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Adjuvant Discovery for Vaccines and for Autoimmune and Allergic Diseases



Adjuvant Discovery for Vaccines and for Autoimmune and Allergic Diseases

Fast-Track proposals will be accepted Number of anticipated awards: 1-3 Budget (total costs, per award): Phase I: up to $300,000/year for up to 2 years; Phase II: up to $1,000,000/year for up to 3 years



The goal of this program is to support the screening for new vaccine adjuvant candidates against infectious diseases or for tolerogenic adjuvants for autoimmune or allergic diseases. Traditionally, adjuvants are defined as compounds that stimulate innate and/or adaptive immune responses. The goal of this program is to support the discovery of novel vaccine adjuvants as well as adjuvants with tolerogenic properties. For the purpose of this SBIR, vaccine adjuvants are defined according to the U.S. Food and Drug Administration (FDA) as "agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen." Tolerogenic adjuvants are defined as compounds that promote immunoregulatory or immunosuppressive signals to induce non-responsiveness to self-antigens in autoimmune diseases, or environmental antigens in allergic diseases.

Currently, only four adjuvants have been licensed as components of vaccines in the United States - aluminum hydroxide/aluminum phosphate (alum); 4’-monophosphoryl lipid A (MPL), adsorbed to alum as an adjuvant for an HPV vaccine; MPL and QS-21 combined in a liposomal formulation for a varicella vaccine; and the oil-in-water emulsion MF59 as part of the FLUAD influenza vaccine for people age 65 years and older. The gaps that need to be addressed by new adjuvants include improvements to existing efficacious vaccines (e.g., the acellular pertussis vaccine), and development of vaccines: for emerging threats (e.g., Ebola outbreaks); for special populations that respond poorly to existing vaccines (i.e., elderly, newborns/infants, immunosuppressed patients); or to treat/prevent immune-mediated diseases (e.g., allergic rhinitis, asthma, food allergy, autoimmunity, transplant rejection). Recent advances in understanding innate immunity have led to new putative targets for vaccine adjuvants and for allergen immunotherapy. Simultaneously, progress is slowly being made in the identification of in vitro correlates of clinical adjuvanticity which allows the design of in vitro screening assays to discover novel adjuvant candidates in a systematic manner.

The field of tolerogenic adjuvants is still in its infancy. No compounds have been licensed yet in the US and immune-mediated diseases continue to be treated mostly with broadly immunosuppressive drugs or long-term single or multi-allergen immunotherapy. In contrast to drugs, tolerogenic (or immunomodulatory) adjuvants would interfere with immune responses to specific antigens through a variety of mechanisms which include the induction of regulatory T cells, or by changing the profile of the pathogenic lymphocyte response (e.g., Th1/Th2/Th17, etc). The combination of tolerogenic adjuvants with allergen immunotherapy should aim at accelerating tolerance induction, increasing the magnitude of tolerance and decreasing the duration of treatment.

Project Goal:

The objective of this program is to support the screening for new adjuvant candidates for vaccines against infectious diseases or for autoimmune and allergic diseases; their characterization; and early-stage optimization.

Phase I Activities include, but are not limited to:

Optimize and scale-up screening assays to identify new potential vaccine- or tolerogenic adjuvant candidates

• Create targeted libraries of putative ligands of innate immune receptors

• Pilot screening assays to validate HTS approaches for identifying adjuvant candidates

• Develop in silico screening approaches to pre-select adjuvant candidates

Phase II Activities include, but are not limited to:

High-throughput screening of compound libraries and confirmation of adjuvant activity of lead compounds

• Confirmatory in vitro screening of hits identified by HTS or in silico prediction algorithms

• Optimization of lead candidates identified through screening campaigns through medicinal chemistry and/or formulation

• Screening of adjuvant candidates for their usefulness in special populations, such as the use of cells from cord blood or infants and/or elderly/frail humans or animal models representing human special populations

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