Seth Lederman

Seth Lederman
File:Sethlederman-750xx720-963-0-117.jpg Seth Lederman
Born	(1957-07-30) July 30, 1957 New York, New York, United States
Fields	Immunology, medicine, and pharmaceuticals
Institutions	Tonix Pharmaceuticals
Alma mater	Princeton University, Columbia University
Known for	Basic and translational research in immunology and therapeutics for autoimmunity, cancer and central nervous system disorders

Seth Lederman, MD is a physician, scientist and specialty pharmaceuticals entrepreneur. He is a co-founder and the current President and Chairman of Tonix Pharmaceuticals, a specialty pharmaceutical product development and commercialization company.

Biography

Lederman earned his Bachelor's degree in Chemistry from Princeton University where he graduated cum laude in 1979. He completed his M.D. from Columbia University in 1983 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. In 2015 he took a leave from Columbia.

As Assistant Professor at Columbia, Dr. Lederman discovered the CD40-Ligand (CD154) and elucidated the molecular basis of T cell helper function. Dr. Lederman’s work on the CD40-Ligand (CD154) led to the development of therapeutic candidates for autoimmune diseases and organ transplant rejection in collaboration with Biogen and UCB/CellTech. He also collaborated with Professor David Baltimore in identifying and functionally characterizing the CD40 signaling molecule, TRAF-3. 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”.

Lederman founded Targent Pharmaceuticals, which sold levoleucovorin to Spectrum Pharmaceuticals, who market it as Fusilev. Fusilev is approved for the treatment of advanced colorectal cancer and for methotrexate rescue. 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).

Tonix Pharmaceuticals

As of April 2016, Tonix had approximately twenty-five employees. Lederman is a co-founder and current CEO;. Bradley Saenger, CPA and Bruce Daugherty, PhD hold positions of CFO and CSO, respectively. Founded in 2007 and based in New York City, the company specializes in developing next generation medicines for central nervous system disorders. Among the current projects of the company is the development of TNX-102 SL (cyclobenzaprine HCl, 2.8 mg tablets for sublingual administration) for the management of fibromyalgia and TNX-102 SL (cyclobenzaprine HCl, 5.6 mg tablets for sublingual administration) for the treatment of post-traumatic stress disorder. TNX-102 SL 2.8 mg is currently being tested in a Phase 3 study (the AFFIRM Trial) for fibromyalgia. TNX-102 SL 5.6 mg was evaluated a Phase 2 study (the AtEase Trial) for military PTSD and showed significant effects. In addition, TNX-301 (disulfiram 250 mg/selegiline 4 mg tablets), is in preclinical development. The company was listed on the NASDAQ exchange in 2013 under the symbol TNXP. In addition to corporate headquarters in New York City, the company has facilities in La Jolla, CA; San Jose, CA; Montreal, Quebec, Canada and Dublin, Ireland.

Fellowships and grants

1. 1985-1990 National Institutes of Health, Physician Scientist
2. 1988-1993 Co-investigator (with Dr. Leonard Chess) "Biologic and Functional Consequences of CD4- gp120 Interactions": Project #1 of PO-1 AI26886, "Pathogenesis of AIDS: Molecular and Cellular Mechanisms", Dr. Leonard Chess, P.I.
3. 1992-1994 Arthritis Investigator, Arthritis Foundation (National)
4. 1992-1995 "Differentiation and Function of Human Helper T cells", RO-1 (rank 8.1 percentile), P.I., Seth Lederman.
5. 1992-1995 "Differentiation and Function of Human Helper T cells", American Cancer Society (Declined).
6. 1993 Columbia Presbyterian Medical Center, Clinical Research Development Grant, "Preclinical Studies of the mAb 5c8", P.I., Seth Lederman.
7. 1993-1996 "Preclinical Studies of the mAb 5c8", P.I. with Dr. Leonard Chess, Biogen, Inc.
8. 1993-1994 Howard Hughes Medical Student Fellowship and Continuing Scholar Award for Sarah M. Fortune.
9. 1994-1995 Howard Hughes Medical Student Fellowship for Aarif Y. Khakoo
10. 1996-1999 "Molecular Analysis of Helper T cells Function", American Cancer Society (rank, top 10%. (Declined).
11. 1996-2001 "Differentiation and Function of Human Helper T cells", RO-1 (rank 7.3 percentile), P.I., Seth Lederman, Competitive renewal.

Selected Publications

Review Articles

Patents

1. U.S. Patent #5,474,771 (Issued December 12, 1995) “Murine monoclonal antibody (5c8) recognizes a human glycoprotein on the surface of T lymphocytes, Compositions containing same,” Lederman, S., L. Chess and M.J. Yellin.
2. U.S. Patent #5,756,710 (Issued May 26, 1998) “Phosphorothioate oligonucleotides that bind to the V3-loop and uses thereof.” Stein, C.A., S. Lederman and G. Sullivan.
3. U.S. Patent #5,933,816 (Issued November 30, 1999) “Methods to inhibit humoral immune responses, immunoglobulin production, and B cell activation with 5c8-specific antibodies”, Lederman, S., L. Chess and M.J. Yellin.
4. U.S. Patent #6,331,433 B1 (Issued December 18, 2001) “Human T cell leukemia cell line designated D1.1”, Lederman, S., L. Chess and M.J. Yellin.
5. U.S. Patent #6,331,615 B1 (Issued December 18, 2001) “Nucleic acid molecule encoding heavy or light chain of an antibody which specifically recognizes a protein specifically recognized by monoclonal antibody 5c8 (anti-CD40 ligand),” Lederman, S., L. Chess and M.J. Yellin.
6. U.S. Patent #6,340,459 B1 (Issued January 22, 2002) “Therapeutic applications for the anti-T-BAM (CD40-L) monoclonal antibody 5c8 in the treatment of reperfusion injury in non-transplant recipients”, Yellin, M.J., Lederman, S., and L. Chess.
7. U.S. Patent #6,358,944 B1 (Issued March 19, 2002) “Methods and compositions for treating generalized anxiety disorder”, Lederman, S., I. W. Iglehart.
8. U.S. Patent #6,403,091 B1 (Issued June 11, 2002) “Methods for inhibiting the rejection of a transplant organ in a subject with 5c8-specific antibodies”, Lederman, S, M.J. Yellin, and L. Chess.
9. U.S. Patent #6,410,710 B1 (Issued June 25, 2002) “Nucleic acid encoding TRAF-3 deletion isoform”, Lederman, S., W. van Eyndhoven.
10. U.S. Patent #6,451,310 B1 (Issued September 17, 2002) “A method for inhibiting an allergic response with a 5c8-specific antibody”, Lederman, S, M.J. Yellin, and L. Chess.
11. U.S. Patent #6,455,044 B1 (Issued September 24, 2002) “5c8 Antigen”, Lederman, S., M.J. Yellin, and L. Chess.
12. U.S. Patent #6,592,868 B1 (Issued July 15, 2003) “Methods for treating autoimmune disease”, Lederman, S., M.J. Yellin, and L. Chess.
13. U.S. Patent #6,610,294 B1 (Issued August 26, 2003) “Methods of inhibiting an autoimmune response in a human suffering from an autoimmune disease by administering an antibody that binds to a protein to which monoclonal antibody 5c8 binds”, Lederman, S., M.J. Yellin, and L. Chess.
14. U.S. Patent #6,793,924 (Issued September 21, 2004) “Protein recognized by an antibody that specifically binds an epitope that is specifically bound by monoclonal antibody 5c8”, Lederman, S., L. Chess and M.J. Yellin.
15. U.S. Patent #6,822,070 B2 (Issued November 23, 2004) “Truncated CRAF1 inhibits CD40 signaling.”, Baltimore, D, G. Cheng, Z-S Ye, S. Lederman, and A. Cleary.
16. U.S. Patent #6,849,415 B2 (Issued February 1, 2005) “TRAF -3 deletion isoforms and uses thereof”, Lederman, S., W. van Eyndhoven.
17. US Patent #7,070,777 (Issued July 4, 2006) “Method for inhibiting inflammation with an antibody that binds the 5C8 protein,” Lederman, S., L. Chess and M.J. Yellin
18. US Patent 12/145,792 “Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism” (notice of allowance) . Lederman, S.
19. Australia Patent AU 2002354017 “Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism”. Lederman, S.
20. Canada Patent CA 2463987 “Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism”. Lederman, S.
21. European Patent EP 1441708 “Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism”. Lederman, S.
22. New Zealand Patent NZ 532583 “Compositions and Methods for Increasing Compliance with Therapies using Aldehyde Dehydrogenase Inhibitors and Treating Alcoholism” Lederman, S.

Honors and Awards

1. 1993 Dr. Harold and Golden Lamport Award for Excellence in Clinical Science Research
2. 1993 New York Arthritis Foundation Grant Reviewer
3. 1993 Ad Hoc Reviewer; Immunochemical Sciences Study Section, N.I.H.
4. 1993 Ad Hoc Reviewer; Aids and Related Research Study Section (1), N.I.H.
5. 1994-1996 Medical and Scientific Committee, N.Y. Chapter of the Arthritis Foundation
6. 1994-1995 Scientific Program Abstract Reviewer - Am. College of Rheumatology Nat'l Meeting
7. 1996 Ad Hoc Reviewer, American Cancer Society, Immunology Study Section
8. 1999 Scientific Program Abstract Reviewer - Am. College of Rheumatology Nat'l Meeting
9. 1998-2001 Grant Review Committee – Nat’l Arthritis Foundation, Cellular Immunology
10. 2000-2005 American Editor – Human Immunology

External links

• Tonix Pharmaceuticals
• Faculty page at Columbia University
• Personal homepage