Pimicotinib

SHANGHAI, Dec. 8, 2024 /PRNewswire/ -- December 8, 2024, Abbisko Therapeutics (HKEX: 02256) announced the presentation of preliminary Phase 2 study results for pimicotinib (ABSK021) in patients with chronic Graft-versus-Host Disease (cGvHD) who have either progressed or not responded to one or more prior lines of therapy. The presentation took place at the 66th ASH Annual Conference, held December 7-10, 2024, in San Diego, California. Despite most enrolled patients having not yet completed the 6-month treatment cycle required for cGvHD response evaluation, preliminary data from the subset of patients receiving 20mg QD shows that pimicotinib achieved an ORR of 64%. Continue Reading Prof. Xiaodong Mo, Chief Physician of the Department of Hematology, Peking University People's Hospital, reporting on the scene As of November 22, 2024, a preliminary 64% ORR was observed in the subset of patients receiving pimicotinib 20mg QD, with responses observed in all affected organs, including the gastrointestinal tract, oral cavity, eyes, liver, joints and fascia, esophagus, skin, and lungs. In many patients with cGvHD, pulmonary manifestations, such as shortness of breath and diminished lung function, can occur and finally be diagnosed as cGvHD-associated BOS (Bronchiolitis Obliterans Syndrome), which is one of the major challenges in the treatment of cGvHD urgently requiring new therapies. During the oral presentation, researchers highlighted specific lung response results in six subjects at the latest data cut-off: one subject achieved an 11% increase in FEV1 (forced expiratory volume in the first second), one subject's FEV1 recovered to more than 75% after treatment thereby returning to normal levels, and the remaining four subjects saw improvements in the NIH Lung score with significant improvements in shortness of breath. Together, data demonstrate the clinical efficacy of pimicotinib for the treatment of cGvHD-associated BOS. As of the November 22, 2024 data cut-off, the majority of enrolled patients have not yet completed the 6-month treatment cycle to determine the primary endpoint of the study, suggesting the possibility of improved outcomes with longer-term treatment with pimicotinib. The results show that pimicotinib demonstrated robust clinical efficacy and is well tolerated in heavily pre-treated patients with cGvHD. Rapid and durable responses were observed across both inflammation-dominated and fibrosis-dominated organs, accompanied by patient-reported reductions in organ-specific symptom burden. The majority of adverse events were Grade 1 and reversible. Based on latest clinical experience, pimicotinib represents a potentially promising and novel therapeutic option for the management of cGvHD. About Pimicotinib (ABSK021) Pimicotinib (ABSK021), which is being independently developed by Abbisko Therapeutics, is a novel, orally administered, highly selective, and potent small-molecule inhibitor of CSF-1R. Pimicotinib has been granted breakthrough therapy designations (BTD) by China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) and priority medicine (PRIME) designation from the European Medicines Agency (EMA) for the treatment of patients with TGCT that are not amenable to surgery. Pimicotinib is also currently being evaluated for the treatment of patients with chronic Graft-versus-Host Disease. About Abbisko Therapeutics Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology. Please visit for more information. SOURCE Abbisko WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Merck KGaA and Abbisko Therapeutics have announced positive results from a late-stage study of pimicotinib in patients with tenosynovial giant cell tumours (TGCTs). The phase 3 MANEUVER trial has been evaluating the candidate in TGCT patients who are eligible for systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The trial met its primary endpoint, with an objective response rate at week 25 of 54% for pimicotinib versus 3.2% for placebo. Pimicotinib also provided statistically significant and clinically meaningful improvements in secondary endpoints associated with patient outcomes in TGCT, including stiffness and pain. The companies added that the drug was found to be well tolerated, and its safety profile was consistent with previously reported data. TGCT is a rare, benign and locally aggressive disease that originates in the synovial lining of joints, bursae and tendon sheaths. Patients can experience joint pain, stiffness, swelling and a reduced range of motion, and the disease can cause irreversible damage to bones, joints and surrounding tissues if left untreated or in recurrent cases. Pimicotinib, being developed by Abbisko, is an orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. The candidate has already been granted breakthrough therapy designation in the US and China, and priority medicine designation in the EU for TGCT. Merck and Abbisko entered into an agreement in December last year, giving Merck an exclusive licence to commercialise pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for the rest of the world. Danny Bar-Zohar, global head of research and development and chief medical officer for the healthcare business sector of Merck, said: “This phase 3 data from MANEUVER confirms results of Abbisko’s phase 1 study, indicating that targeting CSF-1R with pimicotinib has the potential to offer a new treatment option for patients. “As we work with Abbisko to review the data from this study and prepare to share it with regulators in China, we are focused on our shared goal of bringing pimicotinib to patients in need.”