camupepimut (ELI-002 7P) / Elicio Therap - LARVOL DELTA

Elicio Therapeutics…announced that new pre-specified analyses from the randomized Phase 2 AMPLIFY-7P study of ELI-002 7P in resected pancreatic ductal adenocarcinoma ('PDAC') have been selected for a late-breaking Proffered Paper oral presentation at the European Society for Medical Oncology ('ESMO') Congress 2026 (GlobeNewswire) - "The late-breaking abstract will be available via the ESMO Congress 2026 website beginning at 00:05 CEST on October 23, 2026, the day of the presentation....New pre-specified analyses from the randomized Phase 2 study will further characterize the clinical potential of ELI-002 7P (camupepimut) in adjuvant pancreatic cancer....While the study did not meet its pre-specified primary disease-free survival ('DFS') endpoint in the intent-to-treat population, subsequent analyses have provided important insights into the clinical and biological activity of ELI-002 7P and informed the Company’s continued evaluation of the program."

Late-breaking abstract • P2 data • Pancreatic Ductal Adenocarcinoma

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

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."

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

AMPLIFY-201, a first-in-human safety and efficacy trial of adjuvant ELI-002 2P immunotherapy for patients with high-relapse risk with KRAS G12D- or G12R-mutated pancreatic and colorectal cancer. (ASCO 2023) - P1, P1/2 | "In a 3+3 dose escalation, n=22 received a subcutaneous course of 6 prime and 4 booster injections of fixed dose Amph-peptides (1.4 mg), admixed with escalating Amph-CpG-7909 (Table). ELI-002 2P, evaluated in a novel MRD+ trial, was safe with ctDNA and serum tumor biomarker reduction and clearance and notable immune responses. The RP2D is the start dose for a phase 1/randomized phase 2 study evaluating a new seven peptide formulation for G12 D, R, V, S, A, C, and G13D mutated solid tumors (NCT05726864). Clinical trial information: NCT04853017."

Clinical • IO biomarker • P1 data • Colorectal Cancer • Fatigue • Gastrointestinal Cancer • Oncology • Pain • Pancreatic Cancer • Solid Tumor • CA 19-9 • CD4 • CD8 • KRAS • NRAS • RAS

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

First-in-human phase 1 trial of ELI-002 immunotherapy as treatment for subjects with Kirsten rat sarcoma (KRAS)-mutated pancreatic ductal adenocarcinoma and other solid tumors. (ASCO 2022) - P1 | "Patients with colon and pancreas cancer with Stage IV oligometastatic disease (< 3 lesions in one organ) rendered surgically free of disease and with MRD, are also eligible. The dose escalation portion of the study is currently enrolling."

IO biomarker • P1 data • Preclinical • Colorectal Cancer • Gallbladder Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • KRAS • NRAS

Elicio Therapeutics…announced the opening of the investigator-initiated ('IIT') Phase 1 neoadjuvant study (NCT07671339) evaluating ELI-002 7P in combination with chemotherapy and an anti-PD1 checkpoint inhibitor in borderline resectable and resectable PDAC (GlobeNewswire) - "The randomized, open-label Phase 1 trial aims to enroll 20 patients with resectable or borderline resectable KRAS-mutant PDAC. Participants will receive ELI-002 7P with standard chemotherapy, mFOLFIRINOX, with or without tislelizumab, an anti-PD1 checkpoint inhibitor, starting before surgery."

Trial status • Pancreatic Ductal Adenocarcinoma

AMPLIFY-7P: A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors (clinicaltrials.gov) - P1/2 | N=158 | Active, not recruiting | Sponsor: Elicio Therapeutics | Trial primary completion date: Nov 2026 ➔ Apr 2026

First-in-human • IO biomarker • Trial primary completion date • Colorectal Cancer • Neuroblastoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • KRAS • NRAS

A Study of ELI-002 7P, With or Without Tislelizumab, in People With Pancreatic Cancer (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center

New P1 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

Elicio Therapeutics Reports Results from Phase 2 AMPLIFY-7P Study and Outlines Refined Phase 3 Development Strategy for ELI-002 7P in Adjuvant Pancreatic Cancer (GlobeNewswire) - "Post-hoc landmark analyses demonstrated a ~14% absolute improvement in DFS rates during active treatment at both 3 months (90.3% vs. 76.6%, p=0.022) and 6 months (75.7% vs. 61.7%, p=0.056); Randomization was stratified by nodal status; however, there was an imbalance in baseline R1 resection status, a known adverse prognostic factor, which disproportionately favored the observation arm (ELI-002 7P 19% vs. observation 10%); Multivariable analyses identified R1 resection as an adverse prognostic factor for recurrence (HR 1.56, p=0.181). Post-hoc analyses demonstrated stronger treatment effect in the R0 resected patient population (HR 0.65, p=0.048, n=121)...Subject to financing, the Company plans to initiate a Phase 3 study with the following key elements: Enrollment of R0 resected patients following completion of standard locoregional therapy; Additional dosing beyond the initial ELI-002 7P immunization and booster regimen; A registrational study with a primary endpoint of DFS."

New P3 trial • P2 data • Retrospective data • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Reports Multiple Complete Responses After ELI-002 7P Treatment and Subsequent Therapy with Checkpoint Inhibition in Metastatic mKRAS Pancreatic Cancer (GlobeNewswire) - "100% confirmed complete radiographic and complete metabolic responses in three patients who progressed on ELI-002 7P treatment during the Phase 2 AMPLIFY-7P study and received nivolumab-based subsequent therapy. Complete responses ('CRs') are rarely (0-8%) observed in metastatic pancreatic cancer in published studies evaluating chemotherapy-, checkpoint inhibitor-, and RAS inhibitor-based regimens....The Company also announced plans to conduct a Phase 1 study in first-line metastatic mKRAS PDAC, subject to funding. If validated by a Phase 1 study, activity in metastatic PDAC may allow a rapid development pathway for ELI-002 7P and inform the design of the future Phase 3 trial in adjuvant PDAC."

New P1 trial • P2 data • Pancreatic Ductal Adenocarcinoma

The event-driven primary DFS endpoint analysis for Elicio’s randomized Phase 2 AMPLIFY-7P trial in post-resection mKRAS PDAC is anticipated mid-year 2026. (The Manila Times) - "Fewer disease progressions and deaths than projected to date have been observed...The Company remains blinded to the Phase 2 AMPLIFY-7P trial clinical efficacy outcomes. The Company plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to align on the Phase 3 trial design for ELI-002 7P in resected mKRAS PDAC and to advance ELI-002 7P toward initiation of a registrational study"

New P3 trial • P2 data • Trial status • Pancreatic Ductal Adenocarcinoma

AMP-peptide vaccination against multiple p53 mutant epitopes promotes lymph node delivery to generate potent, functional T cell immunity (AACR 2024) - P1/2 | "This approach was shown to promote activation of polyfunctional, cytotoxic T cells with promising safety and improved clinical outcomes in a Phase 1 trial of ELI-002, an mKRAS AMP therapeutic vaccine (AMPLIFY-201 NCT05726864). These substantially improved immune responses induced by ELI-008 represent a promising therapeutic opportunity for targeting cancer in a large fraction of human tumors. The AMP-platform technology is simple, rapid and scalable, promising broad clinical, off-the-shelf application for treating p53 mutated tumors."

IO biomarker • P53mut • Oncology • GZMB • IFNG • IL2 • TNFA • TP53

AMP-peptide vaccination against mutant BRAF epitopes promotes lymph node delivery to generate potent, functional T cell immunity (AACR 2024) - P1 | "This approach was shown to promote activation of polyfunctional, cytotoxic T cells with promising safety, and improved clinical outcomes in a Phase 1 trial of ELI-002, an mKRAS AMP therapeutic vaccine (AMPLIFY-201 NCT04853017). These enhanced immune responses provide an encouraging therapeutic opportunity to treat >90% of BRAF-mutated cancers[5] with the AMP-mBRAF vaccine, ELI-007. Moreover, the AMP-platform technology is simple, rapidly executable, and scalable, promising broad clinical off-the-shelf application for BRAF."

IO biomarker • Oncology • BRAF • IFNG • IL2 • TNFA

Upcoming Anticipated Milestones for the AMPLIFY-7P Phase 2 Trial (GlobeNewswire) - "(i) Oral presentation in the Targeted Immunotherapies section at the World Vaccine Congress Washington 2026...highlighting the ELI-002 platform overview, updated Phase 1 2P data (safety, T-cell responses, correlations to tumor biomarkers, RFS and OS), Phase 1 7P data, and Phase 2 AMPLIFY-7P updates (T-cell responses, HLA association and antigen spreading); (ii) ELI-002 to be highlighted...at the American Association for Cancer Research ('AACR') Annual Meeting 2026...; (iii) Event-driven primary DFS analysis of the Phase 2 AMPLIFY-7P trial anticipated in 1H 2026; (iv) Plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration ('FDA') to finalize the Phase 3 trial design for ELI-002 7P in resected mKRAS PDAC following completion of the primary DFS analysis."

Clinical data • FDA event • Colorectal Cancer • Pancreatic Ductal Adenocarcinoma

Upcoming Anticipated Milestones for the Phase 2 AMPLIFY-7P Trial (Elicio Press Release) - "Upon reaching the event-driven primary DFS endpoint analysis, Elicio will request an End of Phase 2 meeting with the U.S. Food and Drug Administration ('FDA') to finalize the Phase 3 trial design for ELI-002 7P. Alignment on key elements of the Phase 3 study design was reached with the FDA at the End of Phase 1 meeting announced in Q1 2025."

FDA event • Colorectal Cancer • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Updates (Elicio Press Release) - "The Company expects that its current cash and cash equivalents will support operations through Q2 2026, beyond the anticipated Phase 2 AMPLIFY-7P event-driven primary DFS endpoint analysis anticipated in 1H 2026."

Commercial • P2 data • Colorectal Cancer • Pancreatic Ductal Adenocarcinoma

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

Amphiphile (AMP)-Immunomodulator therapy controls growth and eradicates syngeneic solid tumors (SITC 2025) - P1, P1/2 | "Amphiphile (AMP)-CpG-7909 (ELI-004) is an ideal candidate in this context, as it has been designed to enhance tumor tissue retention by anchoring into cell membranes via its lipophilic AMP-tail.1 ELI-004 has been evaluated in multiple phase 1/2 trials (NCT04853017/NCT05726864) as part of an AMP-CpG-7909-adjuvanted peptide immunotherapy targeting mutant KRAS antigens (ELI-002). On day 42, ten days after the therapy phase concluded, tumor growth remained well controlled with 25% of mice achieving complete response and long-term non-progression, and no mice reaching euthanasia criteria. The 5 nmol AMP-CpG-7909 in situ treatment was well tolerated with no adverse safety observations.Conclusions Overall, these results demonstrate the potential for AMP-immunomodulators as promising off-the-shelf agents for in situ immunotherapy that is not patient-restricted or limited to specific tumor mutations and can induce potent cellular immune responses to control tumor growth."

Immunomodulating • IO biomarker • Oncology • Solid Tumor • KRAS

Title: 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 (GlobeNewswire) - "Elicio Therapeutics reports robust, cytolytic mKRAS-specific T cell responses across diverse patient HLA in ongoing phase 2 AMPLIFY-7P Trial of ELI-002 7P...at SITC....Among 90 evaluable patients treated with ELI-002 7P in the ongoing Phase 2 AMPLIFY-7P trial, 99% achieved robust mKRAS-specific T cell responses, with a mean145-fold increase over baseline. Consistent and broad immunogenicity was observed, with 85% of patients showing combined CD4 and CD8 T cell activation-previously correlated with clinical activity-and 86% of mKRAS target antigens (540/630) eliciting immune responses."

Late-breaking abstract • P2 data • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics to Present Clinical…Data at the SITC 2025 Annual Meeting (GlobeNewswire) - "Late-breaking poster presentation to highlight new immunogenicity data from ongoing Phase 2 AMPLIFY-7P trial of ELI-002 in patients with mKRAS-driven pancreatic cancer."

Late-breaking abstract • P2 data • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Reports Robust T cell Responses Across Diverse HLA backgrounds in Ongoing Phase 2 AMPLIFY-7P Trial (Elicio Press Release) - "ELI-002 7P demonstrated robust mKRAS-specific T cell responses across a broad range of HLA types, highlighting its potential for use among a diverse patient population; Patients treated with ELI-002 7P represented a diverse HLA repertoire including 1,132 unique types identified among 1,398 total HLA backgrounds in assessed patients; 99% (88/89) of patients assessed for HLA background induced mKRAS-specific T cell responses after treatment with ELI-002 7P; Induction of mKRAS-specific T cell responses suggest that ELI-002 7P may address a broad patient population with high unmet need for pancreatic ductal adenocarcinoma ('PDAC')."

P2 data • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Announces Investigator-Initiated Phase 1 Trial to be Conducted by Memorial Sloan Kettering Cancer Center and funded by The Lustgarten Foundation for Neoadjuvant ELI-002 7P in Pancreatic Ductal Adenocarcinoma (GlobeNewswire) - "The IIT will evaluate mFOLFIRINOX in combination with ELI-002 7P, with or without the anti–PD-1 antibody. The study is designed to enroll 20 patients across two cohorts (10 per arm). The trial is expected to commence in H1’2026."

New P1 trial • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Reports ELI-002 7P Achieved Robust mKRAS-Specific T Cell Responses in 99% of Evaluable Patients in Ongoing Phase 2 AMPLIFY-7P Trial (GlobeNewswire) - "ELI-002 induced mKRAS-specific T cell responses in 99% of evaluable patients (89 of 90) who were treated with the investigational vaccine immunotherapy. Robust mKRAS-specific T cell responses were observed with an average of 145.3x increase over baseline (median 44.3x; range 2.13-1310x), consistent with prior ELI-002 Phase 1 trial results....Final disease-free survival analysis in the AMPLIFY-7P trial...is anticipated to occur in the fourth quarter of 2025."

P2 data • Colorectal Cancer • Pancreatic Ductal Adenocarcinoma

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