Recently, Bio-Thera Solutions, Ltd. (Bio-Thera) has been approved for clinical application of BAT8006 for injection, a product under development for the treatment of advanced solid tumors.
This is the first China-produced
antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) to enter the clinical trial phase. It is also the first ADC developed by Bio-Thera using the self-developed ADC platform to enter the clinical trial. This is also another successful example of Shanghai Medicilon Inc. (Medicilon) antibody-drug conjugate (ADC) preclinical research and development service platform.
The First Domestic FRα ADC
BAT8006 is expected to become the best-in-class new tumor drug
FRα is a membrane-localized folate-binding protein that is overexpressed in a variety of solid tumors such as ovarian, lung, endometrial, and breast cancers. However, the distribution of FRα in normal human tissues is limited to the apical surface of organs such as kidney, lung, and choroid plexus, and the expression level is low. The difference in expression levels in tumor and normal tissues makes FRα an attractive target for ADCs in FRα-expressing tumors.
BAT8006 is composed of a recombinant humanized anti-FRα antibody and a toxic small molecule topoisomerase I inhibitor connected by a self-developed cleavable linker. BAT8006 has efficient anti-tumor activity, and the toxin small molecule has strong cell membrane penetration ability. After the ADC kills cancer cells, it can release and kill nearby cancer cells, resulting in a bystander effect and effectively overcoming the heterogeneity of tumor cells. At the same time, BAT8006 has good stability and safety, and the release of small toxin molecules in plasma is extremely low, which could reduce the risk of off-target toxicity. BAT8006 has shown potent anti-tumor activity in in vitro and in vivo pharmacological studies, and is a potential "best-in-class" antibody conjugated drug targeting FRα.
At present, there is no approved anti-FRα antibody drug conjugate in the world, and there is only one FRα ADC (The new FRα ADC drug IMGN853 introduced by Huadong Medicine from Immunogen) undergoing the clinical trials in China.
Up to now, Medicilon has undertaken more than 100 IND application biopharmaceutical projects, including monoclonal antibodies, double antibodies, polyclonal antibodies, ADCs, viral vaccines and fusion proteins. As of May 2022, Medicilon has successfully helped 10 ADC drugs to be approved for clinical trails, and has multiple ADC projects under development. Medicilon has in-depth exchanges with customers in the formulation of the preclinical integrated research plan of ADC. The backbone of scientific research combines the characteristics of each case with years of practical experience and technical accumulation, and carefully submits high-quality experimental plans and results to customers.
Medicilon ADC Preclinical R&D Service Platform
Empowering and Accelerating ADC Drug Development
The research and development of ADC drugs requires comprehensive consideration of antibodies, toxins, groupings, linkers and coupling methods, and has high R&D barriers. During the R&D of BAT8006, Medicilon's ADC preclinical research and development service platform has extensive practical technology and experience in the field of ADC drug preclinical R&D, followed the ICH guidelines S6 and S9 and combined with the specific situation of the BAT8006 project, to customize a personalized safety evaluation plan and overcome the complexity and diversity of drug-to-antibody ratio (DAR), stability, for BAT8006. We will make every effort to ensure the efficient and high-quality research and development of BAT8006 safety evaluation test, and provide professional services for the successful clinical approval.
Currently, the Medicilon ADC preclinical R&D service platform could provide clients with services such as ADC Payloads synthesis, ADC pharmacodynamic evaluation, ADC pharmacokinetic evaluation and ADC safety evaluation.
Medicilon congratulates Bio-Thera on the clinical approval of BAT8006, and expects BAT8006 to bring good news to patients with advanced solid tumors. In addition we also congratulate Bio-Thera for making important progress in the field of innovative tumor drug research and development. The successful clinical approval of Bio-Thera BAT8006 has laid a solid foundation for the successful development and approval of more innovative ADC drugs in the future with the help of the Medicilon antibody-drug conjugate (ADC) preclinical R&D service platform.
About Bio-Thera
Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next-generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials, one of which, QLETLI®, a biosimilar to Humira® (adalimumab), is available to patients with rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, Crohn's disease or uveitis in China. In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases.
About Medicilon
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. Medicilon grows together with the clients and delivers the new drug research and development services to more than 900 clients globally. Medicilon is proud to contribute to human health in the globe.
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