suzhou, china, january 14, 2025 - alphamab oncology (stock code: 9966.hk) announced that the first patient has been successfully dosed in fudan university shanghai cancer center in the phase i/ii clinical study (study id: jskn033-102) of jskn033, a high-concentration subcutaneous co-formulation consisting of anti-her2 bispecific antibody-drug conjugate (adc) and pd-l1 immune checkpoint inhibitor, for the treatment of advanced metastatic malignant tumors.
jskn033 is the global first high-concentration subcutaneous co-formulation consisting of adc and pd-l1 immune checkpoint inhibitor in first-in-human clinical trial, which is independently developed by the company. by combining immunotherapy and adc, jskn033 is anticipated to significantly enhance efficacy. leveraging the superior solubility and stability of envafolimab, this formulation makes adc subcutaneous injectable and leads to improved safety and convenience. the first-in-human phase i/ii clinical study of jskn033 conducted in australia demonstrated favorable safety profile and encouraging anti-tumor activity.
jskn033-102 is an open-label, multicenter, phase ⅰ/ⅱ clinical study designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and anti-tumor activity of jskn033 in chinese patients with advanced metastatic malignant tumors, and to determine the maximum tolerated dose (mtd) and/or the recommended phase ii dose (rp2d). this study has previously been included in the "pilot program for optimizing the review and approval of clinical trials for innovative drugs".
about jskn033
jskn033 is the global first high-concentration subcutaneous co-formulation consisting of adc (jskn003) and immune checkpoint inhibitor (envafolimab), which is independently developed by the company. jskn003 is a an anti-her2 bispecific adc, comprising of three components: a bispecific antibody targeting two non-overlapping epitopes of her2 extracellular domains, a cleavable linker, and a topoisomerase i inhibitor. envafolimab is a fc fusion protein consisting of humanized anti-pd-l1 single domain antibody and human igg1 fc fragment, which has been approved by chinese authorities as the global-first subcutaneous injection pd-(l)1 inhibitor in november 2021. by combining immunotherapy and adc, jskn033 is anticipated to significantly enhance efficacy. leveraging the superior solubility and stability of envafolimab, this formulation makes adc subcutaneous injectable and leads to improved safety and convenience. the phase i/ii clinical study of jskn033 for the treatment of advanced or metastatic solid tumors is currently being conducted in china and australia.
about alphamab oncology
alphamab oncology is a leading biopharmaceutical company committed to the development, manufacturing, and commercialization of cutting-edge biotherapeutics for the treatment of cancer. on december 12, 2019, the company was successfully listed on the main board of the hong kong stock exchange, trading under the stock code 9966.
our integrated platform seamlessly combines research, development, and manufacturing capabilities for biologics. we take pride in our extensive intellectual property portfolio, which encompasses protein/antibody engineering, antibody screening, and multi-module/multi-functional antibody modification.
distinguished by a globally competitive pipeline, alphamab oncology specializes in antibody-drug conjugation (adc), single domain antibody, and bispecific antibodies. notably, envafolimab, the world's first subcutaneously injectable pd-l1 inhibitor, was approved by chinese authorities in 2021, making a significant breakthrough in the convenience and accessibility of cancer treatment. three assets are currently undergoing phase iii or pivotal clinical trials, and several other bispecific adc new drug candidates are in early clinical stage. multiple strategic collaborations based on innovative products or technology platforms have been established with partners such as cspc, arrivent, and glenmark.
our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. alphamab oncology is dedicated to the development of safe, effective and affordable drugs, leveraging a global competitive edge.
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