#China #Shanghai #Abbisko #Pimicotinib #cGvHD

Abbisko's Promising Phase 2 Results for Pimicotinib in Chronic Graft-versus-Host Disease

On December 8, 2024, Abbisko Therapeutics unveiled preliminary Phase 2 study results for their drug pimicotinib (ABSK021) during the 66th ASH Annual Meeting held in San Diego, California. This presentation focused on its application for patients suffering from chronic Graft-versus-Host Disease (cGvHD) who were either unresponsive or had progressed after receiving one or more previous therapies.

The early results are particularly noteworthy, showing that among patients treated with a daily dosage of 20mg of pimicotinib, the overall response rate (ORR) stood at an impressive 64%. This statistic is compelling, especially considering that many of the participants have not yet completed the required six-month treatment cycle for full response evaluation.

The presentation by Prof. Xiaodong Mo, Chief Physician at the Department of Hematology at Peking University People's Hospital, indicated that responses spanned across various affected organs, including the gastrointestinal tract, oral cavity, eyes, liver, joints, fascia, esophagus, skin, and lungs. The findings are especially significant given the potential for pulmonary complications in cGvHD patients, often characterized as Bronchiolitis Obliterans Syndrome (BOS). Addressing this issue, specific lung response results highlighted an 11% increase in forced expiratory volume (FEV1) for one participant, while another saw their FEV1 levels recover to over 75% after treatment. Thus, it appeared that pimicotinib could potentially address critical respiratory issues for cGvHD patients.

The ongoing response evaluation suggests that longer treatment durations could yield even better outcomes. Interim data show that pimicotinib has a robust clinical efficacy and is generally well tolerated. Most side effects experienced by patients were of Grade 1 severity and reversible, indicating a strong safety profile for the drug. These developments showcase the need for innovative therapies in the treatment of cGvHD, a condition with high unmet medical needs.

About Pimicotinib

Pimicotinib, the focus of Abbisko's investigation, is a novel, orally administered potent small-molecule inhibitor specifically targeting CSF-1R. It has garnered break-through therapy designations from both the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). Additionally, it received a priority medicine designation from the European Medicines Agency (EMA). Beyond cGvHD, pimicotinib is also being explored for its effectiveness in other medical conditions, particularly given its promising early results in treating tenosynovial giant cell tumor (TGCT).

About Abbisko Therapeutics

Founded in 2016, Abbisko Therapeutics is a Shanghai-based biopharmaceutical company with a primary focus on oncology. Committed to addressing unmet medical needs both locally and globally, the organization has developed a comprehensive pipeline centered on precision oncology and immuno-oncology. Given the promising results from this Phase 2 study, the development of pimicotinib may represent a significant advancement in managing the challenges presented by cGvHD and similar ailments. For further information, visit Abbisko's official website.