NEW YORK – Suzhou, China-based Alphamab Oncology today announced plans to partner with Sanofi China to study the investigational agent KN026 with the chemotherapy agent docetaxel.
The drug combination will be evaluated as a treatment for patients with HER2-positive breast cancer. Under the terms of the partnership, Alphamab's wholly owned subsidiary Jiangsu Alphamed and Sanofi China will jointly evaluate the drug combination, and Sanofi will be granted an exclusivity period to negotiate the in-licensing of KN026, contingent on the agent achieving certain clinical milestones.
Alphamab-developed KN026 was granted investigational new drug authorization in both China and the US in 2018, and is currently being evaluated in Phase I/II studies in both countries. Patient enrollment has already begun for the initial, multicenter open-label study evaluating the KN026 and docetaxel combination.
KN026 is a bispecific antibody against HER2 that binds to two non-overlapping epitopes of HER2 at once, resulting in dual HER2 signal blockade. According to Alphamab, data from pre-clinical studies suggest that KN026 may be equivalent or superior to other HER2 agents, such as trastuzumab (Genentech's Herecptin) or pertuzumab (Genentech's Perjeta), when given as single agents or in combination. The drug has also demonstrated a potential inhibitory effect on HER2-low tumor cells, as well as in cell lines that are resistant to trastuzumab.
Phase I studies have demonstrated KN026's safety and tolerability, as well as its anti-tumor activity in patients with HER2-positive breast cancer who have experienced disease progression after receiving several previous HER2-targeting treatment regimens.
"There is significant unmet need for the treatment of HER2-positive breast cancer," Alphamab CEO and Founder Ting Xu said in a statement. "We hope, through the collaboration with Sanofi … to further drive KN026's China and global development strategy [and] to provide a superior therapeutic solution to HER2-positive patients."
The news of Alphamab's collaboration with Sanofi China follows the company's March announcement that it would study KN026 in combination with Pfizer's palbociclib (Ibrance), an agent already approved in the US for hormone receptor-positive, HER2-negative breast cancer. In addition to the breast cancer combinations being tested, KN026 is being evaluated in multiple HER2-expressing solid tumors, such as gastric, urothelial, and gynecologic cancers.