SUZHOU, China, May 6, 2024 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that data from the clinical study conducted in China (JSKN003-102) of anti-HER2 bispecific antibody-drug conjugate (ADC) JSKN003 for the treatment of HER2-expressing advanced solid tumors, will be presented for the first time at the 2024 Annual Meeting of American Society of Clinical Oncology (2024 ASCO Annual Meeting) from May 31 to June 4, 2024, in Chicago, IL, U.S..
Title:Evaluation of the safety, pharmacokinetics, and efficacy of JSKN003 in patients with advanced solid tumors: A phase I/II clinical study
Abstract Number for Publication: 3031
Session Type and Title: Poster Session - Developmental Therapeutics -Molecularly Targeted Agents and Tumor Biology
Session Date and Time: 6/1/2024 9:00 AM-12:00 PM CDT
JSKN003, an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), developed inhouse with proprietary Glycan-specific conjugation platform, shows better serum stability which may lead to a broader therapeutic window. The data of the phase I clinical trial conducted in Australia presented at the 2024 Annual Meeting of American Association for Cancer Research (AACR) in April demonstrated favorable tolerability, safety profile and encouraging preliminary anti-tumor activity. Multiple clinical studies of JSKN003 are currently being conducted in Australia and China, and we are also actively making the progress in its pivotal clinical trial in advanced HER2 low-expression breast cancer in China.
JSKN003-102 (NCT05744427) is a phase I (dose escalation and expansion) and phase II (cohort expansion) clinical study in Chinese patients with advanced solid tumors. Patients with histologically documented HER2-expressing (IHC≥1+) or patients with HER2-mutant cancers who failed prior systemic therapies were recruited and received JSKN003 monotherapy in phase I study. The objectives were safety, pharmacokinetics (PK), preliminary antitumor activity of JSKN003 and to determine the maximum tolerated dose (MTD) or the recommended phase II dose (RP2D). The results of the phase I study will be presented at this ASCO Annual Meeting.
About JSKN003
JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), which is developed inhouse with proprietary Glycan-specific conjugation platform. JSKN003 targets HER2 and triggers internalization and release the cytotoxic drug. Compared with its counterparts, JSKN003 demonstrated better serum stability, stronger bystander effect and comparable tumor killing activity, which effectively expands the therapeutic window. Multiple clinical studies of JSKN003 are currently being conducted in Australia and China, and we are also actively making the progress in its pivotal clinical trial in advanced HER2 low-expression breast cancer in China.
About Alphamab Oncology
Alphamab Oncology is a leading biopharmaceutical company committed to the discovery, 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, encompassing 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, single domain antibody/monoclonal antibodies, and multi-functional antibodies. Notably, Envafolimab, the world's first subcutaneously injectable PD-L1 inhibitor, received approval from Chinese authorities in 2021, offering widespread accessibility to cancer patients. Three additional products are currently in the advanced stages of clinical development, with KN026 having earned Breakthrough Designation from the China National Medical Products Administration. Furthermore, we have cultivated a series of early-stage assets, including two in Phase I development.
Our overarching mission is to enhance the manageability and curability of cancer by addressing unmet medical needs in oncology. Alphamab Oncology is dedicated to the development of safe and affordable drugs, leveraging a global competitive edge.