Elicio Therapeutics, Inc. · NASDAQ:ELTX
Elicio Therapeutics — Investor Presentation (September 2023)
25 slides from Elicio Therapeutics's investor presentation, Sep 28, 2023
Slide 1: Targeting the Lymph Nodes to AMP-lify Immunotherapy
Targeting the Lymph Nodes to AMP-lify Immunotherapy September 2023 1
Slide 2: Disclaimers
Disclaimers 2 Forward-Looking Statements 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, k
Slide 3: Company Highlights
Company Highlights 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 target 7 KRAS mutations that drive ~25% of solid tumors • Initial focus is PDAC whe
Slide 4: Pipeline
CANDIDATE TARGET INDICATIONS PRECLINICAL PHASE 1 PHASE 2 PHASE 3 ELI-002 * mKRAS PDAC, CRC, NSCLC ELI-007 mBRAF GI tumors ELI-008 mTP53 GI tumors Pipeline 4 Innovative pipeline of cancer immunotherapies addressing critical unmet needs * Ph1/2 combination study with CPI in planning stages CRC: colore
Slide 5: Elicio: Amplifying Immunotherapy
5 Elicio: Amplifying Immunotherapy
Slide 6: The AMP Platform
The AMP Platform • Most immune cells are located in lymph nodes, yet these critical sites are not engaged by conventional immunotherapies • AMP promotes targeted delivery of payloads to the lymph nodes via “albumin hitchhiking” • AMP harnesses the unique biology of the lymph nodes to enhance the mag
Slide 7: Mechanism of Action
Mechanism of Action 7 AMP immunotherapy generates an anti-tumor immune response via the lymph nodes Tumor Eradication 5Subcutaneous injection 1 Lymph Node Lymph node targeting 3 Antigen Presenting Cell Delivery to immune cells 4 Albumin-bound Amphiphiles T CellAlbumin-bound Amphiphiles Endogenous Al
Slide 8: AMP Anti-Tumor Activity
10 15 20 25 30 35 0 20 40 60 80 100 Days Tu m or S ize (m m 2 ) 0 20 40 60 80 100 % T um or S pe ci fic a m on g CD 8+ T C el ls CD8+ T Cell Response AMP Anti-Tumor Activity 8 Several studies demonstrate amplifying T cells in lymph nodes enhances cancer immunotherapy CR: 8/10 CR: 2/10 CR: 0/10 Tumor
Slide 9: The mKRAS Opportunity
The mKRAS Opportunity 9 ELI-002 targets the 7 most common KRAS mutations driving 25% of solid tumors ELI-002 addressable Incidence: ~128k Other KRAS mutations 88% Pancreatic Ductal Adenocarcinoma Other KRAS mutations ~88% Colorectal Cancer ~88% Non-Small Cell Lung Cancer ~88% Other mKRAS Opportuniti
Slide 10: mKRAS Differentiation
mKRAS Differentiation 10 Early mKRAS-targeting efforts in the clinic, while promising, leave significant white space 7 key mutations Reduced risk of resistance mechanisms Potent activation of immune mechanisms Expansion/activation of T cell response Promotion of anti- tumor T cell function Validates
Slide 11: ELI-002 Composition
ELI-002 Composition 11 Lymph node targeted therapeutic vaccine comprised of AMP-peptides and AMP-CpG ELI-002 Albumin Binding Lipid for Lymph Node Targeting CpG DNA: TLR-9 Agonist X X Albumin Binding Lipid for Lymph Node Targeting mKRAS PeptidePEG Linker • 2 or 7 AMP-peptides • CD8 and CD4 epitopes •
Slide 12: Preclinical Validation of ELI-002
Preclinical Validation of ELI-002 12 ELI-002 enhances in vivo measures of immune responses across a range of KRAS mutations Robust activity against 7 most common KRAS mutations Spleen T Cell Response Stimulation G12D G12V G12S G12A G12C G12R G13D Vehicle Adjuvant Only ELI-002 -20 0 20 40 60 80 % S p
Slide 13: ELI-002: Lymph node targeted mKRAS immunotherapy
13 ELI-002: Lymph node targeted mKRAS immunotherapy
Slide 14: ELI-002 At-a-Glance
ELI-002 At-a-Glance 14 mKRAS immunotherapy eliciting strong T cell activity leveraging the AMP platform’s lymph node targeting design 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
Slide 15: AMPLIFY-201 Study Overview
AMPLIFY-201 Study Overview Elicio Non-Confidential 15 Phase 1 dose-ranging study to assess safety and efficacy of ELI-002 2P as adjuvant treatment in patients who completed standard therapy and have molecular disease 20-Months Follow-up Boost (4 doses over 4 weeks) Prime (6 doses over 8 weeks) Local
Slide 16: AMPLIFY-201 Biomarker Responses
P P P P P P P C P P P P P C P P C P C P C PTumor Type D D D D D D D D R D D D D D R R D D D R D DmKRAS Biomarker -100 -75 -50 -25 0 25 50 75 100 28 0 90 38 22 -2 8 -3 0 -4 1 -4 4 -4 7 -7 4 -1 00 -1 00 -1 00 -1 00 -1 00 -1 00 Be st O ve ra ll Bi om ar ke r R es po ns e (% o f Ba se lin e) -9 -1 1-20
Slide 17: AMPLIFY-201 T Cell Responses
Baseline Max response 0 5 10 20 30 40 50 450 Fo ld c ha ng e fr om b as el in e 2 AMPLIFY-201 T Cell Responses 17 Vast majority of patients showed robust T cell response across dose cohorts Direct Ex Vivo Immune Response AMP-CpG Dose Level ex vivo T cell response (n, %) Average fold-change 0.1 mg 2/
Slide 18: AMPLIFY-201 T Cell Fold-Change Predicts Tumor Biomarker Response
≥Median <Median -100 0 100 200 300 T Cell Response (Fold change from baseline) Be st O ve ra ll Bi om ar ke r R es po ns e (% o f Ba se lin e) ✱✱P = 0.0017 AMPLIFY-201 T Cell Fold-Change Predicts Tumor Biomarker Response 18 All patients with T cell responses over median showed tumor biomarker respon
Slide 19: Median Relapse-Free Survival of Above Median T Cell Responders
0 3 6 9 12 15 18 0 25 50 75 100 Months Re la ps e- fr ee S ur vi va l ( % ) At risk ≥ Median 12 8 4 1 0 0 0 < Median 10 5 1 1 1 1 0 ≥ Median T Cell Response (n = 12) < Median T Cell Response (n = 10) P = 0.0134 HR: 0.1376 (0.03106 – 0.6096) Median RFS: not reached Median RFS: 3.91 months AMPLIFY-201
Slide 20: ctDNA CA19-9 / CEA D G12D R G12R P PDAC C CRC Co ho
ctDNA CA19-9 / CEA D G12D R G12R P PDAC C CRC Co ho rt T Cells ≥ Median < Median CD4 CD8 x no ICS Biomarker Non-responder Biomarker Reduction Biomarker Clearance Prime Immunization Complete Boost Immunization Complete Subsequent Therapy iCPD RFS Censor Date + Death On Treatment Ongoing Follow-up 0 8
Slide 21: AMPLIFY-201 T Cell Tumor Infiltration
AMPLIFY-201 T Cell Tumor Infiltration 21 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
Slide 22: AMPLIFY-201 Safety & Tolerability
AMPLIFY-201 Safety & Tolerability 22 ELI-002 was well tolerated at all dose levels, with no DLTs or SAEs Cohort 1 (0.1 mg) n=3 Cohort 2 (0.5 mg) n=6 Cohort 3 (2.5 mg) n=5 Cohort 4 (5.0 mg) n=5 Cohort 5 (10.0 mg) n=6 Overall n=25 Adverse Event Term Patients with Any Related TEAE, n (%) 1 (33.3) 3 (50
Slide 23: AMPLIFY-201 Results Summary
AMPLIFY-201 Results Summary 23 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 DATA • Significant reduction in risk of progression
Slide 24: ELI-002 Differentiation
ELI-002 Differentiation* 24 Distinct clinical and operational advantages over comparable cancer vaccines ELI-002 SLATE-KRAS - - GRANITE - - - ** - Autogene- cevumeran - - ** - mRNA-4157 - - ** - Enhanced immune responses, no spleen requirement Broadest coverage vs driver mutations, limits resistance
Slide 25: ELI-002 Anticipated Milestones
ELI-002 Anticipated Milestones 25 Milestone Timing AMPLIFY-7P Phase 1a First Patient Enrolled 2023 Apr AMPLIFY-201 Interim Analysis biomarker and safety 2023 Jun AMPLIFY-201 Interim Analysis RFS of T cell responders 2023 Sep AMPLIFY-7P Randomized Phase 2 Initiation (PDAC) 2024 Q1 AMPLIFY-7P Phase 1a
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