Chinese biotech firm Akeso Inc (HK:9926) said on Tuesday its experimental cancer therapy ligufalimab has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration for the treatment of acute myeloid leukemia (AML).
The designation, aimed at encouraging development of medicines for rare diseases, offers benefits including tax incentives, fee waivers and up to seven years of U.S. market exclusivity if the drug is approved, Akeso said in a statement.
Ligufalimab, also known as AK117, is a monoclonal antibody that targets CD47, a protein often described as a “don’t eat me” signal used by tumor cells to evade the immune system.
Akeso said the drug is being tested in blood cancers as well as solid tumors, with ongoing Phase III trials in pancreatic cancer and head and neck squamous cell carcinoma.
The company added that it was advancing studies of ligufalimab in combination therapies for AML patients ineligible for intensive chemotherapy.
Hong Kong-listed shares of the company traded nearly 1% higher at HK$130.10 as of 04:47 GMT.
Source :
https://www.investing.com/news/stock-market-news/akesos-cancer-therapy-gets-orphan-status-from-us-fda-4239729
