Seth Lederman

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Seth Lederman (born July 30, 1957) is an American physician[1][2][3] of Tonix Pharmaceuticals,[4] a specialty pharmaceutical product development company.

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 an 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 to 1996 and served as associate attending physician at Columbia Presbyterian Hospital until 2000 (now New York Presbyterian Hospital).

As assistant professor at Columbia, Lederman discovered the CD40-Ligand (CD154) and elucidated the molecular basis of T cell helper function. He also collaborated with Professor David Baltimore in identifying and functionally characterizing the CD40 signaling molecule, TRAF-3.[7] 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. He 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 developed TNX-102 SL, an investigational sublingual tablet for post-traumatic stress disorder (PTSD) and fibromyalgia. In January 2024, Tonix announced that the U.S. Food and Drug Administration (FDA) had conditionally accepted the trade name, TONMYA™, for TNX-102 SL for the management of fibromyalgia. [8]

On August 15, 2025, the U.S. Food and Drug Administration approved TNX-102 SL as TONMYA™ for the management of fibromyalgia, making it the first new FDA-approved fibromyalgia therapy in over 15 years. (NDA 219428) [9][10]

The approval was supported by statistically significant results from two pivotal Phase 3 studies: the RELIEF trial (TNX-FIH-301)[11] and the RESILIENT trial (TNX-FIH-304).[12]

Discovery of CD40-ligand (CD154)

As assistant professor at Columbia, Lederman discovered the CD40-Ligand (CD154) and elucidated the molecular basis of T cell helper function. His 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.[13] UCB is currently in Phase 2 trials with dapirolizumab pegol (a pegylated anti-CD40L Fab').[14] Transcriptional changes in Dapirolizumab pegol treated Systemic Lupus Erythematosus (SLE) patients were recently reported.[15]

Tonix Pharmaceuticals and biodefense

TNX-801 is a new potential vaccine for smallpox. TNX-801 is a synthetic form of horsepox, an otherwise extinct virus.[16] 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.[17] 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.[18][19][20][21][22][23][24] 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.[25]

TNX-1800 (live modified horsepox virus vaccine) is being developed by Tonix Pharmaceuticals in a strategic collaboration with Southern Research to support the development of a vaccine to protect against the new coronavirus disease, COVID-19. TNX-1800 is based on Tonix's proprietary horsepox vaccine platform. It is believed that horsepox has the potential to serve as a vector for vaccines to protect against other infectious agents. The new research collaboration will develop and test a potential horsepox vaccine that expresses protein from the virus that causes COVID-19 to protect against the disease.[26]

International biotechnology policy and cooperation

In September 2015, Lederman represented U.S. biotechnology at a summit with CCP General Secretary Xi Jinping.[27][28] 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 seventh 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.

References

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  1. ^ Page Module:Citation/CS1/styles.css has no content."Executive Profile". Bloomberg Business Week Executive Profiles. Bloomberg Business Week.[dead link]
  2. ^ a b c Page Module:Citation/CS1/styles.css has no content."About Us - Board of Directors". Tonix Pharmaceuticals. Retrieved 15 December 2011.
  3. ^ Page Module:Citation/CS1/styles.css has no content."Management Team". Tonix Pharmaceuticals. Archived from the original on 23 May 2013. Retrieved 10 March 2014.
  4. ^ Page Module:Citation/CS1/styles.css has no content.Dutton, Gail (15 January 2014). "Tonix Targets Reformulation to Create Value". BioBusiness. Vol. 34, no. 4. p. 10.
  5. ^ Page Module:Citation/CS1/styles.css has no content."Department of Medicine Faculty". Columbia University website. Retrieved 30 January 2012.
  6. ^ Page Module:Citation/CS1/styles.css has no content."Research Faculty - Seth Lederman, M.D." Columbia University Website. Retrieved 30 January 2012.
  7. ^ a b Page Module:Citation/CS1/styles.css has no content."Research Summary". Seth Lederman. Retrieved 30 January 2012.
  8. ^ Page Module:Citation/CS1/styles.css has no content."Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya™ as Trade Name for TNX-102 SL for the Management of Fibromyalgia".
  9. ^ Page Module:Citation/CS1/styles.css has no content."Approval Letter" (PDF).
  10. ^ Page Module:Citation/CS1/styles.css has no content."Tonmya Prescribing Information" (PDF).
  11. ^ Page Module:Citation/CS1/styles.css has no content.Lederman, Seth; Arnold, Lesley M.; Vaughn, Ben; Kelley, Mary; Sullivan, Gregory M. (July 4, 2023). "Efficacy and Safety of Sublingual Cyclobenzaprine for the Treatment of Fibromyalgia: Results From a Randomized, Double-Blind, Placebo-Controlled Trial". Arthritis Care & Research. 75 (11): 2359–2368. doi:10.1002/acr.25142. ISSN 2151-4658. PMID 37165930.
  12. ^ Page Module:Citation/CS1/styles.css has no content.S, Lederman; LM, Arnold; B, Vaughn; JM, Engels; M, Kelley; GM, Sullivan (8 July 2025). "Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine". Pain Medicine. 00: 1–9. doi:10.1093/pm/pnaf089. PMID 40627411.
  13. ^ Page Module:Citation/CS1/styles.css has no content."Patent 5,474,771" (PDF). UNITED STATES PATENT AND TRADEMARK OFFICE. U.S. Patent Office. Archived from the original (PDF) on 2016-03-04. Retrieved 2011-12-21.
  14. ^ Page Module:Citation/CS1/styles.css has no content."Anti-CD40L Fab, Dapirolizumab pegol (CD40L, CDP7657)". BioCentury Online Intelligence. BioCentury.
  15. ^ Page Module:Citation/CS1/styles.css has no content."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.
  16. ^ Page Module:Citation/CS1/styles.css has no content."Tonix Demonstrates Vaccine Activity in First-Ever Synthesized Chimeric Horsepox Virus, March 3, 2017" (PDF).
  17. ^ Page Module:Citation/CS1/styles.css has no content.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.
  18. ^ Page Module:Citation/CS1/styles.css has no content."Canadian synthesizes a better smallpox vaccine — just in case terrorists bring the disease back, The National Post, by Tristin Hopper, March 3, 2017".[dead link]
  19. ^ Page Module:Citation/CS1/styles.css has no content."How Canadian researchers reconstituted an extinct poxvirus for $100,000 using mail-order DNA, Science, by Kai Kupferschmidt, July 6, 2017". 2017-07-06.
  20. ^ Page Module:Citation/CS1/styles.css has no content."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".
  21. ^ Page Module:Citation/CS1/styles.css has no content.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.
  22. ^ Page Module:Citation/CS1/styles.css has no content.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.
  23. ^ Page Module:Citation/CS1/styles.css has no content."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.
  24. ^ Page Module:Citation/CS1/styles.css has no content."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.
  25. ^ Page Module:Citation/CS1/styles.css has no content."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.
  26. ^ Page Module:Citation/CS1/styles.css has no content."TNX-1800 (Coronavirus Vaccine)". www.tonixpharma.com. Retrieved 2020-11-03.
  27. ^ Page Module:Citation/CS1/styles.css has no content."China committed to building major-country relations with U.S.: President Xi". Xinhuanet. China Daily. Archived from the original on September 21, 2015.
  28. ^ Page Module:Citation/CS1/styles.css has no content."Xi meets U.S. delegates attending 7th China-U.S. business leaders' and former senior officials' dialogue". Xinhuanet. China Daily. Archived from the original on September 21, 2015.
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