Elicio Therapeutics, Inc. · NASDAQ:ELTX
Elicio Therapeutics — Investor Presentation (June 2024)
40 slides from Elicio Therapeutics's investor presentation, Jun 27, 2024
Slide 1: Targeting the Lymph Nodes to AMPlify Immunotherapy
Targeting the Lymph Nodes to AMPlify Immunotherapy Nasdaq: ELTX June 2024
Slide 2: Disclaimers: No Representation or Warranty
Disclaimers 2 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 th e P resentation or the accuracy or completeness or the information contained in or incorporated by refer
Slide 3: Disclaimers: Forward-Looking Statements
Disclaimers 3 Forward - Looking Statements The Presentation contains forward - looking statements as that term is defined in Section 27A of the Securities Act of 1933, as am ended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 199
Slide 4: Amphiphile (AMP) Technology and ELI-002 overview
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: Harnessing the immune system with AMP technology
• Elicio is harnessing the natural power of the immune system with AMP technology , to deliver therapeutic payloads directly to the lymph nodes, enhancing the immune system’s cancer - fighting capabilities. • Our targeted - delivery approach generates a robust immune response that amplifies cancer f
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
Slide 7: Targeting Immunity in the Lymph Nodes: The AMP Technology
7 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 magnitude, potency
Slide 8: MOA: AMP Locates to Lymph Node Orchestrating Immunity
8 Pant, 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 Response 5 Subcutaneous injection 1 Lymph Node Lymph node targeting 3 Antigen Presenting Cell Delivery to immune cell
Slide 9: AMP Platform Technology
AMP Platform Technology 9 Cancer Vaccines Immunotherapy / Combinations CAR - T Cell Adoptive Therapy TCR - T Cell Adoptive Therapy Infectious Disease Vaccines Lymph Node Delivery Adjuvants Lung - specific Delivery Mucosal Delivery (NALT) Autoimmunity Versatile | Simple | Clinical stage 2014 Liu Natu
Slide 10: ELI-007 and ELI-008 preclinical vaccines
10 ELI - 007 (Mutant BRAF - Peptide Vaccine) ELI - 008 (p53 Hotspot Mutant - Peptide Vaccine) 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 can be found here . Similar to KRAS,
Slide 11: ELI-002 Composition
11 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 Peptide PEG Linker • 2 or 7 AMP - peptides • CD8 and CD4 epitopes • Potent TLR - 9 immune acti
Slide 12: ELI-002 addressable incidence in mKRAS cancers
12 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, 2 021), BTC: 15% of liver cancers + gallbladder Sources for KRAS
Slide 13: ELI-002's Differentiated Approach to mKRAS
13 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 immune - targeting, and affects multiple mutations BUT Poor lymph node targeting and weaker T - cell activation
Slide 14: ELI-002 2P: Phase 1A Adjuvant Dose Ranging
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 Phase 1A Study Overview
15 20 - Months Follow - up Boost (4 doses over 4 weeks) Prime (6 doses over 8 weeks) Complete Local Therapy (e.g., Surgery, Chemo) ELI - 002 MONOTHERAPY: NCT04853017 Pancreatic Ductal Adenocarcinoma (PDAC) Colorectal Cancer (CRC) n=20 n=5 x mKRAS G12D / R – aligned to 2 peptide formulation x No radi
Slide 16: 2P: Tumor biomarker response
16 • 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
Slide 17: 2P AMPLIFY-201: Immune Response
Baseline Max Response 0 5 10 20 30 40 50 450 F o l d C h a n g e f r o m B a s e l i n e 2 17 • 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
Slide 18: 2P: T Cell Fold-change Predicts Tumor Biomarker Response
Clearance Reduction Non - Responder ≥Median <Median -100 0 100 200 300 T Cell Response (Fold change from baseline) B e s t O v e r a l l B i o m a r k e r R e s p o n s e ( % o f B a s e l i n e ) ✱✱ 18 • Strength of T cell response to ELI - 002 is strongly correlated to tumor biomarker response • 1
Slide 19: 2P: Above Median T Cell Responders Include CD4 and CD8
19 • Strength of T cell response to ELI - 002 is correlated to tumor response and duration of ELI - 002 administration • Patients with both CD4 and CD8 T cell responses have favorable clinical outcomes mKRAS T Cell Response Clinical Response Data cutoff 6 - Sept - 23 AMPLIFY - 201: Majority of Above
Slide 20: 2P: Above Median T Cell Responders Median RFS Prolonged
0 3 6 9 12 15 18 0 25 50 75 100 Months R e l a p s e - f r e e S u r v i v a l ( % ) 20 • At a median follow up of 8.5 months, median RFS was not reached for above median T cell responders 1 compared to 4.01 months among below median T cell responders (HR 0.14, 95% CI 0.03 - 0.63, P=0.0167) • 86% Re
Slide 21: 2P: ELI-002 Amplifies Cytotoxic mKRAS-specific CD4+ T cells
21 • T cells detectable by standard direct ex vivo FluoroSpot and flow cytometry, with no expansion required • 68% of evaluated patients (13/19) developed increased cytotoxic CD4 + T cell responses targeting mKRAS • ELI - 002 vaccination induces development of central and effector memory phenotype m
Slide 22: 2P: ELI-002 Amplifies Cytotoxic mKRAS-specific CD8+ T cells
0 20 40 60 80 100 % C D 8 + T c e l l s 0 5 5 20 35 50 200 400 F o l d c h a n g e f r o m b a s e l i n e 2 22 • T cells detectable by standard direct ex vivo FluoroSpot and flow cytometry, with no expansion required • 84% of evaluated patients (16/19) developed increased cytotoxic CD8 + T cell res
Slide 23: 2P: ELI-002 Stimulates Antigen Spreading
1 2 3 4 4 4 4 5 5 0 1 2 3 4 5 6 7 8 9 10 # o f P e r s o n a l i z e d T u m o r N e o a n t i g e n s A s s a y e d f o r T c e l l R e s p o n s e 23 • ELI - 002 2P vaccination led to expansion of T cell responses targeting passenger mutations alongside mKRAS driver mutations in a majority of eval
Slide 24: 2P: Safety
24 • No Grade 3/4 TEAEs, no CRS, no DLTs at time of data cutoff (6 - Sept - 2023) • 12/25 (48%) had Grade 1 or 2 AEs • 4/25 (16%) had injection site reactions • 10 mg dose selected as RP2D for Phase 1/2 AMPLIFY - 7P study TEAE: Treatment Emergent Adverse Event | CRS: Cytokine release syndrome | DLT:
Slide 25: ELI-002 7P: Phase 1A Peptide Dose Ranging
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
26 32 - Months Follow - up Boost (4 doses over 4 weeks) Prime (6 doses over 8 weeks) Complete Local Therapy (e.g., Surgery, Chemo) ELI - 002 MONOTHERAPY: NCT05726864 Pancreatic Ductal Adenocarcinoma (PDAC) Colorectal Cancer (CRC) n=13 n=1 x Includes: mKRAS G12D/R/V/C/A/S/G13D x No radiographic evide
Slide 27: 7P AMPLIFY-7P: T Cell Responses
Baseline Max response 0 5 10 15 20 25 50 100 150 200 F o l d c h a n g e f r o m b a s e l i n e 27 • 100% of patients showed T cell responses • 4.9 mg dose group selected for Phase 2 • Median fold change = 109.2x • 66.7% with CD4 and CD8 T cells • T cells detectable by standard direct ex vivo Fluor
Slide 28: 7P: Phase 2 Dose Generates Higher Immune Response than 2P
28 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 23.6 109.2 % CD4 + CD8 T cells 59% 63.6% 66.7% Response to 7 mKRAS Antigens 52.4% 45.5% 66.7% Response to Tumor Antigen 81% 72.7% 83.3% ELI - 002 7P data based on n=11 Patients (1
Slide 29: 7P: ELI-002 Stimulates Antigen Spreading
29 • 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
Slide 30: 7P: Tumor Biomarker Responses
30 • 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
Slide 31: 7P: T Cell Response Drives Tumor Biomarker Response
≥Median <Median -100 0 100 200 300 T Cell Response (Fold change from baseline) Median = 17.3 B e s t O v e r a l l B i o m a r k e r R e s p o n s e ( % o f B a s e l i n e ) P = 0.0317 Clearance Reduction Non - Responder 31 • Strength of T cell response to ELI - 002 is correlated to tumor biomarker
Slide 32: 7P AMPLIFY-7P: Safety
32 • 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 33: 7P: Preliminary Disease-free Survival by Dose
33 AMPLIFY - 7P: Preliminary Phase 1 Disease - free Survival Improved DFS observed at 4.9mg Phase 2 dose versus 1.4 mg dose Phase 1A ELI - 002 7P 0 12 24 36 48 60 0 25 50 75 100 Weeks on Study D i s e a s e - f r e e S u r v i v a l ( % ) 4.9 mg (n = 8) P = 0.0939 1.4 mg (n = 6) HR: 0.186 (0.024 – 1
Slide 34: 7P: DFS by T cell response
0 12 24 36 48 60 0 25 50 75 100 Weeks on Study D i s e a s e - f r e e S u r v i v a l ( % ) 34 Phase 1A ELI - 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
Slide 35: 7P: DFS by biomarker response
0 12 24 36 48 60 0 25 50 75 100 Weeks on Study D i s e a s e - f r e e S u r v i v a l ( % ) 35 Phase 1A ELI - 002 7P 6 mo 12 mo Median DFS: not reached Supervised by Biomarker Response Median DFS: 11.00 weeks AMPLIFY - 7P: Phase 1 Disease - free Survival Improved DFS associated with biomarker respo
Slide 36: 7P: Favorable overall DFS observed
36 AMPLIFY - 7P: Preliminary Phase 1 Disease - free Survival Favorable overall DFS observed Phase 1A ELI - 002 7P 0 12 24 36 48 60 0 25 50 75 100 Weeks on Study D i s e a s e - f r e e S u r v i v a l ( % ) 6 mo 12 mo Median DFS: not reached All Patients (n = 14) No. at Risk ELI - 002 - 7P 14 10 6 3
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: Phase 2 Clinical Study Overview
x mKRAS : Expanded Antigen Coverage G12D / R / V / C / A / S / G13D 38 CLINICAL STUDY OVERVIEW: NCT05726864 x Includes: mKRAS G12D/R/V/C/A/S/G13D x Up front resectable Stage I, II or III disease (PDAC) x Complete R0/R1 resection x Radiographic NED status within 6 months following completion of locor
Slide 39: Key Milestones and Growth Initiatives 2024-2025
x Published Preliminary Phase 1a Data in Nature Medicine x Antigen spreading and expanded immunogenicity data (AACR) □ Updated RFS and T Cell response data (4Q 2024) x Preliminary Phase 1 T Cell and biomarker response (ASCO) □ Complete 135 patient Phase 2 enrollment (4Q 2024) □ Phase 2 DFS Interim A
Slide 40: Targeting the Lymph Nodes to AMPlify Immunotherapy
Targeting the Lymph Nodes to AMPlify Immunotherapy Nasdaq: ELTX June 2024
Elicio Therapeutics — Investor Presentation (June 2024) on 6ix