Core Viewpoint - Elicio Therapeutics is initiating a Phase 1 investigator-initiated trial to evaluate ELI-002 7P in combination with chemotherapy and an anti-PD1 checkpoint inhibitor for treating borderline and resectable pancreatic ductal adenocarcinoma (PDAC) [1][2][4] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for cancer, particularly targeting high-prevalence cancers like mKRAS-positive pancreatic and colorectal cancers [11] - The company's lead product candidate, ELI-002, is an investigational AMP cancer vaccine targeting KRAS mutations, which are prevalent in many human cancers [5][11] Trial Details - The upcoming trial will evaluate mFOLFIRINOX in combination with ELI-002 7P, with or without the anti-PD-1 antibody, enrolling 20 patients across two cohorts [2][8] - The trial is expected to commence in the first half of 2026 [2][8] Scientific Rationale - The combination of standard neoadjuvant chemotherapy with innovative immunotherapies aims to convert "cold" tumors into "hot" tumors, enhancing T-cell responses and potentially improving surgical outcomes and long-term survival [3][4] - ELI-002 7P has shown robust T-cell responses in previous trials, targeting the immunosuppressive tumor microenvironment of PDAC [3][4] Future Prospects - If Phase 1 results are positive, the company plans to expand the treatment to a broader population, potentially benefiting more PDAC patients and enhancing commercial opportunities [4][11] - Elicio's AMP technology aims to improve immune activation and promote durable cancer immunosurveillance, with plans to expand ELI-002 to other indications, including mKRAS-positive lung cancer [11]

Core Viewpoint - Actuate Therapeutics has initiated a Phase 1b clinical trial to evaluate the combination of elraglusib, retifanlimab, and modified FOLFIRINOX as a frontline therapy for advanced pancreatic adenocarcinoma, aiming to address unmet medical needs in this challenging cancer type [1][4]. Group 1: Clinical Trial Details - The Phase 1b trial, named RiLEY (NCT06896188), will enroll up to 12 patients initially, with plans for expansion based on interim efficacy results [2]. - The primary objective is to determine the recommended phase 2 dose (RP2D) for the combination regimen, while secondary objectives include evaluating overall response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), overall survival (OS), and safety [2]. Group 2: Mechanism and Previous Results - The combination therapy is expected to provide a synergistic immune-modulatory approach, enhancing anti-tumor responses by targeting multiple immune checkpoints [3]. - Previous studies indicated that elraglusib combined with gemcitabine/nab-paclitaxel resulted in a significant increase in median overall survival, a 37% reduction in the risk of death, and a doubling of the 12-month survival rate in patients with metastatic pancreatic adenocarcinoma [3]. Group 3: Company Strategy and Future Plans - The collaboration with UPMC Hillman Cancer Center and Incyte aims to explore new synergistic opportunities for patients who have not yet received systemic therapy, enhancing both efficacy and durability of response [4]. - Actuate is also conducting a separate Phase 2 trial (NCT05077800) studying elraglusib in combination with FOLFIRINOX and losartan, with initial data showing promising results in patients with extensive liver metastases [4].