ImmVira's MVR-T3011 Obtained NMPA's Approval for Intravenous Administration (IV) Phase I Clinical Trial

ImmVira announced that as a global first, its lead oncolytic virus therapy program MVR-T3011 IV (also known as T3011), obtained approval from National Medical Products Administration for clinical trial for treatments using intravenous administration (IV) on August 6, 2021.

Intravenous administration (IV) has long been a big challenge for oncolytic herpes virus and many other types of oncolytic viruses. Most oncolytic viruses cannot overcome multiple obstacles, such as neutralized and eliminated by antibodies and there are also potential risks, such as a large number of viruses that are introduced into the blood may lead to cytokine storm in the body. The new generation of virus design requires that the virus effectively reach tumor site with sufficient potency to replicate to exert anti-cancer effects while maintain a high safety profile.

MVR-T3011, ImmVira's proprietary 3-in-1 oHSV, is a new next-generation design driven by ImmVira's innovative insights in oncolytic viruses and superior gene recombinant technology. MVR-T3011 is a novel genetic engineered oHSV which achieves the most favorable profile of attenuated HSV-1 for replication potency and safety for normal cells, to allow the breakthrough of intravenous administration of oHSV while ensures the safety of tumor selectivity. In addition, selective incorporation of two latest and well-validated payloads encoding exogenous immune modulatory genes, namely PD1 antibody and IL12, can improve the synergistic antitumor ability and promote immunoreaction in the localized tumor environment.

Leveraging the OvPENS new drug R&D platform, the clinical research projects of ImmVira's MVR-T3011 IT (the intratumoral administration of MVR-T3011) have shown good efficacy and safety data to advance to MVR-T3011 IV (the intravenous therapy of MVR-T3011). Following the success of MVR-T3011 IT, ImmVira has made exciting new developments, becoming the first company to conduct clinical trials with intravenous administration of oHSVs in the world. ImmVira will continue researching and developing on the OvPENS platform to expand new product pipelines and commit to providing effective, innovative and safe anti-cancer OV therapies.

About ImmVira

ImmVira is a biotechnology company focused on genetically modified oncolytic viruses as potential cancer therapeutics. The company has developed science, technology and know-how to support ongoing research, development and commercialization of oncolytic viruses on the OvPENS (OV+ Potent, Enabling, Novel & Safe) platform. The OvPENS platform comprises of research, patents, gene-recombinant know-how, manufacturing technology and commercialization analytics to develop next-generation oncolytic viruses that reach drug development targets and that are potent, enabling, novel and safe.