Weekly in Asia（0407-0413）
Medigen and Oncolys Grants an Exclusive License to Chugai on Liver Cancer Medicine OBP-301
Medigen Biotechnology Corp announced the licensing and capital tie-up agreements with Japanese partner Oncolys Biopharma regarding the OBP-301 (Telomelysin) liver cancer medicine on April 8. OBP-301 is a cancer treatment developed by Medigen and Oncolys over more than 10 years. Telomelysin is a gene-modified oncolytic adenovirus in which selectively replicate in cancer cells by introducing human telomerase reverse transcriptase (hTERT) promotor. Oncolytic adenoviruses are engineered so that they replicate selectively in cancer tissue, leading to lysis of the cancer cells and release of progeny virus in a process called oncolysis. It is currently being tested in clinical trials for people with esophageal cancer in Japan, for treatment of gastric cancer in the US, as well as in Taiwan and South Korea for liver cancer patients.
Earlier this week, Oncolys entered into an agreement with Chugai Pharmaceutical Co Ltd, granting an exclusive license, with sublicensing rights for the development, manufacture and marketing of OBP-301 in Taiwan and Japan.
Oncolys and Chugai, a member of the Roche Group, also reached a licensing agreement that grants Chugai an exclusive option on the worldwide development, manufacture and marketing of OBP-301, excluding Taiwan, Japan, China, Hong Kong and Macau. According to a statement from Oncolys, the company is to receive ￥550 million (US$4.93 million) from Chugai as an upfront payment for the exclusive licensing agreement. Medigen could enjoy up to one-third of commercial interests of OBP-301.
Established in late 1999, Taiwanese drugmaker Medigen Biotechnology Corp. focuses on the development of therapies for liver diseases and cancers in Taiwan. The company also develops human native mAbs for therapeutic applications related to infectious diseases; cell-based vaccine products; and nucleic acid testing products for diagnostics.
Founded in 2004 and headquartered in Japan, Oncolys BioPharma Inc. continuously evolve its business to develop breakthrough therapy and diagnostics in cancer treatment from early to late stage, including early detection, loco-regional therapy, prognostic test, and systemic treatments.
As an important member of the Roche Group, Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies. Chugai is actively involved in the R&D of oncological drugs.
AiLife Diagnostics and BGI Americas Collaborate to Provide Clinical WGS Diagnostic Test
Genetic disorders are leading causes of childhood mortality, current genetic diagnostic tests typically include gene panels, whole exome sequencing and chromosomal microarray analysis, each only interrogating part of the genome. By investigating the full genome in a single test, whole-genome sequencing (WGS) can detect known and potential disease-causing single nucleotide variants (SNVs), insertions or deletions (indels), as well as copy number variants (CNVs) and structural variations (SVs) in both coding and noncoding regions.
WGS-based clinical diagnostic testing has been demonstrated to harness the potential to permit comprehensive and timely scan of genetic diseases.
AiLife Diagnostics Inc, a clinical molecular diagnostic and bioinformatics company, and BGI Americas, a leading global genomic services company, announced that they have partnered to develop DNBseq™ technology-based clinical whole genome sequencing solution for diagnosis of genetic diseases. This collaboration will combine BGI’s DNBseq™ next generation sequencing (NGS) technology and AiLife’s A-GPS™, I-GPS™ and D-GPS™ pipelines for clinical NGS data analysis, interpretation and reporting.
About BGI Americas
BGI Americas is a subsidiary of BGI Genomics. The company provides comprehensive sequencing and bioinformatics services for basic and translational research as well as pharmaceutical drug development in North, Central and South America.
About AiLife Diagnostics
AiLife Diagnostics, Inc., founded by a group of experts in genome medicine, bioinformatics, quality management, customer services and finance, has developed several NGS analysis tools that can greatly facilitate the analysis, interpretation and research mining of NGS data.
The Newly Launched Cytovant Sciences Partners with Medigene to Develop Cellular Therapies in Asia
Sinovant Sciences and Roivant Sciences launched Cytovant Sciences, a biopharmaceutical company focusing on the development and commercialization of innovative cellular therapeutics in Asia. Cytovant subsequently entered into a multi-program license and collaboration agreement with Medigene AG, a clinical stage T cell immunotherapies developing biotechnology company, to develop, manufacture, and commercialize MediGene’s research-stage T-cell immunotherapy against tumor antigen NY-ESO-1 as well as rights for Medigene’s dendritic cell (DC) vaccine for the treatment of patients in Greater China, South Korea, and Japan. Cytovant and Medigene also signed a strategic collaboration and discovery deal for two more targets of T-cell receptor (TCR) immunotherapies, leveraging MediGene’s TCR discovery and isolation platform to generate and deliver TCR constructs tailored specifically to Asian patients. Cytovant will accordingly develop and commercialize the TCR therapies.
Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D in China to meet the needs of patients in Greater China and around the world.
Roivant Sciences, Founded in 2014 in New York, U.S., develops late-stage drug candidates. Its pharmaceutical pipeline includes solutions for neurology, endocrinology, oncology, dermatology, urology, and rare diseases.
Medigene AG is a biotechnology company headquartered in Germany. The company concentrates on the development of personalized T cell-based therapies with the focus on T cell receptor-modified T cells and has projects currently in preclinical and clinical development.
Korea Spends ￦480 Billion to Boost its Bioindustry
In the global precision medicine era, pharmaceutical and biotech industries can create jobs and add value through innovative growth. According to the Korea Biomedical Review, the South Korean government is spending 477.9 billion won ($419.3 million) to help grow the pharmaceutical and biotech industry in 2019, which includes R&D support for the artificial intelligence-based new drug development platform and building smart clinical trial infrastructure.
The government introduced the innovative pharmaceutical company designation system in 2012 and picked 43 firms. In 2014, it newly designated five companies, and in 2016, seven. In 2018, 16 qualified pharmaceutical companies were added. A state-designated innovative pharmaceutical company gets priority to participate in state R&D projects including an international joint research and tax benefits. Seven drugmakers, including Dong-A ST, Dongwha Pharm, Yungjin Pharm, Corestem, Pharma Research Products, Pharmicell, and Tego Science, designated as innovative pharmaceutical firms in 2016, are facing the expiration of the certification for innovative pharmaceutical companies. The Ministry of Health and Welfare formed a committee to extend the 2016 certification of innovative pharmaceutical companies. The government also decided to operate a public-private joint body to support drug exports, to upgrade the certification process for innovative pharmaceutical companies.
Japan Grants Sakigake Designation to Eisai’s Novel FGFR Selective Tyrosine Kinase Inhibitor E7090
Genetic aberrations in fibroblast growth factor receptors (FGFRs) was found to be critical in the proliferation, survival and migration of cancer cells as well as tumor angiogenesis and drug resistance. FGFRs are gaining attention as a promising target for cancer therapy. E7090, a FGFR tyrosine kinase inhibitor discovered by Eisai Co., Ltd., has the potential to become a new molecular targeted therapy for cancers with FGFR genetic aberrations by selectively inhibiting FGFR1, 2 and 3, and blocking those signal pathways.
In Japan, E7090 is currently being investigated in a Phase I clinical study targeting patients with solid tumors including cholangiocarcinoma harboring FGFR2 gene fusion, which account for 15-30% of biliary tract cancers.
On April 8, 2019, E7090 was granted the SAKIGAKE designation by Japan’s Ministry of Health, Labour and Welfare for the treatment of unresectable biliary tract cancer with FGFR2 gene fusion. The Sakigake Designation System promotes R&D in Japan aiming at early practical applications for innovative new medicines and other product, and is similar to the USA’s Breakthrough Therapy designation and Europe’s PRIME status.
Eisai is a Japanese pharmaceutical company headquartered in Tokyo, Japan. The company positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer.