonal antibodies at up to 13.5 grams/liter. We engineer CHO cells to contain up to 40-fold higher endoplasmic reticulum per cell and these cells are high producers. We can also engineer cells to contain much higher amounts of Golgi apparatus per cell. We believe we can increase sialic acid site occupancy from the common range of 60-80% to approximately 90%. Higher sialic acid is known to increase serum half-life. We can make YTE mutations in the Fc portion of the mAbs that have been shown to increase serum half-life and used in many licensed antibody therapeutics. The CHO Plus innovation will combine our high productivity cell lines to make higher sialic acid mAbs, YTE mutation mAbs, and mAbs that combine both.
CHO Plus’s expertise is cell engineering technology not respiratory product development. We seek a partner active in the respiratory therapeutics space to properly test-or to supervise the testing of-the mAbs we produce to measure long acting mAbs potential against influenza, or other high priority targets, with serum PK studies in humanized rodent models.
MucosaTec develops a long-acting monoclonal antibody platform targeting influenza virus and RSV as its initial focus. The platform is based on mAb conjugates, which enhance durability.
A potential partner supplies mAbs at large scales.
Expertise in the molecular characterization of the immune response elicited by vaccines and the extensive evaluation of the biological (binding and functional) activity of monoclonal antibodies. We have a large expertise in animal pre-clinical models (mice and ferrets) of respiratory virus infections for the assessment of the prophylactic and therapeutic efficacy of vaccines, monoclonal antibodies, small compounds, etc. For respiratory viruses our program encompasses influenza virus (seasonal and pre-pandemic), RSV, HMPV and SARS-CoV-2. In partnership with IBM we are also developing large language models for the prediction of the biological activity and optimization/de novo design of monoclonal antibodies.
Co-development of products and resources and know-how sharing; publications and establish a foundation for future collaborations and partnerships.
IITRI is a leading preclinical CRO with extensive experience in supporting vaccine and therapeutic development for respiratory viruses, including models for both seasonal and HPAI strains. We can support biodistribution, efficacy, transmission, immunogenicity, and safety assessment for protein and peptide-based therapeutics in small and large animal models including NHPs. Our expertise in delivery platforms is inclusive of inhalation-based administration and bioaerosol generation systems in our ABSL-2 and ABSL-3 facilities. Supporting bioanalytical capabilities include viral titers (nasal washes and tissues), Hemagglutination inhibition assay (HAI), Immunological assays (ELISA, ELISpot, virus neutralization assays), complete blood cell count with differential, and immunophenotyping by flow cytometry.
IITRI is seeking collaborators with innovative platforms who are looking for a non-profit preclinical CRO partner with BSL2/3 and Select Agent capabilities. We are especially interested in partners with a need for inhalation or intranasal delivery and want a dedicated support team throughout the process. Ideal teaming partners would benefit from our robust preclinical infrastructure, regulatory experience, and proven track record in respiratory virus research of supporting government funded contracts. We can continue to support partners from early development through IND-enabling studies and clinical trial sample analysis.
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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.
No. SAM.gov registration is not required.
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.
This funding opportunity does not support gain of function research or research that involves the manipulation of pathogens resulting in potential gain of function.
Proposals will be evaluated for the appropriate use of strain(s) in proposed studies.
Does your technology not fit under one of the current focus areas, but aligns with BARDA’s mission?
VITAL reviews applications on a rolling basis, and applicants are invited to submit a full proposal based on BARDA priorities and availability of funds.
