ELI-002 7P / Elicio Therap - LARVOL DELTA

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

Elicio Therapeutics Announces Publication of ELI-002 Updated AMPLIFY-201 Phase 1 Follow-up Data in Nature Medicine for Minimal Residual Disease (“MRD”) Positive, Adjuvant-Stage Patients (GlobeNewswire) - "Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients (84%), including both CD4+ and CD8+ T cell responses in 71% of patients, and 6/6 patients (100%) treated at the recommended Phase 2 dose ('RPD2'); the induction of both CD4+ and CD8+ T cells correlated with overall tumor biomarker response (p<0.0035)....At 19.7 months median follow-up (compared to 8.5 months previously), the median relapse-free survival ('RFS') was 16.33 months, and the median OS was 28.94 months for the 25-patient cohort."

P1 data • Colorectal Cancer • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Updates (The Manila Times) - "Second Quarter 2025 Financial Results R&D expense for the second quarter of 2025 was $7.0 million, compared to $8.2 million for the second quarter of 2024. The decrease of $1.2 million was primarily due to less clinical trial manufacturing as we advanced ELI-002 7P clinical development...The Company expects that its current cash and cash equivalents will support operations into Q1 2026, beyond the anticipated AMPLIFY-7P Phase 2 final analysis."

Commercial • Colorectal Cancer • Neuroblastoma • Pancreatic Ductal Adenocarcinoma • Sarcoma

Elicio Therapeutics, Inc…announced that following the Independent Data Monitoring Committee’s (’IDMC’) pre-specified interim review of the unblinded safety and efficacy data in the Company’s Phase 2 AMPLIFY-7P study in mutant KRAS (’mKRAS’)-driven pancreatic ductal adenocarcinoma (GlobeNewswire) - "the IDMC recommended that the trial continue to the final analysis without modifications. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P to date...'We look forward to the final disease-free survival ('DFS') analysis anticipated to occur in the fourth quarter of 2025...we previously reached alignment with the U.S. Food and Drug Administration ('FDA') on the key elements of the planned pivotal Phase 3 study design, and, upon final DFS analysis, plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study...The Company remains blinded to the trial clinical efficacy outcomes."

DSMB • P1/2 data • Pancreatic Ductal Adenocarcinoma

AMPLIFY-EAP: Expanded Access Protocol of ELI-002-102 in Subjects With KRAS/NRAS Mutated Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Elicio Therapeutics

IO biomarker • New trial • Neuroblastoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor

Elicio Therapeutics to Host Virtual KOL Event on June 25, 2025 to Discuss AMP-Powered ELI-002 for the Treatment of KRAS mutation-driven Pancreatic Cancer (GlobeNewswire) - "Elicio Therapeutics...announced that it will host a virtual key opinion leader ('KOL') event on Wednesday, June 25, 2025 at 2:00 PM ET to discuss the significant unmet need and current treatment landscape for mutant-KRAS ('mKRAS') driven pancreatic ductal adenocarcinoma ('PDAC'), one of the most lethal and underserved solid tumors....The discussion will also focus on Elicio’s lead product candidate, ELI-002, an AMP-powered therapeutic vaccine designed to overcome immune evasion. ELI-002 is currently being evaluated in a randomized Phase 2 trial for the adjuvant treatment of mKRAS-driven PDAC, and an event-driven disease-free survival interim analysis of the study is anticipated in Q3 2025."

Clinical • P2 data • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Secures $10 Million in Financing (The Manila Times) - "The proceeds from the Note Financing, together with Elicio’s current cash and cash equivalents, are expected to support Elicio’s operations into the first quarter of 2026, beyond the anticipated AMPLIFY-7P Phase 2 interim analysis expected in the third quarter of 2025."

Commercial • P2 data • Colorectal Cancer • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Updates (GlobeNewswire) - "Upcoming Anticipated Milestones: (i) DFS event-driven interim analysis of Phase 2 AMPLIFY-7P clinical trial expected in Q3 2025; (ii) Potential to finalize pivotal Phase 3 trial protocol for ELI-002 in resected mKRAS PDAC in H2 2025."

New P3 trial • P2 data • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Reaches Alignment with FDA on ELI-002 Registrational Strategy (GlobeNewswire) - "Elicio Therapeutics, Inc...today announced that it has received supportive feedback in an End of Phase 1 Type B meeting with the U.S. Food and Drug Administration ('FDA') regarding the registrational strategy for ELI-002. Based on the feedback received, Elicio would expect to file a Biologics License Application ('BLA') if supported by a planned Phase 3 trial."

FDA event • Pancreatic Cancer

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 | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • CNS Tumor • Colorectal Cancer • Neuroblastoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • KRAS • NRAS

…we look forward to the interim analysis of the randomized Phase 2 portion of AMPLIFY-7P, expected in the first half of 2025. (GlobeNewswire) - "A seven-peptide formulation of ELI-002 (ELI-002 7P), designed to target additional KRAS mutations (G12D, G12R, G12V, G12C, G12A, G12S and G13D), is currently being evaluated in a fully-enrolled, randomized Phase 2 study (NCT05726864), which an interim analysis is expected in H1 2025."

P2 data • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Announces Completion of Phase 2 AMPLIFY-7P Study Enrollment (GlobeNewswire) - "The Phase 2 AMPLIFY-7P study is a multicenter, open-label, randomized trial designed to evaluate the safety, tolerability and efficacy of ELI-002 7P. The trial enrolled a total of 135 PDAC patients, who were randomized 2:1 to receive subcutaneous injections of ELI-002 7P versus standard of care observation....A formal interim Phase 2 analysis, including DFS, reviewed by the study’s Independent Data Monitoring Committee, is on track for the first half of 2025. Possible outcomes include: (1) successfully achieving pre-specified criteria for reporting primary endpoint analysis; (2) continuing to final DFS analysis, expected in the second half of 2025; or (3) meeting pre-specified criteria for futility."

Enrollment closed • P1/2 data • Pancreatic Ductal Adenocarcinoma

AMPLIFY-7P phase 1a: lymph node-targeted amphiphile therapeutic cancer vaccine in patients with high relapse risk KRAS mutated pancreatic ductal adenocarcinoma and colorectal cancer (SITC 2024) - P1/2 | "ELI-002 7P consists of Amph-modified G12D, V, R, C, S, A and G13D mKRAS peptides with an Amph-modified immune-stimulatory oligonucleotide adjuvant (Amph-CpG-7909). Ethics Approval The study was approved by the local institutional review board at each study site and conducted under an FDA Investigational New Drug application or 'IND'. Consent All patients provided written informed consent."

Clinical • IO biomarker • Late-breaking abstract • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor • CD4 • CD8 • KRAS

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 Presents Updated Translational Data from ELI-002 Phase 1 AMPLIFY-7P Study at the Society for Immunotherapy of Cancer (“SITC”) 2024 Annual Meeting (GlobeNewswire) - P1/2 | N=156 | AMPLIFY-7P (NCT05726864) | Sponsor: Elicio Therapeutics | "The randomized Phase 2 portion of AMPLIFY-7P in patients with pancreatic cancer is ongoing, with enrollment expected to be completed in Q4 2024....mKRAS-specific T cell responses versus baseline were observed in all evaluable patients; median response in 4.9 mg (RP2D) group was 12-fold higher than the 1.4 mg dose group. T cell specificities covered all seven KRAS mutants targeted by ELI-002; strongest responses observed were against the most common variants, including KRAS G12R, G12D, and G12V....Magnitude of T cell response correlated with duration of DFS, based on a May 23, 2024 cutoff date; highest three quartiles of T cell responders have not yet reached mDFS, whereas the lowest quartile achieved a mDFS of 3.1 months (p=0.0027)....'We expect to provide an additional clinical data update from AMPLIFY-201 in December'."

P1 data • Trial status • Pancreatic Cancer

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

Elicio Therapeutics Announces Preliminary Data from the Ongoing AMPLIFY-7P Phase 1a Study of ELI-002 7P in Patients with mKRAS-driven Solid Tumors at the 2024 ASCO Annual Meeting (GlobeNewswire) - P1/2 | N=156 | AMPLIFY-7P (NCT05726864) | Sponsor: Elicio Therapeutics | "At data cutoff December 18, 2023, polyfunctional mKRAS-specific T cells were observed in 100% (n = 11/11) of evaluable patients. Both CD8+ and CD4+ responses were induced in 66.7% (4/6) of evaluable patients, at the RP2D 4.9 mg dose level, with higher median fold-change from baseline. Biomarker reductions were observed in 2/5 (40%) at the 1.4 mg AMP-Peptides 7P dose level and in 5/7 (71%) at the RP2D 4.9 mg dose level in patients with reductions/clearance observed for all the common G12 (G12D, G12V, G12R) and G13 (D) KRAS mutations enrolled in the study to date. Minimum residual disease clearance was observed in one (1) G12V pancreatic (PDAC) patient at 4.9 mg. Antigen-spreading was observed with increased T cell responses targeting non-immunizing, personalized tumor neoantigens observed in 7/10 (70%) evaluable patients, 6/6 (100%) evaluable patients treated at the 4.9 mg RP2D dose level."

P1 data • Pancreatic Ductal Adenocarcinoma

Elicio Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Updates (GlobeNewswire) - "Upcoming Anticipated Milestones: (i) 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; (ii) AMPLIFY-201: Provide updated immunogenicity and relapse-free survival data in the fourth quarter of 2024."

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

Elicio Therapeutics to Present New Preliminary Data from the Ongoing AMPLIFY-7P Phase 1/2 Study of ELI-002 7P in Patients with mKRAS-driven Solid Tumors at the 2024 ASCO Annual Meeting (GlobeNewswire) - "Elicio Therapeutics, Inc...today announced that it will be sharing new preliminary data from the ongoing AMPLIFY-7P Phase 1/2 study in a poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 31-June 4, 2024 in Chicago, IL."

P1/2 data • Colorectal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

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

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 • Oncology • GZMB • IFNG • IL2 • TNFA • TP53