Alphamab Oncology and Sanofi Enter Collaboration on KN026 in HER2+ Breast Cancer

• Published Month : Tuesday, 09 Jun 2020 03:00 pm

KN026 is an anti-HER2 bispecific antibody which can simultaneously bind two non-overlapping epitopes of HER2 and lead to a dual HER2 signal blockade, presumedly causing HER2 to aggregate on the cell surface and endocytose. Current clinicals trials shown promising preliminary efficacy and excellent safety profile in late-stage breast cancer patients who have failed multiple treatments in China, laying a solid foundation for future development of combination therapies in multiple front line settings. Given its clinical profile, KN026 has the potential to address the medical needs of around 2 million patients suffering from HER2-positive breast cancer in China, USA and key European markets.

Alphamab Oncology a clinical stage biopharmaceutical company focusing on innovative biologics medicine for oncology, and Sanofi, a global biopharmaceutical leader, announced today that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of Alphamab Oncology, signed an agreement with Sanofi (China) Investment Co., Ltd (" Sanofi") to establish strategic collaboration to advance clinical studies to investigate KN026 in combination with Taxotere® (Docetaxel) in HER2+ breast cancer, and Sanofi is granted an exclusivity period to negotiate the in-licensing of KN026 subject to the achievement of certain clinical milestones.

KN026 is an anti-HER2 bispecific antibody which can simultaneously bind two non-overlapping epitopes of HER2 and lead to a dual HER2 signal blockade, presumedly causing HER2 to aggregate on the cell surface and endocytose. Current clinicals trials shown promising preliminary efficacy and excellent safety profile in late-stage breast cancer patients who have failed multiple treatments in China, laying a solid foundation for future development of combination therapies in multiple front line settings. Given its clinical profile, KN026 has the potential to address the medical needs of around 2 million patients suffering from HER2-positive breast cancer in China, USA and key European markets.

Taxotere® (Docetaxel) is a microtubule inhibitor that interferes with the growth and spread of cancer cells in the body. It is used to treat breast cancer, lung cancer, prostate cancer, gastric cancer. In China, Taxotere® is indicated for breast cancer (BC) including: 1) single agent for locally advanced or metastatic BC after chemotherapy failure; 2) with trastuzumab for the 1st line treatment of metastatic BC patients with HER2 overexpression; 3) and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC.

Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "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."

Pius S. Hornstein, PhD, General Manager General Medicines and Country Lead, Sanofi China commented, "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."

Under terms of the agreement, Jiangsu Alphamab and Sanofi will collaborate to evaluate the combination of KN026 and Taxotere® (Docetaxel) for HER2+ breast cancer. Patient enrollment has started for the initial multicenter, open-label study.