On June 2, 2021 ImmVira reported that it will present results from its clinical Phase I study of MVR-T3011 via intratumoral (IT) administration at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 4-8, 2021 for the first time (Press release, Immvira, JUN 2, 2021, View Source [SID1234583430]).
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MVR-T3011 is ImmVira’s first proprietary next-generation, genetically modified oncolytic herpes simplex virus ("oHSV"), is a novel virus backbone design driven by ImmVira’s innovative insights in oncolytic viruses and superior gene recombinant technology. oHSV can selectively replicate in and kill tumor cells without harming normal cells. Additionally, MVR-T3011 incorporates two exogenous genes, PD-1 antibody and IL12, which further enhances immune responses.
This Phase I study is being conducted at multiple sites in Australia and the U.S. Subjects with advanced solid tumors who have accessible injectable lesions were enrolled to receive MVR-T3011 as an IT injection once every other week. Preliminary results from this Phase I study demonstrate a favorable safety profile. MVR-T3011 has been well tolerated at the dose levels tested with no dose limiting toxicities or treatment-related Severe Adverse Events in the dose escalation phase of the study. Analysis from biopsy samples taken pre- and post-treatment from subjects with accessible lesions showed significant tumor cell reduction as well as increased lymphocyte infiltration, indicating on-target anti-tumor activity. Many subjects have achieved stable disease and remain on study.
The dose escalation portion of the Phase I clinical studies of MVR-T3011 via IT administration in China, Australia, and the U.S. has completed and the dose expansion portion of the studies are on-going. ImmVira is continuing its research and development on its unique OvPENS platform to further expand its new product pipelines and commit to providing effective, innovative and safe anti-cancer oncolytic virotherapies.