Today (December 14), Abbisko Therapeutics announced that its innovative CSF-1R inhibitor, Pimicotinib (ABSK021), has been granted Fast Track Designation (FTD) by the US FDA for patients with inoperable tenosynovial giant cell tumor (TGCT). Earlier this month, Abbisko Pharma licensed the commercialization rights of pimicotinib in Greater China to Merck KGaA for a $70 million down payment, with a total transaction value of more than US$600 million.
Abbisko Pharmaceuticals announcement.
Synchronized clinical practice in multiple places
Towards globalization
TGCT is a group of locally aggressive tumors originating from the synovium, bursa, tendon sheath or adjacent soft tissues of the joint, showing synovial differentiation and is one of the more common soft tissue tumors, which usually causes swelling, pain, stiffness and reduced mobility of the related joints, seriously affecting the quality of life of patients. In 2013, the World Health Organization (WHO) classified TGCT into two types: limited and diffuse, based on lesion morphology, growth patterns, and biological behaviors. According to relevant literature, more than 50% of patients with diffuse TGCT will continue to have ** after surgical resection.
Pimicotinib, developed by Abbisko Therapeutics, is a novel oral, highly selective, and highly active CSF-1R small molecule inhibitor that has been in a global multi-center Phase 3 clinical trial in China, the United States, Canada and EuropeThe first global Phase III study in the field of tenosynovial giant cell tumor disease to be conducted simultaneously in China, the United States, Canada and Europe.
***clinicaltrials.gov
At the CTOS Annual Meeting in November this year, Abbisko also updated the one-year long-term follow-up data of the Phase Ib clinical trial of Pimicotinib**TGCT patients, with an ORR of 875%, showing the anti-tumor activity and good safety profile of the drug.
According to Abbisko Therapeutics, pimicotinib has received Breakthrough Drug Designation and Priority Drug Designation in China, the United States and Europe for the treatment of inoperable tenosynovial giant cell tumor. In addition, the NMPA has approved pimicotinib for clinical trials in chronic graft-versus-host disease and advanced pancreatic cancer, and Abbisko is still exploring the clinical potential of the drug in a variety of solid tumors. To date, no highly selective CSF-1R inhibitor has been approved for marketing in China, and Abbisko is expected to be the first in China.
Focus on the field of anti-tumor
A variety of drugs are highly effective
Focusing on anti-oncology, Abbisko has established a multi-target R&D pipeline, including its key product Pimicotinib, the FGFR4 inhibitor Irpagratinib (ASK011), and the pan-FGFR inhibitor Fexagratinib (ASK091).
Abbisko Pharmaceutical's official website.
irpagratinib（ask011）
Irpagratinib is an FGFR4 inhibitor that is being studied for the treatment of advanced hepatocellular carcinoma (HCC)**. At the ESMO Conference held in October this year, Abbisko Therapeutics disclosed data from the twice-daily (BID) cohort of irpagratinib in treated patients with FGF19 overexpressing HCC, showing that the drug achieved an ORR of 407%, with outstanding efficacy. Abbisko has said that irpagratinib has the potential to become:**Novel leading FGFR4 inhibitor in HCC patients with FGF19 FGFR4 pathway.
fexagratinib（ask091）
Fexagratinib is a highly potent and selective FGFR1-3 inhibitor intended for urothelial carcinoma and other types of solid tumors. In February 2022, Abbisko Therapeutics and BeiGene collaborated on the combination of fexagratinib and tislelizumab in FGFR2 3-mutated urothelial carcinoma**. In March of the same year, fexagratinib received orphan drug designation from the US FDA for the treatment of gastric cancer.
In January 2022, Abbisko also entered into a collaboration agreement with Eli Lilly in areas such as cardiometabolic diseases, with Abbisko Pharma responsible for the discovery and development of small molecule drugs using its proprietary drug discovery platform, and is expected to receive 2$5.8 billion in potential fees. Looking at Abbisko Pharmaceutical's current product pipeline, P151 may be one of the results of the collaboration between the two companies. At the same time, Abbisko continues to promote cooperation with other companies, including AstraZeneca, Suke, Allist, X4, etc.
Summary
With the excellent efficacy, the drug is expected to become the world's leading highly selective CSF-1R inhibitor as the research and development process of pimicotinib continues to advance globally.
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