MEDI5395 / AstraZeneca - LARVOL DELTA

Phase I study of a recombinant attenuated oncolytic virus, MEDI5395 (NDV-GM-CSF), administered systemically in combination with durvalumab in patients with advanced solid tumors. (PubMed, J Immunother Cancer) - P1 | "This study demonstrates the feasibility, safety and preliminary efficacy of MEDI5395 with durvalumab in patients with advanced solid tumors."

Combination therapy • Journal • Metastases • Oncolytic virus • P1 data • Fatigue • Oncology • Solid Tumor • CD8 • CSF2 • PD-1

A Study of MEDI5395 in Combination With Durvalumab in Participants With Select Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: MedImmune LLC | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Oncology • Solid Tumor • CD8 • PD-L1

A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=39 | Active, not recruiting | Sponsor: MedImmune LLC | Trial completion date: May 2023 ➔ Dec 2022

Combination therapy • Trial completion date • Oncology • Solid Tumor • CD8 • CSF2 • PD-L1

A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov) - P1; N=39; Active, not recruiting; Sponsor: MedImmune LLC; Trial primary completion date: May 2023 ➔ Nov 2021

Clinical • Combination therapy • Trial primary completion date • Oncology • Solid Tumor • CD8 • CSF2 • PD-L1

"Other $AZN Q3 pipeline movements: AZD4604 (inhaled Jak1) into ph1; MEDI5395 (GM-CSF-expressing oncolytic virus) discontinued." (@JacobPlieth)

Oncolytic virus • Infectious Disease • CSF2 • JAK1

A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov) - P1; N=38; Active, not recruiting; Sponsor: MedImmune LLC; Recruiting ➔ Active, not recruiting; N=188 ➔ 38; Trial completion date: May 2025 ➔ May 2023; Trial primary completion date: May 2025 ➔ May 2023

Clinical • Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • CD8 • CSF2 • PD-L1

[VIRTUAL] A phase 1 study of IV MEDI5395, an oncolytic virus, in combination with durvalumab in patients with advanced solid tumors (AACR-I 2020) - P1 | "Secondary objectives include assessing MEDI5395 pharmacokinetics (viremia and GM-CSF transgene expression), pharmacodynamics in the TME, immunogenicity, and initial efficacy in combination with durvalumab. The trial is actively accruing."

Clinical • Combination therapy • IO biomarker • Oncolytic Virus • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • CSF2 • IFNG

Recombinant Newcastle disease virus immunotherapy drives oncolytic effects and durable systemic antitumor immunity. (PubMed, Mol Cancer Ther) - "CRISPR modifications rendered CT26 significantly more permissive to NDV replication, and in this setting NDVmuGM-CSF confers immune-mediated¬¬¬¬¬¬ effects in the non-injected tumor in vivo. Taken together the data supports the thesis that MEDI5395 primes and augments cell mediated antitumor immunity and has significant utility as a combination partner with other immunomodulatory cancer treatments."

Journal • Immune Modulation • Inflammation • Oncology • CSF2

A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov) - P1; N=164; Recruiting; Sponsor: MedImmune LLC; Active, not recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Oncology • Solid Tumor • CD8 • CSF2 • PD-L1

Oncolytic Newcastle disease virus activation of the innate immune response and priming of antitumor adaptive responses in vitro. (PubMed, Cancer Immunol Immunother) - "MEDI5395 therefore exhibited potent immunostimulatory activity and an ability to enhance antigen-specific T-cell priming. This, coupled with its tumor-selective oncolytic capacity, underscores the promise of MEDI5395 as a multimodal therapeutic, with potential to both enhance current responding patient populations and elicit de novo responses in resistant patients."

IO Biomarker • Journal • Preclinical • Immune Modulation • Immunology • Inflammation • Oncology

A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov) - P1; N=164; Active, not recruiting; Sponsor: MedImmune LLC; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Oncology • Solid Tumor • CD8 • CSF2 • PD-L1

A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov) - P1; N=164; Recruiting; Sponsor: MedImmune LLC; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open

A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors (clinicaltrials.gov) - P1; N=164; Not yet recruiting; Sponsor: MedImmune LLC

Clinical • Combination therapy • New P1 trial