ImmVira has concluded the Phase I clinical trial of its oncolytic product, MVR-T3011 IV, to treat patients with various kinds of late-stage tumours in the US.
A three-in-one genetically engineered oncolytic herpes simplex virus (oHSV), MVR-T3011 is administered intravenously (IV).
According to the trial findings, the product showed encouraging safety and initial efficacy for some indications.
As of 31 October 2023, 94.4% of trial subjects reported treatment-emergent adverse events (TEAEs) while 88.89% had treatment-related adverse events (TRAEs) linked to the drug.
All the reported adverse events were of grade 1 or 2 severity in nature without any TRAEs of Grade 3 or higher reported.
Overall, an IV dose of MVR-T3011 demonstrated a safety profile in the trial.
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Based on RECIST 1.1 criteria, subjects with cancer of appendices, endometrium and gallbladder showed a substantial decline in tumour burden.
ImmVira chairwoman and CEO Dr Grace Guoying Zhou said: “The development of intravenously administered oncolytic virus products has long been a challenging bottleneck.
“Oncolytic viruses must overcome numerous hurdles, such as neutralisation by antibodies or the risk of cytokine storms, in order to effectively reach tumour sites with a sufficient number of viruses to achieve anti-tumour effects.
“With the successful Phase I clinical study results of MVR-T3011 IV, a global-first clinical-stage intravenous oHSV product, our company is now fully confident and committed to expediting clinical explorations in colorectal cancer, non-small cell lung cancer, and other indications, including combination treatments with immune checkpoint inhibitor or chemotherapy.”