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November 2021; 8 (6) ArticleOpen Access

Safety and Immune Effects of Blocking CD40 Ligand in Multiple Sclerosis

Camilo E. Fadul, Yang Mao-Draayer, Kathleen A. Ryan, Randolph J. Noelle, Heather A. Wishart, Jacqueline Y. Channon, Isaac R. Kasper, Brant Oliver, Daniel W. Mielcarz, Lloyd H. Kasper
First published October 15, 2021, DOI: https://doi.org/10.1212/NXI.0000000000001096
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Article Information

vol. 8 no. 6 e1096
DOI: 
https://doi.org/10.1212/NXI.0000000000001096
PubMed: 
34654708
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Online ISSN: 
2332-7812
History: 
  • Received March 16, 2021
  • Accepted in final form August 11, 2021
  • First Published October 15, 2021.
Copyright & Usage: 
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Author Disclosures

    1. Camilo E. Fadul, MD* (cef3w{at}virginia.edu),
    2. Yang Mao-Draayer, MD, PhD*,
    3. Kathleen A. Ryan, RN (kthleenryan{at}gmail.com),
    4. Randolph J. Noelle, PhD (rjn{at}dartmouth.edu),
    5. Heather A. Wishart, PhD (heather.a.wishart{at}dartmouth.edu),
    6. Jacqueline Y. Channon, PhD (jacqueline.smith{at}dartmouth.edu),
    7. Isaac R. Kasper, MD (ikasper{at}melrosewakefield.org),
    8. Brant Oliver, PhD, MPH, APRN-BC (brant.j.oliver{at}dartmouth.edu),
    9. Daniel W. Mielcarz, PhD (daniel.w.mielcarz{at}dartmouth.edu) and
    10. Lloyd H. Kasper, MD (lloydkasper{at}gmail.com)
  1. Camilo E. Fadul, MD* (cef3w{at}virginia.edu),
    2. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. Journal of Neuro-Oncology, Editorial Board, 2018-present

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Novartis- Grant funding to the University of Virginia.

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  2. Yang Mao-Draayer, MD, PhD*,
    3. Scientific Advisory Boards:

    1. Acorda, Bayer Pharmaceutical, Biogen Idec, EMD Serono, Sanofi-Genzyme, Novartis, Celgene/Bristol Myers Squibb, Roche-Genentech, Janssen, Questor, Chugai, and Teva Neuroscience

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Acorda, Bayer Pharmaceutical, Biogen Idec, EMD Serono, Sanofi-Genzyme, Novartis, Celgene/Bristol Myers Squibb, Roche-Genentech, Janssen, Questor, Chugai, and Teva Neuroscience

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Acorda, Bayer Pharmaceutical, Biogen Idec, EMD Serono, Sanofi-Genzyme, Novartis, Celgene, Roche-Genentech, Questor, Chugai, and Teva Neuroscience

    Speakers' Bureaus:

    1. Teva neuroscience, Biogen Idec, Janssen, EMD Serono,

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NIH NIAID Autoimmune Center of Excellence: UM1-AI110557; 1UM1AI144298; NIH NINDS R01-NS080821

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  3. Kathleen A. Ryan, RN (kthleenryan{at}gmail.com),
    4. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  4. Randolph J. Noelle, PhD (rjn{at}dartmouth.edu),
    5. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. A company I cofounded licensed an anti-CD154 to Sanofi and it is in development for the treatment of MS (this is confidential)

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. Use of engineered anti-CD154 for the treatment of inflammatory disease

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. I am an employee of ImmuNext, a company that has licensed an anti-CD154 for the treatment of inflammatory disorders.

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License fee payments, Technology or Inventions:

    1. License fees have been received from Sanofi for the licensing of anti-CD154.

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  5. Heather A. Wishart, PhD (heather.a.wishart{at}dartmouth.edu),
    6. Scientific Advisory Boards:

    1. scientific advisory board for Bayer HealthCare

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Travel to a meeting of the above-noted Bayer scientific advisory board. Travel to a 2001 conference supported by pharma and/or research grants (this was arranged through the MS clinic and so I do not know the details).

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Independent investigator-intiated research grants from Teva, Bayer and Serono; Site PI for two investigator- initiated studies sponsored by Genzyme

    Research Support, Government Entities:

    1. Research grants from: NIH (K23NS045830 PI 2005-11) NIH (R03NS056228 PI 2007-11) Department of Defense (PR 080408 PI 2009-12) Department of Defense (MS090182 PI 2010-11) National Science Foundation (CoPI, Proposal No. 0312629, 2005-2008)

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. Research grants from: Dartmouth Center for Clinical and Translational Science (PI, 2009-11). National MS Society (PI 2005-2008) National MS Society (PI 2001-2005; Mentor 2002-2004) Hitchcock Foundation (career development award 2001-2004) Hitchcock Foundation (research grant PI 1998-2000)

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  6. Jacqueline Y. Channon, PhD (jacqueline.smith{at}dartmouth.edu),
    7. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Curis CI8993 Phase 1 clinical trial. Shared Resource fee-for-service assays.

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  7. Isaac R. Kasper, MD (ikasper{at}melrosewakefield.org),
    8. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  8. Brant Oliver, PhD, MPH, APRN-BC (brant.j.oliver{at}dartmouth.edu),
    9. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. 1) At Point of Care (Medical CME)- Limited consulting. Curriculum design and instruction, educational research

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Biogen- investigator initiated research grant (2017-2020)- MSCQI Collaborative (population health/improvement research) EMD Serono- sponsored research agreement (research grant) (2020-2023)- population health/improvement/implementation research

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. Crohn's & Colitis Foundation for role as national improvement advisor for IBD multicenter improvement collaborative in the US (2017- 2023)

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  9. Daniel W. Mielcarz, PhD (daniel.w.mielcarz{at}dartmouth.edu) and
    10. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Curis CI-8993 Phase I clinical trial. Shared resource fee-for-service.

    Research Support, Government Entities:

    1. NCI Cancer Center Support Grant, Senior Research Scientist, 2011-present, 5P30 CA023108-41

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  10. Lloyd H. Kasper, MD (lloydkasper{at}gmail.com)
    11. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. speaker bureau honoraria unrelated to sponsored funding

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. NONE

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  1. From the Department of Neurology (C.E.F.), University of Virginia School of Medicine, Charlottesville; Department of Medicine, Microbiology/Immunology and Psychiatry (K.A.R., R.J.N., H.A.W., J.Y.C., J.R.K., B.O., D.W.M., L.H.K.), Dartmouth Medical School, Lebanon, NH; and Department of Neurology (Y.M.-D.), Autoimmunity Center of Excellence, University of Michigan Medical School, Ann Arbor.
  1. Correspondence
    Dr. Mao-Draayer maodraay{at}umich.edu, or Dr. Kasper lloydkasper{at}gmail.com

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