mRNA-4359 / Moderna - LARVOL DELTA

First-in-human, phase I/II, monotherapy, dose-escalation study of mRNA-4359, an mRNA-encoded PD-L1/IDO1 antigen-specific therapy, in advanced/refractory solid tumors (ESMO 2024) - P1/2 | "mRNA-4359 monotherapy was well tolerated at all tested dose levels with observation of SD and detectable antigen-specific T cell response. Enrollment continues in the mRNA-4359 + pembrolizumab combination arms, followed by expansion cohorts in pts with melanoma and non-small cell lung cancer."

Metastases • Monotherapy • P1/2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IDO1 • PD-L1

Experimental mRNA cancer vaccine shows potential for advanced stage cancer patients in Phase 1 trial (Eurekalert) - P1 | N=194 | NCT05533697 | Sponsor: ModernaTX, Inc. | "Interim data from the Phase I dose escalation part of the mRNA cancer immunotherapy (mRNA-4359), show promise in patients with advanced solid cancers...The investigational mRNA cancer immunotherapy is targeted for patients with lung cancer, melanoma and other solid tumours. Nineteen patients with advanced stage cancers received between one and nine doses of the immunotherapy treatment...Data also showed the mRNA immunotherapy could activate the immune system in many patients, generating immune cells in the blood that could recognise the two proteins of interest (PD-L1 and IDO1)....The trial continues to recruit patients with melanoma and lung cancer in combination with the immunotherapy drug pembrolizumab to provide more information on the safety and efficacy of the therapy."

Enrollment status • P1 data • Lung Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor

New mRNA 'cancer vaccine' trial launches in UK (Live Science) - "An 81-year-old man from Surrey became the first patient in the U.K. to receive a new 'vaccine' designed to treat solid-tumor cancers, such as the skin cancer melanoma....The new vaccine being tested in the U.K. and elsewhere around the world is called mRNA-4359..."

New trial • Melanoma • Skin Cancer • Solid Tumor

Phase 1/2 study of mRNA-4359 administered alone and in combination with immune checkpoint blockade in adult participants with advanced solid tumors. (ASCO 2023) - P1/2 | "Arm 1b will be dose confirmatory and will run concurrently with a pharmacodynamic arm; both will assess mRNA-4359 in combination with pembrolizumab in patients with primary/secondary checkpoint inhibitor refractory locally advanced/metastatic melanoma or NSCLC. Study enrollment into Arm 1a has commenced in the United States and Australia with plans to open sites in Europe later in 2023. Clinical trial information: NCT05533697."

Checkpoint block • Checkpoint inhibition • Clinical • Combination therapy • Metastases • P1/2 data • Basal Cell Carcinoma • Bladder Cancer • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Immune Modulation • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • IDO1

Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=194 | Recruiting | Sponsor: ModernaTX, Inc.

Checkpoint inhibition • Combination therapy • New P1/2 trial • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ALK • CD4 • CD8 • EGFR • FOXP3 • ROS1

Moderna Expands Its mRNA Pipeline with Three New Development Programs (Yahoo Finance) - "Moderna's new checkpoint cancer vaccine candidate (mRNA-4359) expresses Indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1) antigens. Moderna designed mRNA-4359 with the goal of stimulating effector T-cells that target and kill suppressive immune and tumor cells that express target antigens. Moderna is planning to explore initial indications for advanced or metastatic cutaneous melanoma and non-small cell lung carcinoma (NSCLC)."

Pipeline update • Cutaneous Melanoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor