SUZHOU, March 26, 2024/PRNewswire/ -- Corning Jerry Biopharmaceuticals (stock code: 9966.HK) announced that a clinical study for the treatment of advanced HER2 expression or metastatic solid tumors with advanced HER2 expression or metastatic solid tumors (study number JSKN033-101) has completed the first patient administration in Australia.
Clinical research results have shown that ADC combined immunotherapy can improve treatment efficacy and significantly prolong survival. However, combination treatment increases the patient's infusion time and hospitalization time, as well as the risk of an infusion reaction. In particular, when treatment requires an increase in the combination chemotherapy regimen, it seriously affects patients' adherence to medication.
Using the advantages of good stability and high solubility of enwalimab, JSKN033 combines immunotherapy with ADC and improves safety and convenience through optimization of administration routes, which is expected to provide patients with more compliant and effective treatment options.
JSKN033-101 is an open, multicenter, phase I/II trial. The trial includes two parts: dose escalation and dose expansion: the phase I dose escalation phase aims to evaluate the safety, tolerability, pharmacokinetics (PK) and initial efficacy of JSKN033 in patients with advanced HER2 expression or metastatic solid tumors, to determine the maximum tolerable dose (MTD) and/or phase II recommended dose (RP2D); the phase II dose extension phase will evaluate the efficacy and safety of JSKN033 in HER2-expressing gastrointestinal tumors at RP2D doses.
regardingJSKN033
JSKN033 is the world's first subcutaneous HER2 bispecific antibody conjugate drug and immune checkpoint inhibitor compound formulation independently developed by Corning Jerry. It consists of JSKN003 and envolimab (KN035). Among them, JSKN003 is a glycos-based fixed-point antibody conjugate drug targeting the HER2 double epitope. The drug consists of three parts: a bispecific antibody with two non-overlapping epitopes of the HER2 extracellular domain, a cleavable ligator, and a topoisomerase I inhibitor; envorimab is an Fc fusion protein composed of a humanized PD-L1 single-domain antibody and a human IgG1 Fc fragment. It was approved for marketing in China in November 2021. It is the world's first subcutaneous PD- (L) 1 inhibitor.
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, KN035 (the world's first subcutaneous PD- (L) 1 inhibitor, Envolimab injection, product name: Enweida) was approved for marketing in China in 2021, making it a widely accessible drug for cancer patients; 3 products are in late clinical development; HER2 double antibody KN026 was recognized as a breakthrough therapy by China's 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.
Welcome to the company's website: