Alphamab’s JSKN003 gets FDA breakthrough therapy designation

Alphamab Oncology announced today that its drug candidate, JSKN003, has been granted Breakthrough Therapy Designation (BTD) by the U.S. FDA. This designation is for the treatment of adult patients with advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancers (collectively, PROC) that express HER2 (IHC 1+, 2+, and 3+) and have previously received bevacizumab. This marks a critical step in accelerating the development and review of JSKN003.

JSKN003 is a biparatopic HER2-targeting antibody-drug conjugate (ADC). This BTD follows previous approvals for a Phase II clinical study in PROC by the FDA and BTDs by China's NMPA for both PROC and colorectal cancer (CRC). JSKN003 also holds Fast Track Designation and Orphan Drug Designation by the FDA for gastric cancer and gastroesophageal junction cancer.

The BTD is based on a pooled analysis from the Phase I clinical study in Australia (JSKN003-101) and the Phase I/II clinical study in China (JSKN003-102). The company believes this designation will expedite the drug's clinical development and regulatory review, offering new treatment options for PROC patients globally, as current non-platinum single-agent chemotherapies show limited efficacy with ORR of only 10-15%.