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康宁杰瑞HER3/TROP2双抗ADC药物JSKN016Ⅰ期临床研究完成首例患者给药

Corning Jerry completes first patient administration in phase I clinical study of HER3/TROP2 dual antibody ADC drug JSKN016

PR Newswire ·  May 21 21:16

SUZHOU, May 22, 2024/PRNewswire/ -- Corning Jerry Biopharmaceuticals (stock code: 9966.HK) announced that the Phase I clinical study (study number: JSKN016-101) of the HER3/TROP2 dual-antibody ADC drug JSKN016 in patients with advanced malignant solid tumors in China has completed its first patient administration.

TROP2 (Trophoblast cell surface antigen 2, human trophoblast cell surface antigen 2) is widely expressed in solid tumors, and its upregulation can promote tumor growth, proliferation and invasion. Research shows that TROP2 has a high expression rate of 64% in lung adenocarcinoma, 75% in lung squamous cell carcinoma, and 78% in breast cancer. Excessive expression of HER3 (human epidermal growth factor receptor 3) may be associated with poor prognosis for various solid tumors such as lung cancer, breast cancer, stomach cancer, ovarian cancer, and melanoma. Therefore, drugs targeting TROP2 and HER3 may exert antitumor activity in various solid tumors.

JSKN016 is a dual anti-ADC drug independently developed by Corning Jerry that targets HER3 and TROP2 at the same time. After binding to TROP2 and/or HER3 on the surface of tumor cells, it enters the lysosome through target-mediated endocytosis, releasing cytotoxic topoisomerase I inhibitors (TOPII), which in turn induces apoptosis of TROP2 and/or HER3 positive tumor cells. In addition, the inhibitor can also penetrate cell membranes and exert a bystander effect into antigen-negative tumor cells. The combined effect of the two can effectively inhibit the growth of tumor cells.

JSKN016-101 is a phase I open, multicenter, first-ever human clinical study in advanced malignant solid tumor subjects in China. It includes dose escalation and dose expansion to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antineoplastic activity of JSKN016, and determine the maximum tolerable dose (MTD) and/or phase II recommended dose (RP2D).

regardingJSKN016

JSKN016 is a bispecific antibody conjugation drug (ADC) targeting HER3 and TROP2. It was independently developed by Corning Jerry using a unique sugar fixed-point conjugation platform. JSKN016 can induce apoptosis of TROP2 or HER3-positive tumor cells, and cytotoxic drugs released at the same time penetrate the cell membrane and exert a bystander effect into antigen-negative tumor cells, thereby effectively inhibiting tumor cell growth. Currently, JSKN016 is carrying out phase I clinical research for the treatment of advanced malignant solid tumors in China.

About Corning Jerry

Corning Jerry is an innovative biopharmaceutical company dedicated to the discovery, development, production and commercialization of world-class anti-tumor drugs to provide patients with innovative biologic therapies. On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange (stock code: 9966.HK).

Corning Jerry has created a biomacromolecular drug development and production technology platform with independent intellectual property rights, such as protein/antibody engineering, antibody screening, and multi-module/multifunctional antibody modification. A product pipeline with significant differentiation advantages and strong international competitiveness has been created, covering innovative anti-tumor drugs such as single-domain antibody/monoclonal antibodies, multi-functional antibodies and antibody conjugates: 1 product is KN035 (the world's first subcutaneous PD- (L) 1 inhibitor, Envolimab injection, product name: Envida) It was approved for marketing in China in 2021 and has become a widely accessible drug for cancer patients; 3 products are in advanced clinical development; HER2 dual antibody KN026 has been recognized as a breakthrough therapy by the Chinese NMPA. In addition, the company has a rich early development pipeline, and 2 new drug molecules have already entered the clinical research stage.

“Kangda patients, Regis family”. Corning Jerry has always focused on unmet clinical needs and continues to develop safe, affordable, and globally competitive anti-tumor drugs to benefit patients.

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