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Medicilon Assists | China's First CD19×CD3×CD28 Trispecific Antibody Obtained FDA Implicit Approval

2022-06-10
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Recently, CytoCares (Shanghai) Inc. (CytoCares) obtained the FDA's implied approval for the IND application of its first CD19/CD3/CD28-targeting trispecific antibody CC312.  This is the first trispecific antibody in China and the third in the world to enter the clinical development stage based on the CD28 costimulatory signal.
Shanghai Medicilon Inc. (Medicilon) provided CC312 with a comprehensive preclinical study (including pharmacokinetics and safety evaluation) that complied with GLP specifications with compliant, efficient and high-quality services.

CD19×CD3×CD28 Trispecific Antibody
Exploring New Possibilities in Tumor Immunotherapy

CytoCares focuses on the design and development of innovative multi-specific antibodies, and has its own tertiary antibody platform - TriTETM (Tri-specific T-cell Engager).  The platform is based on the "dual signal" activation mechanism of T cells, and uses the costimulatory signal as the "amplifier" of the first stimulation signal to achieve continuous and sufficient activation of T cells.
CC312 was the product of the CytoCares's TriTETM platform.  According to its related patent WO2018120843A1, CC312 is composed of three scFvs targeting CD19, CD3 and CD28 in tandem.  While targeting CD19, CC312 also contains two functional fragments on the same antibody molecule that can simultaneously activate CD3 and CD28 on T cells, which can effectively activate T cells, induce memory T cell proliferation, and prevent T cell anergy.  Compared with the double antibody with only CD3 activation signal, it can more effectively maintain the persistence of T cell activation.  CC312 showed significant pharmacodynamic effects and good safety in preclinical studies on hematological tumors.

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Medicilon Preclinical Research Platform
One-Stop assist for new drug research and development

    In the R&D of CC312, Medicilon facilitated the preclinical research platform, including the protein/antibody pharmacokinetic research platform and the biotechnology drug non-human primate safety evaluation technical service platform, and carefully organized an expert technical team to tackle key problems.  Medicilon has solved key issues such as drug metabolism, safety evaluation, and regulatory reporting for the clients, kept project risks to a minimum, and ensured the final delivery quality.
The preclinical research platform of Medicilon consists of three parts: pharmacokinetic studies, pharmacology studies, and drug safety evaluation. Our services include protocol design, in vivo research, sample analysis, professional data analysis, IACUC review, as well as the preparation of application materials with IND filing capabilities and rich successful experience.
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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