ImmVira enters clinical development in combination therapy of MVR-T3011 IT and MEK inhibitor in the U.S.

SHENZHEN,China,April 20,2022 -- ImmVira announced that,company has reached a cooperation agreement with Roche to establish clinical research partnership recently,to conduct clinical studies in the U.S. on the combination therapy of ImmVira's MVR-T3011 IT and Roche's MEK inhibitor cobimetinib,to evaluate the safety and efficacy of this combo strategy.

MVR-T3011,ImmVira's proprietary 3-in-1oncolytic herpes simplex virus ("oHSV"),is a novel genetically engineered oHSV which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells. The incorporation of two latest and well-validated exogenous genes,PD-1 antibody and IL-12,further enhances immune responses in the tumor microenvironment. MVR-T3011 IT clinical trials started in 2020 and are currently in Phase II in both the U.S. and China. Single agent treatment has demonstrated good safety profile and preliminary efficacy results.

In 2021,ImmVira research group published a scientific paper,"Enhancing Therapeutic Efficacy of Oncolytic Herpes Simplex Virus with MEK Inhibitor Trametinib in Some BRAF or KRAS-Mutated Colorectal or Lung Carcinoma Models". In vitro and in vivo anti-tumor studies showed that,treatment with MEKi augmented oHSV oncolytic activity in BRAF V600E-mutated tumor cells and the combination treatment enhanced virus replication mediated by down-regulation of STAT1 and PKR expression or phosphorylation in BRAF V600E-mutated tumor cells as well as BRAF wt/KRAS-mutated tumor cells. Furthermore,a significant synergistic therapeutic efficacy was shown in vivo for BRAF wt/KRAS-mutated tumor models,when a combination of MEK inhibition and oHSV expressing PD-1 blockade antibody and IL-12.

"This combo clinical study further demonstrates the potential ability of MVR-T3011 to further extend clinical benefit to a wide range of approved treatment programs. This is also the first combination therapy other than checkpoint inhibitor of our core oncolytic products,and the first application of from scientific exploration to clinical studies. We are particularly pleased to collaborate with Roche with their leadership in the industry,global footprint and a deep pocket of established as well as novel programs driven by the inspiring purpose of doing now what patients need next," said Dr. Grace Zhou,CEO of ImmVira.

"Based on OvPENS new drug R&D platform,ImmVira will continue to push forward the envelope of vector-based oncology solutions. Leveraging a unique approach to modify the tumor environment,our pipeline of single agent and combo programs aims to become a new generation of safer and more effective therapies to address the increasingly complex cancer patients' needs worldwide."

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 (OV+ 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.

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