Business Model & Timeline

Business Model & Timeline

Our Development Plan

  • Synthesis and screening of hundreds of peptide VIP antagonists
  • Generate additional proof of concept data in cancer cell lines and animal models
  • Build our development/management team with industry leading external consultants
  • Non-GLP PK/Tox data on most promising molecules
  • Selection of lead candidate molecule
  • Optimization of peptide sequence for ADME properties*
  • Manufacturing process development for toxicology batch
  • Continued patent prosecution; new filings for improved inhibitors
  • File IND for Phase I/Phase II clinical trials (second half of 2021 or first half of 2022)

*ADME: absorption, distribution, metabolism, and excretion

Discovery Timeline

  • In silico screening

    In silico screening for predicted binding affinity to VPAC1 VIP receptor

  • In vitro screening

    In vitro screening to measure binding to VIP-receptor positive human cells and competition with native VIP

  • Pre Clinical/POC

    • In vivo screening to measure anti-cancer activity in vivo in mice using leukemia and pancreatic cancer models
    • ADME studies
  • Conduct Human Clinical Trials In Pancreatic Cancer

    Human clinical trials to measure anti-cancer activity

Chemistry Manufacturing & Control Timeline

  • Q2-20

    Synthesis Development

  • Q3-20

    • Reference Standard
    • Tox Batch
    • Analytical Development
  • Q4-20

    • Fill/Finish
    • Stability Studies
  • Q1-21

    • GMP Synthesis

  • Q2-21

    • IND Documentation

  • Q3-21

    • Fill/Finish

Investigational New Drug Timeline (based on series A funding)

  • Q2-20

    • CMC
  • Q4-20

    Pre-IND Meeting

  • Q1-21

    • IND-enabling studies
    • Pharmacodynamic Studies
  • Q3-21

    • Phase 1