ImmVira announced that in the Phase II Clinical Trials of its leading oncolytic virus product, MVR-T3011* as intratumoral administration (MVR-T3011 IT), ImmVira has completed the first dosing in both China and the U.S. on May 28 2021 and June 11 2021, respectively.

MVR-T3011, ImmVira's proprietary next-generation, genetically modified oncolytic herpes simplex virus ("oHSV"), is developed on a novel virus backbone design driven by ImmVira's innovative insights in oncolytic viruses and superior gene recombinant technology. The incorporation of two exogenous genes, PD-1 antibody and IL-12, further enhances immune responses. MVR-T3011 is ImmVira's first pipeline undergoing clinical trial and includes intratumoral administration of MVR-T3011. Phase I clinical trials commenced in China in April 2020 and commenced in the United States and Australia in September 2020. Data collected from these preliminary Phase I clinical studies have demonstrated a favorable safety profile and promising efficacy profile. No dose-limiting toxicities have been observed in participants.

The U.S. Phase IIa portion of the study consists of two parts: (i) MVR-T3011 as a single agent for melanoma and metastatic solid tumors; (ii) MVR-T3011 in combination with pembrolizumab for non-small-cell lung carcinoma. The China Phase IIa (MVR-T3011 as a single agent) study targets head and neck cancer, sarcoma and breast cancer. These multi-center studies cover various indications providing highly efficient and cost-effective clinical development strategy to rapidly advance clinical development for MVR-T3011 across regions.

"Leveraging the OvPENS new drug R&D platform, ImmVira is a pioneer in the field," said Dr. Grace Zhou, Chairwoman of the Board of ImmVira. "ImmVira will make best use of its long-term experience and creative insights in oncolytic virus to construct broader product pipelines and provide effective, innovative and safe single-agent as well as combined oncolytic virotherapies for the anti-tumor market." Professor Bernard Roizman has resigned from as Chairman of the Board in February 2020 due to personal health reason and he has not held any positions in ImmVira and its subsidiaries since then. Dr. Grace Zhou has been appointed as Chairwoman of the Board since February 2020.

* Note: MVR-T3011 is the pipeline designation representing T3011, the product code registered in the US and China for clinical trials.