Kangfang bio-anti-PD-1/CTLA-4 dual-specific antibodies to treat metastatic cervical cancer, obtained the FDA rapid designation.

Akeso, announced that the U.S. Food and Drug Administration (FDA) has awarded its new anti-PD-1/CTLA-4 dual-specific antibody AK104 fast-track designation as a single therapy for patients with relapsed or metastatic squamous cervical cancer who develop the disease after platinum chemotherapy.
photo source: AK104 is a new humanized IgG1 tetra-specific antibody developed in-house by Akeso to prioritize the binding of tumor-immersed lymphocytes over normal exome lymphocytes.
AK104 is based on Akeso's proprietary "TETRABODY" technology and can target two immune checkpoint molecules at the same time: PD-1 and CTLA-4.
results show that PD-1 and CTLA-4 combined blocking is effective and less toxic.
, the drug is currently being used in phase IB/II and Phase II clinical trials in China and Australia for a variety of adaptations.
, Chairman and CEO of Kangfang Bio, said, "Ak104's fast-track title is an important milestone in the development of innovative dual-specific antibodies.
, we are encouraged that the FDA recognizes that AK104 can address serious diseases and meet the medical needs of patients with worsening cancer.
hope to continue to work closely with the FDA to bring AK104 to cervical cancer patients earlier.
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