Technology

Overview

Avaxia uses its proprietary technology platform to develop recombinant, gut-targeted antibody therapeutics, called Avaximabs™. These antibodies share many common properties with conventional monoclonal antibodies, enabling Avaxia to leverage decades of industry experience with traditional antibodies, and move quickly into the clinic. One of the many advantages we see with our recombinant technology is our ability to rapidly create Avaximabs™ to any target of interest, whenever the sequence of a relevant mAb binding domain is known. In addition to the CMC and protein engineering benefits of our Avaximab™ platform, we believe that there is a unique opportunity for combination therapies, which is enabled by the lack of systemic exposure and the resulting anticipated high therapeutic index of our Avaximabs™. This creates the potential to significantly transform the treatment of GI-related inflammatory diseases where a single agent alone is not sufficient.

Overall, we believe that Avaximabs™ have a number of unique properties, which enable them to address important gut-related clinical targets of interest. These include:

  • Ability to neutralize GI-tract receptors and ligands
    • Avaximabs™ can withstand harsh GI environment
  • Ability to maintain long-term efficacy
    • Minimal immunogenic potential
  • High therapeutic index, improving safety outcomes and enabling combination therapy
    • Minimal systemic exposure
  • Greater convenience
    • Oral dosage form

Oral Administration

Avaxia antibodies are taken by mouth in capsules or specialized liquid formulations. This is different than traditional antibody therapeutics, which must be injected or infused because they would not survive in the gastrointestinal (GI) tract.

Local Activity

Avaxia antibodies act locally on biological targets that are present in the GI tract. The range of potential targets is extremely broad and includes soluble proteins, such as TNF, and cell-bound proteins, such as sugar transporters. Traditional antibody therapeutics are given systemically and therefore cannot selectively act on these targets in the gut.

Reduced Risks

Preclinical and clinical studies have shown that Avaxia antibodies enter the bloodstream at levels too low to be detected using current assays. Confinement of the antibodies to the GI tract should minimize the risk of side effects in other parts of the body.

New Targets

Numerous biological targets on the intestinal surface have recently been found to influence serious diseases outside of the gut, such as type 2 diabetes and hypertension. These targets are only accessible from the interior of the intestines. Avaxia antibodies can access these targets to provide new opportunities for therapeutic intervention for many serious diseases.


Addressing Critical Medical Needs in the Treatment of Gastrointestinal Diseases

Addressing Critical Medical Needs in the Treatment of Gastrointestinal Diseases


Multiple Therapeutic Target Opportunities

Multiple Therapeutic Target Opportunities


AVX-470 Differentiated from Parental Anti-TNFs

AVX-470 Differentiated from Parental Anti-TNFs


Key Attributes for Effective Gut-Targeted Antibodies

  • Stability to pancreatic proteases
    • Demonstrated using bovine Ig in animals and humans
    • Successfully transferred to Avaximab recombinant platform
  • Stability through gastric transit
    • Address using standard enteric formulations
    • Potential to engineer pepsin resistance
  • Penetration into local tissue (needed for inflammatory targets)
  • Minimal systemic exposure and low immunogenicity
  • Activity in face of clearance and induced antibody
    • All above demonstrated using bovine Ig in animals and humans

Product Platforms – AVX 470 and Avaximabs: Positioned for successful commercialization

  • Phase 2-ready lead program (AVX-470): Oral anti-TNF polyclonal antibody
    • Early safety and proof-of-mechanism established in ulcerative colitis
    • Product manufacturing process and trials established
    • Ideal lead indication: Pediatric ulcerative colitis
    • Lead program demonstrates platform’s strengths
      • Rapid speed to clinic (target selection to clinic in ~2 years)
        • No need to spend 1-2 years developing a lead candidate
      • Not encumbered by traditional mAb IP
      • Ability to effectively deliver antibodies to GI tract
    • Analysis and plans for product development and pipeline available for review
  • Established technology for oral monoclonal recombinant platform
    • Demonstrated stability in gut for recombinant delivery with strong IP foundation
    • Analysis and plans for product development and pipeline available for review