Elicio Therapeutics, Inc. · NASDAQ:ELTX
Elicio Therapeutics — Investor Presentation (December 2024)
32 slides from Elicio Therapeutics's investor presentation, Dec 12, 2024
Slide 1: Targeting the Lymph Nodes to AMPlify Immunotherapy
Targeting the Lymph Nodes to AMPlify Immunotherapy Nasdaq: ELTX December 2024
Slide 2: Disclaimers: No Representation or Warranty
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 3 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 4: Amphiphile (AMP) Technology and ELI-002
4 Amphiphile (“AMP”) Technology • AMP delivers payloads to lymph nodes eliciting immune responses with increased magnitude, function, and durability • Designed to harness the lymph nodes’ natural ability to educate, activate and amplify differentiated T cell responses, which are essential for recogn
Slide 5: H2 2024 Execution
• $33M in new capital raised – Company funded into the second quarter of 2025 past anticipated Phase 2 interim analysis • Pipeline of cancer vaccines and immunomodulators expands and advances • ELI-002 Phase 1/2 7-peptide updated Phase 1a data presented at AACR-Special Conference-Pancreatic Cancer •
Slide 6: Lymph Nodes: Eliciting a Robust T Cell Response
6 • Expansion • Phenotype • Effector Function • Anti-tumor Activity Response Coordination The Immune “School House” Numerous Immune Cells APC : T Cell Interaction T Cell Response Lymph Node Lymph Nodes: Eliciting a Robust T Cell Response Immune biology in the Lymph Nodes directs the development of a
Slide 7: MOA: AMP Locates to Lymph Node Orchestrating Immunity
7Pant, et al. Nature Medicine 2024; Liu, et al. Nature 2014; Moynihan, et al. Nature Medicine 2016; Ma, et al. Science 2019 APC Activation T Cell Expansion and Activation Immune Response5Subcutaneous injection1 Lymph Node Lymph node targeting3 Antigen Presenting Cell Delivery to immune cells4 Al
Slide 8: ELI-002 Composition
8 ELI-002 G12X G13X Peptide Composition 2P D R 7P D R V C S A D 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 • Potent TLR-9 immune activator AMP-mK
Slide 9: mKRAS Opportunity and ELI-002 Addressable Incidence
9 Incidence for the 7 Major Markets (MM): US, France, Germany, Italy, Spain, UK, and Japan Sources for tumor incidence obtained from GLOBOCAN (2020). PDAC: 90% of pancreatic cancers (O’Reilly, 2021), NSCLC 84.3% of lung cancers (SEER, 2021), BTC: 15% of liver cancers + gallbladder Sources for KRAS m
Slide 10: Lymph Node Targeted Vaccine vs Other mKRAS Approaches
10 Clinically advanced vaccine: PDAC Targeting 7 mKRAS driver mutations Lymph Node Targeting MOA Off-the-shelf simplicity, cost Robust T cell Response (CD4 + CD8) Monotherapy activity Potential durable clinical benefit Potential broad application for ~25% of human solid cancers expressing mKRAS Sign
Slide 11: Phase 1 AMPLIFY-201 Summary
• PDAC (33) or CRC (6) patients treated after local surgery and chemotherapy yet with minimal residual disease (Adjuvant setting) • Phase 1 trials included dose-ranging for both peptide and adjuvant components of ELI-002 • Data from both trials have shown: • ELI-002 was well tolerated at all dose le
Slide 12: ELI-002 2P: 2-Peptide 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 13: AMPLIFY-201 Trial Design and Baseline
13 20-Months Follow-up Boost (4 doses over 4 weeks) Prime (6 doses over 8 weeks) Complete Local Therapy (e.g., Surgery, Chemo) E L I - 0 0 2 M O N O T H E R A P Y : N C T 0 4 8 5 3 0 1 7 Pancreatic Ductal Adenocarcinoma (PDAC) Colorectal Cancer (CRC) n=20 n=5 mKRAS G12D / R – aligned to 2 peptide
Slide 14: Tumor Biomarker Responses
14 • Waterfall displays best response of ctDNA or serum tumor biomarker • Most patients (84%, 21/25) showed decline from baseline in ctDNA or CEA/CA19-9 levels • 24% of patients (6/25) showed complete clearance of ctDNA • Responses observed in PDAC and CRC, mKRAS G12D and G12R • Responses observed d
Slide 15: AMPLIFY-201: Immune Response
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 15 • T cells detectable by standard direct ex vivo FluoroSpot and flow cytometry, with no expansion required • 84% of patients showed T cell responses; 100% at the RP2D (10 mg) • 58x average fold-change in T cell numbe
Slide 16: T Cell Fold-change Predicts Tumor Biomarker Response
Clearance Reduction Non-Responder ≥Median <Median -100 0 100 200 300 T Cell Response (Fold change f rom baseline) Be st O ve ra ll Bi om ar ke r R es po ns e (% o f Ba se lin e) ✱✱ 16 • Strength of T cell response to ELI-002 is strongly correlated to tumor biomarker response • 100% of the above medi
Slide 17: ESMO-IO Update: Relapse-free Survival
17 Phase 1AELI-002 2PESMO-IO UPDATE: Full Cohort (n=25) vs PDAC Subgroup (n=20): Median follow up has increased to 19.7 months vs 8.5 months in Pant et al., 2024 Nature Med Median RFS times similar for the full cohort and PDAC subgroup: Data cut-off Sept 24, 2024 Full Cohort (n=25)Relapse-free Survi
Slide 18: RFS Prolonged in Above Median T Cell Group
18 Phase 1AELI-002 2PESMO-IO Relapse-Free Survival UPDATE: RFS Prolonged - no relapse or death in 10/13 (77%) of above median T cell group Data cut-off (DCO): September 24, 2024 • 10/13 in the above median T cell group have not relapsed or died • Favorable RFS stratified by T cell response was maint
Slide 19: Overall Survival in Full Cohort and Subgroups
19 Phase 1AELI-002 2POVERALL Survival in FULL COHORT AND SUBGROUPS Full Cohort (n=25) Overall Survival; mOS 28.94 mo is longer than historical for PDAC, CRC not yet estimable DCO September 24, 2024 Overall Survival: O ve ra ll Su rv iv al Months No. at Risk 25 25 23 23 22 20 13 6 2 2 1 1 0 Median OS
Slide 20: ELI-002 7P: 7-Peptide 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 21: AMPLIFY-7P Trial Design and Baseline
21 32-Months Follow-up Boost (4 doses over 4 weeks) Prime (6 doses over 8 weeks) Complete Local Therapy (e.g., Surgery, Chemo) E L I - 0 0 2 M O N O T H E R A P Y : N C T 0 5 7 2 6 8 6 4 Pancreatic Ductal Adenocarcinoma (PDAC) Colorectal Cancer (CRC) n=13 n=1 Includes: mKRAS G12D/R/V/C/A/S/G13D
Slide 22: AMPLIFY-7P: T Cell Responses
0 5 10 15 20 25 30 100 200 300 Fo ld -c ha ng e fr om b as el in e 22 • 100% of patients showed T cell responses • 4.9 mg dose group selected for Phase 2 • Median fold change = 113.3x • 85.7% with CD4 and CD8 T cells • T cells detectable by standard direct ex vivo FluoroSpot and flow cytometry, with
Slide 23: ELI-002 2P vs ELI-002 7P 4.9 mg
23 ELI-002 2P (Nat Med) ELI-002 7P (All) ELI-002 7P (4.9 mg) Response Rate 84% 100% 100% Median Fold Change 12.8 18.5 113.3 CD4 + CD8 T cells 59% 75.0% 85.7% Response to 7 mKRAS Antigens 52.4% 50.0% 71.4% Response to Tumor Antigen 81% 83.3% 100% • ELI-002 7P data based on n=12 Patients (1.4 mg, n=5;
Slide 24: ELI-002 Stimulates Antigen Spreading
24 • ELI-002 7P vaccination led to expansion of T cell responses targeting passenger mutations alongside mKRAS driver mutations in a majority of evaluable patients • T cells detectable by standard direct ex vivo FluoroSpot and flow cytometry, with no expansion required • 70% of evaluated patients (7
Slide 25: Tumor Biomarker Responses
25 • 71% (5/7) of patients in the 4.9 mg dose had biomarker decline • 40% (2/5) of patients in the 1.4 mg dose had biomarker decline • 14% (1/7) PDAC patients at 4.9 mg dose had complete clearance • Response may deepen over time (some patients not yet finished boosters) Amph-Peptides-7P Dose 1.4 mg
Slide 26: T Cell Response Drives Tumor Biomarker Response
> Median < Median -100 0 100 200 T Cell Response (Fold change f rom baseline) Be st O ve ra ll Bi om ar ke r R es po ns e (% o f B as el in e) ✱ Clearance Reduction Non-Responder 26 • Strength of T cell response to ELI-002 is correlated to tumor biomarker response • 100% (6/6) of the above median T
Slide 27: Preliminary Phase 1 Disease-free Survival
0 12 24 36 48 60 0 25 50 75 100 Weeks on Study D is ea se -f re e Su rv iv al (% ) 27 Phase 1AELI-002 7P Supervised by Median T cell Fold Change 6 mo 12 mo Median DFS: not reached Median DFS: not reached ≥ Median T Cell Response (n = 6) < Median T Cell Response (n = 6) No. at Risk 6 6 5 3 1 0 6 4 1
Slide 28: ELI-002 7P Safety / Tolerability
28 • No DLT observed, No CRS or T cell Toxicities • Most common TRAE (>20%) were Fatigue (28.6%; all Gr1) and Malaise (21.4%; all Gr1) • One (1) pt had SAE (107-002) 1.4 mg dose non- treatment related intestinal obstruction resulted in hospitalization and w/d from treatment • No dose modification •
Slide 29: 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 30: mKRAS: Expanded Antigen Coverage, Phase 2 Study Overview
mKRAS: Expanded Antigen Coverage G12D / R / V / C / A / S / G13D 30 C L I N I C A L S T U D Y O V E R V I E W : N C T 0 5 7 2 6 8 6 4 Includes: mKRAS G12D/R/V/C/A/S/G13D Up front resectable Stage I, II or III disease (PDAC) Complete R0/R1 resection Radiographic NED status within 6 months f
Slide 31: Key Milestones Achieved and Growth Initiatives 2025-2026
Published Preliminary Phase 1a Data in Nature Medicine Antigen spreading and expanded immunogenicity data (AACR) Updated RFS and OS response data (ESMO- IO: 4Q 2024) Preliminary Phase 1 T Cell and biomarker response (ASCO) T cell and Antigen Spreading (SITC) Complete 135 patient Phase 2
Slide 32: Targeting the Lymph Nodes to AMPlify Immunotherapy
Targeting the Lymph Nodes to AMPlify Immunotherapy Nasdaq: ELTX December 2024
Elicio Therapeutics — Investor Presentation (December 2024) on 6ix