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        English 中文簡體 中文繁體
        KN026
        Pipeline Programs
        • KN035(Envafolimab)
        • KN046
        • KN026
        • KN026+KN046
        • KN019

          The therapeutic effect of HER2 targeted therapy depends on the body's adaptive immune response. Therefore, the combination of immune checkpoint inhibitors such as PD-1/PD-L1 and CTLA-4 can synergistically enhance the anti-tumor effect of HER2 therapies. The combination of HER2 targeted drugs and PD-1 antibody has shown great efficacy in HER2-positive breast cancer and gastric cancer, including a phase 2 trial of triple combination regimen (pembrolizumab,trastuzumab,and chemotherapy) as first-line therapy for HER2-positive metastatic gastric cancer showing 91% ORR,13.0 months median PFS and 27.3 months median overall survival. The phase Ⅲ trial of this triple combination regimen (KEYNOTE-811 study) is ongoing.

          Mechanism of action

          KN026 and KN046 have shown good safety, tolerability and anti-tumor efficacy in mono-drug clinical trials. The combination of KN026 plus KN046 demonstrated preliminary good efficacy, safety, and tolerability in an open label, multi-center clinical study in patients with advanced HER2-expressing solid tumors and have failed the standard of care treatment.The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to KN026 in combination with KN046 for the treatment of HER2-positive or low expressing gastric or gastroesophageal junction cancer. SEARCH-01 is an phaseⅡ registration clinical study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 for HER2-positive solid tumors. This study is planned to be conducted in 20-30 clinical centers in China and 10-20 US clinical centers with advanced HER2-positive solid tumors, including HER2-positive gastric and gastroesophageal junction cancer etc.

           

          KN019 is a biosimilar of Belatacept (Nulojix?), an immunosuppressive agent approved for prophylaxis of organ rejection in adult patients receiving a kidney transplant. As a fusion protein composed of the Fc-fragment of a human IgG1 immunoglobulin linked to the extracellular domain of CTLA-4, Belatacept acts as a selective T cell co-stimulation blocker. Belatacept’s superior efficacy profile has been demonstrated in long-term outcome studies*.


          KN019 : Crystal Structure

          Belatacept is an improved version of Abatacept (Orencia?) with higher potency. Orencia is approved for rheumatoid arthritis, idiopathic arthritis, and psoriatic arthritis, and it achieved global sales of about US$2.7 billion in 2017.


          KN019 has started phase II trial for rheumatoid arthritis in August 2019 and will expand to oncology-related indications in the future.

          Due to its structure of a fusion protein with complex glycosylation, Belatacept is very difficult to manufacture as the biosimilar product. So far, few companies are able to develop a competitive biosimilar of Belatacept. In contrast, KN019 has demonstrated robust CMC and superior quality in multiple batches of large-scale production.