Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase III clinical study for its Category 1 drug, ABSK021. The randomized, double-blind, placebo-controlled, multi-center Phase III study is designed to assess the efficacy and safety of the drug in patients with giant cell tumor of tendon sheath (GCTTS).
ABSK021: Mechanism and Development
ABSK021, discovered and developed by Abbisko, is an orally administered, highly potent, and selective small-molecule inhibitor of CSF-1R. The drug is being developed to treat both tumor and non-tumor indications. CSF-1R signaling plays a critical role in macrophage recruitment, proliferation, survival, and polarization. By inhibiting CSF-1R activity, ABSK021 aims to relieve the immunosuppressive function of tumor-associated macrophages (TAMs) and achieve therapeutic effects in cancer treatment. In July of this year, ABSK021 received the breakthrough therapy designation (BTD) for use in GCTTS in China.
Clinical Development and Partnerships
ABSK021 is currently being evaluated in a Phase Ib clinical study in the US and China, focusing on safety and efficacy in GCTTS, triple-negative breast cancer, lung cancer, and pancreatic cancer. In July 2021, Sperogenix Therapeutics entered into a licensing agreement with Abbisko to co-develop the drug for rare nervous system diseases, with amyotrophic lateral sclerosis (ALS) as the first indication. Currently, there is no highly selective CSF-1R inhibitor commercially available in China.-Fineline Info & Tech
