Indaptus Therapeutics, Inc. · NASDAQ:INDP
Indaptus Therapeutics — Investor Presentation (January 2024)
25 slides from Indaptus Therapeutics's investor presentation, January 2024
Slide 1: Corporate Presentation January 2024
JANUARY 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: 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 5: 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 6: 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 7: How Decoy Therapeutics Are Produced
HOW DECOY THERAPEUTICS ARE PRODUCED • Naturally occurring bacteria are challenging for use as a therapy (particularly toxicity) • First, an engineered bacterium is developed that requires a molecule not found in humans so it cannot replicate nor grow in the human body • Next, lipopolysaccharides (LP
Slide 8: 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 9: Decoy Therapeutics Produce a Multi-Targeted Package of Immune System Activating Signals
DECOY THERAPUETICS PRODUCE A MULTI-TARGETED PACKAGE OF IMMUNE SYSTEM ACTIVATING SIGNALS DECOY PRODUCT: A MULTI-TARGETED PACKAGE OF IMMUNE RESULTS AND PREDICTED ADVANTAGE ACTIVATORS • Start with a single, pure strain of • Decoy therapeutics contain multiple immune non-pathogenic, Gram-negative bacter
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: Comparison to Approved Checkpoint and CAR-T Therapies
COMPARISON TO APPROVED CHECKPOINT AND CAR-T THERAPIES NASDAQ: INDP 13
Slide 14: 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 15: 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 First
Slide 16: LPS Reduction Does Not Impair Anti-Tumor Cytokine/Chemokine Induction
LPS REDUCTION DOES NOT IMPAIR ANTI-TUMOR CYTOKINE/CHEMOKINE INDUCTION Secretion by Decoy Decoy Human PBMCs* Untreated Therapeutic Therapeutic In Vitro Bacteria (Decoy10) (Decoy20) Despite being less toxic than untreated Anti-Tumor pg/mL (mean of triplicate determinations ± %CV Cytokine bacteria, Dec
Slide 17: 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 Decoy20 vs. No Treatment Decoy i.v. 2x perBoth weekDoses x 3 P ≤ 0.0008
Slide 18: 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 19: 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 All animals also received NSAID Mean Tumor Volume (mm3 ± SEM) Control Control (6 mice per group) Indomethacin 3,000 Decoy 2x10^8 Indomethacin i.v. 1xDecoy10 + 2x10^8 per week x6 x6 1x/week Anti-PD-1 1
Slide 20: 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 Fresh tumor re-challenge *All 1st challenge tumor sites remained tumor-free 12 mice with
Slide 21: 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 (Initial Tumor Types) High Unmet Medical Need % of Yearly % of Yearly Deaths Cases 3% - 17% 1 Lung 18.4 11.6 2 Colorectal 9.0 10.0 3 Stomach 8.2 5.7 Percent five-year survival 4 Liver 8.2 4.7 for patient
Slide 22: 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 23: Indaptus Immunotherapy Pipeline
INDAPTUS IMMUNOTHERAPY PIPELINE NASDAQ: INDP 23
Slide 24: 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 25: Investor & Media Relations
Investor & Media Relations: CORE IR Louie Toma louie@coreir.com
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