Metastatic Cervical Cancer Treatment Granted FDA Fast Track Designation

Akeso announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AK104, a novel anti-PD-1/CTLA-4 bi-specific antibody, as monotherapy for the treatment of patients with recurrent or metastatic squamous cervical cancer who have disease progression on or after platinum-based chemotherapy.

"The Fast Track Designation of AK104 is another significant milestone in the development of this innovative bispecific antibody. We are encouraged that the FDA recognizes the potential of AK104 to address a serious condition and fill an unmet medical need in patients whose cancer has unfortunately worsened despite standard of care chemotherapy," said Dr Michelle Xia, Chairman and CEO of Akeso. "We look forward with much optimism to continue working closely with the FDA to bring AK104 to cervical cancer patients earlier."

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

AK104 is a potential next-generation, first-in-class humanized IgG1 tetrameric bi-specific antibody drug candidate that is developed in house by Akeso is designed to achieve preferential binding to tumor infiltrating lymphocytes rather than normal peripheral tissue lymphocytes. Based on Akeso's proprietary "TETRABODY" technology, AK104 can simultaneously targets two immune checkpoint molecules: PD-1 and CTLA-4. AK104 is in a tetrameric form, which is designed to bind to PD-1 and CTLA-4 simultaneously and have so far displayed the efficacy of PD-1 and CTLA-4 combination blockade with lower toxicity. It is currently in Phase Ib/II and Phase II clinical trials in China and Australia for multiple indications.