Imunon, Inc. · NASDAQ:IMNN
Imunon — Vaccine Technology Summit 2023
23 slides from Imunon's conference presentation, Mar 20, 2023
Slide 1: PLACCINE Nucleic Acid Vaccine Platform
PLACCINE Nucleic Acid Vaccine Platform PLACCINE: A Novel DNA Vaccine P l a t fo r m w i th Po te n t i a l t o C r e a t e Next Generation Vaccines Khursheed Anwer Vaccine Technology Summit March 20-21, 2023 Cambridge, Massachusetts, USA © 2022 IMUNON Inc. PAGE 1
Slide 2: PLACCINE – A Novel DNA Vaccine Platform
PLACCINE – A Novel DNA Vaccine Platform Key Attributes Multiple antigens in a single plasmid DNA Multi-valent Breadth of Immune Responses Durable Durable antigen expression/nAB & T-cell responses Novel Formulation Independent of virus, device, or LNPs Flexible Design “Plug & Play”, rapid Manufacturi
Slide 3: PLACCINE Technology Platform
PLACCINE Technology Platform Multicistronic or Single Antigen Vector Formulations Independent of Virus or Device PLACCINE pDNA PLACCINE Delivery Systems Constructs -Synthetic Delivery Systems • Non-viral • Non-device Expression Vector Nanoparticles/Complexes Antigen DNA 1 Antigen DNA 2 Optional Immu
Slide 4: Current Vaccines Despite Some Success Have Significant Limitations
Current Vaccines Despite Some Success Have Significant Limitations PLACCINE Technology to Potentially Address These Limitations mRNA • Short-lived responses requiring frequent boosts • Poor stability at working temperatures Protein • Manufacturing challenges • Poor cytolytic T-cell responses pDNA We
Slide 5: A Synthetic PLACCINE Delivery System for Intramuscular Delivery
A Synthetic PLACCINE Delivery System for Intramuscular Delivery DNA Protection, Enhanced Antigen Expression and Muscle Distribution in Mice PLACCINE Delivery System PLACCINE Formulation Yields 10-15-fold Higher • An amphiphilic polymer that promotes DNA Gene Expression than Naked DNA 24 hours 7 days
Slide 6: pDNA Yields More Durable Antigen Expression than Protein or Modified mRNA
pDNA Yields More Durable Antigen Expression than the Protein or Modified mRNA PBS pVac-Luc Average Radiance [p/s/cm2/sr] PLACCINE Formulation Chien KR Cold Spring Harb Perspect Med 2015;5:a014035 © 2022 IMUNON Inc. PAGE 6
Slide 7: Formulation Yields Higher Immunogenicity than Naked pDNA
PLACCINE Formulation Yields Higher Immunogenicity than Naked pDNA • DNA vector pVac-9 (Spike-D614G) • Formulation PLACCINE • 125 mg DNA IgG Titer T-cell Response (IFN-g) Day 14 Day 35 Day 35 Endpoint Titer PBS PLACCINE Naked DNA PBS PLACCINE Naked DNA Balb/c mice © 2022 IMUNON Inc. PAGE 7
Slide 8: Immunogenicity of Single Antigen PLACCINE Vectors - IgG and nAB titers
Immunogenicity of Single Antigen PLACCINE Vectors - IgG and nAB titers Viral Mutation Warrants Vaccine Effectiveness Against Multiple Variants • Optimized vectors pVac-15 (D614G), pVac-16 (Delta) • Formulation: PLACCINE including an adjuvant • 125 mg DNA IgG Titer- Day 35 Neutralizing Antibody Titer
Slide 9: Immunogenicity of a Multi-variant PLACCINE Vaccine
Immunogenicity of a Multi-variant PLACCINE Vaccine A Bivalent Vaccine is Well Suited for a Mutating Virus • Multicistronic vector pVac-17 (D614G-Delta) • Formulation: PLACCINE including an adjuvant • 125 mg DNA IgG Titer (Day 35) nAb (Day 35) IgG Titer (day 35 after prime) D614G Variant Delta Varian
Slide 10: Vaccines Provide Protection Against Viral Challenge
PLACCINE Vaccines Provide Protection Against Viral Challenge hACE2:K18 Mouse Model • pVac-15 (D614G), pVac-16 (Delta), pVac-17 (D614G-Delta) • Formulation: PLACCINE including an adjuvant • Dose - 125 mg DNA, Day-1, 21 7 days post challenge D614G Challenge- 2.5 X 106 Delta Challenge - 7 X 104 TCID50/
Slide 11: T-cell Responses Associated with Increases in CD8+ Cells
PLACCINE-induced T-cell Responses are Associated with Increases in CD8+ Cells Population in Spleenocytes • Vectors: pVac-16 (Delta), pVac-17 (D614G+Delta) • Formulation: PLACCINE • 125 mg DNA • Pseudo-typed lentivirus assay CD8 T-cells T-cell Response TNF-a (IFN-g) IFN-g CD8+ T-cells (%) SFC/106 Cel
Slide 12: Single Dose PLACCINE Vs mRNA Vaccine
Single Dose PLACCINE Vs mRNA Vaccine Better Immune Quality with PLACCINE IgG Response 500 T-cell Response (IFN-g) 400 Endpoint Titer 300 200 100 0 PBS mRNA pVac50 Additional Studies on Immune Quality Comparison are in Progress © 2022 IMUNON Inc. PAGE 12
Slide 13: Vaccines Provide Durable Neutralizing Antibody Response
PLACCINE Vaccines Provide Durable Neutralizing Antibody Response >12-months Durability in Mice • Vectors: pVac-16 (Delta), pVac-17 (D614G+Delta) • Formulation: PLACCINE including an adjuvant • 125 mg DNA • Pseudo-typed lentivirus assay for nAb nAb (Delta) Responses T-cell Response (IFN-g) ✱✱ PBS pVa
Slide 14: PLACCINE Induces Robust Immune Response after a Single Injection
PLACCINE Induces Robust Immune Response after a Single Injection Wistar Institute Collaboration Group Antigen pVax N/A pVAC50 (125ug) Delta spike-Imunon pVAC50 (50ug) Delta spike-Imunon pVAC50 (25ug) Delta spike-Imunon 0 125 50 25 0 125 50 25 0 125 50 25 Dose mg Dose mg Dose mg © 2022 IMUNON Inc. PA
Slide 15: Vaccines are Immunogenic in Cynomolgus Monkeys
PLACCINE Vaccines are Immunogenic in Cynomolgus Monkeys PLACCINE Subjects Showed IgG and Neutralizing Antibody Response • Single antigen vector: pVac-15 (D614G) or pVac-16 (DELTA) • Comparator mRNA: Commercial mRNA Vaccine (LNP) • Formulation: PLACCINE including an adjuvant • Dosing schedule: Day 1,
Slide 16: Neutralizing Antibody Titers in PLACCINE-Vaccinated Cynomolgus Monkeys
Neutralizing Antibody Titers in PLACCINE-Vaccinated Cynomolgus Monkeys 90% of PLACCINE Subjects Showed Neutralizing Ab Response • Single antigen vector pVac-15 (D614G) in PLACCINE • Comparator mRNA Commercial mRNA Vaccine (LNP) • Dosing schedule Day 1, 28, 84 • nAB titer Day 105 (21 days after 3rd d
Slide 17: Vaccines Provide Complete Protection Against Viral Challenge
PLACCINE Vaccines Provide Complete Protection Against Viral Challenge Comparable Efficacy to a Commercial mRNA Vaccine- Challenge dose: 1 x 106 TCID50 qRT-PCR Bronchoalveolar Lavage 2 Days after Challenge 4 Days after Challenge 7 Days after Challenge Log Copies/ml Nasal Swab Placebo Log Copies/ml pV
Slide 18: Vaccines Provide Complete Protection Against Viral Challenge
PLACCINE Vaccines Provide Complete Protection Against Viral Challenge Comparable Efficacy to a Commercial mRNA Vaccine- Challenge dose: 1 x 106 TCID50 TCID50 Assay Vaccine Bronchoalveolar lavage Nasal swab Day-2 Day-4 Day -7 Day-2 Day-4 Day -7 Placebo 6.20 4.37 3.70 5.37 4.70 4.20 3.20 4.37 <2.7 6.3
Slide 19: PLACCINE is Stable at 4°C for at Least Months
PLACCINE is Stable at 4⁰C for at Least 9 Months Immunogenicity Studies in Mice • Vector: pVac-17 (D614G-Delta) • Formulation: PLACCINE IgG Response PLACCINE Endpoint Titer 4⁰C Storage 1 3 6 9 12 1 month Months 3 month 6 month 9 month Fresh 4o C © 2022 IMUNON Inc. PAGE 19
Slide 20: A Phase 1/2 Clinical Trial of a PLACCINE COVID-19 Booster Vaccine
A Phase 1 / 2 Clinical Trial of a PLACCINE COVID-19 Booster Vaccine Omicron XBB1.5 + A Highly Conserved Antigen Phase 1 Phase 2 Expansion • Total subjects: 60 (potentially 3-6 months into Phase 1, • Age: 18-55 years initially; expand into elderly based on the data) population after 3-6 month of data
Slide 21: Flexible Design Allows for a Rapid Response to Changing Pathogen
Flexible Design Allows for a Rapid Response to Changing Pathogen “Plug & Play” Design and Leveraging Existing Preclinical Toxicology “Plug & Play” Design Antigen DNA Clinical Vector with Standard Backbone © 2022 IMUNON Inc. PAGE 21
Slide 22: Summary
Summary PLACCINE - A Potential Alternative to Current Vaccine Approaches Robust nAb & T-cell responses Durable & broad-spectrum Immunity Longer shelf-life at workable temperature Flexible design for rapid production © 2022 IMUNON Inc. PAGE 22
Slide 23: Thank You
T h a n k Yo u © 2022 IMUNON Inc. PAGE 23