Jiangsu Alphamab Biopharmaceuticals, a wholly-owned subsidiary of Alphamab Oncology, has collaborated with global biopharmaceutical firm Sanofi to advance clinical studies investigating KN026 plus Taxotere (Docetaxel) to treat HER2+ breast cancer.

The two companies have already started enrolling patients for the initial multicentre, open-label study to evaluate the combination for HER2+ breast cancer.

In addition, Sanofi will be granted an exclusivity period to negotiate the in-licensing of KN026 depending on the achievement of certain clinical milestones.

Sanofi general manager and general medicines China country lead Pius S Hornstein said: “Building on Sanofi’s heritage in oncology, we see a significant opportunity to impact the health of breast cancer patients by partnering with Alphamab, a biopharmaceutical leader in China.

“This strategic partnership also demonstrates Sanofi’s ambition to play a more active role in the Chinese healthcare ecosystem, offering more new treatments for the large Chinese population with joint efforts from other leading companies.”

Alphamab has developed KN026 by leveraging Fc-based heterodimer bispecific technology

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using its original Fc-based heterodimer bispecific platform technology, dubbed Charge Repulsion Induced Bispecific (CRIB).

It has been designed to simultaneously bind two non-overlapping epitopes of HER2, causing HER2 to aggregate on the cell surface and endocytose.

Taxotere is a microtubule inhibitor that interferes with the growth and spread of cancer cells in the body, and is used in treatment of breast cancer, lung cancer, prostate cancer, gastric cancer, and is indicated for breast cancer (BC) in China.

The BC indication include single agent for metastatic BC after chemotherapy failure;  with trastuzumab for the 1st line treatment of metastatic BC patients with HER2 overexpression; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC.

Alphamab Oncology founder, chairman and CEO Ting XU said: “KN026 is a core candidate of our innovative bispecific antibody pipeline, and has shown convincing advantages in safety and efficacy from current clinical studies.

“There are significant unmet need for the treatment of HER2-positive breast cancer. We hope, through the collaboration with Sanofi, a global biopharmaceutical leader, to further drive KN026’s China and global development strategy, to provide a superior therapeutic solution to Her-2 positive patients.”