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Corning Jereh Biopharmaceuticals announced that the company has received the "Clinical Trial Approval Letter" approved and issued by the National Medical Products Administration (NMPA), approving the company's innovative double antibody KN052 injection (PD-L1/OX40 double antibody) for the development of A clinical study of the treatment of advanced solid tumors
.
At present, there is no PD-(L)1/OX40 double antibody approved for marketing in the world
.
In recent years, with the development of immunotherapy, tumor treatment has entered a new era
.
KN052 is an innovative biological drug independently developed by Corning Jereh using the company's dual-antibody platform technology.
It can recognize both PD-L1 and OX40, effectively block the interaction between PD-L1 and PD-1, and activate the OX40 signaling pathway
.
On the one hand, it prevents the "immune escape" of tumor cells, and on the other hand, it enhances the activation of T cells and reduces Treg-mediated immunosuppression, synergistically enhancing anti-tumor activity
.
Currently, PD-(L)1/OX40 dual antibody or OX40 combined with PD-(L)1, and 040 monotherapy and other therapies under development in the world are all in the early clinical research stage
.
In preclinical studies, the activity of KN052 was significantly stronger than that of the two single-target control antibodies alone and in combination.
Based on this approval, Corning Jereh will conduct a Phase Ia/Ib clinical study of KN052 in the treatment of advanced solid tumors to evaluate the efficacy of the drug.
Safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity
.
The study will also be expanded with selected doses in specific tumor types
.