NEW YORK – Jiangsu Alphamab Biopharmaceuticals announced today that it has obtained access to palbociclib (Ibrance) through a supply agreement with Pfizer and that this will enable it to conduct a study combining its investigational KNO26 and palbociclib in HER2-positive breast cancer.
Jiangsu Alphamab, a subsidiary of Suzhou, China-based Alphamab Oncology, will study its dual-HER2 signal blocking drug with palbociclib in previously treated, locally advanced and/or metastatic HER2-positive breast cancer. The company is conducting a Phase Ib/II trial to investigate the efficacy, safety, and tolerability of the chemotherapy-free regimen in this subset of patients.
Preclinical studies suggest that KN026 works against tumor cells that have medium or low HER2 expression, as well as against cells that are resistant to trastuzumab.
The National Medical Products Administration of China and the US Food and Drug Administration granted investigational new drug authorization to KNO206 in 2018, allowing it to be studied in human trials. The drug is being evaluated in multiple Phase I/II trials in China, and in the US, it is in Phase I trials for HER2-expressiing solid tumors, including breast, gastric, urothelial, and gynecological cancers.
Palbociclib is already approved in the US for hormone receptor-positive, HER2-negative breast cancer.