SuzhouMay 27, 2022/ PRNewswire /-- Corning Jerry Biopharmaceuticals (stock code: 9966.HK) announced that its self-developed HER2 bispecific antibody KN026 in combination with Pfizer Inc Aiboxin ®(piperazide) and flurvist group in the treatment of locally advanced unresectable or metastatic HER2 positive breast cancer phase Ⅱ clinical trial (KN026-205) has completed the first patient administration. In 2020, the company reached a clinical cooperation agreement with Pfizer Inc to promote the combination trial of KN026 and oral CDK4/6 inhibitor ®(piperacil), and was approved by NMPA to conduct clinical research.
KN026-205is a multicenter, open-label phase Ⅱ study for breast cancer patients with progression after treatment with trastuzumab and paclitaxel to evaluate the efficacy, safety and tolerance of KN026 combined with piperacil + flurvist in patients with locally advanced unresectable or metastatic HER2-positive breast cancer. The study plans to recruit about 36 patients, with the objective remission rate (ORR) assessed by the researchers according to the RECIST 1.1 criteria as the main end point.
Professor Wu Jie, the lead researcher of the study and Professor of the Cancer Hospital affiliated to Fudan University, said:Breast cancer, as the highest incidence of malignant tumor in the world, is a serious threat to women's physical and mental health. 15% of breast cancer, 30% of breast cancer will have HER2 gene amplification or overexpression, this type of breast cancer has a high degree of malignancy and poor prognosis. Although anti-HER2 monoclonal antibody can improve the survival of patients, but the disease progression is still inevitable. As an innovative double antibody, KN026 can combine two non-overlapping epitopes of HER2 at the same time. We very much expect that KN026, in combination with CDK4/6 inhibitors and estrogen receptor antagonists, will bring better treatment to patients. "
AboutKN026
KN026 is a HER2 bispecific antibody developed by Corning Jerry using Fc heterodimer platform technology (CRIB) with independent intellectual property rights. It can bind to two non-overlapping epitopes of HER2 at the same time, resulting in HER2 signal blocking, which is better than trastuzumab or patuzumab, which can achieve the effect of combination of trastuzumab and patuzumab, such as showing higher affinity and excellent tumor inhibition in HER2 positive tumor cell lines. At the same time, KN026 could also inhibit the low expression of tumor and trastuzumab-resistant cell lines in HER2.
KN026 IND was approved by the State Drug Administration (NMPA) of China and the Food and Drug Administration (FDA) of the United States in 2018, and is currently conducting a number of phase Ⅰ / Ⅱ clinical trials in China and phase Ⅰ clinical trials in the United States. The results of phase Ⅰ clinical trials showed that KN026 was well tolerated and safe, and still showed significant anti-tumor activity in HER2-positive breast cancer patients who developed after multi-line anti-HER2 therapy.
About Corning, Jerry.
Corning Jerry Biopharmaceuticals focuses on R & D, production and commercial innovation of antineoplastic drugs. On December 12, 2019, the company was listed on the main board of the Stock Exchange of Hong Kong (stock code: 9966).
Corning Jerry Biopharmaceuticals has the discovery, research and manufacturing platform of the whole industry chain in bispecific antibody and protein engineering. The company's highly differentiated product pipeline is composed of new anti-tumor drugs such as monoclonal antibodies, bispecific antibodies and antibody conjugates. Five of these products are in Ⅰ-Ⅲ phase clinical trials in China, the United States, Japan and Australia. In November 2021, Envida ®(Envoli Monoclonal Antibody injection) was officially approved for sale in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene deficiency (dMMR) adult patients with advanced solid tumors.
The company has a number of technology platforms with independent intellectual property rights, such as heterodimers and mixed antibodies, and a large-scale production capacity that meets the cGMP standards of China, the United States and the European Union, and has passed a complete quality system audited many times, including the European Union QP. The company is committed to building an international leading, multi-dimensional drug development and industrialization platform, focusing on multi-functional biomolecule new drugs, benefiting Chinese and global patients.
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