A Genomic Approach to Epilepsy: From discovery to precision therapy

Heather C. Mefford, MD, PhD Associate Professor, Pediatrics Division of Genetic Medicine University of Washington

2018 ISBP Tel Aviv Epilepsy

• Recurrent, unprovoked seizures

• Excessive, hypersynchronous activity in the brain

• Prevalence ~0.5-1%

• 50 million affected worldwide

2018 ISBP Tel Aviv Epilepsy Classification

• Seizure type – Generalized – Focal

• Age of onset>50 syndromes described – Infancy, childhood, adolescence, adult

• Etiology

– Genetic CUREepilepsy.org – Acquired

2018 ISBP Tel Aviv Epilepsy Classification

Generalized Focal Epilepsy Epilepsy (GGE) JME ADNFLE CAE Developmental ADPEAF TLE GEFS+ & Epileptic Encephalopathy* (DEE) Dravet Ohtahara Infantile spasms LGS 2018 ISBP Tel Aviv Genetics of Epilepsy

• Twin concordance – GGE ~80% – Focal ~36%

• Family studies

– Overall RR 2-5% Helbig et al., 2008, Lancet Neurol – Evidence for linkage in some families – De novo mutations in severe cases

2018 ISBP Tel Aviv Gene discovery in epilepsy

STX1B SLC6A1 Next-gen GABRA1 GABRB3 Sequencing Era SIK1 KCNA2 ALG13 GRIN2B PURA KCNB1 KCNC1 DNM1 HCN1 Microdeletions CHD2 SCN8A 15q13.3 SCN2A 16p13.11 GRIN2A 15q11.2 DEPDC5 KCNT1 PRRT2 TBC1D24 STXBP1 PCDH19

GABRA1 LGI1 CACNA1H GABRG2 ARX CDKL5 Channelopathy SCN1A Era SLC2A1 KCNQ3 KCNQ2 SCN1B CHRNA4

1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015

2018 ISBP Tel Aviv Gene discovery in epilepsy

STX1B SLC6A1 GABRA1 GABRB3 SIK1 KCNA2 ALG13 GRIN2B PURA KCNB1 KCNC1 DNM1 HCN1 Microdeletions CHD2 SCN8A 15q13.3 SCN2A 16p13.11 GRIN2A 15q11.2 DEPDC5 KCNT1 PRRT2 TBC1D24 STXBP1 PCDH19

GABRA1 LGI1 CACNA1H GABRG2 ARX CDKL5 Channelopathy SCN1A Era SLC2A1 KCNQ3 KCNQ2 SCN1B CHRNA4

1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015

2018 ISBP Tel Aviv Gene discovery in epilepsy

STX1B SLC6A1 Next-gen GABRA1 GABRB3 Sequencing Era SIK1 KCNA2 ALG13 GRIN2B PURA KCNB1 KCNC1 DNM1 HCN1 Microdeletions CHD2 SCN8A 15q13.3 SCN2A 16p13.11 GRIN2A 15q11.2 DEPDC5 KCNT1 PRRT2 TBC1D24 STXBP1 PCDH19

GABRA1 LGI1 CACNA1H GABRG2 ARX CDKL5 Channelopathy SCN1A Era SLC2A1 KCNQ3 KCNQ2 SCN1B CHRNA4

1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015

2018 ISBP Tel Aviv From gene discovery to precision therapy

Pediatric epilepsy

Gene discovery

Precision therapy

2018 ISBP Tel Aviv Approach #1 – targeted sequencing

50

TGCCATGC GATGAGTG

~800 patients Various epilepsies

Do any patients have Do two or more patients have pathogenic variants in * pathogenic variants in the same * * ‘known’ epilepsy genes? (new) gene?

2018 ISBP Tel Aviv EE Cohort

Syndrome N Dravet 38 Epilepsy aphasia 56 Eyelid myoclonus 10 Early myoclonic 5 Early onset EE 43 Infantile spasms 97 Lennox Gastaut 45 Myoclonic astatic 96 Migrating focal sz of infancy 15 Ohtahara 4 ID+GGE 50 FE+ID 41 Other 300 TOTAL 799

2018 ISBP Tel Aviv EE is genetically heterogeneous

20 39 Genetic diagnosis in ~45% of cases 15 * * * <1% of cases * 10 * ** * * 5 * * * * * **

0

CNV

PNKP

CUX2

NBEA

UBA5

CHD2 CHD8

GNB1

PNPO

STX1B

MBD5

CDKL5

DNM1

ALG13 USP9X

SCN1B

KCNT1

SCN1A SCN2A SCN8A

KCNB1

UBE3A

KCNA2

KCNH1 KCNH5

MEF2C

KCNQ2 KCNQ3

MECP2

IQSEC2

SMC1A

SLC6A1 SLC1A2 SLC2A1

GNAO1

EEF1A2

STXBP1

ARID1B

GRIN2B

GRIN2A

DEPDC5

PCDH19

GABRB3

GABRA1

GABRG2

TBC1D24

PPP2R5D

SYNGAP1

ARHGEF9

DYNC1H1

CACNA1A KIAA2022

2018 ISBP Tel Aviv Carvill et al., 2013, Nat Genet & unpublished CHD2: chromatin remodeler

• ~1% of EE cohort

• Phenotype: • Onset 1-3 yrs • Myoclonic seizures • Photosensitivity • Eyelid myoclonus • Broader NDV phenotype

• CHD7 – CHARGE syndrome • CHD8 – syndromic autism Carvill et al., 2012, Nat Genet • CHD4 – syndromic ID Thomas et al., 2015, Neurology 2018 ISBP Tel Aviv PPP3CA

• Co-expressed with known EE genes

• Encodes calcineurin A – Dephosphorylates DNM1 – Regulatory step for endocytosis at nerve terminal

• 1 patient with a de novo mutation – 5 additional patients through collaborators

2018 ISBP Tel Aviv CUX2: transcription factor

Targeted resequencing in large DEE cohort 2 patients with de WES de novo novo variant CUX2 variant in CUX2 2 patients with epilepsy + ID 5 patients with de novo variant

Chatron et al. (2018) Ann Neurology

2018 ISBP Tel Aviv CUX2 recurrent pathogenic variant

CUX2 9 patients same de novo variant

• Developmental epileptic encephalopathy

• Multiple seizure types – onset 6 months

• Severe intellectual disability

Chatron et al. (2018) Ann Neurology

2018 ISBP Tel Aviv CACNA1E-related epilepsy

• Encodes pore-forming subunit of voltage-gated Ca++ channel at pre-synapse

• 30 patients with de novo variants identified

• Early onset seizures, profound DD • Congenital contractures, movement disorder

Helbig K et al (2018) AJHG

2018 ISBP Tel Aviv CACNA1E-related epilepsy

Missense variants confer gain of function

Helbig K et al (2018) AJHG

2018 ISBP Tel Aviv GRIN2A mutations cause epilepsy aphasia

622 patients

4 GRIN2A mutations

All epilepsy aphasia syndromes

Carvill et al, 2013, Nat Genet also Lemke et al, Lesca et al

2018 ISBP Tel Aviv GRIN2A mutations cause epilepsy aphasia

10-20% of epilepsy aphasia spectrum (EAS) cases

2018 ISBP Tel Aviv Approach #2 – whole exome sequencing

We identified a genetic cause in 18.7% of our cohort Prescreen DEE cohort 209 individuals with DEE Exome Sequencing Data Analysis AGTTGTCA Targeted sequencing of 58 DEE genes 167 Trios De novo, Recessive, X-linked 20 Duos analysis 22 Singletons

Muir, Mefford unpublished

2018 ISBP Tel Aviv De novo analysis of exomes

NDV Gene Variant Diagnosis

ASH1L p.R1559X MAE DEE genes NDV genes ATP1A3 p.870_871del IS 13.9% CIC p.P786fs MAE COL4A1 c.4022-1G>A IS DEAF1 p.R229P EE 69 candidate DPF2 p.R179C EE genes in 58 DYNC1H1 p.R4449S MAE individuals FBXO11 p.P905R MAE HECW2 p.R1139K IS HIVEP2 p.Q1726X LGS Pathogenic or likely pathogenic de novo varaints IQSEC2 c.3016-3A LOS Candidate de novo variant IRF2BPL p.L713fs LGS Exome Negative MTOR p.Q222E EOAE SLC16A2 p.E134fs EE SMARCA2 p.G1164W EOEE Muir, Mefford unpublished 2018 ISBP Tel Aviv Increased cohort size facilitates discovery

Candidate De novo Diagnosis Gene Variant AKAP6 p.T343fs EOEE CMPK2 p.T263M IEE CPSF1 p.A837S LGS CPSF1 p.R91fs EOAE DENND6B p.A122V MAE FBXW7 p.I490V EOAE GRIA2 p.V647L EOEE KCNV2 p.R405H EOEE Targeted sequencing of MAST3 p.G510S IEE Entered genes 44 candidate SRGAP2 p.L159T EE into genes in >600 Matchmaker TANC2 p.E529fs EOEE DEE patients YWHAE p.M1fs CAE Exchange ZMIZ1 p.T945fs EAS Muir, Mefford unpublished

2018 ISBP Tel Aviv Gene discovery in epilepsy

STX1B SLC6A1 Next-gen GABRA1 GABRB3 Sequencing Era SIK1 KCNA2 ALG13 GRIN2B PURA KCNB1 KCNC1 DNM1 HCN1 Microdeletions CHD2 SCN8A 15q13.3 SCN2A 16p13.11 GRIN2A 15q11.2 DEPDC5 KCNT1 PRRT2 TBC1D24 STXBP1 PCDH19

GABRA1 LGI1 CACNA1H GABRG2 ARX CDKL5 Channelopathy SCN1A Era SLC2A1 KCNQ3 KCNQ2 SCN1B CHRNA4

1995 1997 1999 2001 2003 2005 2007 2009 2011 2013 2015

2018 ISBP Tel Aviv Diverse biological mechanisms

Metabolism Intracellular signaling ALG13, PNKP, PNPO ARHGEF9 MTOR SYNGAP1 GNAO1 DEPDC5 PLCB1 GNB1 PCDH19

Synaptic vesicle trafficking DNM1 STXBP1 Gene regulation Chromatin remodeling CDKL5 mRNA regulation UBE3A HNRNPU Neurotransmission MECP2 MBD5 Txn factors GABRA1/B1/B3/G2 KCNH5 CHD2 ARX GRIN2A/2B KCNT1 FOXG1 CACNA1A SLC13A5 HCN1 SLC25A22 SCN1A/1B/2A/8A SLC2A1 KCNQ2/3 SLC6A1 2018 ISBP Tel Aviv Epilepsy genetics in the clinic

Genetic CNV testing diagnosis achieved in 40- 50% of patients

Panels/exomes

2018 ISBP Tel Aviv How do we solve the rest?

Patient iPSCs CGTGCAT CGTGCAT fibroblasts

CGTACAT Cortical spheroids GENOME sequencing in RNA-seq to aid trios to identify de novo variant interpretation Cell Functional variants morphology studies

Electrophysiology Drug discovery

2018 ISBP Tel Aviv WGS + RNAseq

WGS +

Aberrant splicing of disease gene

2018 ISBP Tel Aviv WGS + RNAseq

WGS +

Aberrant splicing of disease gene

Adapted from Cummings et al. (2017) SciTransMed

2018 ISBP Tel Aviv How do we solve the rest?

• Noncoding variation

• Epigenetics

• Alternative modes of inheritance

• Somatic mosaic mutations

2018 ISBP Tel Aviv Large-scale collaborations

• Epilepsy Genetics Initiative (EGI) – Repository for exome data – Regular re-analysis of data – CURE Foundation + NINDS

• Epi25 – International effort to combine available cohorts – >30,000 available epilepsy samples identified – Whole exome/genome sequencing

2018 ISBP Tel Aviv How do we go from a precision diagnosis to a precision therapy?

2018 ISBP Tel Aviv Precision Medicine in Epilepsy TODAY

SCN1A (Dravet) *AVOID sodium Channel blockers

*USE sodium SCN8A mutations channel blockers *NO Keppra

ALDH7A1 (PDE) Pyridoxine (Vit B6)

GLUT1 deficiency Ketogenic diet

2018 ISBP Tel Aviv From diagnosis to therapy

• Studies in cells

• Model organism experiments

• Patient cells: stem cell studies

• Eventually…clinical trials

2018 ISBP Tel Aviv Epilepsy in a fish…

“Treat” with various potential drugs

2018 ISBP Tel Aviv Adapted from Baraban et al., 2013, Nat Comm (Human) epilepsy in a dish…

“Treat” with various potential drugs

2018 ISBP Tel Aviv Precision Medicine in Epilepsy

KCNT1 quinidine

GRIN2A memantine

KCNQ2 ezogabine mTOR pathway rapamycin

2018 ISBP Tel Aviv SUMMARY

• Accelerated gene discovery in EE

• Significant genetic heterogeneity

• Genetics teaching us about biology

• Precision medicine in epilepsy: challenging but promising

2018 ISBP Tel Aviv Acknowledgments

Mefford Lab U Melbourne Alison Muir Ingrid Scheffer Candace Myers Lynette Sadleir Amy LaCroix Sam Berkovic Michele Mehaffey Amy Schneider Edith Fuerte Georgie Hollingsworth John Nguyen Aaron Rosen

Northwestern Gemma Carvill

2018 ISBP Tel Aviv Epi4K: Exome sequencing

INFANTILE SPASMS (IS) Trio analysis • Onset in first year of life • Characteristic EEG: hypsarrhythmia • Often evolves to LGS

LENNOX GASTAUT SYNDROME (LGS) • Onset before 4 years • Multiple, refractory seizure types • Moderate to severe ID Sequence mom + dad + child

Look for de novo change in child 356 Trios analyzed: 429 de novo variants in >400 genes Severe, de novo disorders ~15% solved

2018 ISBP Tel Aviv Epi4K: Trio exome sequencing in EE

15% solved

* *

2018 ISBP Tel Aviv