Abbisko will present ABSK021 Phase IB clinical study data at the 2022 CTOS Annual Meeting

Shanghai Abbisko, an innovative pharmaceutical company focused on small molecule oncology, announced that it will present a significant progress in its pipeline ABSK021 at the 2022 Connective Tissue Oncology Society (CTOS) Annual Meeting
.
This development is a Phase IB study on the excellent antitumor activity and good safety profile of ABSK021 in the treatment of advanced gangsheath giant cell tumor (TGCT), and will be presented
in poster format at the Annual Meeting.

ABSK021 is a new oral, highly selective and highly active CSF-1R small molecule inhibitor independently developed by Abbisko Pharmaceutical, and it is also the first highly selective CSF-1R inhibitor
independently developed and clinically developed by a Chinese company.
It has been approved by CDE for a pivotal clinical phase III trial
in patients with gangsheath giant cell tumor.

Studies have shown that blocking the CSF1/CSF-1R signaling pathway regulates and alters macrophage function and plays a role
in a variety of macrophage-related diseases.
ABSK021 has completed a Phase Ia dose-escalation trial in the United States, is conducting a phase IB multi-cohort expansion study in China and the United States, and was approved by the China Food and Drug Administration in July 2022 as a breakthrough therapy for the treatment of inoperable TGCT.

In addition to the TGCT indications, Abbisko is also actively exploring the clinical potential of ABSK021 in a variety of solid tumors, and exploring its application
in neurological diseases such as ALS with Subobo.
As of the date of this publication, no highly selective CSF-1R inhibitors have been approved for marketing
in China.

At this CTOS Annual Meeting, Abbisko will disclose for the first time preliminary efficacy, safety and pharmacokinetic data
of ABSK021 in patients with inoperable TGCT.
As of June 2022, the Phase 1B study for TGCT included a total of 27 TGCT patients, most of whom had tumors located in lower extremity joints such as knees and hips, and more than half of whom had previously undergone surgery, but the treatment results were not satisfactory
.

The data show that ABSK021 shows promising antitumor activity
in TGCT patients.
Almost all patients had reduced tumor size compared with before treatment, and the range of motion, pain and stiffness of the affected joints were improved, and the clinical benefit was obvious
.
At the same time, ABSK021 also showed good safety and tolerability, and patients were well complied with and willing to continue treatment
.

This will be the first time oral CSF-1R inhibitors have been reported in TGCT patients in China, and ABSK021 has shown encouraging preliminary efficacy and safety results, which will strongly support the continuation of related studies
.

In addition to continuing to advance the Phase 1B study, Abbisko will soon conduct a pivotal Phase III clinical trial in patients with gangsheng cytoma to further evaluate the efficacy and safety
of ABSK021 in subjects with gangsheng cytoma tumor.