ORAL ANTIBODIES
Antibody targets
Avaxia´s oral antibodies are designed to work within the environment of the gastrointestinal tract. Our antibodies are designed to be stable to the enzymes of the oral cavity and to gastric digestion. Oral antibodies can be used to target antigens exmediaed within the lumen of the GI tract (e.g. gluten and other food antigens). The antibodies can also target antigens exmediaed on the luminal face of the GI tract (e.g. sugar transporters and receptors in the small intestine). Finally, the antibodies can target antigens exmediaed below the mucosal barrier of the GI tract (e.g. inflammatory cytokines). These antibodies only gain access to the submucosal space when the GI tract has been damaged by injury or disease, effectively leveraging the disease process for drug delivery and ensuring that the antibody is targeted to those areas where it can be most effective.
In addition to the products in our current pipeline, we have identified dozens of additional targets that are accessible to oral antibody treatments. These antibodies may be used for cancer, cardiovascular, renal and other diseases, including for example, bile acid transporters for cardiovascular disease and serotonin receptors for regulating GI motility.
Properties of Avaxia´s Oral Antibodies
We are developing bovine polyclonal antibodies isolated from the early milk, or colostrum, of immunized cows. These antibodies are ideally suited for use as oral antibody therapeutics.
Safe
Since nearly all humans consume large quantities of cow´s milk, bovine antibodies are extremely safe for oral administration. Regular cow´s milk contains over 1 gram of antibody per liter and the average American will have consumed approximately 6.5 kg of bovine immunoglobulin by age 18.
Stable to Gastric Digestion
The antibodies in bovine colostrum have evolved to be stable to gastric digestion in order to transfer passive immunity from cow to calf. These antibodies contain a unique carbohydrate moiety that makes them exceptionally stable to acid and proteolytic degradation.
Polyclonal
Polyclonal antibodies are generally more efficacious than monoclonals due to their broad pattern of reactivity. For injected therapeutics, monoclonal antibodies are preferred because they can be humanized to minimize immunogenicity. However, immunogenicity is not a concern for oral dosing, and in this setting more efficacious polyclonal antibodies are preferred.
Low Cost
Bovine colostrum is a scaleable and inexpensive source of immunoglobulin. A single dairy cow can produce 1 kg of immunoglobulin (of which 2-5% is target-specific) in four days. Unlike transgenic animal systems, our manufacturing process does not require a dedicated animal herd, so we can harness the existing capacity of the dairy industry.
Comparison of Avaxia´s Oral Antibodies with Systemic Antibodies
| Avaxia´s Oral Antibodies | Systemic Antibodies | |
|---|---|---|
| Market Opportunity | $5B for disease targets accessible via the GI tract | $50B for disease targets accessible via the bloodstream |
| Technology Platform | Polyclonals made in milk of immunized cows | Monoclonals made in mammalian cell culture |
| Strengths | Lower manufacturing cost, inherent safety and rapid development path | Established technology and proven markets |
| Weaknesses | Novel technology | High manufacturing cost, long development path and systemic side effects |
