ELI-002 2P / Elicio Therap - LARVOL DELTA

AMPLIFY-7P Phase 2: T cell responses induced by ELI-002 7P, a lymph node-targeted amphiphile therapeutic cancer vaccine in patients with KRAS mutated pancreatic ductal adenocarcinoma (SITC 2025) - "ELI-002 7P includes Amph-modified G12D, V, R, C, S, A and G13D mKRAS peptides with an Amph-modified immune-stimulatory oligonucleotide adjuvant (Amph-CpG-7909)...Prior ELI-002 2P Phase 1A results indicated initial safety, tolerability, and robust induction of mKRAS-specific T cell responses associated with improved disease-free survival (DFS) and overall survival (OS).1 2 The randomized Phase 2 trial is proceeding to final DFS analysis.Methods The ongoing randomized multicenter Phase 2 cohort was designed to assess the primary endpoint of DFS and immunogenicity as an exploratory endpoint...Local IRB approvals included: Memorial Sloan Kettering Cancer Center IRB (#22-352 and 22-352A(8)), Advarra (ID#s Pro00065733 and Pro00067455), the University of Iowa IRB (ID# 202212072), Feinstein Institutes for Medical Research, Northwell Health IRB (ID# 22-0814), University of California, Los Angeles Office of the Human Research Protection Program (ID# 22-001911), Mass General..."

Clinical • IO biomarker • Late-breaking abstract • P2 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • CD4 • CD8 • IFNG • IL2 • KRAS • TNFA

Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: phase 1 AMPLIFY-201 trial final results. (PubMed, Nat Med) - P1 | "We present the final results of the phase 1 AMPLIFY-201 trial, in which patients who completed standard locoregional treatment, with minimal residual mKRAS disease (n = 25, 20 pancreatic cancer and 5 colorectal cancer), received monotherapy vaccination with lymph node-targeting ELI-002 2P, including mutant KRAS (mKRAS) amphiphile-peptide antigens (G12D, G12R) and amphiphile-adjuvant CpG-7909. Therefore, lymph node-targeting amphiphile vaccination induces persistent T cell responses targeting oncogenic driver KRAS mutations, alongside personalized, tumor antigen-specific T cells, which may correlate to clinical outcomes in pancreatic and colorectal cancer. ClinicalTrials.gov registration: NCT04853017 ."

IO biomarker • Journal • P1 data • Colorectal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • KRAS

AMPLIFY-201: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Elicio Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Sep 2024

IO biomarker • Trial completion • Trial completion date • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gallbladder Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • KRAS • NRAS

Elicio Therapeutics Presents Updated Results from ELI-002 Phase 1 AMPLIFY-201 Study at ESMO Immuno-Oncology Congress 2024 (GlobeNewswire) - P1 | N=25 | AMPLIFY-201 (NCT04853017) | Sponsor: Elicio Therapeutics | "Elicio Therapeutics, Inc...presented updated results from the Phase 1 AMPLIFY-201 clinical trial (NCT04853017) of ELI-002...Key observations include: A 16.3-month mRFS and 28.9-month mOS for the full study cohort (n=25); mRFS has not yet been reached in patients with above-median T cell responses (n=13); patients who achieved below-median T cell responses (n=12) achieved a 4.0-month mRFS (HR=0.226; p=0.0184); Similar mRFS was observed between the PDAC subgroup (15.3 months; n=20), the CRC subgroup (16.3 months; n=5) and the full study cohort (16.3 months; n=25); 28.9-month mOS was identical for the PDAC subgroup and the full study cohort, comparing favorably to a historical PDAC control group...mOS was not reached in the CRC subgroup (n=5)."

P1 data • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Elicio Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Updates (GlobeNewswire) - "Upcoming Anticipated Clinical Milestones: (i) AMPLIFY-201: Provide updated RFS and OS data in an oral presentation at the 2024 ESMO Immuno-Oncology Congress, taking place from December 11-13, 2024, in Geneva, Switzerland; (ii) AMPLIFY-7P: Complete enrollment in the randomized Phase 2 study, expected in Q4 2024; (iii) AMPLIFY-7P: Formal interim Phase 2 analysis, including DFS, reviewed by IDMC in H1 2025. Possible outcomes include: (1) successfully achieving pre-specified criteria for reporting primary endpoint analysis, (2) continuing to final DFS analysis, expected in H2 2025, or (3) meeting pre-specified criteria for futility."

Enrollment status • P1 data • P2 data • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Elicio Therapeutics to Present Clinical Data at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting and Stand Up to Cancer (SU2C) Innovation Summit (GlobeNewswire) - "The first presentation will take place at the upcoming Society for Immunotherapy of Cancer ('SITC') 39th Annual Meeting, being held November 6-10, 2024...The presentation will include updated T cell and Disease-Free Survival ('DFS') data from the ongoing AMPLIFY-7P Phase 1 clinical trial (NCT05726864) of ELI-002, an Amphiphile ('AMP') cancer vaccine that targets KRAS-mutant tumors. The Phase 2 portion of AMPLIFY-7P is ongoing in patients with pancreatic cancer with enrollment expected to complete in Q4 2024...The second presentation will take place at the Stand Up To Cancer...Innovation Summit: Cancer Detection and Vaccines, being held November 4, 2024, in New York. Peter Demuth....will present updates on the AMP platform and data from the AMPLIFY-7P (NCT05726864) and AMPLIFY-201 (NCT04853017) Phase 1 trials."

Clinical data • Enrollment status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Elicio Therapeutics Announces Three Upcoming Presentations Focused on its Lymph Node Targeted, mKRAS-Specific Amphiphile Vaccines (GlobeNewswire) - "The first presentation will take place at the upcoming American Association for Cancer Research ('AACR') Special Conference in Cancer Research: Advances in Pancreatic Cancer Research being held September 15-18, 2024, in Boston, Massachusetts. Dr. Eileen O’Reilly...will include recent Phase I AMPLIFY-7P trial updates in her keynote lecture...The second presentation will take place at the RAS-Targeted Drug Development Summit being held September 25, 2024, in Boston, Massachusetts. Dr. Pete DeMuth...will present on the clinical translation of the Elicio RAS-targeted Amphiphile vaccines...The third presentation will take place at the Stuart and Molly Sloan Precision Oncology Institute Symposium: Advances in Cancer Vaccines Summit being held October 1, 2024....Dr. Christopher Haqq..will present on the Phase I experience with ELI-002 2P and ELI-002 7P."

Clinical • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Elicio Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Updates (GlobeNewswire) - "Upcoming Anticipated Milestones: (i) AMPLIFY-201: Provide updated immunogenicity and relapse free survival data in the fourth quarter of 2024; (ii) AMPLIFY-7P: Provide updated preliminary DFS data from ELI-002 7P monotherapy Phase 1a arm in the first quarter of 2025; (iii) AMPLIFY-7P: Complete enrollment in the randomized Phase 2 trial in the fourth quarter of 2024 with interim analysis expected in the first quarter of 2025."

Enrollment status • P1 data • P2 data • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Announces Preliminary Disease-Free Survival analysis from the Ongoing AMPLIFY-7P Phase 1a Study of ELI-002 7P (GlobeNewswire) - P1/2 | N=156 | AMPLIFY-7P (NCT05726864) | Sponsor: Elicio Therapeutics | "Data were based on the May 24, 2024 data cutoff date of 14 patients with minimal residual disease who enrolled in the Phase 1 cohort of the AMPLIFY-7P study, with a median follow up for the DFS endpoint of 29.1 weeks: The median DFS has not yet been reached (n=14). The median disease-free survival ('mDFS') has not been reached in patients receiving the 4.9mg AMP-peptide dose (n=8) vs. 12.6 weeks for patients receiving the 1.4mg AMP-peptide dose (n=6). Patients achieving a reduction in their tumor biomarker levels had no progression events vs. mDFS of 11.0 weeks for patients whose tumor biomarker did not respond to ELI-002 7P....We look forward to providing additional clinical data updates from the AMPLIFY Phase 1 trials expected later in 2024 and the randomized Phase 2 interim analysis expected in first quarter of 2025."

P1 data • P2 data • Pancreatic Ductal Adenocarcinoma

AMPLIFY-7P, a first-in-human safety and efficacy trial of adjuvant mKRAS-specific lymph node targeted amphiphile ELI-002 7P vaccine in patients with minimal residual disease–positive pancreatic and colorectal cancer. (ASCO 2024) - P1/2 | "Earlier ELI-002 2P showed high rates of T cell and tumor biomarker response (both 21/25, 84%), with median relapse-free survival not reached versus 4.01 months (HR 0.14; p=0.0167) comparing patients (pts) above versus below T cell median (12.75X)...Pts with elevated circulating tumor DNA (ctDNA) and/or serum tumor biomarker (CA19-9/CEA), and KRAS mutation were enrolled and treated with subcutaneous fixed dose Amph-CpG-7909 and 1.4 mg or 4.9 mg of Amph-Peptides 7P (Table)... ELI-002 7P was safe with median RP2D T cell responses exceeding the prior formulation (7P median 109.2; 2P 12.75), and early indications of antitumor activity. The randomized phase II is now open in patients with pancreas cancer."

Clinical • Minimal residual disease • P1 data • Residual disease • Colorectal Cancer • Fatigue • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CA 19-9 • CD4 • CD8 • KRAS

Durable immunogenicity of ELI-002 2P in AMPLIFY-201: Lymph node targeted mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer (AACR 2024) - P1, P1/2 | "ELI-002 2P consists of 2 Amph-modified mKRAS peptide antigens, Amph-G12D and Amph-G12R (Amph-Peptides 2P), and an Amph-modified immune-stimulatory oligonucleotide adjuvant (Amph-CpG-7909). ELI-002 is an off-the-shelf vaccine targeting common KRAS tumor mutations demonstrating several key advantages: lymph node-targeted vaccine design, high immunogenicity, with balanced CD4+ and CD8+ T cell responses, HLA-agnostic activity, and targeting of vaccine antigens critical for tumor survival. A randomized Phase 2 clinical trial (NCT05726864) investigating a 7-peptide formulation (G12D, R, V, A, C, S, G13D) is underway."

IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • CD4 • CD8 • GZMB • IFNG • IL2 • KRAS • TNFA

Elicio Therapeutics to Present Updated Clinical T Cell and Antigen Spreading Response Data from the Ongoing AMPLIFY-201 Phase 1 Study of ELI-002 and Preclinical Data on ELI-007 and ELI-008 at the AACR Annual Meeting (GlobeNewswire) - P1 | N=25 | AMPLIFY-201 (NCT04853017) | Sponsor: Elicio Therapeutics | "In the first-in-human, Phase 1 (AMPLIFY-201) study, ELI-002 was given as adjuvant treatment for patients with high relapse-risk mKRAS-driven colorectal cancer ('CRC') and pancreatic ductal adenocarcinoma ('PDAC')....25 patients received ELI-002 2P at 1.4 mg of Amph-Peptides 2P and Amph-CpG-7909 at 5 escalating dose levels: 0.1, 0.5, 2.5, 5, and 10 mg.....68% of patients treated with ELI-002 developed cytotoxic mKRAS-specific CD4+ T cells. 84% of patients treated with ELI-002 developed cytotoxic mKRAS-specific CD8+ T cells. The majority of ELI-002-treated patients tested had antigen spreading where induced T cells targeted additional patient-specific tumor mutations beyond mKRAS. The majority of patients who received a ELI-002 booster dose were observed to have durable mKRAS-specific T cell response with increased memory T cell phenotype."

P1 data • Colorectal Cancer • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Announces Upcoming Presentations at the American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "Elicio Therapeutics, Inc...announced three upcoming poster presentations at the American Association for Cancer Research ('AACR') Annual Meeting taking place from April 5-10, 2024, in San Diego, California. The presentations will highlight data on Elicio’s therapeutic cancer vaccine candidates, ELI-002, ELI-007 and ELI-008, built using Elicio’s Amphiphile ('AMP') technology, which harnesses the power of the lymph nodes to generate and activate T cells to target solid tumors."

Clinical data • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

AMPLIFY-7P: Phase 1 and randomized phase 2 study of amphiphile immunotherapy ELI-002 7P as adjuvant treatment for subjects with G12D, G12R, G12V, G12C, G12A, G12S and G13D Kirsten rat sarcoma (KRAS)-mutated pancreatic ductal adenocarcinoma. (ASCO-GI 2024) - P1/2 | "ELI-002 2P is a lymph node targeted immunotherapy comprised of Amphiphile (Amph)-modified G12D, G12R, G12V, G12C, G12A, G12S and G13D mutant KRAS peptides together with an Amph-modified CpG oligonucleotide adjuvant...Subsequent patients will receive up to 10 doses of Amph-peptides 7P 700 mcg each (4.9 mg total), together with Amph-CpG-7909 (10.0 mg) administered over a five-month treatment period...An interim analysis is planned using group sequential design for control of overall alpha 0.10. Clinical trial information: NCT05726864."

IO biomarker • P1 data • P2 data • Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9 • KRAS

Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial. (PubMed, Nat Med) - P1 | "Cancer vaccine ELI-002 2P enhances lymph node delivery and immune response using amphiphile (Amph) modification of G12D and G12R mutant KRAS (mKRAS) peptides (Amph-Peptides-2P) together with CpG oligonucleotide adjuvant (Amph-CpG-7909). ELI-002 2P was safe and induced considerable T cell responses in patients with immunotherapy-recalcitrant KRAS-mutated tumors. ClinicalTrials.gov identifier: NCT04853017 ."

IO biomarker • Journal • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8 • KRAS

Nature Medicine Publishes Updated Preliminary Phase 1 Data From Elicio Therapeutic’s AMPLIFY-201 Phase 1 Solid Tumor Study of ELI-002 (GlobeNewswire) - P1 | N=25 | AMPLIFY-201 (NCT04853017) | Sponsor: Elicio Therapeutics | "Elicio Therapeutics, Inc...announced the publication of data from the Phase 1 (AMPLIFY-201) study of ELI-002 2P in Nature Medicine...Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients (84%; 59% both CD4+ and CD8+). Tumor biomarker responses were observed in 21/25 patients (84%) and biomarker clearance in 6/25 patients, as determined by tumor-informed circulating tumor DNA (24%; 3 pancreatic, 3 colorectal). At 8.5 months median follow-up the median RFS of the 25-patient cohort was 16.33 months....Elicio’s plans to initiate a randomized phase 2 trial studying ELI-002 as a monotherapy in adjuvant PDAC patients early in 2024; and Elicio’s plans to research, develop and commercialize its current and future product candidates."

New P2 trial • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

AMPLIFY-201: A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: Elicio Therapeutics

Trial completion date • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • KRAS • NRAS