Considerations for Clinical Translation of MG1 Maraba Virus

• Published in: Methods in molecular biology (Clifton, N.J.) Vol. 2058; p. 285
• Main Author: Breitbach, Caroline J
• Format: Journal Article
• Language: English
• Published: United States 01.01.2020
• Subjects: Animals; Clinical Trials as Topic; Drug Evaluation, Preclinical; Genetic Engineering; Genetic Therapy - methods; Genetic Vectors - genetics; Humans; Immunotherapy - methods; Neoplasms - genetics; Neoplasms - immunology; Neoplasms - therapy; Oncolytic Virotherapy - methods; Oncolytic Viruses - genetics; Oncolytic Viruses - immunology; Research Design; Rhabdoviridae - genetics; Rhabdoviridae - immunology; Translational Medical Research; Clinical translation; Heterologous prime–boost; Clinical trial design; Oncolytic virus; Maraba virus
• ISSN: 1940-6029
• DOI: 10.1007/978-1-4939-9794-7_19

Oncolytic viral immunotherapy based on the MG1 Maraba platform has undergone extensive preclinical evaluation, resulting in the advancement of two programs into clinical trials. MG1 Maraba encoding tumor antigens (tumor associated antigens or viral antigens) are used to boost antitumor immunity, while MG1 Maraba infects tumors, causes oncolysis and transforms the tumor microenvironment. An overview of MG1 Maraba clinical development is outlined here, along with general considerations relating to the design of clinical trials for complex biologic products such as oncolytic viral immunotherapies. These include choice of patient population, optimized treatment regimen, and endpoints which provide early signals of activity and inform the late-stage development path of these agents with novel mechanisms of action.