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.

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.

❖ Medicilon’s pharmacokinetics services

Our Preclinical Pharmacokinetics Department has a number of professionals with rich theoretical knowledge and experimental experience for experiment design, experiment implementation, bioanalysis and data analysis. Our Pharmacokinetics Lab has passed the GLP certification by NMPA. Following the guiding principles of ICH, NMPA and FDA. The lab offers in vivo and in vitro pharmacokinetic tests according to the needs of our clients and provide them with complete sets of pharmacokinetic evaluation and optimization services. Our acclaimed quality data collection and efficient experiment can meet our clients’ needs from early drug discovery to new drug filing.

❖ Medicilon’s drug safety evaluation

Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.

❖ Antibody R&D Service

Medicilon provides antibody drugs discovery, CMC research (API + formulation), pharmacodynamics research, PK study, safety evaluation and other services. As of the end of June 2023, Medicilon has successfully assisted in the clinical approval of 31 antibody drugs (8 approved by FDA and NMPA, 1 approved by NMPA and TGA, 1 approved by FDA, NMPA, and TGA) and has multiple antibody projects under development.

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.

Service Cases

Medicilon Assistant| Jimincare's lgE Antibody Drug JYB1904 has been Approved for Clinical Trials
Medicilon Assist| Sinovent's New Class 1 Anti-tumor Drug XNW14010 has been Approved for Clinical Trials
Medicilon assisted China's First Original Research Highly Selective EP4 Receptor Antagonist YY001 Obtained Clinical Approval

CD19×CD3×CD28-Trispecific-Antibody Antibody

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

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

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

Service Cases

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

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