Alphamab Oncology announced that its clinical trial (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, 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. This inclusion is expected to expedite the initiation of a Phase I/II clinical trial for advanced malignant tumors.
The National Medical Products Administration (NMPA) of China issued the pilot program on July 31, 2024, aiming to complete the review and approval of innovative drug clinical trial applications within 30 working days.
JSKN033-102 Trial Design
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. The study will also 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.
Background on Malignant Tumors
Malignant tumors are a leading cause of death globally and in China, with incidence and mortality rates rising annually. In 2020, there were 19.3 million new cancer cases worldwide, and nearly 10 million deaths from malignant tumors. Breast cancer, lung cancer, colorectal cancer, prostate cancer, and gastric cancer are among the top five most common tumor types. Despite advancements in immunotherapy and molecular targeted therapies, there remains a significant demand for innovative drugs and new treatment options.
About JSKN033
JSKN033 is a first-in-human high-concentration subcutaneous co-formulation consisting of an ADC and a PD-L1 immune checkpoint inhibitor. It leverages the solubility and stability of Envafolimab, Alphamab's subcutaneously injectable PD-L1 inhibitor. JSKN033 combines immunotherapy (KN035) and ADC (JSKN003), making ADC subcutaneous injectable, which improves safety and convenience. A Phase I/II clinical study of JSKN033 in Australia (JSKN033-101, NCT06226766) demonstrated a favorable safety profile and encouraging anti-cancer activity in heavily pretreated patients. These data were presented at the Society for Immunotherapy of Cancer Annual Meeting in 2024 (SITC 2024).
JSKN003 is an anti-HER2 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 expected to enhance efficacy. Alphamab Oncology anticipates that the accelerated clinical development of JSKN033 in China will offer a safe, effective, and more compliant treatment option for patients.
