SHENZHEN, China I July 20, 2022 I ImmVira’s global first intravenous (“IV“) administered oncolytic herpes simplex virus (“oHSV“) product MVR-T3011 IV has completed the first three cohort escalation in the U.S. Phase I clinical trial, tested dosage from 1×106 to 1×108 PFU on 10 subjects with late-stage pancreatic, colon, lung, endometrial, breast, head and neck, gastrointestinal cancers and other advanced tumors. Preliminary biodistribution and clinical results of MVR-T3011 IV demonstrated promising biological activities of MVR-T3011 IV.

I. 80% of subjects’ blood samples have pre-existing Anti-Drug antibody (“ADA“) with herpes simplex virus-1 (“HSV-1“) IgG antibody positive at baseline. Post first and repeating dose of MVR-T3011, viral DNA can be detected in blood in a dose-dependent manner with additivity from repeating dose.

II. The numbers and percentages of various types of immune cells in peripheral blood of subjects were altered post MVR-T3011 dosing, and levels of cytokines IFNγ, IL-6, IL-8, and TNFα in blood samples were altered differentially. Some patients were observed with a significant increase in IFNγ on Day 3 post-dosing representing on-target biological activities.

III. In particular, one subject in the low-dose cohort (1×106 PFU) who had continuous 17-week Stable Disease (“SD“) was observed with a significant increase in IFNγ+ CD8 cells in peripheral blood, nearly doubled after administration. In addition, RNA sequence analysis in tumor biopsy on Day 50 post first dose showed that genes related to neutrophil activation, T-cell activation, adaptive immune response, leukocyte differentiation, and cytokine secretion were notably up-regulated compared to baseline.

Intravenous injection as a delivery method remains a huge scientific and clinical challenge for oHSV candidates for many years. In application, IV dosage tends to be higher compared to intratumoral injection so that a sufficient amount of virus can reach tumor sites, countered by a higher risk of systemic cytokine storm and other severe adverse events related to a higher dosage. Moreover, generic intravenous administered viruses may be neutralized by antibodies after repeating dose. ImmVira’s proprietary breakthrough viral candidate MVR-T3011 IV is designed to become the global first clinical-stage oHSV product via intravenous injection overcoming the aforementioned challenges. ImmVira will continue to monitor and analyze ongoing clinical biodistribution data in the human body as Phase I clinical study simultaneously goes on in the U.S. and China.

About ImmVira

ImmVira is a biotechnology company focused on development of new generation novel anti-cancer drug vectors. Our advanced engineering created vectors that are highly oncolytic competent and as ideal exogenous gene delivery mechanisms. Leveraging intrinsic mechanism of action and tumor microenvironment modification, our products include replication capable oncolytic herpes simplex virus, and non-replicating exosome and tumor vaccine. The company has developed science, technology and know-how to support ongoing research, development and commercialization of best-in-class mono and combo therapies on the OvPENS (Oncological vector+ Potent, Enabling, Novel & Safe) platform.

Our clinical stage and development stage pipelines target a wide range of solid tumors and hematologic malignancies, to be used as single agent or combination treatment solutions for cancer patients at different stages, unresponsive to immunotherapy or with rare tumors, by various administration methods including intratumoral, as well as first-in-class intravenous and intraperitoneal/pleural/vesical injections. The first three oncolytic virus products are currently undergoing five Phase I or Phase II clinical trials in both United States and China.