Imunon, Inc. · NASDAQ:IMNN
Imunon — World Vaccine & Immunotherapy Congress 2022
27 slides from Imunon's conference presentation, Dec 1, 2022
Slide 1: PLACCINE Nucleic Acid Vaccine Platform
PLACCINE Nucleic Acid Vaccine Platform Preclinical Proof of Concept Using a SARS-CoV-2 pDNA Construct World Vaccine & Immunotherapy Congress Nov 28 – Dec 1, 2022 © 2022 IMUNON Inc. PAGE 1
Slide 2: PLACCINE – A New Class of Nucleic Acid Vaccines
PLACCINE – A New Class of Nucleic Acid Vaccines Executive Summary • Plasmid DNA (pDNA)-based modality targeting multiple antigens PLACCINE pDNA PLACCINE Delivery Systems from a single vector Constructs • Non-viral • Non-device • Independent of virus or device for delivery • Preclinical POC achieved
Slide 3: Current Vaccines Despite some Success have Significant Limitations
Current Vaccines Despite some Success have Significant Limitations PLACCINE Technology is Designed to Address these Limitations mRNA • Short-lived responses requiring frequent boosts • Poor stability at working temperatures Protein • Challenges in manufacturing & subunit mixtures • Poor cytolytic CD
Slide 4: pDNA Yields More Durable Antigen Expression than the Protein or Modified mRNA
pDNA Yields More Durable Antigen Expression than the Protein or Modified mRNA PBS pVac-Luc Chien KR Cold Spring Harb Perspect Med 2015;5:a014035 PLACCINE Formulation © 2022 IMUNON Inc. PAGE 4
Slide 5: 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 PLACCINE Vacc
Slide 6: A PLACCINE Formulation for Intramuscular Delivery without a Device/Virus
A PLACCINE Formulation for Intramuscular Delivery without a Device/Virus Early Antigen Expression (24 hr) and Bio-distribution in Mouse Muscle Tissue (day 7) 10 to 15-Fold Improvement over naked DNA intensity Luciferase (RLU/mg protein) 21-025 Naked DNA Lot#1 Lot#2 PLACCINE Formulation © 2022 IMUNON
Slide 7: Mouse Studies
Mouse Studies © 2022 IMUNON Inc. PAGE 7
Slide 8: Standard Vaccine Regimen for In Vivo Studies
Standard Vaccine Regimen for In Vivo Studies • Prime Day 0 • Bost Day 14 • Bleed for IgG Day 14, 35 • Spleen (IFN-g) Day 35 BALB/c mice © 2022 IMUNON Inc. PAGE 8
Slide 9: Higher Immunogenicity of PLACCINE Formulation than Naked pDNA
Higher Immunogenicity of PLACCINE Formulation than Naked pDNA • DNA vector pVac-9 • Spike antigen D614G • Formulation PLACCINE • 125 mg DNA IgG Titer IFN-g Day 14 Day 35 Day 35 PBS PLACCINE Naked DNA PBS PLACCINE Naked DNA © 2022 IMUNON Inc. PAGE 9
Slide 10: 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, pVac-16 • Spike antigen D614G, Delta • Formulation: PLACCINE • 125 mg DNA • IgG & nAB titer (day-35) • Balb/c mice IgG Titer Neu
Slide 11: 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 • Spike antigen D614G, Delta • Formulation: PLACCINE • 125 mg DNA • IgG & nAB titer (day 35) Neutralizing Antibody Titer IgG Titer (pseudovirus competition assay)
Slide 12: Single pDNA Multivariant Vaccine as Effective as Vaccine Mixture
Single pDNA Multivariant Vaccine as Effective as Vaccine Mixture Executive Summary • Vectors pVac-15 (D614G) pVac-16 (Delta) pVac-17 (D614G+Delta) • Formulation: PLACCINE • 125 mg DNA • nAb titer (day 35) Neutralizing Antibody Titer (pseudovirus D614Gcompetition (Euro) L assay) Variant Antigen D614G
Slide 13: PLACCINE Vaccines are Protective Against Viral Challenge - hACE2:K18 Model
PLACCINE Vaccines are Protective Against Viral Challenge - hACE2:K18 Model • pVac-15 - D614G • pVac-16 - Delta • pVac-17 - D614G - Delta • Formulation: PLACCINE • Dose - 125 ug DNA TCID50 Tissue Culture Infection Dose (7 days post challenge) D614G Challenge (2.5 X 106) Delta Challenge (7 X 104) TCID
Slide 14: NHP Studies
NHP Studies © 2022 IMUNON Inc. PAGE 14
Slide 15: NHP Study Protocol
NHP Study Protocol Challenge (Wuhan wild type) Prime Boost-1 Boost-2 Harvest 4weeks 8 weeks* 3 week 2 week 0 14 28 42 56 84 108 122 IgG, nAb * Due to the time lag for sample analysis and data review the second boost was given 8 weeks after the first boost @ Post Challenge Samples Collection Scheme D
Slide 16: Binding IgG Titers after Complete Vaccination (Prime and Two Boosters)
Binding IgG Titers after Complete Vaccination (Prime and Two Boosters) 100% of PLACCINE Subjects Showed IgG Response • Single antigen vector pVac-15 (D614G) in PLACCINE • Comparator mRNA Commercial mRNA Vaccine (LNP) • Dosing schedule Day 1, 28, 84 • IgG titer Day 105 (21 days after 3rd dose) Day 0
Slide 17: Neutralizing Antibody Titers after Vaccination
Neutralizing Antibody Titers after Vaccination 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 dose) Day 56 Day 105 mRNA
Slide 18: Additional Immune Analysis to Better Define the PLACCINE Technology
Additional Immune Analysis to Better Define the PLACCINE Technology In Progress Additional Humoral and B Cell Analysis • Functional antibody analysis • Antibody-dependent cellular toxicity (ADCC) • Antibody-dependent cellular phagocytosis (ADCP) • Avidity testing • B cell mapping • Pseudovirus neutr
Slide 19: Viral Clearance by PLACCINE is Comparable to mRNA Vaccine
Viral Clearance by PLACCINE is Comparable to mRNA Vaccine Genomic RNA- Bronchoalveolar Lavage Challenge dose: 1x106 TCID50 2 Days after Challenge 4 Days after Challenge 7 6 5 Log copies/ml Log copies/ml 4 3 2 1 Placebo mRNA 100 mg pVac-15 1.0 mg pVac-15 5.0 mg © 2022 IMUNON Inc. PAGE 19
Slide 20: Viral Clearance by PLACCINE is Comparable to mRNA Vaccine
Viral Clearance by PLACCINE is Comparable to mRNA Vaccine Sub-genomic RNA- Bronchoalveolar Lavage 2 Days after Challenge 4 Days after Challenge Log copies/ml Log copies/ml Placebo mRNA 100 mg pVac-15 1.0 mg pVac-15 5.0 mg © 2022 IMUNON Inc. PAGE 20
Slide 21: Viral Clearance by PLACCINE is Comparable to mRNA Vaccine
Viral Clearance by PLACCINE is Comparable to mRNA Vaccine Genomic RNA- Nasal Swab 2 Days after Challenge 4 Days after Challenge 8 7 6 Log copies/ml Log copies/ml 5 4 3 2 1 Placebo mRNA 100 mg pVac-15 1.0 mg pVac-15 5.0 mg © 2022 IMUNON Inc. PAGE 21
Slide 22: Viral Clearance by PLACCINE is Comparable to mRNA Vaccine
Viral Clearance by PLACCINE is Comparable to mRNA Vaccine Sub-genomic RNA- Nasal Swab 2 Days after Challenge 4 Days after Challenge 6 6 5 5 Log copies/ml 4 4 3 3 2 2 1 1 Placebo mRNA 100 mg pVac-15 1.0 mg pVac-15 5.0 mg © 2022 IMUNON Inc. PAGE 22
Slide 23: Viral Clearance from BAL & NS after Challenge- TCID50 Assay
Viral Clearance from BAL & NS after Challenge- TCID50 Assay Clearance Efficiency Comparable to mRNA Vaccine Challenge dose: 1 x 106 TCID50 Group Vaccine Viral Load LOG TCID50/ml LOG TCID50/ml Bronchoalveolar lavage Nasal swab Day-2 Day-4 Day -7 Day-2 Day-4 Day -7 1 Placebo 6.20 4.37 3.70 5.37 4.70 4
Slide 24: Durability of Neutralizing Antibody Response
Durability of Neutralizing Antibody Response Eight-month Durability in Mice • Vectors: pVac-15 (D614G), pVac-16 (Delta), pVac-17 (D614G+Delta) • Formulation: PLACCINE • 125 ug DNA • Pseudo-typed lentivirus assay D614G ✱✱ Delta © 2022 IMUNON Inc. PAGE 24
Slide 25: PLACCINE is Stable at 4⁰C for Six Months or Longer
PLACCINE is Stable at 4⁰C for Six Months or Longer Vector: pVac -17 (D614G-Delta) Formulation: PLACCINE PLACCINE 4⁰C Storage Months 1 3 6 9 12 Immunogenicity Studies in Mice Fresh 4o C © 2022 IMUNON Inc. PAGE 25
Slide 26: PLACCINE – Summary
PLACCINE – Summary • PLACCINE- a new class of vaccines leveraging Inherent pDNA advantages including: • Multivalency, durability, cytotoxic responses, storage stability and rapid production and scale up • Independent of virus or device for delivery for better safety compliance. • Preclinical POC in
Slide 27: Corporate Information
Corporate Information Headquarters Research Facility Princeton, NJ Huntsville, AL IMUNON 997 Lenox Drive, Suite 100 P 609-896-9100 www.imunon.com Lawrenceville, NJ 08648 F 609-896-2200 Nasdaq: IMNN © 2022 IMUNON Inc. PAGE 27