Precision Gene Therapy · Rare Disease

Arcivus Lab

Building patient-specific gene therapies for rare neurological disease — starting with a single mutation, scaling to a platform.
Jongmin Lee, Founder|Vancouver, BC|March 2026
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"You deserve to be treated as who you are — not as a data point."

Every rare disease patient carries a unique molecular story. Arcivus Lab reads it.

The Problem No One Is Solving

DYT-SGCE myoclonus-dystonia affects approximately 1 in 500,000 individuals worldwide. There is no approved disease-modifying therapy. Current treatment is limited to symptomatic pharmacology that reaches a ceiling of ~60% symptom control and does nothing to address the underlying molecular defect: complete absence of functional epsilon-sarcoglycan protein in the brain.

1 in 500,000
Prevalence
0
Approved Therapies
~60%
Symptom Ceiling

Arcivus Lab was founded to change this — first for its founder, then for every rare disease patient whose condition is too small for the pharmaceutical industry to prioritize, yet too devastating to leave untreated.

The company's lead program is an AAV-based gene replacement therapy for DYT-SGCE. The founder is also the index patient: a 21-year-old bioinformatics researcher with a confirmed pathogenic SGCE frameshift mutation (c.108dup) and a decade of systematic self-experimentation generating what may be the most detailed single-patient phenotypic dataset for this condition in existence.

DYT-SGCE Myoclonus-Dystonia

Gene: SGCE (sarcoglycan epsilon), chromosome 7q21.3. Encodes a 437-amino-acid transmembrane protein that functions within the dystrophin-glycoprotein complex in the brain — predominantly in striatal neurons of the basal ganglia.

Imprinting architecture: SGCE is maternally imprinted. Only the paternal allele is expressed. A loss-of-function mutation on the paternal allele produces complete absence of functional protein, with no compensatory expression from the intact but silenced maternal copy. This imprinting mechanism also opens a unique therapeutic axis: epigenetic reactivation of the maternal allele.

Pathophysiology: Loss of epsilon-sarcoglycan disrupts GABAergic interneuron and medium spiny neuron circuits in the striatum, as well as basal ganglia dopaminergic signaling. The clinical result is myoclonus-dominant involuntary movements with secondary dystonia, affecting fine motor function, social interaction, and quality of life across all domains.

Index Patient — Genetic Identity

Primary Variant — SGCE (Pathogenic)
TranscriptNM_003919.3
DNA changec.108dup
Protein effectp.Val37SerfsTer32 — frameshift → premature stop at position 68
Mechanism1 bp duplication in exon 3 → reading frame shift → NMD → complete protein loss
ClassificationLikely Pathogenic Variant (LPV); absent from gnomAD and KRGDB
InheritanceAutosomal dominant, maternally imprinted (paternal allele affected)
Secondary Variant — THAP1 (VUS)
TranscriptNM_018105.3
Changec.496G>A (p.Ala166Thr) — Variant of Uncertain Significance
RelevanceDYT6 (torsion dystonia); ClinVar VUS, conflicting in-silico predictions
ActionFamily segregation study recommended to clarify clinical significance

Neuroimaging (April 2025): Brain MRI including SWI demonstrated preserved nigrostriatal pathways bilaterally with no structural abnormality, confirming a functional (biochemical/circuit-level) pathology consistent with the DYT-SGCE phenotype.

Treatment History

The patient has systematically evaluated over 50 pharmacological interventions across multiple compound classes. The current regimen — tranylcypromine 20 mg (MAOI), levetiracetam 1,000 mg/day, and clonazepam 1 mg/day — achieves approximately 60% symptom reduction at best. A recent formulation switch (Indian generic → Canadian brand tranylcypromine) was temporally associated with ~40% symptom worsening, with a 2-week lag consistent with MAOI steady-state kinetics. Dose adjustment is underway, and a neurology specialist referral has been initiated.

The pharmacological ceiling has been reached. No further optimization of symptom management can substitute for restoring the missing protein.

AAV-SGCE Gene Replacement

Deliver a functional copy of the SGCE gene directly to striatal neurons using an adeno-associated virus (AAV) vector. One injection. Lifelong expression. The same therapeutic logic that earned FDA approval for Kebilidi (AADC deficiency) in November 2024.

Why This Works

SGCE is an ideal gene therapy target. The coding sequence is only ~1.3 kb — fitting comfortably within AAV's 4.7 kb packaging limit with room for a strong promoter, regulatory elements, and validation tags. Neurons are post-mitotic: they do not divide, so AAV-delivered episomal DNA persists indefinitely. A single administration has the potential for permanent therapeutic effect.

// Proposed transfer construct
ITR — [SYN1/CAG Promoter] — KozakSGCE cDNA (codon-opt) — WPREbGH polyAITR

Strategy Landscape

Primary Strategy
AAV Gene Replacement

Mutation-agnostic. Delivers full-length functional protein via episomal transgene. Strong CNS clinical precedent (Kebilidi). Single-vector packaging.

Secondary Strategy
Maternal Allele De-repression

Reactivate the silenced wildtype maternal allele via targeted epigenetic editing (dCas9-TET1 or ASO). Also mutation-agnostic. Higher complexity, lower clinical validation.

Long-term Watch
Prime Editing

The only editing tool capable of deleting a 1 bp insertion. Could correct c.108dup at the genomic level. Preclinical; requires dual-AAV CNS delivery.

Transient / Backup
mRNA (LNP)

Repeat-dose mRNA delivery. No genome modification. Limited by CNS penetration and dosing frequency. Early-stage for neurological targets.

Eliminated Approaches

The confirmed mutation type — a frameshift (1 bp duplication) rather than a nonsense (point) mutation — eliminates two strategies that would otherwise have been viable:

✗ Adenine Base Editing

Performs A→G substitutions only. Cannot delete an inserted nucleotide. Mechanistically incompatible with frameshift mutations.

✗ Readthrough / Suppressor tRNA

Promotes read-through of premature stop codons — but only works when downstream reading frame is intact. In a +1 frameshift, all downstream codons are wrong. Read-through produces junk protein.

Comparative Analysis

Criterion AAV Replacement Epigenetic Reactivation Prime Editing mRNA (LNP)
Implementation complexityLowMediumVery HighVery High
CNS clinical validationStrongPreclinicalPreclinicalEarly
Genome modificationNoneEpigenome only1 nt deletionNone
Durability (single dose)Lifelong*UncertainLifelong*Transient
Vector packagingSingle AAVN/ADual AAVLNP
Off-target riskMinimalModerateModerateLow
Compatible with c.108dupYesYesYesYes

* In post-mitotic neurons. AAV episomal DNA persists without cell division.

From Bench to Bedside

Phase 0 — Data Aggregation & Foundation
In Progress
  • Genetic testing: SGCE c.108dup (p.Val37SerfsTer32) confirmed via dystonia NGS panel
  • Brain MRI: structurally normal, consistent with functional disorder
  • Neurologist referral initiated in Vancouver
  • Clinical master document: medication history, response profiles, symptom quantification
  • Literature deep-dive: SGCE mouse models, AAV serotype comparison, Kebilidi protocol analysis
  • Imprinted gene cluster mapping (PEG10, neighboring loci) for off-target risk
Phase 1 — Construct Design
Ready to Initiate
  • AAV transfer plasmid: promoter selection (CAG vs SYN1), codon-optimized SGCE cDNA, WPRE, polyA, ITR
  • Serotype selection: AAV2 (direct injection precedent) vs AAV9/AAVrh10 (broader tropism)
  • Adenine base editing parallel track — eliminated (incompatible with frameshift)
  • Validation assay design: Western blot, qPCR, immunofluorescence
  • THAP1 VUS clinical evaluation — family segregation study
Phase 2 — In Silico Validation
Pending
  • AlphaFold: wildtype epsilon-sarcoglycan structure; tag impact on folding/membrane insertion
  • AAV packaging simulation: ITR-to-ITR size, secondary structure analysis
  • Molecular dynamics: epsilon-sarcoglycan integration into the DGC complex
  • Prime editing literature monitoring (long-term alternative)
Phase 3 — In Vitro Validation
Lab Access Required
  • Gene synthesis: codon-optimized SGCE cDNA (Twist / GenScript / IDT)
  • Cloning into AAV transfer plasmid; HEK293T transfection → Western blot
  • Neuronal cell line transduction (SH-SY5Y) → expression confirmation
  • AAV packaging via core facility or CRO (VectorBuilder, Addgene)
  • Serotype comparison: transduction efficiency and expression levels
Phase 4 — Ex Vivo & Animal Validation
Collaboration Required
  • Patient-derived fibroblasts → iPSC → differentiated neurons
  • SGCE KO mouse model: AAV injection → motor phenotype rescue
  • Biodistribution, expression durability, immune profiling
Phase 5 — Delivery & Dose Optimization
Translational
  • Stereotactic injection protocol (striatum/putamen)
  • Dose-response: vector genomes per injection site
  • Immunosuppression evaluation; multi-site injection assessment
  • BBB-crossing capsid watch (BI-hTFR1 and successors)
Phase 6 — Safety, Regulatory & Clinical Path
Long-Term
  • Off-target transduction assessment; long-term expression stability
  • Efficacy measurement framework (self-quantification + clinical motor scales)
  • Regulatory pathway: compassionate use, Right to Try, or n-of-1 IND (Canada)
  • Gene therapy regulatory specialist consultation

Beyond One Patient

Arcivus Lab begins with a single patient and a single mutation. But the architecture being built — patient-specific genetic characterization, mutation-informed strategy selection, individualized construct design, and self-quantified outcome measurement — is not specific to DYT-SGCE. It is a framework.

The Long-Term Thesis

Rare diseases are not rare in aggregate. There are over 7,000 known rare diseases affecting 300 million people globally. Most share a common structural pattern: a single gene, a known mutation, and no approved therapy — because each individual condition is too small for conventional drug development economics.

Arcivus Lab is building toward a future where each patient's molecular identity drives a custom therapeutic — not one drug for one disease, but one therapy for one person. The same mutation class can produce radically different phenotypes; the same phenotype can arise from different mutations. Treatment must match the patient, not the diagnosis code.

Platform Trajectory

I
n-of-1 Proof

AAV-SGCE for a single patient. Build pipeline.

II
DYT-SGCE Expansion

Other mutations in SGCE. Mutation-specific strategies.

III
Monogenic Neuro

Other rare neurological diseases with analogous logic.

IV
Full Platform

AI-driven mutation analysis. Automated construct design.

Unresolved Technical & Regulatory Issues

1 SGCE mutation identity — Resolved. c.108dup, frameshift. Gene replacement confirmed as primary strategy.
2 Optimal promoter: CAG (ubiquitous, strong) vs SYN1 (neuron-specific) — which produces better therapeutic outcomes with fewer off-target effects?
3 Regional sufficiency: is striatal-only restoration adequate, or does the myoclonus component require epsilon-sarcoglycan in additional brain regions (cerebellum, cortex)?
4 Pre-existing immunity: what is the patient's neutralizing antibody titer against candidate AAV serotypes?
5 Durability: what is the realistic expression half-life of AAV-delivered transgene in human neurons?
6 Regulatory path: feasibility of compassionate use, Right to Try, or n-of-1 IND in Canada for a self-initiated gene therapy program.
7 THAP1 VUS (p.Ala166Thr): does this variant contribute to the phenotype? Family segregation data needed.
8 NMD completeness: does the early truncation (position 68/437) trigger complete nonsense-mediated decay, or is a truncated fragment produced with potential dominant-negative effects?

What Arcivus Lab Brings — and What It Needs

✓ Available

Computational infrastructure

Personal workstation for molecular simulations; AI-assisted pipeline (Claude AI, Claude Code) for literature analysis, construct design, and automation.

Domain expertise

Self-directed bioinformatics training with cross-domain fluency in AI, molecular biology, and computational tools. Extensive first-person clinical data from years of systematic self-experimentation.

Clinical relationships

Neurology referral in progress (Vancouver); full diagnostic history at Chung-Ang University Hospital (Seoul) including genetic testing and neuroimaging.

Genetic data

Confirmed variant identity, dystonia NGS panel, brain MRI — all documented and available for collaborator review.

➜ Needed

Wet lab access

BSL-2 cell culture facility for transfection/transduction experiments.

AAV production

Core facility or CRO access for vector packaging.

Expertise

AAV construct optimization, neuronal cell culture, in vivo delivery protocols.

Animal models

SGCE KO mice for phenotype rescue validation.

Regulatory guidance

Navigating compassionate use or n-of-1 frameworks in Canada.

Let's Build This Together

If you have expertise, resources, or shared purpose in rare disease gene therapy — Arcivus Lab is looking for collaborators, advisors, and partners.

Get in Touch
cyan@northprot.com