Overview

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