Message from the Founder

Striving to become a global leader in the field of gene therapy

Ken-ichiro Kosai
Executive Chairman,
Founder & Chief Scientific Officer

A realm of gene therapy, including oncolytic virus (OV), in vivo gene therapy, and ex vivo gene therapy, is one of the most essential technological fields in next-generation medicine. In particular, oncolytic virus (OV), a therapeutic agent for innovative cancer treatment, is witnessing its increasing worldwide applications.

The only currently-approved gene therapy drugs (excluding ex vivo gene/cell therapy and SARS-CoV-2 vaccines) are 3 products in the U.S. and 2 conditionally-approved products in Japan. Of these, only two OV therapies have been approved throughout the U.S., EU and Japan. We have developed a proprietary technology termed “technology for constructing conditionally-replicating adenovirus regulated with multiple tumor-specific factors (m-CRA)” and have leveraged this technology to create therapeutic viruses that can outperform other Ovs. Our first drug candidate, “Surv.m-CRA-1” (survivin-responsive m-CRA), was developed in compliance with GMP, GLP and other global regulatory standards and in 2020, underwent an investigator-initiated Phase I (“P1”) first-in-human clinical study. Due to the high levels of safety & efficacy data obtained from the P1 study, a P2 proof-of-concept (POC) study is currently underway in 20 patients to confirm the effects of Surv.m-CRA-1 as a therapeutic virus.

We will continue our R&D efforts in future to discover and develop multiple drug candidates. By realizing innovative gene therapies, we intend to contribute to improved health outcomes for people around the world.

Message from the President

Masaki Yamada
President

Our corporate philosophy at Surv BioPharma is “to contribute to improved global health outcomes by creating innovative pharmaceuticals that fulfill unmet medical needs”. As a drug discovery venture company originating from Kagoshima University, we intend to contribute to the growth of gene therapy in society by leveraging academic research breakthroughs to deliver novel gene therapy drugs to patients expediently.

By utilizing our company’s core strength—namely, our virus production technology platform (“m-CRA construction technology”)—we will create highly-safe & highly-effective therapeutic viruses. As the first stage in this strategy, we have created a novel OV (“Type 1”) that only attacks cancer cells, and are now working to file a new drug application (NDA) in 2025 for the treatment of bone and soft tissue tumors for which no therapeutic drugs are currently available. In addition to the Type 1 OV, we also possess several promising drug candidates. We will continue to consolidate our position as a specialty pharma company engaged in the global-scale development of novel gene therapy drugs.

Japan represents a highly-suitable environment for the resource-limited & intellectual property-intensive pharmaceutical R&D sector, and we at Surv BioPharma intend to fulfill our corporate social responsibility by creating employment and fostering the next generation of human capital through our business.