Alphamab Oncology's Anti-HER2 Bispecific ADC Subcutaneous Co-formulation Receives Priority Review in China
核心洞察
Alphamab Oncology (搜索)'s JSKN033, a subcutaneous co-formulation of anti-HER2 (搜索) bispecific ADC and PD-L1 (搜索) inhibitor, has been included in Shanghai's pilot program for accelerated clinical trial review.
The Phase I/II trial (JSKN033-102) will assess the safety, pharmacokinetics, and anti-tumor activity of JSKN033 in patients with advanced metastatic malignant tumors (搜索).
JSKN033 combines immunotherapy (KN035) and ADC (JSKN003), offering improved safety and convenience through subcutaneous administration, with promising early clinical data.
Alphamab Oncology (搜索) announced that its clinical trial (Study ID: JSKN033-102) of JSKN033, a high-concentration subcutaneous co-formulation consisting of anti-HER2 (搜索) bispecific antibody-drug conjugate (ADC) and PD-L1 (搜索) immune checkpoint inhibitor, has been included in the "Pilot Program for Optimizing the Review and Approval of Clinical Trials for Innovative Drugs" by the Shanghai Municipal Drug Administration, with the consent of the Center for Drug Evaluation (CDE). This inclusion is expected to accelerate the review and approval process, expediting the initiation of the Phase I/II clinical trial for advanced malignant tumors (搜索). The IND application will be submitted to CDE accordingly.
JSKN033-102 Trial Details
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 patients with advanced metastatic malignant tumors (搜索). The study aims to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D). The pilot leading site for this study is Fudan University Shanghai Cancer Center.
Addressing Unmet Needs in Cancer Treatment
Malignant tumors (搜索) are a leading cause of death globally, with nearly 10 million deaths in 2020. The incidence rates of breast cancer (搜索), lung cancer (搜索), colorectal cancer (搜索), prostate cancer (搜索), and gastric cancer (搜索) rank among the top five tumor types. Despite advancements in immunotherapy and molecular targeted therapies, there remains a significant demand for innovative drugs and new treatment options. Alphamab Oncology (搜索) focuses on these unmet clinical needs, aiming to develop differentiated, clinically valuable, and globally competitive new drugs to help cancer patients extend survival and improve their quality of life.
About JSKN033
JSKN033 is the first high-concentration subcutaneous co-formulation consisting of an ADC and a PD-L1 (搜索) immune checkpoint inhibitor in first-in-human clinical trials. Developed using the superior solubility and stability of Envafolimab, Alphamab's subcutaneously injectable PD-L1 inhibitor, JSKN033 combines immunotherapy (KN035) and ADC (JSKN003), making ADC subcutaneous injectable for improved safety and convenience. A Phase I/II clinical study of JSKN033 conducted in Australia (JSKN033-101, NCT06226766) demonstrated a favorable safety profile and encouraging anti-cancer activity in heavily pretreated patients. Detailed clinical data were presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in 2024.
JSKN003 is an anti-HER2 (搜索) bispecific ADC, comprising a bispecific antibody targeting two non-overlapping epitopes of HER2 extracellular domains, a cleavable linker, and a topoisomerase I inhibitor. Envafolimab, approved in China in November 2021, is a subcutaneous injection PD-(L)1 inhibitor. The combination of immunotherapy and ADC in JSKN033 is anticipated to significantly enhance efficacy.