ImmVira’s breakthrough product MVR-T3011 IV, global first clinical-stage oncolytic herpes simplex virus (oHSV) via intravenous injection, has recently completed first 2 cohorts dose-escalation of U.S. Phase I clinical study, and demonstrated good safety and tolerability results.
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Late stage patients with pancreatic, colon, lung, and endometrial cancer have been enrolled for the first two dose levels. MVR-T3011 IV has showed good safety and tolerability data at the first two dose levels tested with no dose limiting toxicities (DLT) or treatment-related severe adverse events (SAEs). ImmVira will continue exploring safety and tolerability for higher doses, and determine recommended phase II dose (RP2D) based on integrated analysis of preliminary efficacy and pharmacokinetics/pharmacodynamics (PK/PD) data.
Intravenous administration (IV) has long been a big challenge for the research and development of oncolytic viruses, especially oHSV. Most oncolytic viruses cannot overcome multiple obstacles, such as being neutralized and eliminated by antibodies, while present potential risks, such as a large number of viruses inducing cytokine storm in the body when entering the blood stream. The ideal design of intravenous oncolytic virus requires that the virus effectively reach tumor site with sufficient potency to replicate to fully exert anti-cancer effects while maintain a high safety profile. Additionally, the virus can escape from elimination of neutralizing antibodies to allow repeated administration.
MVR-T3011 IV, ImmVira’s proprietary 3-in-1 oHSV, is a novel genetic engineered oHSV which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells, to achieve the breakthrough of intravenous administration of oHSV. In addition, MVR-T3011 IV carries two latest and well-validated exogenous immune modulatory genes, namely PD-1 antibody and IL-12, and these exogenous payloads are only expressed when virus selectively replicates in tumor cells after intravenous injection, thus achieving synergistic antitumor effect, promoting immunoreaction in the localized tumor microenvironment and ensuring tumor-specific delivery of exogenous therapeutic proteins.