Indaptus Therapeutics, Inc. · NASDAQ:INDP
Indaptus Therapeutics — Investor Presentation (April 2024)
28 slides from Indaptus Therapeutics's investor presentation, April 2024
Slide 1: Corporate Presentation
April 2024 CORPORATE PRESENTATION NASDAQ: INDP
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation contains forward‐looking statements with the meaning of the Private Securities Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things: our product candidates development, i
Slide 3: Investor Highlights and Key Metrics
INVESTOR HIGHLIGHTS AND KEY METRICS Developing novel and patented systemically-administered anti-cancer and anti-viral immunotherapy • First cohort of phase 1 clinical trial of INDP020 STOCK SYMBOL : INDP (NASDAQ) (Decoy20) for treatment of solid tumors completed in August 2023 with second cohort St
Slide 4: Current cancer immunotherapies only address a limited part of the immune system
CURRENT CANCER IMMUNOTHERAPIES ONLY ADDRESS A LIMITED PART OF THE IMMUNE SYSTEM AND THEREFORE HAVE LOW CURE RATES IN ADVANCED CANCERS Targeted Antibodies IL-2 and IFN-α T-vec/GM-CSF Checkpoint CAR-T Gamma- TAA Delta Natural Killer T-Cell T-Cell Natural Killer Cell Dendritic Cell INNATE ADAPTIVE Neut
Slide 5: No one has figured out how to safely activate most pathways
NO ONE HAS FIGURED OUT HOW TO SAFELY ACTIVATE MOST PATHWAYS… BUT HISTORY HAS PROVIDED A CLUE DECOY Targeted Antibodies IL-2 and IFN-α T-vec/GM-CSF Checkpoint CAR-T Gamma- TAA Delta Natural Killer T-Cell T-Cell Natural Killer Cell Dendritic Cell INNATE ADAPTIVE Neutrophil CD8+ T-Cell TAA Macrophage C
Slide 6: Re-imagining Immunotherapy: A Broad, Brief Immune Activation Approach
RE-IMAGINING IMMUNOTHERAPY: A BROAD, BRIEF IMMUNE ACTIVATION APPROACH Current Immunotherapy Approaches Decoy Platform Approach • Most approaches target one or only a few • Decoy therapeutics contain a package of immune components immune activators that activate both innate and adaptive immune pathwa
Slide 7: Why Bacteria?
WHY BACTERIA ? • Gram negative bacteria contain many innate (immediate) and adaptive (learned) immune activators • Bacteria provide both a short duration of exposure and the ability to activate innate and adaptive pathways • Most of the steps of innate (immediate) and adaptive (learned) immune activ
Slide 8: Challenge – IV Administered Gram-Negative Bacteria Are Toxic Due to LPS
CHALLENGE – IV ADMINISTERED GRAM-NEGATIVE BACTERIA ARE TOXIC DUE TO HIGH AMOUNTS OF LIPOPOLYSACCHARIDE Lipopolysaccharide (LPS-endotoxin) TLR4 agonist is: 1. One of the most potent and broadly acting immune system activators 2. Constitutes about 75% of Gram-negative bacterial cell membrane 3. Potent
Slide 9: How Decoy Therapeutics Are Produced
HOW DECOY THERAPEUTICS ARE PRODUCED Naturally occurring bacteria are challenging for use as a therapy (particularly toxicity) First, we start with a laboratory-strain E.coli that requires a molecule not found in humans so it cannot replicate nor grow in the human body Next, lipopolysaccharide (LPS)
Slide 10: Summary of Decoy20 Clinical Observations
SUMMARY OF DECOY20 CLINICAL OBSERVATIONS Early Phase 1 data: PULSE-PRIME HYPOTHESIS CONFIRMED • Decoy20 clears within 2 hours • Unprecedented transient induction of more than 50 cytokines/chemokines involved in anti-tumor immune response • Tolerability consistent with the mechanism of action • Mostl
Slide 11: Summary of Decoy20 Clinical Observations in Phase 1
SUMMARY OF DECOY20 CLINICAL OBSERVATIONS IN PHASE 1 Early Phase 1 data: PULSE-PRIME HYPOTHESIS CONFIRMED • Decoy20 clears within 2 hours • Unprecedented transient induction of more than 50 cytokines/chemokines involved in anti-tumor immune response • Tolerability consistent with the mechanism of act
Slide 12: Summary of Decoy20 Clinical Observations in Phase 1
SUMMARY OF DECOY20 CLINICAL OBSERVATIONS IN PHASE 1 Early Phase 1 data: PULSE-PRIME HYPOTHESIS CONFIRMED • Decoy20 clears within 2 hours • Unprecedented transient induction of more than 50 cytokines/chemokines involved in anti-tumor immune response • Tolerability consistent with the mechanism of act
Slide 13: Plasma Cytokine/Chemokine Data from 1st Decoy20 Clinical Cohort
PLASMA CYTOKINE/CHEMOKINE DATA FROM 1ST DECOY20 CLINICAL COHORT Cytokines and Chemokines Responsive Immune Cell Type: Inducing Migration, Activation, Maturation All Participate in and/or Proliferation of Immune Cells Anti-Tumor Immune Responses GM-CSF, IL-1β, IL-4, IL-12, IL-15, IFN-αβ, IFN-γ Dendri
Slide 14: Comparison to Approved Checkpoint and CAR-T Therapies
COMPARISON TO APPROVED CHECKPOINT AND CAR-T THERAPIES Indaptus' Decoy Technology - Comparison to Approved Checkpoint and CAR-T Immunotherapies Approved Therapies Immune Polarization/Activation & Key Features Anti-CTLA-4 Anti-PD-(L)1 CAR-T Decoy M1 Macrophages ? ü NK Cells ü NKT Cells ü Dendritic Cel
Slide 15: Clinical Trial Design
Clinical Trial Design Single-Dose Safety/Tolerability Combination Safety and Efficacy Cohort 1 Any solid tumor Combinations: ( 7x107 KB) • NSAID Tumor types: To be determined dose Cohort 2 • CTX reduction (3x107 KB) • Anti PD-1 Multi-Dose Safety/Tolerability If tolerable Tumor types: If tolerable Fi
Slide 16: Indaptus Clinical Development Plan
INDAPTUS CLINICAL DEVELOPMENT PLAN PHASE 1 SOLID TUMOR IND CLEARED BY US FDA 2023 2023 2024 2024 2025 2025 2026 Q1/2 Q3/4 Q1/2 Q3/4 Q1/2 Q3/4 Q1/2 Dose Escalation Single Ascending Doses Expansion Multiple Doses Select Tumors Ph1b Combination Checkpoint / NSAID/ Low Dose Chemo Key Milestones ü First
Slide 17: LPS Reduction Does Not Impair Anti-Tumor Cytokine/Chemokine Induction
LPS REDUCTION DOES NOT IMPAIR ANTI-TUMOR CYTOKINE/CHEMOKINE INDUCTION Despite being less toxic than untreated bacteria, Decoy therapeutics induce similar amounts of most anti-tumor cytokines and chemokines Secretion by Decoy Decoy Human PBMCs* Untreated Therapeutic Therapeutic In Vitro Bacteria (Dec
Slide 18: Decoy Therapeutics Are More Broadly Active Than Mono-Specific TLR Agonists
DECOY THERAPEUTICS ARE MORE BROADLY ACTIVE THAN MONO-SPECIFIC TLR AGONISTS Secretion by Human PBMCs CpG Poly(I:C) R848 LPS Decoy10* In Vitro (TLR9) (TLR3) (TLR7/8) (TLR4) (TLR2,4,8,9) pg/mL Anti-Tumor Cytokine (triplicate full titration peak average from two exp) GM-CSF 0 2 136 27 1,246 IFNγ 7 248 6
Slide 19: Single Agent Activity - Metastatic Mouse Pancreatic Carcinoma
SINGLE AGENT ACTIVITY - METASTATIC MOUSE PANCREATIC CARCINOMA No Decoy Decoy Gem 100 Treatment 5x10^7 2x10^8 No Treatment Median 35 Days 41 Days 75 Days 27 Days Survival P<0.01 P<0.01 P<0.01 80 Gemcitabine 50 mg/kg Log-Rank Test Survival Decoy20 vs. No Treatment Decoy i.v. 2x perBoth weekDoses x 3 P
Slide 20: Single Agent Activity – Orthotopic CT26 Mouse Colorectal Carcinoma
SINGLE AGENT ACTIVITY – ORTHOTOPIC CT26 MOUSE COLORECTAL CARCINOMA Tumor fragments were sewn onto the cecal wall on Day 0 (7 mice/group) NASDAQ: INDP 20
Slide 21: Decoy + NSAID Safely Eradicates Subcutaneous Mouse HCC
DECOY + NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) SAFELY ERADICATES SUBCUTANEOUS MOUSE HEPATOCELLULAR CARCINOMAS (HCC) Treat 6 mice per group with Decoy 2x per week i.v. for 7 weeks / Start treatment at 103 mm3 NSAIDS reduce myeloid-derived immune suppressive cells Decoy + NSAID NSAID alone 4,000
Slide 22: Combination with Anti-PD-1 Checkpoint Therapy Produces Up to 100% Complete Responses
COMBINATION WITH ANTI-PD-1 CHECKPOINT THERAPY PRODUCES UP TO 100% COMPLETE RESPONSES WITH HCC 3,500 3 ± SEM) All animals also received NSAID Control Control (6 mice per group) Indomethacin 3 ± SEM) 3,000 Decoy 2x10^8 Indomethacin i.v. 1xDecoy10 + 2x10^8 per week x6 x6 1x/week Anti-PD-1 1/6 CR (mm An
Slide 23: Immunological Memory Is Seen When Cured Mice Are Re-Challenged
IMMUNOLOGICAL MEMORY IS SEEN WHEN “CURED” MICE ARE RE-CHALLENGED Mice cured by DECOY + NSAID + Checkpoint Inhibitor and Re-Challenged on Day 91 on the opposite flank with fresh HCC tumor cells reject the tumors 800 700 600 Tumor Volume (mm3) 500 400 Fresh tumor 300 re-challenge 200 100 0 7 14 21 28
Slide 24: Target Indications Include 6 of the World's 12 Deadliest Cancers
TARGET INDICATIONS INCLUDE 6 OF THE WORLD’S 12 DEADLIEST CANCERS 12 Deadliest Cancers World-Wide High Unmet Medical Need (Potential Initial Tumor Types) % of Yearly % of Yearly Deaths Cases 1 Lung 18.4 11.6 3% - 17% 2 Colorectal 9.0 10.0 Percent five-year survival 3 Stomach 8.2 5.7 for patients with
Slide 25: Potential Utility as Anti-Viral Therapy: HBV, HIV and Others
POTENTIAL UTILITY AS ANTI-VIRAL THERAPY HEPATITIS B VIRUS (HBV), HIV AND OTHERS • HBV is a chronic liver infection affecting 257 million people world-wide ⎼ Only 2% treated with current therapies / Major cause of cirrhosis and HCC / 887,000 deaths per year • Cytokines have strong anti-viral activity
Slide 26: Indaptus Immunotherapy Pipeline
INDAPTUS IMMUNOTHERAPY PIPELINE NASDAQ: INDP 26
Slide 27: Experienced Management Team
EXPERIENCED MANAGEMENT TEAM Leadership experience in new modalities and early development Jeffrey Meckler - Chief Executive Officer Jeffrey Meckler currently serves as our Chief Executive Officer, bringing more than 30 years of financial and healthcare leadership experience to the company. Most rece
Slide 28: Investor & Media Relations
Investor & Media Relations: CORE IR Louie Toma [email protected]
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