Seth Lederman

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Seth Lederman
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Born (1957-07-30) July 30, 1957 (age 66)
New York, New York, United States
Alma mater Princeton University, Columbia University
Known forBasic and translational research in immunology and therapeutics for autoimmunity, cancer and central nervous system disorders
Scientific career
Fields Immunology, medicine, and pharmaceuticals
Institutions Tonix Pharmaceuticals

Seth Lederman (born July 30, 1957) is an American 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.

Contents

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 is developing TNX-102 SL for post-traumatic stress disorder (PTSD). FDA awarded TNX -102 SL "Breakthrough Therapy" designation for PTSD because its effects in military-related PTSD have the potential to improve upon existing therapies. [8]

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. [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, 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]

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. [22]

International biotechnology policy and cooperation

In September 2015, Lederman represented U.S. biotechnology at a summit with China's President Xi Jinping. [23] [24] 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.

Related Research Articles

<span class="mw-page-title-main">Vaccine</span> Pathogen-derived preparation that provides acquired immunity to an infectious disease

A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and recognize further and destroy any of the microorganisms associated with that agent that it may encounter in the future.

<span class="mw-page-title-main">Cowpox</span> Disease of humans and animals

Cowpox is an infectious disease caused by the cowpox virus (CPXV). It presents with large blisters in the skin, a fever and swollen glands, historically typically following contact with an infected cow, though in the last several decades more often from infected cats. The hands and face are most frequently affected and the spots are generally very painful.

<span class="mw-page-title-main">Smallpox vaccine</span> Vaccine against Variola virus

The smallpox vaccine is the first vaccine to have been developed against a contagious disease. In 1796, British physician Edward Jenner demonstrated that an infection with the relatively mild cowpox virus conferred immunity against the deadly smallpox virus. Cowpox served as a natural vaccine until the modern smallpox vaccine emerged in the 20th century. From 1958 to 1977, the World Health Organization (WHO) conducted a global vaccination campaign that eradicated smallpox, making it the only human disease to be eradicated. Although routine smallpox vaccination is no longer performed on the general public, the vaccine is still being produced to guard against bioterrorism, biological warfare, and mpox.

<span class="mw-page-title-main">Immunization</span> Process by which an individuals immune system becomes fortified against an infectious agent

Immunization, or immunisation, is the process by which an individual's immune system becomes fortified against an infectious agent.

<span class="mw-page-title-main">Vaccinia</span> Strain of poxvirus

Vaccinia virus is a large, complex, enveloped virus belonging to the poxvirus family. It has a linear, double-stranded DNA genome approximately 190 kbp in length, which encodes approximately 250 genes. The dimensions of the virion are roughly 360 × 270 × 250 nm, with a mass of approximately 5–10 fg. The vaccinia virus is the source of the modern smallpox vaccine, which the World Health Organization (WHO) used to eradicate smallpox in a global vaccination campaign in 1958–1977. Although smallpox no longer exists in the wild, vaccinia virus is still studied widely by scientists as a tool for gene therapy and genetic engineering.

Modified vaccinia Ankara (MVA) is an attenuated (weakened) strain of the vaccinia virus. It is being used as a vaccine against smallpox and mpox, having fewer side effects than smallpox vaccines derived from other poxviruses.

Orthopoxvirus is a genus of viruses in the family Poxviridae and subfamily Chordopoxvirinae. Vertebrates, including mammals and humans, and arthropods serve as natural hosts. There are 12 species in this genus. Diseases associated with this genus include smallpox, cowpox, horsepox, camelpox, and monkeypox. The most widely known member of the genus is Variola virus, which causes smallpox. It was eradicated globally by 1977, through the use of Vaccinia virus as a vaccine. The most recently described species is the Alaskapox virus, first isolated in 2015.

<span class="mw-page-title-main">CD154</span> Protein-coding gene in humans

CD154, also called CD40 ligand or CD40L, is a protein that is primarily expressed on activated T cells and is a member of the TNF superfamily of molecules. It binds to CD40 on antigen-presenting cells (APC), which leads to many effects depending on the target cell type. In total CD40L has three binding partners: CD40, α5β1 integrin and integrin αIIbβ3. CD154 acts as a costimulatory molecule and is particularly important on a subset of T cells called T follicular helper cells. On TFH cells, CD154 promotes B cell maturation and function by engaging CD40 on the B cell surface and therefore facilitating cell-cell communication. A defect in this gene results in an inability to undergo immunoglobulin class switching and is associated with hyper IgM syndrome. Absence of CD154 also stops the formation of germinal centers and therefore prohibiting antibody affinity maturation, an important process in the adaptive immune system.

Immunization during pregnancy is the administration of a vaccine to a pregnant individual. This may be done either to protect the individual from disease or to induce an antibody response, such that the antibodies cross the placenta and provide passive immunity to the infant after birth. In many countries, including the US, Canada, UK, Australia and New Zealand, vaccination against influenza, COVID-19 and whooping cough is routinely offered during pregnancy.

<span class="mw-page-title-main">Smallpox</span> Eradicated viral disease

Smallpox was an infectious disease caused by variola virus which belongs to the genus Orthopoxvirus. The last naturally occurring case was diagnosed in October 1977, and the World Health Organization (WHO) certified the global eradication of the disease in 1980, making smallpox the only human disease to be eradicated.

A subunit vaccine is a vaccine that contains purified parts of the pathogen that are antigenic, or necessary to elicit a protective immune response. Subunit vaccine can be made from dissembled viral particles in cell culture or recombinant DNA expression, in which case it is a recombinant subunit vaccine.

<span class="mw-page-title-main">Merck & Co.</span> American multinational pharmaceutical company

Merck & Co., Inc. is an American multinational pharmaceutical company headquartered in Rahway, New Jersey, and is named for Merck Group, founded in Germany in 1668, of whom it was once the American arm. The company does business as Merck Sharp & Dohme or MSD outside the United States and Canada. It is one of the largest pharmaceutical companies in the world, generally ranking in the global top five by revenue.

Vaccinia immune globulin (VIG) is made from the pooled blood of individuals who have been inoculated with the smallpox vaccine. The antibodies these individuals developed in response to the smallpox vaccine are removed and purified. This results in VIG. It can be administered intravenously. It is used to treat individuals who have developed progressive vaccinia after smallpox vaccination.

<span class="mw-page-title-main">Moderna</span> American biotechnology company

Moderna, Inc. is a pharmaceutical and biotechnology company based in Cambridge, Massachusetts, that focuses on RNA therapeutics, primarily mRNA vaccines. These vaccines use a copy of a molecule called messenger RNA (mRNA) to carry instructions for proteins to produce an immune response. The company's name is derived from the terms "modified", "RNA", and "modern".

<span class="mw-page-title-main">Ebola vaccine</span> Vaccine against Ebola

Ebola vaccines are vaccines either approved or in development to prevent Ebola. As of 2022, there are only vaccines against the Zaire ebolavirus. The first vaccine to be approved in the United States was rVSV-ZEBOV in December 2019. It had been used extensively in the Kivu Ebola epidemic under a compassionate use protocol. During the early 21st century, several vaccine candidates displayed efficacy to protect nonhuman primates against lethal infection.

Roselyn J. Eisenberg is a professor at The University of Pennsylvania and a member of the University's School of Veterinary Medicine and School of Dental Medicine. The majority of Eisenberg's research is focused on the herpes simplex virus and the poxvirus and how they enter into susceptible cells. She also studies glycoproteins, vaccines, virology and microbiology.

Tonix Pharmaceuticals is a pharmaceutical company based in Chatham, New Jersey that focuses on repurposed drugs for central nervous system conditions and as of 2020 was also pursuing a vaccine for COVID-19 and a biodefense project.

<span class="mw-page-title-main">Coalition for Epidemic Preparedness Innovations</span> Public-private organization for vaccine development

The Coalition for Epidemic Preparedness Innovations (CEPI) is a foundation that takes donations from public, private, philanthropic, and civil society organisations, to finance independent research projects to develop vaccines against emerging infectious diseases (EID).

<span class="mw-page-title-main">Viral vector vaccine</span> Type of vaccine

A viral vector vaccine is a vaccine that uses a viral vector to deliver genetic material (DNA) that can be transcribed by the recipient's host cells as mRNA coding for a desired protein, or antigen, to elicit an immune response. As of April 2021, six viral vector vaccines, four COVID-19 vaccines and two Ebola vaccines, have been authorized for use in humans.

Cornelis Joseph Maria Melief is a globally recognised immunology expert specialising in cancer immunology and immunotherapy, with special focus on therapeutic cancer vaccines. He is Emeritus Professor, former head of the Department of Immunohematology and Blood Transfusion at the Leiden University Medical Center, and Chief Scientific Officer at ISA Therapeutics in Netherlands. He is known for his work in the field of cancer immunology, devising new cancer therapies based on the activation of the patient’s own immune system.

References

  1. ↑ "Executive Profile". Bloomberg Business Week Executive Profiles. Bloomberg Business Week.[ dead link ]
  2. 1 2 3 "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. Vol. 34, no. 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. 1 2 "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. ↑ "TNX-1800 (Coronavirus Vaccine)". www.tonixpharma.com. Retrieved 2020-11-03.
  23. ↑ "China committed to building major-country relations with U.S.: President Xi". Xinhuanet. China Daily. Archived from the original on September 21, 2015.
  24. ↑ "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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