Katie & Allie Buryk Research Fund

Supports research for Late Onset Tay-Sachs and Sandhoff (LOTSS) disease.

$967,343.20

Fundraising Goal: $1,250,000

After being diagnosed with Late Onset Tay-Sachs disease, Katie Buryk and her family established a fund to raise money for research for a cure. In under 4 years, support for the cause has raised enough funds to finance seven Research Grants. Here is their story.

It has been eight years since I began trying to find out what’s wrong.

I first noticed in college I had trouble climbing stairs. Since then my leg muscles have gotten weaker and weaker. Everyday tasks have grown harder, whether dressing myself or getting up from a sitting position. Now I can’t take the subway or wear high heels.

Sometimes I fall when I’m walking. My legs just give out. And at times, some people can’t understand what I’m saying. It is scary. I expected to be spending my 20s having fun, meeting boys and beginning a career. Instead I’ve spent my time in pursuit of an answer. What’s the matter with me? I visited multiple neurologists. I underwent tests at a series of New York hospitals. I went to the Mayo Clinic. Finally, a good friend of my mom’s suggested genome sequencing for my entire family. We arranged that and heartbreakingly, now we finally know. I have a rare disorder called Late Onset Tay-Sachs disease. So does my twin sister. My Mom and Dad are carriers and never suspected they had the recessive gene. We’re among the fewer than 100 cases reported worldwide according to the National Tay-Sachs & Allied Diseases Association (NTSAD).

Why we started the fund

Our bodies don’t produce enough of an enzyme which, right now, has no replacement. Infants who develop symptoms early usually die by age 2. Juveniles with symptoms pass away in their teens. So I guess we’re lucky that at my age, we are still alive. But the disease’s progression will continue. And I have to ponder a future where swallowing might prove difficult and my mobility will be via a wheelchair. I may face a cognitive decline and mental illness.

How the funds raised will be used

There isn’t much money to finance a search for a cure and there’s no celebrity who leads telethons. It seems that pharmaceutical companies don’t want to invest in a drug for a cure. Maybe there aren’t enough of us to make it a profitable investment. I guess that means it’s up to me.

I have decided to go public and try to raise money, awareness and mount a search for a cure. Sure it’s for me and Allie, but it is also for infants and kids who aren’t as lucky as we are. And it’s for the families who have to embark on this difficult, sad and baffling journey. I will be giving regular posts updating my Facebook friend network about our progress. Every dollar donated will go into a family fund that is completely dedicated to research a cure. Research will cost far more and we are hoping to get the attention of the National Institutes of Health and possibly pharmaceutical companies to help with this cause.

So please help and do what you can. I know we have your love and support and we appreciate it. Whatever your contribution will go to making a difference in our lives and so many other children’s lives. It offers hope.

Where are we today?

September 2022

  • A clinical trial is in progress for a drug developed by Sanofi Genzyme. It is a multinational, double-blind, placebo-controlled study. Patients are enrolled in the study in New York, Boston, Los Angeles and Bethesda, Maryland at the National Institutes of Health (NIH), and sites around the world.

  • Gene therapy is being developed for adults with Late Onset Tay-Sachs. A team at the University of Massachusetts (UMass) Chan Medical School led by Heather Gray-Edwards, DVM, PhD and Miguel Sena-Esteves, PhD has developed an AAV gene therapy and working toward a clinical trial. Your donation makes gene therapy for LOTS patients possible, bringing us closer to treatments.

  • The Buryk Fund sponsors an annual Late Onset Tay-Sachs Think Tank retreat led by Dr. Cynthia Tifft, National Human Genome Research Institute, National Institutes of Health (NIH) and Dr. Steven Walkley, Albert Einstein College of Medicine. The goal is to accelerate research toward effective treatments for Late Onset Tay-Sachs. Since the first Think Tank in 2018, four critically important clinical trials have launched; two gene therapy studies for children with GM2 (known as Tay-Sachs and Sandhoff diseases) and a similar disease, GM1 gangliosidosis, and two small molecule drug trials for adults with LOTS. This year’s meeting will take place October 20 – 22, 2022. We will not give up, and we hope you’ll join us and the many families who need our help. Whatever your contribution, it will matter and make a difference in our lives and those of so many.

Ways to Give

Credit Card

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PayPal

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Mail or Phone Donations

(617) 277-4463

Checks payable to NTSAD.

Mailing Address:
2001 Beacon Street
Suite 204
Boston, MA 02135.

NTSAD Research Initiative Grants supported by the Katie & Allie Buryk Research Fund

Late Onset GM2 Gangliosidoses Registry and Repository

Principal Investigator:
Florian S. Eichler, MD, Massachusetts General Hospital

This project aims to develop a both a clinical registry and a repository of samples for Late Onset GM2 Gangliosidoses. The registry will use the NeuroBANK platform to create and implement use of electronic case report forms, allowing standardized data to be collected from patients with LOTS. Review of current medical literature and surveys of patients will help determine which data to include in the registry in order to establish meaningful outcome measures. Prospective evaluations of patients will also be used to determine these optimal outcome measures, looking at change over time, patient value of measures, and variability among patients. Samples collected will be used to identify potential biomarkers of disease progression and to correlate these biomarkers with clinical outcomes. Both clinical outcome measures and biomarkers are essential components of clinical trial readiness, necessary to show effect of any experimental therapy.

Generation of a knock-in mutant Hexbmouse model

Principal Investigator:
Eric R. Sjoberg, PhD , OrPhi Therapeutics

This project supports the development of a mouse model for Late Onset Tay Sachs and Sandhoff diseases. Mice with Sandhoff disease are used to study both diseases because both store GM2 gangliosides and because mice with mutations in the HEXA gene which causes TSD do not develop features of TSD due to an alternate pathway for GM2 degradation. This model is different from currently existing SD mouse models in that it has a specific mutation that leads to residual enzyme, as is seen in the late onset forms of these diseases in humans. This new model will be used to study pharmacological chaperones, small molecules that can bind and stabilize mutated enzyme. This allows the misfolded enzyme to reach the lysosome and degrade stored material correctly. The two chaperones that will be studied have been previously shown to increase both HexA and HexB enzyme in healthy mice. The project will look for increased enzyme activity and reduced ganglioside storage in the brain. The mouse model will also be made available for other late onset research.

Identifying Novel Therapeutics for Treating GM2 Gangliosidoses

Principal Investigator:
Beverly L Davidson, Ph.D., Children’s Hospital of Philadelphia (CHOP)

The drug Miglustat (approved for Gaucher disease in 2002) does not cross the blood-brain barrier to an extent that could mediate benefit in a clinical trial in patients with late onset Tay-Sachs disease. In this study, they are using a powerful drug discovery approach to identify FDA approved drugs that have improved brain penetrance while simultaneously share the same efficacy as Miglustat.

They have submitted 49 samples to the University of Iowa, Genomics division for high-throughput RNA-sequencing. These samples represent 7 donors treated with the three drug treatments and controls at two different doses.

Next Steps: They will query the LINCS database with the RNA-seq data, identify drugs and validate hits over the next 4-6 months. Importance: These important preliminary studies will help identify additional, brain penetrable drugs that may find use in substrate reduction therapy for the gangliosidoses.

Clinically Relevant Outcome Measures for Patients with Late Onset Tay-Sachs disease Ascertained Real-Time Through Patient Wearable Technology

Principal Investigator:
Cynthia J. Tifft, MD, PhD, National Human Genome Research Institute, National Institutes of Health

This proposal is a next step in identifying relevant outcome measures for clinical trials. Considerable data on the late onset Tay-Sachs (LOTS) and Sandhoff (LOSD) patients has recently been collected at two sites (Massachusetts General Hospital and the NIH Clinical Center) as well as the last two NTSAD Annual Family Conferences and this exploratory study would expand the range of outcomes to metrics relevant to the daily lives of LOTS and LOSD adults, including their ability to move about and participate in the activities of daily living.

This is a 6 month exploratory study using 5-8 ambulatory or partially ambulatory adult patients with late onset Tay-Sachs or Sandhoff disease to collect patient data on ambulation, falls, and wake/sleep cycles and other patient input that can be tested as clinically relevant outcome measures for future clinical trials. Data is collected through a wearable device and transmitted through a mobile app to Dr. Tifft for analysis. The data collected will be compared to clinical testing including gait lab metrics to be conducted at the NIH Clinical Center at the time of initial evaluation and at the 6 month endpoint.

Accelerated program for CSF delivery of AAV gene therapy for Tay-Sachs and Sandhoff patients

Principal Investigator:
Miguel Sena-Esteves, PhD, University of Massachusetts Medical School

While intracranial injection of AAV vectors is the most advanced gene therapy for Tay-Sachs and Sandhoff diseases, the current approach involves two vectors encoding separately the hexosaminidase A (HexA) alpha- and beta-subunits, which are injected bilaterally in the thalamus and one cerebral lateral ventricle. There are drawbacks to this approach, such as the invasiveness of direct injections into the brain that require a neurosurgical procedure, and its use of two AAV vectors which double the costs of manufacturing and an eventual treatment. After much initial work, there are now single AAV vectors carrying both subunits that show promising results in GM2 mice. These new vectors can enter the brain effectively after injection into the bloodstream, or injection into the cerebral spinal fluid (CSF). Presently it is unknown which approach will be the most effective and therefore it is important to test both.

To date, ongoing studies testing bloodstream delivery of these new AAV vectors in GM2 mice have shown very promising results. This project will focus on the delivery of AAV vectors to the central nervous system through CSF administration (e.g. intrathecal space) which has several advantages to treat Late Onset patients. The funding will primarily support a research associate to conduct mouse studies related to CSF delivery of AAV9 vector in GM2 mice including generating mice, injections, behavioral studies, histological and biochemical analyses of tissues post-mortem.

Minimally invasive delivery of AAV gene therapy in the Tay-Sachs Sheep

Principal Investigator:
Heather Gray-Edwards, PhD, Scott-Ritchey Research Center, Auburn University, Auburn, AL

Goals of the Proposal

  • To evaluate efficacy of adeno associated viral (AAV) gene therapy after cerebrospinal fluid (CSF) delivery in the sheep model of Tay-Sachs disease (TSD)
  • To confirm previously proposed biomarkers of TSD, including MRI image, lipidomic signatures, cognitive testing, and neurologic evaluation
  • To study the biodistribution and clearance of CSF delivered AAV gene therapy in the Tay-Sachs sheep

Impact of Research

Gene therapy, is one of the most promising treatment options in development. The study will evaluate the efficacy and biodistribution of the state-of-the-art gene therapy in TSD sheep. Tay-Sachs sheep is one of the most relevant animal models of the disease, due to its large brain size and suitability for various biomarker studies.

The findings in this proposal will aid in expanding our knowledge on the treatment’s administration and biodistribution. The efficacy profile from the work with be necessary and helpful for future regulatory application before FDA. Most importantly, this study will generate useful data and insight about TSD biomarkers and contribute to future clinical studies in human patients.

Amendment to complete safety study in non-human primates

Principal Investigator:
Miguel Sena-Esteves, PhD, University of Massachusetts Medical School

Thank you from the bottom of our hearts for your support!

As of March 2, 2023, the fund has recieved 3,627 donations from 2,377 generous donors!

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Michael and Carol Racioppi

Michele Hirsch

Michelle Kraemer

Michael Oreskovich

Robin Grove

David Shifrin

Michael Sands

Milton Klein

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Mitch Scherzer

Manuela Paz

Emily Peck

Michelle Gaines

Mark Lisnow

Michael Schindel

Marcia Mellitz

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Mary Jane McAleavy

Megan Hess

Martha Niessen

Mollie Reisman

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Monica Callan

Monte MacDiarmid

Morgan DeAmicis

Galicia Contracting and Restoration Corp.

Marc Fishbein

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Marjorie Levin

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Norman & Mary Rita Weissman

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Goetz Middle School

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Neiman Marcus

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Anonymous

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Compass Mining, Inc

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Peter Berman

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Polina Petkova

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Gould Family Foundation

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Joy Fallek

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Ruth Reibstein

Lauretta Prestera

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Savaria Drumm

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Macy’s

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Sherry Maher

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Judith Itzkowitz

Susan Luciani

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Sharen Levine

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Steven Karash

Susan and Jerry Hale

Michael Scipione

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Sara Kosowsky

Nancy Slavin

Sarah Yu

Stanley Lenkowsky

Samantha Levine

Solon Liberman

Mariya Bugayenko

Steven Bernstein

San and Bob Miller

Sheila and Dennis Smith

Jeffrey Smith

Stephanie Liotta

Sandy Mervak

Sherri Morr

Paul Smurl

Stephen Ochser

Eileen Lewis

Sarah Hogan

Laura Sonnenfeld

Sophie Brownlow

Susan Peck

Cindy Goldman

Samantha Prusin

Stuart Stoller

Stuart Freedman

Sandra Michaelson

Suzanne & Robert Schaps

Stephanie Gelber

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Samuel Chodosh

Stacey Block

Stanley Runyon

Susan Tarrence

Stephanie Shnay

Steven Walkley

Steven Rappaport

Stephen Hamburg

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Steven Shalit

Steven Shapiro

Stephen Shobin

David Strome

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Susan Brancati

Sue and Don James

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Barry Sufrin

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Sonia Hudes

Susan Silverman

Susan Staub

Susan Westlake

Susan Ferber

Susan Krimer

Susan Green

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Susan and Joel Landau

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Susy Korb

David Sutton

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Sydney Liss

Sharen Moghavem

Shari Teitelbaum

Tara House Jaffe

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Tom Bodkin

Tom DiCerbo

Tom McDowell

Lord & Taylor

Terri Friedman

Terry Oster

Tressa Seetin

SourceIndia, Inc.

Todd Haskell

E Baldwin

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Renu Lonial

Theresa McCann

Seth Rogin

Thomas Demarzo

Elizabeth and Thomas Mela

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Timothy Lawrence

Christina Kydoniefs

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Tom Liotta

Thomas Carley

Janet Liotta

Tracy Fudula

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Toby Fox

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M Updyke

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Victoria Heslop

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Victoria Miller

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Victor Parada

Vincent Sabio

Valerie Salembier

Valerie Weitzner

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Brie Walsh

Alex and Nancy Ward

Warren Bimblick

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William Buryk

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William Abernathy

Diane Wisniewski

Brian Evans

Willy Cepeda

Lester Krasnogor

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Susan Winter

William DeMarzo

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William Pollak

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Anne and Richard Yagoda

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Sarita and Stanley Fish

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