Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD) status from the US FDA for its Category 1 drug ABSK021, also known as pimicotinib. The designation is for the treatment of inoperable tenosynovial giant cell tumor (TGCT) and is based on positive Phase Ib data.
Clinical Results and Development
The Phase Ib study for pimicotinib in advanced TGCT demonstrated a 68% objective response rate (ORR) along with a favorable safety and pharmacokinetic/pharmacodynamic (PK/PD) profile. In July of last year, pimicotinib was awarded BTD status in China for the same TGCT indication. Abbisko has advanced pimicotinib to Phase III clinical trials in China, initiated in October 2022.
Partnership and Future Indications
In July 2021, Abbisko entered into a licensing agreement with Sperogenix Therapeutics to co-develop pimicotinib for rare nervous system diseases, with amyotrophic lateral sclerosis (ALS) as the first indication. This partnership underscores Abbisko’s commitment to expanding the therapeutic potential of pimicotinib beyond TGCT into other high-unmet-need areas.-Fineline Info & Tech
