• About CS1001
  • About PD-L1
About CS1001


CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone Pharmaceuticals. Authorized by the U.S.-based Ligand Corporation, CS1001 is a monoclonal antibody developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which could reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.

 

A first-in-human Phase I study (CS1001-101) has been conducted by CStone Pharmaceuticals since October 2017 to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in patients with advanced tumors in China. The Phase Ia (dose escalation) part was completed in May 2018, and the Phase Ib (dose expansion) part has recently started patient recruitment. In parallel, several pivotal studies are underway, including tumor types with high incidence and prevalence rates in China.



About PD-L1


Programmed cell death ligand-1 (PD-L1) is a 40 kDa type I transmembrane protein. Under normal physiological conditions, the immune system responds to antigens in the lymph nodes or spleen by promoting the proliferation of antigen specific T cells. The combination of programmed cell death protein-1 (PD-1) and PD-L1 can transduce inhibitory signals to reduce the proliferation of T cells and control an overreaction by the immune system, enabling the body to resume its natural immune balance after the pathogens are removed.


However, within the tumor microenvironment, cancer cells can up-regulate PD-L1 expression levels, strongly inhibiting the body's natural antitumor immune response and allowing tumor cells to "escape" the recognition and attack by the immune system. Currently, monoclonal antibody drugs targeting PD-1 or PD-L1 have been developed and approved globally. In China, there are more anti-PD-1 targeting monoclonal drugs being developed than anti-PD-L1. As such, the clinical study of CS1001, the first fully human, full-length anti-PD-L1 monoclonal antibody in China, has significant scientific and therapeutic value.


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