Incyte Showcases First-in-Class Mutant Calreticulin Antibody INCA033989 at ASH 2025 with Over 50 Presentations
核心洞察
Incyte will present data on INCA033989, a first-in-class mutant calreticulin (搜索)-targeted monoclonal antibody, in three oral presentations at ASH 2025, including new Phase 1 monotherapy and combination data in myelofibrosis (搜索) patients.
The company announced more than 50 abstracts accepted for presentation at the 2025 American Society of Hematology Annual Meeting, covering key programs in myeloproliferative neoplasms (搜索), GVHD, and hematology.
INCA033989 targets mutant calreticulin (搜索), which drives 25-35% of essential thrombocythemia (搜索) and myelofibrosis (搜索) cases, representing approximately 60,000 patients in the U.S. and Europe with mutCALR positive essential thrombocythemia.
Incyte Corporation announced that data from its oncology portfolio will be featured in more than 50 presentations at the 2025 American Society of Hematology (ASH) Annual Meeting, scheduled for December 6-9, 2025, in Orlando. The presentations will highlight the company's first-in-class mutant calreticulin (搜索) (mutCALR)-targeted monoclonal antibody INCA033989, along with updates from programs targeting myeloproliferative neoplasms (搜索) (MPNs), graft-versus-host disease (搜索) (GVHD), and other hematologic malignancies.
INCA033989 Takes Center Stage with Three Oral Presentations
INCA033989, Incyte's novel mutCALR-targeted therapy, will be showcased in three oral presentations featuring new Phase 1 monotherapy and combination data in myelofibrosis (搜索) (MF), updated data in essential thrombocythemia (搜索) (ET), and translational data demonstrating disease-modifying activity in both conditions.
"New data for our first-in-class mutCALR-targeted monoclonal antibody, INCA033989, as a monotherapy in patients with myelofibrosis (搜索) (MF) who are intolerant or refractory to ruxolitinib, and in combination with ruxolitinib in patients with MF who experience a suboptimal response to ruxolitinib monotherapy will be highlighted as an oral presentation," said Pablo J. Cagnoni, M.D., President and Head of Research and Development at Incyte.
The oral presentations will include molecular characterization data demonstrating selective targeting of CALR mutant hematopoietic cells, preliminary safety and efficacy results from dose escalation studies, and updated data in essential thrombocythemia (搜索) patients.
Targeting a Significant Patient Population
Mutations in calreticulin (mutCALR) drive 25-35% of essential thrombocythemia (搜索) and myelofibrosis (搜索) cases, representing a substantial unmet medical need. According to Incyte, there are approximately 60,000 patients in the U.S. and Europe with mutCALR positive essential thrombocythemia. The company estimates that as many as 200,000 people in the U.S. are living with the most prevalent MPNs: myelofibrosis, polycythemia vera (搜索), or essential thrombocythemia.
Calreticulin is a protein involved in the regulation of cellular calcium levels and normal protein folding. Somatic DNA mutations in the CALR gene can result in abnormal protein function and lead to the development of myeloproliferative neoplasms (搜索), a closely related group of clonal blood cancers in which the bone marrow functions abnormally, overproducing blood cells.
Comprehensive Clinical Development Program
The INCA033989 clinical trial program encompasses two multicenter, open-label Phase 1 studies: INCA33989-101 (NCT05936359) enrolling approximately 225 patients outside of the U.S., and INCA33989-102 (NCT06034002) enrolling approximately 140 patients in the U.S. The studies are evaluating the safety, tolerability, dose-limiting toxicity, and maximum tolerated dose of INCA033989 administered as monotherapy or in combination with ruxolitinib.
In Part 1A (dose escalation), INCA033989 is administered intravenously every two weeks at protocol-defined doses ranging from 24 mg to 2,500 mg. The primary endpoint focuses on safety and tolerability, measured by dose-limiting toxicities up to 28 days and treatment-emergent adverse events up to 3 years and 60 days. Secondary endpoints include response rates, symptom score changes, spleen volume reduction, anemia response, and changes in disease-related allele burden.
Broader Portfolio Presentations
Beyond INCA033989, Incyte will present data on several other key programs. Axatilimab (Niktimvo), a first-in-class CSF-1R (搜索)-blocking antibody approved for chronic GVHD treatment, will be featured in multiple presentations including interim safety data evaluating its combination with ruxolitinib in GVHD patients.
The company will also showcase results from tafasitamab (Monjuvi) in follicular lymphoma (搜索) through its Phase 3 inMIND study, along with data from various investigational compounds including INCB057643 (a BET inhibitor), INCB000928 (an ALK2 inhibitor), and INCB160058 (a JAK2V617F (搜索) mutant-selective inhibitor).
Investor Focus on mutCALR Data
Incyte will host an investor event and webcast on Sunday, December 7, 2025, from 11:00 a.m. to 12:30 p.m. ET to discuss the key mutCALR data being presented at ASH. The event will be available for replay for 30 days via the company's investor relations website.
"This year's Incyte presentations highlight the potential of our portfolio to transform the treatment of blood cancers, specifically for patients with myeloproliferative neoplasms (搜索)," Cagnoni noted, emphasizing the company's commitment to developing targeted therapies that address significant unmet medical needs in hematologic malignancies.