Milk is a valuable source of high quality protein, vitamins and minerals and an important contributor to global health

The Department of Agriculture National Institute of Food and Agriculture awarded Pentamer Biologics LLC $649,548 on September 1, 2026, under the Small Business Innovation Research (SBIR) Program (CFDA 10.212) to develop and validate a vaccine against Staphylococcus aureus mastitis in dairy cattle.

The recipient will optimize and scale vaccine production in the laboratory and establish the optimal route of udder delivery for immune induction. The vaccine is a protein-based formulation designed to induce both systemic and local immunity in milk to prevent bacterial colonization and clinical mastitis. Building on Phase I outcomes, the work includes a large field trial to verify vaccine design and establish a path to licensure, supporting challenge trials necessary for regulatory approval. Mastitis causes annual economic losses of up to $20 billion in dairy cattle worldwide; an effective licensed vaccine will reduce economic burdens on farmers while improving animal welfare and food production quality.

Performance occurs in Longwood, Florida, with a period of performance through August 31, 2028. Pentamer Biologics is a small business subsidiary working toward commercialization of the innovation. This Phase II award continues research begun under a prior Phase I grant, focusing on transforming scientific discovery into a product with commercial potential and societal benefit aligned with USDA NIFA's agricultural research mission.

Infectious diseases in dairy cattle can substantially reduce milk production and quality, and have large economic impacts. Mastitis, or infection of the udder, is the costliest disease in dairy cattle worldwide; resulting in annual losses of up to $20 billion. The bacterium staphylococcus aureus is a top cause of mastitis. We have constructed a vaccine that can be administered to the udder with the goal of blocking infection. This vaccine is made of protein and contains a unique structure that supports the induction of immunity in the blood as well as local immunity in the milk to prevent both bacterial colonization and clinical mastitis. Delivery to the udder also has the potential to be a cost-effective route that leverages current farm dry-off protocols. Our goal is to produce this vaccine in a cost-effective way and establish its safety and immunogenicity to support the path to licensure. Our objectives are to 1) optimize and scale-up vaccine production in the laboratory, and 2) establish the route of vaccine delivery for optimal immune induction. For this project we are building upon phase I outcomes to verify vaccine design using a large field trial. Studies will establish a path to independence for a start-up biotech company, pentamer biologics, LLC to facilitate challenge trials for vaccine licensure. This research supports the mission of USDA nifa to advance agricultural research. An effective licensed vaccine will reduce economic burdens on farmers while increasing animal welfare and improving food production and quality.