Elicio Therapeutics, Inc. · NASDAQ:ELTX
Elicio Therapeutics — Investor Presentation (June 2024)
40 slides from Elicio Therapeutics's investor presentation, June 2024
Slide 1: Targeting the Lymph Nodes to AMPlify Immunotherapy
Targeting the Lymph Nodes to AMPlify Immunotherapy Nasdaq: ELTX June 2024
Slide 2: Disclaimers
Disclaimers No Representation or Warranty We do not make and hereby expressly disclaim any representation or warranty, express or implied, as to the reasonableness of the assumptions made in the Presentation or the accuracy or completeness or the information contained in or incorporated by reference
Slide 3: Disclaimers: Forward-Looking Statements
Disclaimers Forward-Looking Statements The Presentation contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, know
Slide 4: Company Overview
Company Overview Clinical-stage biotech developing novel lymph node-targeted immunotherapies • AMP delivers payloads to lymph nodes eliciting immune responses with increased magnitude, function, and durability Amphiphile (“AMP”) • Designed to harness the lymph nodes’ natural ability to educate, acti
Slide 5: Engaging the Lymph Node
Engaging the Lymph Node A critical component to activating the immune response in the fight against cancer Amphiphile (AMP) Lymph Nodes T Cell Response Technology • The lymph nodes, known as the • Proper education, multiplication, and • Elicio is harnessing the natural power of the “command center”
Slide 6: Lymph Nodes: Eliciting a Robust T Cell Response
Lymph Nodes: Eliciting a Robust T Cell Response Immune biology in the Lymph Nodes directs the development of anti-tumor immunity Lymph Node The Immune “School House” Numerous Immune Cells T Cell Response Response Coordination • Expansion • Phenotype APC : T Cell Interaction • Effector Function • Ant
Slide 7: The Amphiphile (AMP) Technology
The Amphiphile (AMP) Technology Harnessing the untapped potential of the lymph nodes for immunotherapy Targeting Immunity in the Lymph Nodes Tissue Injection Site Blood Vessel • Most immune cells are located in lymph nodes, yet these critical sites are not engaged by conventional immunotherapies Blo
Slide 8: MOA: AMP Locates to Lymph Node Orchestrating Immunity
MOA: AMP Locates to Lymph Node Orchestrating Immunity AMP technology capable of delivering payloads to lymph nodes generating robust immune response Tissue Injection Site Lymph Node AMP Endogenous Albumin Albumin-bound AMP ➢ APC Activation ➢ T Cell Expansion and Activation • Expansion • Persistence
Slide 9: AMP Platform Technology
AMP Platform Technology Cancer Vaccines Versatile | Simple | Clinical stage Immunotherapy / Combinations 2014 Liu Nature 2016 Moynihan Nature Medicine CAR-T Cell Adoptive Therapy 2018 Moynihan Cancer Immunology Research 2019 Ma Science TCR-T Cell Adoptive Therapy Applications 2021 Rakhra Science Imm
Slide 10: AMP Technology has the potential to address several mutations
AMP Technology has the potential to address several mutations Preclinical programs funded by Gastro-Intestinal (GI) Research Foundation In preclinical models, ELI-007 and ELI-008 have shown strong induction of tumor antigen-specific T cell responses Preclinical Data presented at AACR 2024. Posters c
Slide 11: ELI-002 Composition
ELI-002 Composition Lymph node targeted therapeutic vaccine candidate comprised of AMP-peptides and AMP-CpG ELI-002 G12X G13X Peptide 2P D R Composition 7P D R V C S A D AMP-mKRAS X X Peptide Antigen ELI-002 • 2 or 7 AMP-peptides • CD8 and CD4 epitopes Albumin Binding Lipid for PEG Linker mKRAS Pept
Slide 12: The mKRAS Opportunity
The mKRAS Opportunity ELI-002 targets the 7 most common KRAS mutations driving 25% of solid tumors Pancreatic Ductal Colorectal Non-Small Cell Other mKRAS Adenocarcinoma Cancer Lung Cancer Opportunities ELI-002 addressable ELI-002 addressable ELI-002 addressable 17% Incidence: ~128k Incidence: ~192k
Slide 13: ELI-002's Differentiated Approach to mKRAS
ELI-002’s Differentiated Approach to mKRAS Early mKRAS-targeting efforts in the clinic, while promising, leave significant white space Small Molecules Directly Small Molecules Indirectly Vaccines Targeting Lymph Node Targeted Inhibiting Mutant KRAS Inhibiting Mutant KRAS Mutant KRAS Vaccine vs Mutan
Slide 14: ELI-002 2P: 2-Peptide (2P) Formulation
ELI-002 2P: 2-Peptide (2P) Formulation Phase 1A: Adjuvant Dose Ranging 0.1mg to 10mg doses First-in-human Study: mKRAS G12D or G12R-expressing, Adjuvant treatment of MRD+ PDAC and CRC
Slide 15: AMPLIFY-201 Study Overview
ELI-002 2P Phase 1A AMPLIFY-201 Study Overview * Published in Nature Medicine Phase 1 adjuvant dose-ranging study to assess safety and efficacy of ELI-002 2P in patients who completed standard therapy and have molecular disease ELI-002 MONOTHERAPY: NCT04853017 Monotherapy (no chemo, CPI combo) Compl
Slide 16: AMPLIFY-201: Tumor Biomarker Response
AMPLIFY-201: Tumor Biomarker Response ELI-002 2P Phase 1A Robust responses observed across tumor types and KRAS mutations with ELI-002 monotherapy Tumor Biomarker Responses AMPLIFY-201 Waterfall Plot: Biomarker Reduction/Clearance Best Overall Biomarker Response 100 Cohort 1: 0.1 mg • Waterfall disp
Slide 17: AMPLIFY-201: Immune Response
AMPLIFY-201: Immune Response ELI-002 2P Phase 1A 84% of patients generated mKRAS-specific T cells directly ex vivo; 100% at RP2D mKRAS T Cell Responses AMPLIFY-201 T Cell Fold-Changes Direct Ex Vivo T Cell Response • T cells detectable by standard direct ex vivo FluoroSpot and flow cytometry, with n
Slide 18: T Cell Fold-change Predicts Tumor Biomarker Response
AMPLIFY-201: T Cell Fold-change Predicts Tumor Biomarker Response ELI-002 2P Phase 1A All patients with T cell responses over the median showed tumor biomarker response mKRAS T Cell Response Tumor Biomarker Response Best Overall Tumor Biomarker Response Clearance Reduction Non-Responder • Strength o
Slide 19: Majority of Above Median T Cell Responders Include CD4 and CD8 T cells
AMPLIFY-201: Majority of Above Median T Cell Responders Include ELI-002 2P Phase 1A CD4 and CD8 T cells Above median mKRAS-specific T cell response correlated to improved clinical outcome mKRAS T Cell Response Clinical Response • Strength of T cell response to ELI-002 is correlated to tumor response
Slide 20: Above Median T Cell Responders Median RFS Significantly Prolonged
AMPLIFY-201: Above Median T Cell Responders Median RFS ELI-002 2P Phase 1A Significantly Prolonged 86% reduction in the risk of progression or death in above median T cell responders mKRAS T Cell Response Clinical Response Relapse-free Survival • At a median follow up of 8.5 months, median RFS was n
Slide 21: ELI-002 Amplifies Cytotoxic mKRAS-specific CD4+ T cells
ELI-002 2P Phase 1A AMPLIFY-201: ELI-002 Amplifies Cytotoxic mKRAS-specific CD4+ T cells Induced mKRAS-specific CD4+ T cells develop enhanced cytotoxic function, memory phenotype mKRAS Cytotoxic CD4+ T Cell Response Cytotoxic CD4+ T Cell Fold-Changes CD4+ T cell Memory • T cells detectable by standa
Slide 22: ELI-002 Amplifies Cytotoxic mKRAS-specific CD8+ T cells
AMPLIFY-201: ELI-002 Amplifies Cytotoxic mKRAS-specific CD8+ T cells ELI-002 2P Phase 1A Induced mKRAS-specific CD8+ T cells develop enhanced cytotoxic function, memory phenotype mKRAS Cytotoxic CD8+ T Cell Response Cytotoxic CD8+ T Cell Fold-Changes CD8+ T cell Memory • T cells detectable by standa
Slide 23: ELI-002 Stimulates Antigen Spreading
AMPLIFY-201: ELI-002 Stimulates Antigen Spreading ELI-002 2P Phase 1A Expansion of T cells specific to personalized tumor antigens not targeted by vaccination Antigen Spreading to Personal Tumor Neoantigens Immunogenic Non-immunogenic 10 • ELI-002 2P vaccination led to expansion of T cell responses
Slide 24: AMPLIFY-201: Safety & Tolerability
AMPLIFY-201: Safety & Tolerability ELI-002 2P Phase 1A ELI-002 was well tolerated at all dose levels, with no DLTs or SAEs Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Overall ELI-002 Safety / Tolerability (0.1 mg) (0.5 mg) (2.5 mg) (5.0 mg) (10.0 mg) n=3 n=6 n=5 n=5 n=6 n = 25 • No Grade 3/4 TEAEs,
Slide 25: ELI-002 7P: 7-Peptide (7P) Formulation
ELI-002 7P: 7-Peptide (7P) Formulation Phase 1A: Peptide Dose Ranging 1.4mg or 4.9mg doses First-in-human Study: mKRAS G12x or G13D-expressing, Adjuvant treatment of MRD+ PDAC and CRC
Slide 26: AMPLIFY-7P Phase 1A Study Overview
AMPLIFY-7P Phase 1A Study Overview ELI-002 7P Phase 1A Phase 1 peptide dose-ranging study to assess safety and efficacy of ELI-002 7P in patients who completed standard therapy and have minimal residual disease ELI-002 MONOTHERAPY: NCT05726864 Monotherapy (no chemo, CPI combo) Complete Local Therapy
Slide 27: AMPLIFY-7P: T Cell Responses
AMPLIFY-7P: T Cell Responses ELI-002 7P Phase 1A 100% of patients with robust T cell response mKRAS T Cell Responses AMPLIFY-201 T Cell Fold-Changes by Dose Level • 100% of patients showed T cell responses Direct Ex Vivo T Cell Response Dose T Cell Response 200 Average Median • 4.9 mg dose group sel
Slide 28: AMPLIFY-7P: T Cell Responses vs ELI-002 2P
AMPLIFY-7P: T Cell Responses ELI-002 7P Phase 1A Phase 2 Dose generates higher immune response than seen with ELI-002 2P ELI-002 2P vs ELI-002 7P 4.9 mg ELI-002 2P ELI-002 7P ELI-002 7P (Nat Med) (All) (4.9 mg) • ELI-002 7P data based on n=11 Patients (1.4 mg, Response Rate 84% 100% 100% n=5; 4.9 mg
Slide 29: AMPLIFY-7P: ELI-002 Stimulates Antigen Spreading
AMPLIFY-7P: ELI-002 Stimulates Antigen Spreading ELI-002 7P Phase 1A Expansion of T cells specific to personalized tumor antigens not targeted by vaccination Antigen Spreading to Personal Tumor Neoantigens Immunogenic Non-immunogenic 10 • ELI-002 7P vaccination led to expansion of T cell responses t
Slide 30: AMPLIFY-7P: Tumor Biomarker Responses
AMPLIFY-7P: Tumor Biomarker Responses ELI-002 7P Phase 1A Waterfall reflects superiority of 4.9 mg AMP-Peptide 7P dose level Tumor Biomarker Responses AMPLIFY-201 Waterfall Plot: Biomarker Reduction / Clearance • 71% (5/7) of patients in the 4.9 mg dose had * 100* Amph-Peptides-7P Dose biomarker dec
Slide 31: AMPLIFY-7P: T Cell Response Drives Tumor Biomarker Response
AMPLIFY-7P: T Cell Response Drives Tumor Biomarker Response ELI-002 7P Phase 1A All patients with T cell responses above median showed tumor biomarker response mKRAS T Cell Response Tumor Biomarker Response Best Overall Tumor Biomarker Response • Strength of T cell response to ELI-002 is correlated
Slide 32: AMPLIFY-7P: Safety
AMPLIFY-7P: Safety ELI-002 7P Phase 1A ELI-002 was well tolerated at all dose levels with no DLTs ELI-002 7P Safety / Tolerability AMP-Peptide 7P Dose 1.4 mg 4.9 mg Overall n=6 n=8 n=14 • No DLT observed, No CRS or T cell Toxicities Adverse Event Term a • Most common TRAE (>20%) were Fatigue Patient
Slide 33: AMPLIFY-7P: Preliminary Disease-free Survival
AMPLIFY-7P: Preliminary Phase 1 Disease-free Survival ELI-002 7P Phase 1A Improved DFS observed at 4.9mg Phase 2 dose versus 1.4 mg dose 4.9 mg AMP-Peptide Dose versus 1.4 mg dose level ELI-002 7P Disease-free Survival 6 mo 12 mo • AMP-Peptide-7P 4.9 mg dose: 100 Median DFS: not reached • Median DFS
Slide 34: Improved DFS associated with above median T cell response
AMPLIFY-7P: Preliminary Phase 1 Disease-free Survival ELI-002 7P Phase 1A Improved DFS associated with above median T cell response Supervised by Median T cell Fold Change ELI-002 7P Disease-free Survival 6 mo 12 mo • Induction of above median mKRAS-specific T cell 100 responses by ELI-002 7P associ
Slide 35: Improved DFS associated with biomarker response
AMPLIFY-7P: Phase 1 Disease-free Survival ELI-002 7P Phase 1A Improved DFS associated with biomarker response Supervised by Biomarker Response ELI-002 7P Disease-free Survival 6 mo 12 mo • Tumor biomarker reduction or clearance after ELI-002 100 7P treatment associated with decreased risk of disease
Slide 36: Favorable overall DFS observed
AMPLIFY-7P: Preliminary Phase 1 Disease-free Survival ELI-002 7P Phase 1A Favorable overall DFS observed All Patients (n = 14) ELI-002 7P Disease-free Survival 6 mo 12 mo • Full Phase 1 Cohort: 100 • Median DFS not reached Disease-free Survival (%) 75 Median DFS: not reached 50 25 0 0 12 24 36 48 60
Slide 37: ELI-002 7P: Phase 2: PDAC Patients Randomized 2:1
ELI-002 7P: 7-Peptide (7P) Formulation Phase 2: 135 PDAC Patients Randomized 2:1
Slide 38: ELI-002 Randomized Phase 2 PDAC, n=135 patients
ELI-002 Randomized Phase 2 PDAC, n=135 patients ELI-002 7P Phase 2 2:1 Randomized, Open Label Study with 10 DFS endpoint CLINICAL STUDY OVERVIEW: NCT05726864 Monotherapy (no chemo, CPI combo) Schema Endpoints ✓ mKRAS: Expanded Antigen Coverage Primary Endpoint: Disease Free Survival G12D / R / V / C
Slide 39: Key Milestones and Growth Initiatives 2024-2025
Key Milestones and Growth Initiatives 2024-2025 ELI-002 2P ELI-002 7P Growth Initiatives Phase 1 Study Phase 1/2 Study ✓ Published Preliminary Phase 1a ✓ Preliminary Phase 1 T Cell and ❑ Initiate ELI-002 Phase 1B Data in Nature Medicine biomarker response (ASCO) Colorectal Cancer study ✓ Antigen spr
Slide 40: Targeting the Lymph Nodes to AMPlify Immunotherapy
Targeting the Lymph Nodes to AMPlify Immunotherapy Nasdaq: ELTX June 2024
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