Soligenix, Inc. · NASDAQ:SNGX
Soligenix — Investor Presentation (October 2016)
17 slides from Soligenix's investor presentation, October 2016
Slide 1: Introduction to ThermoVax
Non Confidential Introduction to ThermoVax® Proprietary Thermo-Stabilization Platform for Vaccines Outside the Cold Chain
Slide 2: ThermoVax Technology
ThermoVax® Technology A proprietary vaccine formulation platform imparting enhanced thermostability • Stability at high temperatures (>40⁰C) – Extremely labile subunit stable for at least 1 year at 40ºC – Demonstrated stability for at least 16 weeks at 70oC • Delivers long-term stabilization of labi
Slide 3: Avoiding the Cold Chain: The Need for Thermostable Vaccines
Avoiding the Cold Chain: The Need for Thermostable Vaccines • Total vaccine market exceeded $21B in 20101 • $20.6B or 98% of all vaccines require shipment through cold chain2 • Maintaining cold chain increases the cost of vaccination by 14–20%3 – Establishing & maintaining cold chain requires signif
Slide 4: Thermostable Vaccines: Value Proposition
Thermostable Vaccines: Value Proposition • Value Proposition – Established Markets – Drive Market Share with a differentiated product – Thermostable vaccines preferred by Physician offices and pharmacies o Decreased need for refrigerator/freezer space and monitoring o Less waste/returns from questio
Slide 5: Temperature Sensitivity of Marketed Vaccines
Temperature Sensitivity of Marketed Vaccines Source: PATH 5
Slide 6: Vaccines Outside the Cold Chain
Vaccines Outside the Cold Chain • All of the components of a vaccine are subjected to some form of degrading force (water, heat, light) – Complex protein or protein-carbohydrate antigens are susceptible to inactivation – Adjuvants and vehicles are also vulnerable • Special need for long-term stabili
Slide 7: Vaccine Instability
Vaccine Instability Principal pathways of recombinant subunit protein vaccine instability occurring in water Chemical Physical • Oxidation (methionine) • Dimerization/multimerization • Deamidation (asn/gln) • Aggregation • Disulfide exchange (inter- or • Conformational changes intra-chain) − Molten
Slide 8: Proof of Concept Studies
Proof of Concept Studies ThermoVax® applied to the following vaccines: • Ricin vaccine (RiVaxTM) – Based on ricin A-chain protein antigen containing 2 point mutations to minimize toxicity – Liquid vaccine extremely labile at room temperature – Uses an aluminum adjuvant • Anthrax vaccine – Based on D
Slide 9: RiVax Animal Immunogenicity
RiVax™ Animal Immunogenicity Liquid adsorbed RiVaxTM loses potency at 40oC while Thermostable RiVaxTM retains efficacy Mouse Survival/ 350 7/7 4/6 2/8 0/8 0/8 0/8 0/8 No mice survived after ricin challenge: immunization with liquid total anti-ricin µg/mL 300 vaccine at 40˚C 250 200 150 100 50 0 4˚C,
Slide 10: ThermoVax Proof of Concept - RiVax
ThermoVax® Proof of Concept - RiVax™ Vaccine effective at inducing antibodies in mice after storage for 1 year at 40oC when stabilized with ThermoVax® % Im m u n o g e n ic ity 0 0 0 0 0 0 7 8 7 6 3 9 1 2 3 10
Slide 11: Thermostable RiVax Provides 100% Protection
Thermostable RiVaxTM Provides 100% Protection Vaccination protects against lethal ricin challenge in NHPs Neutralizing Antibodies Elicited Vaccinated Animals are Protected after 2 Vaccinations from a Lethal Aerosol Challenge R e c ip ro c a l S e ru m D ilu tio n P e rc e n t s u rv iv a l +15 +30 +
Slide 12: Thermostable Anthrax Vaccine - Immunogenicity
Thermostable Anthrax Vaccine - Immunogenicity Lyophilization prevents loss of neutralizing antibodies w ith N e u t r a liz in g A n t ib o d ie s Demonstrated compatibility with secondary adjuvant (GLA) Introduction of GLA N u m b e r o f A n im a ls increases responses Lyophilization Increases sta
Slide 13: Application to a Commercial Indication
Application to a Commercial Indication Conversion to a subunit vaccine maintains immunogenicity, increases thermostability (no cold chain required) and simplifies manufacturing Capsomere+ Cervarix® Alum + GLA Log Reciprocal Anti-HPV16 Antibody Titer Log Reciprocal Anti-HPV16 Antibody Titer 6 6 5 5 4
Slide 14: Stabilizes Ebola GP Protein
Stabilizes Ebola GP Protein Increases the Physical Stability of the Ebola GP Protein Antigen Liquid Formulation: Lyophilized Formulation: Aggregation over Time Unchanged over Time Protein Structure Studies • Ebola GP protein has a pronounced tendency to aggregate. Monomeric and high and low molecula
Slide 15: Seeking Collaboration
Seeking Collaboration Soligenix is actively seeking partnership opportunities for its ThermoVax® Platform • Research Collaboration – Feasibility Study with an option to License – Utilizing innovator’s antigen/vaccine, Soligenix will formulate and validate thermostable properties • ThermoVax® availab
Slide 16: ThermoVax References
ThermoVax® References • Recent Posters – Chisholm, C.F., Kang, T.K., Lehrer, A., Donini, O, Randolph, T.W. Thermostable Lyophilized Ebola Vaccine Formulations. Poster presentation at the 2016 Workshop on Protein Aggregation and Immunogenicity. August 2-4, 2016. http://www.soligenix.com/wp-content/up
Slide 17: Thank You
THANK YOU For additional information on partnering with Soligenix, please contact us at your convenience: Christopher J Schaber, PhD President & CEO Soligenix, Inc. Ph: 609 538 8200