Roadmap

From in silico construct to first-in-human in 24 months. Four checkpoints. One single-construct gene therapy.

Q1 2026 · Complete

Construct design and in silico validation

  • NKG2D-LIF6 chimera designed (2,123 bp, AAV9-deliverable)
  • AlphaFold + Rosetta structural validation passed
  • PK-PD model predicts ~99% TGI ceiling on CRC syngeneic models
  • 1.4 × 10³ tumor:healthy selectivity ratio across MICA/B atlas
  • Freedom-to-operate analysis complete; clean IP whitespace identified

Q2 2026 · In progress

Provisional patent + capital raise

  • Provisional patent application filing (priority date lock)
  • Seed round opens — target $5M to $15M
  • Federal program submissions: NCI SBIR, ARPA-H, BARDA DRIVe, NSF SBIR
  • Wet-lab scientific lead recruitment

Q3 — Q4 2026

In vivo validation — three syngeneic models

  • CRC, melanoma, pancreatic syngeneic murine tumor models
  • Six dose levels per model, n=8 per group
  • Endpoints: tumor growth kinetics, survival, ex vivo organ histology, biodistribution
  • CRO partnership (Crown Bioscience / Charles River / Champions)

H2 2026

Pre-IND meeting with FDA

  • Pre-IND briefing book assembly
  • FDA pre-IND meeting (CBER — gene therapy)
  • IND-enabling toxicology gap assessment
  • RMAT designation strategy

2027

IND filing and Phase 1 first-in-human

  • IND filing
  • Phase 1 dose escalation, single-arm, biomarker-rich
  • Right-to-Try Act 2018 compassionate-use access pathway in parallel
  • First patient dosed

2028+

Phase 2 expansion + strategic acquisition

  • Adaptive Phase 1/2 master protocol
  • ctDNA Day 60 surrogate endpoint
  • Strategic acquisition by US pharma (exit thesis)