Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — World Vaccine Congress 2023
23 slides from Tonix Pharmaceuticals's conference presentation, Apr 5, 2023
Slide 1: TNX-801: A Novel Mpox Vaccine: Live, Replicating, Attenuated Orthopoxvirus (Horsepox) Vaccine
TNX-801: A Novel Mpox Vaccine: Live, Replicating, Attenuated Orthopoxvirus (Horsepox) Vaccine Zeil Rosenberg MD Executive Vice President, Medical World Vaccine Congress Washington DC, April 5, 2023 © 2023 Tonix Pharmaceuticals Holding Corp.
Slide 2: Cautionary Note on Forward-Looking Statements
Cautionary Note on Forward-Looking Statements Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. These statements may be i
Slide 3: In 1796 Edward Jenner Successfully Used Vaccination to Protect Against Smallpox
In 1796 Edward Jenner Successfully Used Vaccination to Protect Against Smallpox • Jenner reasoned infection with illness similar to smallpox, but less deadly, could protect against smallpox ‒ “Jenner “vaccinated” (vacca, Latin for “cow”) a patient with pustule matter from “cowpox” sores on a milkmai
Slide 4: Vaccinia Induces a Skin Reaction Called "Take" Described by Dr. Edward Jenner
Vaccinia Induces a Skin Reaction Called “Take” Described by Dr. Edward Jenner Vaccine • Biomarker of protection ‒ Smallpox was eradicated using this marker 5 mm ‒ Revaccination indicated for recipients without “take” Take2 • Measure of T cell immunity ‒ No need for blood draws or complex laboratory
Slide 5: TNX-801 Development
TNX-801 Development • U.S. smallpox vaccine manufactured in 1902 (H.K. Mulford) ‒ 99.7% similar to horsepox in core viral sequence1,2 • Tonix-801 is based on a sequence of an isolated horsepox (HPXV) clone3 − Synthesized4 in 2018 (isolate was unavailable outside of CDC) − No new gene elements introd
Slide 6: Illustrative Safety Spectrum Of Pox-based Vaccine Vectors
Illustrative Safety Spectrum Of Pox-based Vaccine Vectors Optimizing Live Virus Vaccines New Live Recombinant Poxvirus Vaccine (rPXV) MVA Parental smallpox vaccines Canarypox Copenhagen Dryvax Fowlpox Tashkent Optimal Replicative Capacity Lister TianTan (“sweet spot”) ΔF4L ΔJ2R ΔJ2R Very safe but ~1
Slide 7: Orthopoxvirus Virulence as Visualized by Plaque Assay
Orthopoxvirus Virulence as Visualized by Plaque Assay 7 7 © 2023 Tonix Pharmaceuticals Holding Corp.
Slide 8: © 2023 Tonix Pharmaceuticals Holding Corp.
8 8 © 2023 Tonix Pharmaceuticals Holding Corp.
Slide 9: TNX-801 Vaccination and Lethal Challenge in Macaques
TNX-801 Vaccination and Lethal Challenge in Macaques TNX-801 (High Dose) TNX-801 (Low Dose) “Take” observed in all TNX-801 vaccinated NHPs except one. • If no take by day 7 were revaccinated on day 14. Post-vaccination, no NHP showed lesions during first 60 days 9 9 © 2023 Tonix Pharmaceuticals Hold
Slide 10: Immunogenicity: Total IgG (ELISA)
Immunogenicity: Total IgG (ELISA) 100% seroconversion in Tonix-801 vaccinated groups with antibody titers 2- 10 to 16-fold higher than baseline by day 28 and 4-to 8–fold higher at day 56. 10 © 2023 Tonix Pharmaceuticals Holding Corp.
Slide 11: Immunogenicity: Neutralizing Antibody (PRNT50 Assay)
Immunogenicity: Neutralizing Antibody (PRNT50 Assay) 88% of TNX-801 vaccinated NHPs had neutralizing antibody responses 11 8- to 50-fold from baseline 11 © 2023 Tonix Pharmaceuticals Holding Corp.
Slide 12: Measured Virus Shedding: Oral Swabs
Measured Virus Shedding: Oral Swabs TNX-801 (High Dose) TNX-801 (Low Dose) rVACV Mock Minimal or no virus shedding in Tonix-801 vaccinated groups 12 12 © 2023 Tonix Pharmaceuticals Holding Corp.
Slide 13: Measured Viremia
Measured Viremia TNX-801 (High Dose) TNX-801 (Low Dose) rVACV Mock Minimal sporadic or no viremia in Tonix-801 vaccinated groups 13 13 © 2023 Tonix Pharmaceuticals Holding Corp.
Slide 14: Clinical Disease: Weight Loss
Clinical Disease: Weight Loss TNX-801 (High Dose) TNX-801 (Low Dose) rVACV Mock Minimal or no weight loss in Tonix-801 vaccinated groups 14 14 © 2023 Tonix Pharmaceuticals Holding Corp.
Slide 15: Clinical Signs After MPXV Challenge
Clinical Signs After MPXV Challenge TNX-801 High Dose TNX-801 Low Dose rVACV NHPs vaccinated with Tonix-801: No lesions observed after MPXV challenge in any of the eight animals 15 1Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented a
Slide 16: Clinical Disease: Lethality
Clinical Disease: Lethality No deaths in Tonix-801 vaccinated groups 16 16 © 2023 Tonix Pharmaceuticals Holding Corp.
Slide 17: Study Conclusions for TNX-801 Non-Human Primate Challenge
Study Conclusions for TNX-801 Non-Human Primate Challenge • A single dose vaccination was well tolerated ‒ No severe adverse events • Vaccination was immunogenic • Mpox disease (lesions) was not observed following MPXV (Zaire) challenge • All vaccinated NHPs survived lethal challenge 17 17 © 2023 To
Slide 18: Live Recombinant Poxvirus (rPXV) Vaccine Platform Profile
Live Recombinant Poxvirus (rPXV) Vaccine Platform Profile POTENTIALLY LONGER DURABILITY DUE TO POX-ENGINEERED ARCHITECTURE • Live virus vaccines present unique “danger signals” (PAMPs) • Results in strong immune response PROGRAMMABLE VECTOR DESIGN FOR USE IN DIFFERENT DISEASES • Large capacity for e
Slide 19: Approved Recombinant Poxvirus-Based Commercial Products
Approved Recombinant Poxvirus-Based Commercial Products1-3 IMMUNOLOGY PORTFOLIO INFECTIOUS DISEASE AND Application / Poxvirus Doses released to Product Location Host restricted? disease vector environment TROVAC-AIV H5N1 Agriculture/avian Mexico, Central No TROVAC-AIV H5N1 2 billion (as of 2006) Boe
Slide 20: Emerging Infectious Disease R&D and Manufacturing Capability
Emerging Infectious Disease R&D and Manufacturing Capability 20 20 © 2023 Tonix Pharmaceuticals Holding Corp.
Slide 21: American Pandemic Preparedness Plan (AP3) White House OSTP
American Pandemic Preparedness Plan (AP3) White House OSTP AP3 Plan Element Tonix rPXV Vaccine Platform Potential Rapid Design, Testing Review 4-6 mo. Design-to-FIH trial <100 days Rapid Production Scale Up Large scale production <130 days possible Distribution Stable Traditional cold-chain Administ
Slide 22: Investigators and Collaborators
Investigators and Collaborators Tonix Univ. of Maryland – Institute of Human Virology • Seth Lederman • José Esparza • Siobhan Fogarty • Sina Bavari Southern Research • Scott Goebel • Fusataka Koide • Bruce Daugherty • Landon Westfall2 • Farooq Nasar • Karen Gilbert3 • Helen Stillwell1 Univ. of Albe
Slide 23: THANK YOU
THANK YOU © 2023 Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals Holding — World Vaccine Congress 2023 on 6ix