Anti-HER2 dual-specific antibody KN026 and Aibo new joint drug treatment program...

Corning Jerry Biopharmaceuticals (stock code: 9966. HK) announced that the Company has recently received a drug clinical trial approval notice issued by the State Drug Administration of China, approving the development of KN026 combined with pyridoxili or KN026 in association with piresili and fluvis groups for the treatment of HER2-positive local late-stage non-excision and/or metastasis breast cancer that failed treatment of curtojuum and yew drugs.
currently used in the international treatment of HER2-positive breast cancer of the large-molecule targeted drugs have curt bead monoantigen and pato pearl monoantigen.
almost all HER2-positive metastasis breast cancer patients develop the disease.
preclinical studies have shown that cell cycle protein-dependent kinase 4 and 6 (CDK4/6) inhibitors show increased HER2 activity and increased sensitivity to HER2 kinase inhibitors or antiHER2 antibodies.
combination therapy with CDK4/6 inhibitors can improve the outcome of hormone-positive (HR-plus)/HER2-positive metastasis breast cancer patients.
KN026 is an anti-HER2 dual-specific antibody developed by Corning Jerry, which binds to two non-overlapping tables of HER2 at the same time, blocking the double HER2 signal.
phase I./II. clinical trials have shown that KN026 has good tolerance and safety, and has significant anti-tumor activity in HER2-positive breast cancer patients who progress after multi-line anti-HER2 treatment.
March 2020, CorningEry signed a clinical supply agreement with Pfizer to advance the KN026's joint drug trial with the oral CDK4/6 inhibitor Aibo new ® (Pybersili).
The joint drug will begin with a multi-center, open-label phase I.b/II. clinical study to assess the effectiveness, safety and tolerance of KN026 combined pyridoxie in the treatment of locally late-stage non-removable or metastasis HER2-positive breast cancer patients.
by Fudan University Affiliated Oncology Hospital Professor Wu Wei as the lead researcher, the main endpoints of the study are dose-limiting toxicity (DLT) and objective mitigation rate (ORR).
trial as a potential chemotherapy-free option will give new hope to HER2-positive breast cancer patients.
this time, based on a large number of previous research work, KN026 liquid large size dosage form has also been approved for clinical use.
than previous freeze-dried preparations, liquid preparations reduce process steps and facilitate clinical use.
About KN026KN026 is Corning Jerry's anti-HER2 dual-specific antibody developed with independent intellectual property Fc isoid platform technology (CRIB), which can bind to two non-overlapping tables of HER2 at the same time, resulting in double HER2 signal blocking, to achieve the effects of cratural bead monoantitor and Pato bead monoantitor and combination, such as showing higher affinity, as well as excellent tumor inhibition in HER2-positive tumor cells.
, KN026 also inhibited her2 medium- and low-expression tumors and crater-beaded single resistant cell strains.
KN026 was approved by China's National Drug Administration (NMPA) and the U.S. Food and Drug Administration (FDA) in 2018, and is currently conducting a number of Phase I./II. clinical trials in China, as well as advancing Phase I. clinical trials in the United States.
phase I. clinical trials showed that KN026 had good tolerance and safety, and showed significant anti-tumor activity in HER2-positive breast cancer patients who progressed after multi-line anti-HER2 treatment.
references: Chen, W., et al., Cancer statistics in China, 2015. CA Cancer J Clin, 2016. 66(2): p. 115-32. [2] Iqbal, N. and N. Iqbal, Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int, 2014. 2014: p. 852748. [3] Qiu, M.Z., et al., HER2-positive patients receiving trastuzumab treatment have a comparable prognosis with HER2-negative advanced gastric cancer patients: a prospective cohort observation. Int J Cancer, 2014. 134(10): p. 2468-77. [4] Kai Zhang, Ruoxi Hong, Lee Kaping, et al. CDK4/6 inhibitor palbociclib enhances the effect of pyrotinib in HER2-positive breast cancer. Cancer Lett. 2019 Apr 10; 447:130-140.[5] Sara M Tolaney , Andrew M Wardley, Stefania Zambelli, et al. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol .2020 Jun; 21 (6): 763-775.Source:Corning Jerry Note: The original text has been cut