Seth Lederman

Seth Lederman (born July 30, 1957) is a physician,[1] scientist and specialty pharmaceuticals entrepreneur. He is a co-founder and the current President and Chairman[2][3] of Tonix Pharmaceuticals,[4] a specialty pharmaceutical product development and commercialization company.

Seth Lederman
Born (1957-07-30) July 30, 1957
New York, New York, United States
Alma materPrinceton University, Columbia University
Known forBasic and translational research in immunology and therapeutics for autoimmunity, cancer and central nervous system disorders
Scientific career
FieldsImmunology, medicine, and pharmaceuticals
InstitutionsTonix Pharmaceuticals

Biography

Lederman earned his bachelor's degree in Chemistry from Princeton University where he graduated cum laude in 1979.[5] He completed his M.D. from Columbia University in 1983[6] and continued his training at the Columbia Presbyterian Medical Center until 1986. Lederman became instructor at Columbia in 1985, Assistant Professor in 1988 and Associate Professor with tenure in 1996. From October 30, 2015 until November 1, 2016 he took a leave of absence and left Columbia in April 2017. In addition to his research, he served as attending physician in the Edward Daniels Faulkner Arthritis Clinic at Columbia Presbyterian Hospital from 1988-1996 and served as Associate Attending physician at Columbia Presbyterian Hospital until 2000 (now New York Presbyterian Hospital).

As Assistant Professor at Columbia, Dr. Lederman discovered the CD40-Ligand (CD154) and elucidated the molecular basis of T cell helper function. Lederman also collaborated with Professor David Baltimore in identifying and functionally characterizing the CD40 signaling molecule, TRAF-3.[7] Dr. Lederman’s “early work on HIV contributed to the understanding of how the V3 loop of HIV gp120 was involved in fusion with CD4 cell membranes, an early and essential event in viral entry and infection”.[7]

Lederman founded Targent Pharmaceuticals, which sold levoleucovorin to Spectrum Pharmaceuticals, which markets it as Fusilev. Lederman co-founded and served as a managing partner of Konanda Pharma Partners and Konanda Pharma Fund I, LP, and its wholly owned operating companies, Validus and Fontus Pharmaceuticals Inc. Validus acquired Fontus and markets Equetro (carbamazepine – Extended Release), Marplan (isocarboxazid) and Rocaltrol (calcitriol).[2]

Lederman founded Tonix Pharmaceuticals which is developing TNX-102 SL for post-traumatic stress disorder (PTSD). FDA awarded TNX -102 SL “Breakthrough Therapy” (breakthrough therapy) designation for PTSD because its effects in military-related PTSD have the potential to be improvements over existing therapies[8]

Discovery of CD40-ligand (CD154): the Molecular Basis of T Helper Function

As Assistant Professor at Columbia, Lederman discovered the CD40-Ligand (CD154) and elucidated the molecular basis of T cell helper function. Lederman's work on the (CD154) led to the development of therapeutic candidates for autoimmune diseases and organ transplant rejection in collaboration with Biogen and UCB/CellTech.[2] Dartmouth College challenged the CD40-Ligand patents, but the challenge (called an interference) was rejected on all claims.[9] UCB is currently in Phase 2 trials with dapirolizumab pegol (a pegylated anti-CD40L Fab').[10] Transcriptional changes in Dapirolizumab pegol treated Systemic Lupus Erythematosus (SLE) patients were recently reported.[11]

Tonix Pharmaceuticals and Biodefense

TNX-801 is a new potential vaccine for smallpox. TNX-801 is a synthetic form of horsepox, which is an otherwise extinct virus.[12] Evolutionary analysis of modern vaccines indicates that the vaccine isolated and used by Edward Jenner to vaccinate against smallpox was either horsepox or something quite similar. A 1902 sample of vaccinia smallpox vaccine was characterized and found to be 99.7% similar to horsepox, further supporting the connection with Jenner's vaccine.[13] The synthesis of horsepox was a collaboration with David Evans and Ryan Noyce at the University of Alberta in Edmonton, Alberta, Canada. TNX-801 or horsepox is the first poxvirus, or poxviridae, to be synthesized and provides a platform for developing new vaccines against infectious disease and cancer.[14][15][16][17][18][19][20] The finding that a horsepox vaccine was in clinical use in the U.S. in 1902 to protect against smallpox provides strong support for the efficacy of TNX-801 horsepox vaccine to protect against smallpox.[21]

International Biotechnology Policy and Cooperation

In September 2015, Lederman represented U.S. Biotechnology at a Summit with China's President Xi Jinping.[22][23] The Summit was organized by the United States Chamber of Commerce and was held September 17–18, 2015 in Beijing. The delegation of U.S. CEOs, former U.S. cabinet officials and leading academic experts was the 7th meeting of the U.S.-China CEO and Former Senior Officials' Dialogue. The Dialogue was co-chaired by the United States Chamber of Commerce and the China Center for International Economic Exchanges (CCIEE), led by former Vice Premier Zeng Peiyan.

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References
  1. "Executive Profile". Bloomberg Business Week Executive Profiles. Bloomberg Business Week.
  2. "About Us - Board of Directors". Tonix Pharmaceuticals. Retrieved 15 December 2011.
  3. "Management Team". Tonix Pharmaceuticals. Archived from the original on 23 May 2013. Retrieved 10 March 2014.
  4. Dutton, Gail (15 January 2014). "Tonix Targets Reformulation to Create Value". BioBusiness. 34 (4). p. 10.
  5. "Department of Medicine Faculty". Columbia University website. Retrieved 30 January 2012.
  6. "Research Faculty - Seth Lederman, M.D." Columbia University Website. Retrieved 30 January 2012.
  7. "Research Summary". Seth Lederman. Retrieved 30 January 2012.
  8. "BRIEF-Tonix Pharmaceuticals' PTSD phase 3-ready drug candidate, TNX-102 SL, granted breakthrough therapy designation by FDA. Reuters". Reuters. 2016-12-19.
  9. "Patent 5,474,771" (PDF). UNITED STATES PATENT AND TRADEMARK OFFICE. U.S. Patent Office.
  10. "Anti-CD40L Fab, Dapirolizumab pegol (CD40L, CDP7657)". BioCentury Online Intelligence. BioCentury.
  11. "Peripheral Blood Transcriptional Changes Elicited by Treatment of Systemic Lupus Erythematosus (SLE) Patients with Dapirolizumab Pegol (A Pegylated anti-CD40L Fab')". European Union League Against Rheumatism (EULAR) Abstract OP0040. EULAR.
  12. "Tonix Demonstrates Vaccine Activity in First-Ever Synthesized Chimeric Horsepox Virus, March 3, 2017" (PDF).
  13. Schrick, Livia; Tausch, Simon H.; Dabrowski, P. Wojciech; Damaso, Clarissa R.; Esparza, José; Nitsche, Andreas (2017). "An Early American Smallpox Vaccine Based on Horsepox, by Schrick L, Tausch SH, Dabrowski PW, Damaso CR, Esparza J, Nitsche A. N Engl J Med. 2017 Oct 12;377(15):1491-1492. No abstract available". New England Journal of Medicine. 377 (15): 1491–1492. doi:10.1056/NEJMc1707600. PMID 29020595.
  14. "Canadian synthesizes a better smallpox vaccine — just in case terrorists bring the disease back, The National Post, by Tristin Hopper, March 3, 2017".
  15. "How Canadian researchers reconstituted an extinct poxvirus for $100,000 using mail-order DNA, Science, by Kai Kupferschmidt, July 6, 2017". 2017-07-06.
  16. "Scientists synthesize smallpox cousin in ominous breakthrough, Washington Post, by Joel Achenbach and Lena H. Sun By Joel Achenbach and Lena H. Sun, July 6, 2017".
  17. Koblentz, Gregory D. (2017). "The De Novo Synthesis of Horsepox Virus: Implications for Biosecurity and Recommendations for Preventing the Reemergence of Smallpox, Science, by Koblentz GD, August 24, 2017 Health Secur". Health Security. 15 (6): 620–628. doi:10.1089/hs.2017.0061. PMID 28836863.
  18. Noyce, Ryan S.; Lederman, Seth; Evans, David H. (2018). "Noyce RS, Lederman S, Evans DH (2018) Construction of an infectious horsepox virus vaccine from chemically synthesized DNA fragments". PLOS ONE. 13 (1): e0188453. Bibcode:2018PLoSO..1388453N. doi:10.1371/journal.pone.0188453. PMC 5774680. PMID 29351298.
  19. "Mice immunized with synthetic horsepox protected against vaccinia virus: Horsepox virus synthesized from DNA fragments may offer alternative to the current smallpox vaccine". EurekaAlert. January 19, 2018.
  20. "A paper showing how to make a smallpox cousin just got published. Critics wonder why. Science, by Kai Kupferschmidt, January 19, 2018". 2018-01-19.
  21. "A century-old vaccine vial sheds light on one of medicine's enduring mysteries, STAT News, by Helen Branswell October 11, 2017". 2017-10-11.
  22. "China committed to building major-country relations with U.S.: President Xi". Xinhuanet. China Daily.
  23. "Xi meets U.S. delegates attending 7th China-U.S. business leaders' and former senior officials' dialogue". Xinhuanet. China Daily.
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