PROOF OF CONCEPT

FLT3-Mutated AML — Preclinical Research Architecture

A complete preclinical research program generated by DGS. 58 structured documents across the full program scope.

Research Scope — Disclaimer

This program is a preclinical hypothesis and experiment architecture only. No laboratory data exists. No molecule has been synthesized. No clinical efficacy is claimed. This is not medical advice. Independent scientific validation is required before any conclusions are drawn.

Program Components
Target Engagement Contracts
Evidence protocols establishing the criteria for confirmed FLT3 binding and target engagement.
Selectivity Separation
Plans to distinguish on-target FLT3 effects from off-target and non-specific cytotoxicity.
Off-Target Screening
Counter-screen architecture to identify and eliminate compounds with off-target activity.
Resistance Mechanisms
Failure playbooks for six known FLT3 resistance mechanisms including TKD mutations and pathway bypass.
Safety Risk Discovery
Preclinical safety assessment architecture covering hepatotoxicity, cardiotoxicity, and genotoxicity risk.
Stage 0–4 Development Plan
Master development plan from target hypothesis through IND-enabling studies. Full stage gate logic included.
Agent Class Specification
Structural and mechanistic criteria for the class of FLT3 inhibitor this program targets.
Translational Feasibility
Assessment of the path from preclinical architecture to clinical hypothesis. No clinical claims made.
Confounder Blocking
Pre-specified confounder identification and blocking protocols across all major experiment types.
Falsification Matrix
Six pre-specified failure modes with predefined routing — what happens if each one triggers.
Gate 0 Reality Check
Independent stress-test of the entire program architecture before Stage 0 execution begins.
Key Documents
ENG-001: Target Engagement Evidence Contract
Defines the exact evidentiary standard for confirmed FLT3 target engagement. Pre-specified before any assay is run.
SEL-001: Selectivity and Non-Specific Kill Separation
The protocol for isolating genuine FLT3 selectivity from non-specific cytotoxic effects.
OFF-001: Off-Target Counter-Screen Plan
Full counter-screen architecture. Identifies which off-target assays run, at what thresholds, and what the failure criteria are.
SAFE-001: Preclinical Safety Risk Discovery Plan
Risk-first safety architecture. Identifies the three highest-probability safety failure modes and builds testing around them.
DEV-001: Stage 0–4 Development Master Plan
The complete program roadmap from target hypothesis to IND-enabling studies. Every stage gate is pre-specified.
Access Tiers
PUBLIC
Scientific overview PDF

Available now. No NDA required. Public scientific overview of the FLT3 program scope and architecture.

NDA REQUIRED
Full program package — all 58 documents

Available to credentialed researchers and institutional partners. Requires a signed NDA. Submit a request and NDA documentation will follow within 48 hours.

LAB PARTNERSHIP
Stage 0 execution collaboration

For research groups who want to run the Stage 0–2 experiments against this architecture. Get in touch to discuss scope and feasibility.

Preclinical research architecture only. No laboratory data exists. No molecule has been synthesized. No clinical efficacy is claimed. This is not medical advice. Independent scientific validation is required before any conclusions are drawn.