Promega and Henlius Developing Microsatellite Instability Companion Diagnostic IVD Kit for Serplulimab in China
Companion diagnostic will identify cancer patients likely to benefit from novel anti-PD-1 monoclonal antibody for treatment of microsatellite instability-high solid tumors
Madison, WI USA. (August 5, 2021)
Shanghai Promega Biological Products Co., Ltd. and Shanghai Henlius Biotech, Inc. will develop and commercialize a microsatellite instability (MSI) companion diagnostic IVD kit to identify cancer patients likely to benefit from serplulimab, a novel anti-PD-1 monoclonal antibody (mAb) developed by Henlius for the potential treatment of microsatellite instability-high (MSI-H) solid tumors. The kit will be available to doctors in the Chinese Mainland to screen for MSI and inform immunotherapy options.
The collaboration agreement, announced today, allows the companies to leverage complementary strengths. The New Drug Application (NDA) of serplulimab was recently granted priority review by the National Medical Products Administration (NMPA) in China. Promega has more than 15 years of experience in MSI research, and its MSI assay has been applied to several clinical studies around the world. The companion diagnostic method being co-developed is multiplex polymerase chain reaction (PCR) by capillary electrophoresis, which is regarded as the “gold standard” of MSI testing in the industry with high accuracy and specificity.
MSI is a form of genomic instability caused by the insertion or deletion of repeating bases called microsatellites during DNA replication and the failure of the mismatch repair (MMR) system to correct these errors. MSI status is a measure of MMR deficiency commonly found in solid tumors.
MSI-H occurs in several cancer types, such as endometrial, colorectal, gastric, renal cell carcinoma, and ovarian. Tumors with MSI-H status have shown higher response rates for immune checkpoint inhibitor (ICI) therapies such as anti-PD-1 mAb drugs. MSI-H is therefore becoming an important biomarker for the immunotherapy predictions of patients with solid tumors, providing oncologists, pathologists,and patients more information to determine the best treatment path.
Promega MSI Global Portfolio
Promega MSI “for research use only” technology is one of the leading standard tests for MSI status detection in research laboratories. The company’s PCR method has been used extensively in clinical research for more than 15 years and is supported by more than 140 peer-reviewed publications.
Promega continues to advance the promise of MSI technology globally. The company’s OncoMate™ MSI Dx Analysis System (OncoMate™ MSI) has been cleared by the US Food and Drug Administration (FDA) as an IVD medical device to determine MSI status in colorectal cancer tumors. OncoMate™ MSI is a CE-marked IVD medical device in the United Kingdom and select European countries. Promega has received innovation status and priority review by the NMPA in China and also intends to seek regulatory clearance for a Promega MSI IVD in China.
About Promega Corporation
Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s product portfolio of over 4,000 products support a range of life science work across areas such as cell biology; DNA, RNA and protein analysis; drug development; human identification and molecular diagnostics. For over 40 years these tools and technologies have grown in their application and are used today by scientists and technicians in labs for academic and government research, forensics, pharmaceuticals, clinical diagnostics and agricultural and environmental testing. Promega is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors.
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 3 products have been launched in China, 1 in the European Union (EU), the New Drug Applications (NDAs) of 3 products accepted for review in China. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary serplulimab (anti-PD-1 mAb) as backbone. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global R&D centers and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).