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Alphamab Oncology, based in Suzhou, China, inked a collaboration deal with Sanofi (China) Investment Co. to advance clinical trials of Alphamab’s KN026 with Sanofi’s Taxotere (docetaxel) in HER2+ breast cancer.
KN026 is an anti-HER2 bispecific antibody. It can bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade. Clinical trials to date have shown promising preliminary efficacy and an excellent safety profile in late-stage breast cancer patients. Taxotere is a form of chemotherapy, a microtubule inhibitor that interrupts tumor growth and metastases.
Specifically, Jiangsu Alphamab Biopharmaceuticals Co, a wholly owned subsidiary of Alphamab Oncology, entered into an agreement with Sanofi (China) Investment Co. to advance clinical trials of the combination in HER2+ breast cancer. Sanofi has an exclusivity period in which to negotiate the in-licensing of KN026 with specific clinical milestones. No financial details were released.
“KN026 is a core candidate of our innovative bispecific antibody pipeline, and has shown convincing advantages in safety and efficacy from current clinical studies,” said Ting Xu, founder, chairman and chief executive officer of Alphamab Oncology. “There is 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.”
KN026 received Investigational New Drug (IND) approval in 2018 in China from the National Medical Products Administration (NMPA) and in the U.S. by the Food and Drug Administration (FDA). The compound is in multiple Phase I/II trials in China and in a Phase I trial in the U.S.
HER2+ breast cancer is a type of breast cancer that tests positive for the human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of cancer cells. According to the Mayo Clinic, about 1 in every 5 breast cancers have extra copies of the gene that codes for the HER2 protein. These types of breast cancers are usually more aggressive than other types. Generally, treatments that target HER2 are very effective.
“Building on Sanofi’s heritage in oncology, we see a significant opportunity to impact the breast cancer patients by partnering with Alphamab, a biopharmaceutical leader in China,” said Pius S. Hornstein, general manager of General Medicines and country lead for Sanofi 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.”
Yesterday, Sanofi announced plans to present data from the Phase III COMET trial of enzyme replacement therapy (ERT) avalglucosidase alfa in patients with late-onset Pompe disease (LOPD). It will be presented on June 16. The presentation is scheduled because of the postponement of the July 2020 International Congress on Neuromuscular Diseases (ICNMD) as the result of the COVID-19 pandemic, where the trial data was to be presented.
Pompe disease is caused by a genetic deficiency of the lysosomal enzyme acid alpha-glucosidase (GAA), which results in the accumulation of glycogen in the muscles, eventually causing progressive and irreversible muscle damage.
On June 2, Sanofi reported that its Sarclisa (isatuximab) added to carfilzomib and dexamethasone decreased the risk of disease progression or death by 47% compared to standard of care carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma. The data was the results of the Phase III IKEMA trial after the topline announcement on May 12 that reported Sarclisa combination therapy met the primary endpoint at the pre-planned interim analysis.
“These results suggest the potential of Sarclisa to become a new standard of care in the relapsed multiple myeloma setting,” said Philippe Moreau, Department of Hematology, University Hospital of Nantes, France.