Elicio Therapeutics, Inc. · NASDAQ:ELTX
Elicio Therapeutics — Investor Presentation (June 2023)
21 slides from Elicio Therapeutics's investor presentation, June 2023
Slide 1: Targeting the Lymph Nodes to AMP-lify Immunotherapy
Targeting the Lymph Nodes to AMP-lify Immunotherapy June 2023 Elicio Non-Confidential 1
Slide 2: Forward Looking Statement
Forward Looking Statement This 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, known as the PSL
Slide 3: Company Highlights
Company Highlights Clinical-stage biotech pioneering novel lymph node targeted cancer immunotherapies NOVEL APPROACH TO IMMUNOTHERAPY • Amphiphile or “AMP” platform traffics payloads to lymph nodes to generate robust immune responses ELI-002: A UNIQUE LYMPH NODE TARGETED mKRAS VACCINE • Designed to
Slide 4: Pipeline
Pipeline Innovative pipeline of cancer immunotherapies addressing critical unmet needs CANDIDATE TARGET INDICATIONS PRECLINICAL PHASE 1 PHASE 2 PHASE 3 ELI-002 * mKRAS PDAC, CRC, NSCLC PDAC ELI-007 mBRAF GI tumors ELI-008 mTP53 GI tumors Ongoing Planned * Ph2 study in planning stages – Ph2 study may
Slide 5: The AMP Platform
The AMP Platform Harnessing the untapped potential of the lymph nodes for immunotherapy • Most immune cells are located in lymph Blood Vessel nodes, yet these critical sites are not engaged by conventional immunotherapies Blood Blood Circulation • AMP promotes targeted delivery of payloads Small Mol
Slide 6: Mechanism of Action
Mechanism of Action AMP immunotherapy generates an anti-tumor immune response via the lymph nodes Tissue Injection Site Lymph Node Tumor Amphiphiles Endogenous Albumin Albumin-bound Amphiphiles Albumin-bound Amphiphiles Antigen Presenting Cell T Cell 1 Subcutaneous 2 Albumin 3 Lymph node 4 Delivery
Slide 7: AMP Anti-Tumor Activity
AMP Anti-Tumor Activity Several studies demonstrate amplifying T cells in lymph nodes enhances cancer immunotherapy CD8+ T Cell Response Tumor Size Survival 100 100 % Tumor Specific among 100 Tumor Size (mm2) 80 80 CD8+ T Cells 80 CR: 8/10 % Survival 60 60 60 40 40 40 20 20 20 CR: 2/10 CR: 0/10 0 0
Slide 8: 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 9: mKRAS Differentiation
mKRAS Differentiation 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 Mutant KRAS FDA approvals
Slide 10: ELI-002 At-a-Glance
ELI-002 At-a-Glance The only lymph node targeted mKRAS immunotherapy, built on the AMP platform 2 PEPTIDE (2P) AND 7 PEPTIDE (7P) FORMULATIONS • 2P used in Phase 1 AMPLIFY-201 for clinical proof-of-concept while 7P CMC finalized • Program now switches to full 7P formulation, to maximize efficacy and
Slide 11: ELI-002 Composition
ELI-002 Composition Lymph node targeted therapeutic vaccine comprised of AMP-peptides and AMP-CpG G12X G13X 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 Peptide Lymph Node Targeting O AMP-CpG NH Adjuvant O
Slide 12: Preclinical Validation of ELI-002
Preclinical Validation of ELI-002 ELI-002 enhances in vivo measures of immune responses across a range of KRAS mutations T Cell Response T Cell Target Killing: G12D Spleen Spleen IFN SFC / 1x106 splenocytes 2000 80 % Specific Killing In Vivo Vehicle 1500 Adjuvant Only 60 ELI-002 40 1000 20 500 0 0
Slide 13: AMPLIFY-201 Study Overview
AMPLIFY-201 Study Overview Phase 1 dose-ranging study to assess safety and efficacy of ELI-002 2P adjuvant therapy Key Criteria Local Therapy Basket Trial Enrollment (e.g., Surgery, Chemo) • mKRAS G12D/R – aligned to 2 peptide formulation Pancreatic Ductal n=20 • No metastatic disease after locoregi
Slide 14: AMPLIFY-201 Biomarker Responses
AMPLIFY-201 Biomarker Responses Robust responses observed across tumor types and KRAS mutations with ELI-002 monotherapy AMPLIFY-201 Waterfall Plot: Biomarker Reduction/Clearance • One third of patients (32%, 7/22) Cohort 1: 0.1 mg Cohort 2: 0.5 mg Cohort 3: 2.5 mg Cohort 4: 5.0 mg Cohort 5: 10.0 mg
Slide 15: AMPLIFY-201 Spider Plot
AMPLIFY-201 Spider Plot ELI-002 response associated with progressive reduction in biomarkers AMPLIFY-201 Spider Plot: Best Overall Biomarker Response (ctDNA, CA19-9/CEA) • Biomarker response shown as percent 600 change from baseline 400 200 Relative to Baseline • Data suggests minority of patients 2
Slide 16: AMPLIFY-201 T Cell Responses
AMPLIFY-201 T Cell Responses Vast majority of patients had robust T cell response across dose cohorts AMPLIFY-201 T Cell Fold-Changes by Dose Level • 87% of patients had T cell responses Direct Ex Vivo Immune Response Response per Dose Level • 100% in two highest dose cohorts, 450 ex vivo T cell AMP
Slide 17: AMPLIFY-201 T Cell Tumor Infiltration
AMPLIFY-201 T Cell Tumor Infiltration Preliminary clinical evidence shows dense T cell tumor infiltration following ELI-002 therapy • 72 T cells/hpf at time of progression, 29x the expected 2-3 T cells/hpf in PDAC 1 • T cell tumor infiltration was associated with complete ctDNA clearance in this pat
Slide 18: AMPLIFY-201 Safety & Tolerability
AMPLIFY-201 Safety & Tolerability ELI-002 was well tolerated at all dose levels, with no DLTs or SAEs • No Grade 3/4 TEAEs, no CRS, no DLTs Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Overall (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 at time of data cutoff (April 25, 20
Slide 19: AMPLIFY-201 Results Summary
AMPLIFY-201 Results Summary ELI-002 monotherapy generates clinically relevant and robust immune response WELL TOLERATED WITH NO DOSE LIMITING TOXICITY • No Grade 3/4 TEAEs, no CRS, No DLTs; 11/25 (44%) had Grade 1 or 2 AEs PROMISING PRELIMINARY EFFICACY • ctDNA and serum tumor biomarker reductions a
Slide 20: ELI-002 Differentiation
ELI-002 Differentiation* Distinct clinical and operational advantages over comparable cancer vaccines Anti-Tumor Clinical Programs Lymph Node Exclusively Targeting “Off-the-Shelf” Immune Responses In Early Disease Engagement KRAS Mutations Neoantigen Vaccines ELI-002 7 Shared KRAS SLATE-KRAS - - 4 G
Slide 21: ELI-002 Anticipated Milestones
ELI-002 Anticipated Milestones Several catalysts can drive value in next 12 months Milestone Timing AMPLIFY-7P Phase 1a First Patient Enrolled 2023 Apr AMPLIFY-201 Interim Analysis & ASCO Readout 2023 Jun AMPLIFY-7P Phase 1a Data Review 2023 H2 AMPLIFY-201 Long-term Follow-up 2023 H2 AMPLIFY-7P Phas
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