On August 10, 2021 ImmVira reported that it has initiated its lead oncolytic virus therapy program MVR-T3011 IV (also known as T3011) (Press release, Immvira, AUG 10, 2021, View Source [SID1234586259]). The first patient has been dosed, receiving MVR-T3011 intravenous (IV) administration in the U.S. on August 10, 2021. The Phase I clinical trial is being conducted at multiple well-established clinical institutions, including Sarah Cannon Research Institute, Mary Crowley Cancer Research, and Prisma Health (ClinicalTrials.gov Identifier: NCT04780217).
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Dr. Joy Zhu, Chief Medical Officer of ImmVira, stated that "MVR-T3011 IV officially entering clinical study is a breakthrough in the administration of the oncolytic herpes simplex virus. We are hopeful that MVR-T3011 IV will demonstrate good safety profile and promising clinical results. Systemic delivery of MVR-T3011 IV provides an opportunity to treat many advanced cancers that cannot be reached via intratumoral injection."
Dr. Joy Zhu joined ImmVira with more than 25 years of drug development experience. She held leadership positions in several biotech companies, as well as several start-up companies, including legacy SUGEN, Amgen, and Halozyme Therapeutics. Dr. Zhu has broad and in-depth experience in pre-IND planning, IND filings, and NDA submissions with the U.S. FDA and many other regulatory agencies. She was responsible for the clinical development of two blockbuster drugs, SUTENT (sunitinib malate) and XGEVA (denosumab), which are widely recognized in the broad market.
"We are excited about the prospects of IV administration of MVR-T3011 IV. After MVR-T3011 IV’s NMPA clinical trial approval in China, the completion of first dosing in the U.S. marks another significant step for ImmVira’s pipeline development. Leveraging the OvPENS new drug R&D platform aimed at next-generation cancer therapy evolution, ImmVira is expected to reshape the future of oncolytic virotherapy and bring hope to cancer patients and their families," Dr. Grace Zhou, CEO of ImmVira, concluded.