Latest news with #PabloJ.Cagnoni
Business Wire
17 hours ago
- Business
- Business Wire
QIAGEN and Incyte Announce Precision Medicine Collaboration to Develop Companion Diagnostics for Patients With Mutant CALR-expressing Myeloproliferative Neoplasms (MPNs)
VENLO, Netherlands & WILMINGTON, Del.--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Incyte (Nasdaq: INCY) today announced a new global collaboration to develop a novel diagnostic panel to support Incyte's extensive portfolio of investigational therapies for patients with myeloproliferative neoplasms (MPNs), a group of rare blood cancers, including Incyte's monoclonal antibody INCA033989, targeting mutant calreticulin (mutCALR), which is being developed in myelofibrosis (MF) and essential thrombocythemia (ET). Under the terms of the Master Collaboration Agreement with Incyte, QIAGEN will develop a multimodal panel using next-generation sequencing (NGS) technology for detecting clinically relevant gene alterations in hematological malignancies. The panel will be validated using the next-generation sequencing (NGS) technology and the Illumina NextSeq 550Dx platform as part of QIAGEN's partnership with Illumina (NASDAQ: ILMN) to leverage its NGS diagnostic platforms for patient testing by laboratories worldwide. QIAGEN will support regulatory submission processes and market access activities across the United States, European Union and Asia-Pacific regions. Myeloproliferative neoplasms are a group of diseases representing about 40% of hematological malignancies, characterized by chronic accumulation of different mature blood cell types in blood. Identifying genomic aberrations in clinically relevant biomarkers like CALR are shown to be key, especially in MPNs. Incyte is at the forefront of developing novel therapies, including INCA033989 for patients with mutCALR ET or MF, that target only malignant cells, sparing normal cells. The use of companion diagnostics helps guide clinicians in making treatment decisions that can lead to better patient outcomes. 'Following our presentation of positive, late-breaking data from our first-in-class mutCALR-targeted antibody at EHA, we are excited to announce this partnership with QIAGEN, which will facilitate CALR testing for patients with MPNs on a global basis. The development of companion diagnostics for mutCALR, coupled with the potential for new medicines to selectively target disease-initiating cells, is a critical step toward changing the course of disease in patients with ET and MF,' said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. 'As a partner, QIAGEN has the proven expertise in companion diagnostics development and approvals needed to support our ongoing work and commitment to transforming the treatment of patients with CALR-mutant MPNs.' 'Together with Incyte we are building a multimodal companion diagnostic using a powerful technology like next-generation sequencing to facilitate highly accurate testing for several blood cancer genes at once,' said Jonathan Arnold, Vice President and Head of Partnering for Precision Diagnostics at QIAGEN. 'This new partnership strengthens our role in offering companion diagnostics for the growing number of biomarkers being discovered in onco-hematology and maximizing the clinical utility of the diagnostic for payor and patient benefit, thus supporting the work of innovative, science-driven companies like Incyte to improve patient outcomes.' About Mutations in Calreticulin (mutCALR) Calreticulin (CALR) is a protein involved in the regulation of cellular calcium levels and normal protein production. Somatic, or non-inherited, DNA mutations in the CALR gene (mutCALR) can result in abnormal protein function and lead to the development of myeloproliferative neoplasms (MPNs), i a closely related group of clonal blood cancers in which the bone marrow functions abnormally, overproducing blood cells. ii,iii Among the two types of MPNs, essential thrombocythemia (ET) and myelofibrosis (MF), mutCALR drives 25-35% of all cases. i,ii About QIAGEN QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of March 31, 2025, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. For more information, visit QIAGEN is a pioneer in precision medicine and the leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics, having more than 30 master collaboration agreements with global pharmaceutical and biotechnology companies to develop and commercialize diagnostic tests. QIAGEN's offering to these companies encompasses technologies ranging from polymerase chain reaction (PCR), near-patient testing and digital PCR (dPCR) to next-generation sequencing (NGS), and sample types from liquid biopsy to tissue. It also spans disease areas from cancer to non-oncology diseases such as neurodegenerative, inflammatory, and metabolic diseases – including 16 FDA-approved PCR-based companion diagnostics. For more information about QIAGEN's efforts in precision medicine please visit About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. QIAGEN Forward-Looking Statement Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN's products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results - such as expected adjusted net sales and adjusted diluted earnings - are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN's products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN's products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other "force majeure" events. There is also no guarantee that anticipated benefits from restructuring programs and acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the 'Risk Factors' contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential for Incyte's mut-CALR targeted antibody (INCA033989) to provide a potential treatment option for patients with ET or MF, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA, and other regulatory authorities; the efficacy or safety of Incyte and its partners' products; the acceptance of Incyte and its partners' products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended March 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements. Source: QIAGEN N.V. Category: Precision Medicine
Business Wire
18 hours ago
- Business
- Business Wire
Positive Late-Breaking Data for Incyte's First-in-Class mutCALR-targeted therapy INCA033989 in Essential Thrombocythemia Presented at EHA2025
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced the first clinical data from two studies evaluating the safety, tolerability and efficacy of INCA033989, a novel, first in class, Incyte-discovered, targeted monoclonal antibody in patients with mutant calreticulin (mutCALR)-expressing myeloproliferative neoplasms (MPNs). These data – featured today in the Late-Breaking Oral Session (#LB4002) at the European Hematology Association 2025 (EHA2025) Congress in Milan, Italy – focus on the dose escalation portion of the studies in patients with high risk essential thrombocythemia (ET) who are resistant/intolerant to prior cytoreductive therapy. 'These findings, and the further development of INCA033989, offer the potential to significantly transform the treatment of patients with CALR-mutant MPNs," said Pablo J. Cagnoni, M.D., President, Head of Research and Development, Incyte. Share The studies evaluated the safety and efficacy of INCA033989 in patients with ET as measured by hematologic response and reduction in mutCALR variant allele frequency (VAF). Results as of April 4, 2025, showed rapid and durable normalization of platelet counts across all dose levels, with a trend toward improved responses in higher doses (>400 mg), in patients with ET treated with INCA033989. Notably, 86% of patients at doses 400 mg and above achieved a complete or partial hematologic response, with the majority (82%) of patients achieving complete response. Eighty-nine (89) percent of evaluable patients (34/38) showed a reduction in mutCALR VAF from baseline. A partial molecular response (>50% VAF reduction) was observed in 21% of evaluable patients (8/38) after only 3 cycles of treatment. An exploratory study using single-cell DNA (scDNA) sequencing showed that INCA033989 directly targets and reduces cells carrying mutCALR. This reduction was seen in early blood-forming (CD34-positive) cells and cells in the myeloid-erythroid (ME) lineage. At the same time, there was a clear increase in healthy (wild-type CALR) cells, suggesting that the treatment supports the return of normal blood production. Bone marrow biopsies further confirmed these effects showing fewer megakaryocytes with mutCALR protein and a notable increase in megakaryocytes without mutCALR protein. Together, these findings demonstrate the selectivity of INCA033989, allowing for normalization of healthy hematopoiesis and disease modification. 'The late-breaking data presented today highlight the impact of INCA033989, a novel agent that selectively targets mutant CALR, to inhibit and eliminate cancer-causing cells in patients with essential thrombocythemia (ET), while sparing healthy cells and normalizing healthy blood production," said Pablo J. Cagnoni, M.D., President, Head of Research and Development, Incyte. 'These findings, and the further development of INCA033989, offer the potential to significantly transform the treatment of patients with CALR-mutant myeloproliferative neoplasms (MPNs).' The results (N=49) showed that INCA033989 was well tolerated across all dose cohorts (24 to 2,500 mg), with no dose-limiting toxicities observed. Only one (1) patient discontinued treatment, and only one (1) dose reduction due to treatment-emergent adverse events (TEAEs) was observed. No infusion interruptions due to TEAEs were reported, and a maximum tolerated dose was not reached. Forty-two (42) patients across the dose cohorts reported a TEAE. The most common TEAEs were fatigue (26.5%) and upper respiratory tract infection (20.4%), all of which were Grade ≤2. Thirteen (13) patients had Grade >3 TEAEs, with transient asymptomatic lipase increase as the most common (6%). 'mutCALR is the second most common oncogenic driver of MPNs, yet the therapeutic landscape lacks a targeted agent for mutCALR expressing MPNs. Currently, ET treatments aim to prevent vascular complications and improve symptoms but are limited by toxicity and tolerability issues,' said John Mascarenhas, M.D., Professor of Medicine at the Icahn School of Medicine at Mt. Sinai and Director, Center of Excellence for Blood Cancers and Myeloid Disorders, The Tisch Cancer Institute. 'These data support the hypothesis that INCA033989 has the potential not only to normalize platelet counts and provide rapid and durable hematologic responses – but to induce molecular responses, which could potentially change the natural history of the disease.' Additional data from the INCA033989 study in patients with myelofibrosis will be submitted for presentation at a future medical meeting. Discussions with regulatory authorities are planned with the goal to initiate a Phase 3 study by early 2026. More information regarding the EHA2025 Congress and the data from Incyte's hematology/oncology portfolio being featured at the meeting can be found on the EHA website: Incyte Conference Call and Webcast Incyte will host an in-person analyst and investor event on Sunday, June 15, 2025, from 6:00 - 7:30 a.m. ET (12:00 - 1:30 p.m. CEST) to discuss key mutCALR data presented at EHA. The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of and it will be available for replay for 30 days. About Myeloproliferative Neoplasms Myeloproliferative neoplasms (MPNs) are a closely related group of blood cancers in which the bone marrow functions abnormally. The bone marrow is where the body's blood cells are made. MPNs are progressive blood cancers that can strike anyone at any age, but they are more common in older adults. Estimates of the prevalence of MPNs vary, but analysis of claims data suggests there may be as many as 200,000 people in the U.S. living with the most prevalent MPNs: myelofibrosis, polycythemia vera or essential thrombocythemia (ET). 1 About Mutations in Calreticulin (mutCALR) Calreticulin (CALR) is a protein involved in the regulation of cellular calcium levels and normal protein folding. Somatic, or non-inherited, DNA mutations in the CALR gene (mutCALR) can result in abnormal protein function and lead to the development of myeloproliferative neoplasms (MPNs), 2 a closely related group of clonal blood cancers in which the bone marrow functions abnormally, overproducing blood cells. 3,4 Among two types of MPNs, essential thrombocythemia (ET) and myelofibrosis (MF), mutCALR drives 25-35% of all cases. 2,3 There are approximately 60,000 patients in the U.S. and Europe with mutCALR positive ET. 5 Incyte is at the forefront of developing novel therapies for patients with mutCALR ET or MF that target only malignant cells, sparing normal cells, including INCA033989, a first-in-class, mutCALR-specific therapy. About the INCA033989 Trial Program The clinical trial program for INCA033989 includes two multicenter, open-label Phase 1 studies, INCA33989-101 (NCT05936359) and INCA33989-102 (NCT06034002), enrolling ~225 patients outside of the U.S. and ~140 patients in the U.S., respectively. The studies are evaluating the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in patients with myeloproliferative neoplasms (MPNs), including essential thrombocythemia (ET) and myelofibrosis (MF). The intent of Part 1A (dose escalation) is to identify the MTD and/or the RDE of INCA033989 among patients with MF and ET. In Part 1A INCA033989 is administered intravenously every two weeks at a protocol defined dose ranging from 24 mg. to 2,500 mg. In Part 1B (dose expansion), INCA033989 is administered at the RDE(s) identified during Part 1A. The primary endpoint of the studies focuses on safety and tolerability as measured by: the number of participants with DLTs up to 28 days, the number of participants with treatment-emergent adverse events (TEAEs) up to 3 years and 60 days, and the number of participants with TEAEs leading to dose modification or discontinuation up to 3 years and 60 days. Secondary endpoints include response rates, mean change of ET total symptom score from baseline, percentage of MF patients achieving spleen volume reduction, MF patient anemia response, mean change in disease-related allele burden and various pharmacokinetics measures up to 3 years and 60 days. For more information on the study, please visit: and About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data for Incyte's anti-mutCALR monoclonal antibody (INCA033989), the potential this monoclonal antibody offers for patients, and expectations regarding ongoing and future clinical trials contain predictions, estimates, and other forward-looking statements. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA, EMA and other regulatory agencies; Incyte's dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte's products and the products of Incyte's collaboration partners; the acceptance of Incyte's products and the products of Incyte's collaboration partners in the marketplace; market competition; unexpected variations in the demand for Incyte's products and the products of Incyte's collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte's products and the products of Incyte's collaboration partners; sales, marketing, manufacturing and distribution requirements, including Incyte's and its collaboration partners' ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte's reports filed with the Securities and Exchange Commission, including its annual report on form 10-K and our quarterly report on Form 10-Q for the quarter ended March 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.
Business Wire
03-06-2025
- Business
- Business Wire
Incyte Announces Multiple Presentations, Including New Late-Breaking Data for its mutCALR-Directed Monoclonal Antibody (INCA033989), Accepted for Presentation at EHA 2025
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that data from numerous programs in its hematology/oncology portfolio will be presented at the 2025 European Hematology Association (EHA) congress, held June 12 – 15, 2025, in Milan. Late-breaking oral presentation will highlight new data from a trial of INCA033989, an anti-mutant calreticulin (mutCALR)-directed monoclonal antibody, in patients with essential thrombocythemia (ET) Share "We're looking forward to presenting new data from across our hematology/oncology portfolio at the 2025 EHA Congress, including late-breaking data for our first in class, mutCALR-directed monoclonal antibody, INCA033989,' said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. 'We believe the data that will be presented at the late-breaking session demonstrate the impact of the novel mechanism of action of this monoclonal antibody against mutCALR-driven essential thrombocythemia (ET), and support its potential to be a disease modifying agent and thus transform the treatment of patients with myeloproliferative neoplasms (MPNs) like essential thrombocythemia (ET)." Key Incyte abstracts accepted for presentation at EHA include: Late-Breaking Oral Presentation INCA033989 (mutCALR) INCA33989 is a Novel, First in Class, Mutant Calreticulin-Specific Monoclonal Antibody That Demonstrates Safety and Efficacy in Patients with Essential Thrombocythemia (ET) (Session Title: Late-Breaking Oral Session. June 15, 3:15 – 4:45 a.m. EDT [9:15-10:45 a.m. CEST]. Abstract #LB4002.) Oral Presentations INCA035784 (mutCALR) INCA035784, a Novel, Equipotent T Cell Redirecting Antibody for Patients with Myeloproliferative Neoplasms Carrying Different Types of Calreticulin Mutations (Session Title: Novel and Experimental Approaches to Study and Treat MPN. June 15, 5:30 – 5:45 a.m. EDT [11:30 – 11:45 a.m. CEST]. Abstract #S212.) Ruxolitinib Clinical Outcomes in Patients with Myelofibrosis Treated with Ruxolitinib and Anemia Supporting Medications (Session Title: Assessment of Risk and Survival in MPN. June 13, 11:45 a.m. – 12:00 p.m. EDT [5:45 – 6:00 p.m. CEST]. Abstract #S218.) Tafasitamab Tafasitamab (tafa) Plus Lenalidomide (len) and Rituximab (R) for Patients with Relapsed or Refractory Follicular Lymphoma (R/R FL): Results from the Phase 3 inMIND Study (Session: Indolent and Mantle-Cell Non-Hodgkin Lymphoma - Clinical. June 14, 11:00 – 11:15 a.m. EDT [5:00 – 5:15 p.m. CEST]. Abstract #S230.) Poster Presentations Axatilimab Trial in Progress: A Randomized, Open-Label, Phase 3 Study of Axatilimab Versus Best Available Therapy in Patients with Chronic Graft-Versus-Host Disease After ≥2 Prior Lines of Systemic Therapy (Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1090.) Dynamics of Overall and Organ-Specific Responses to Axatilimab in Chronic Graft-Versus-Host Disease: Analysis from the AGAVE-201 Study (Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1035.) Correlations of Clinician-Reported Responses with Other Response Measures in Patients with Chronic Graft-Versus-Host Disease: An Analysis From the AGAVE-201 Trial (Session: Poster Session 1. June 13 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1041.) The Effects of Prior Lines of Therapy on Clinical Outcomes for Patients with Chronic Graft-Versus-Host Disease Receiving Axatilimab: A Post Hoc Analysis of AGAVE-201 (Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS2029). INCB057643 (BET) Bromodomain and Extra-Terminal (BET) Protein Inhibitor, INCB057643, Improves Bone Marrow Function and Shifts Megakaryopoiesis to Erythropoiesis in Patients with Myeloproliferative Neoplasms (MPNs) (Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF801.) INCB057643, a Bromodomain and Extra-Terminal Protein Inhibitor, Has Novel Roles in Myeloid Cell Regulation and Immunosuppressive Tumour Environment Remodelling in Myelofibrosis (Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1805.) Safety and Efficacy of Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 in Patients (pts) with Relapsed or Refractory Myelofibrosis (MF) and Other Advanced Myeloid Neoplasms: A Phase 1 Study (Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1822.) Ponatinib Impact of Ponatinib Treatment on Pregnancy Outcomes (Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1598.) Ruxolitinib JAK2 V617F VAF and Presence of Copy Neutral-LOH at Chromosome 9p (chr9p) Predicts Transformation to Myelofibrosis (MF) in Patients with Polycythemia Vera (PV) Enrolled in REVEAL (Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF819.) Clinical and Gene Expression Patterns Associated with Disease Progression in Patients with Low-Risk Myelofibrosis Enrolled in the Myelofibrosis and Essential Thrombocythemia Observational Study (MOST) (Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1808.) Tafasitamab CD19 Expression is Retained in Patients with Relapsed/Refractory Follicular or Marginal Zone Lymphoma After Receiving Tafasitamab, Lenalidomide and Rituximab in the inMIND Study (Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1006.) Tafasitamab plus Lenalidomide and Rituximab in Relapsed or Refractory Follicular Lymphoma: A Post Hoc Analysis of Outcomes by POD24 Status from the inMIND Study (Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1877.) More information regarding the 2025 EHA Congress can be found at: Conference Call and Webcast Incyte will host an in-person analyst and investor event on Sunday, June 15, 2025 from 6:00 - 7:30 a.m. ET (12:00 - 1:30 p.m. CEST) to discuss key mutCALR data being presented at EHA. The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of and it will be available for replay for 30 days. About Mutations in Calreticulin (mutCALR) Calreticulin (CALR) is a protein involved in the regulation of cellular calcium levels and normal protein production. Somatic, or non-inherited, DNA mutations in the CALR gene (mutCALR) can result in abnormal protein function and lead to the development of myeloproliferative neoplasms (MPNs), 1 a closely related group of clonal blood cancers in which the bone marrow functions abnormally, overproducing blood cells. 2,3 Among two types of MPNs, essential thrombocythemia (ET) and myelofibrosis (MF), mutCALR drives 25-35% of all cases. 2,3 Incyte is at the forefront of developing novel therapies for patients with mutCALR ET or MF that target only malignant cells, sparing normal cells, including INCA033989, a first-in-class, mutCALR-specific therapy. About Jakafi ® (ruxolitinib) Jakafi ® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Jakafi is a registered trademark of Incyte. About Tafasitamab (Monjuvi ®) Tafasitamab (Monjuvi ®) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb ® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In the United States, Monjuvi ® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. XmAb ® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the 'triangle' design are registered trademarks of Incyte. About Niktimvo™ (axatilimab-csfr) Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications. Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256). Niktimvo is a trademark of Incyte. All other trademarks are the property of their respective owners. About Iclusig ® (ponatinib) tablets Iclusig ® (ponatinib) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte's clinical development pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, and Incyte's goal of improving the lives of patients, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA, and other regulatory authorities; the efficacy or safety of Incyte and its partners' products; the acceptance of Incyte and its partners' products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended March 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements. 1 Raghavan, M., Wijeyesakere S.J., Peters L.R., Del Cid N. (2013) Calreticulin in the immune system: ins and outs. Trends in Immunology, 34(1):13-21. Link to source ( 2 Nangalia J. Massie C.E., Baxter E.J., Nice F.L., et al. (2013) Somatic CALR mutations in myeloproliferative neoplasms with nonmutated JAK2. New England Journal of Medicine, 369(25):2391-2405. Link to source ( 3 Klampfl T., Gisslinger, H., Harutyunyan A.S., et al. (2013) Somatic mutations of calreticulin in myeloproliferative neoplasms. New England Journal of Medicine, 369(25):2379-2390. Link to source (
Business Wire
23-04-2025
- Business
- Business Wire
Incyte to Showcase New Data from its Oncology Portfolio at 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq: INCY) today announced that multiple abstracts featuring new data from its oncology portfolio will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 30 – June 3, 2025, in Chicago. 'The data featured at the 2025 ASCO Annual Meeting, from both our approved medicines and early-stage pipeline, reflect our ongoing efforts to transform cancer care,' said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. 'We are advancing potential therapies across some of the most difficult-to-treat cancers and hematological diseases, including squamous cell anal cancer, ovarian cancer and myelofibrosis, with the hope of making a meaningful difference for these patients.' Key abstracts accepted for presentation: Oral Presentations INCB123667 Safety and Preliminary Efficacy from a Phase 1 Study of INCB123667, a Selective CDK2 Inhibitor, in Patients with Advanced Platinum-Resistant and Refractory Ovarian Cancer (OC) (Abstract #5514. Session: Rapid Oral Abstract – Gynecologic Cancer. June 3, 9:42 a.m. ET (8:42 a.m. CT)) Pemigatinib A Phase 2 Study of Pemigatinib for Pre-treated Glioblastoma or Other Gliomas with Activating FGFR1-3 Alterations: Results from FIGHT-209 (Abstract #2003. Session: Oral Abstract Session – Central Nervous System Tumors. May 30, 4:21 p.m. ET (3:21 p.m. CT)) Poster Presentations Retifanlimab Experience of Patients with HIV and Squamous Cell Carcinoma of the Anal Canal (SCAC) Treated with Retifanlimab (Abstract #3521. Session: Gastrointestinal Cancer—Colorectal and Anal. May 31, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT)) POD1UM-303/INTERAACT2 Subgroup Analyses and Impact of Delayed Retifanlimab Treatment on Outcomes in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) (Abstract #3525. Session: Gastrointestinal Cancer—Colorectal and Anal. May 31, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT)) Final Results of POD1UM-201, a Phase 2 Study of Retifanlimab, a Humanized Anti–PD-1 Antibody, in Patients with Advanced or Metastatic Merkel Cell Carcinoma (MCC) (Abstract #9536. Session: Melanoma/Skin Cancers. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT)) Long-term Outcomes After Discontinuation of Retifanlimab in Patients with Advanced or Metastatic Merkel Cell Carcinoma (MCC) in the POD1UM-201 Trial (Abstract #9538. Session: Melanoma/Skin Cancers. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT)) INCB123667 Interim Safety and Antitumor Activity Data from a Phase 1 Study of INCB123667, a Selective CDK2 Inhibitor, in Patients with Metastatic Recurrent Endometrial Cancer (Abstract #5603. Session: Gynecologic Cancer. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT)) INCB057643 Safety And Efficacy of Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 In Patients (pts) with Relapsed or Refractory Myelofibrosis (r/r-MF) and Other Advanced Myeloid Neoplasms: A Phase (Ph) 1 Study (Abstract #6574. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant. June 1, 10:00 a.m. – 1:00 p.m. ET (9:00 a.m. – 12:00 p.m. CT)) More information regarding the 2025 ASCO Annual Meeting can be found at: About Pemazyre ® (pemigatinib) Pemazyre ® (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test*. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. In Canada, Pemazyre is approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States, Europe, Japan and Canada. Pemazyre and the Pemazyre logo are registered trademarks of Incyte. * Pemazyre ® (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020. About Zynyz ® (retifanlimab-dlwr) Zynyz ® (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. In Europe, Zynyz (retifanlimab) is approved as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy. In Canada, Zynyz (retifanlimab) is approved as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy. Zynyz is marketed by Incyte in the U.S., Europe and Canada, in 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz is a registered trademark of Incyte. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte's clinical development pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, and Incyte's goal of improving the lives of patients, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA, and other regulatory authorities; the efficacy or safety of Incyte and its partners' products; the acceptance of Incyte and its partners' products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-K for the year ended December 31, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements.
Yahoo
20-02-2025
- Business
- Yahoo
Incyte and Genesis Therapeutics Announce Strategic AI-focused Research Collaboration
Incyte and Genesis will leverage Genesis' GEMS artificial intelligence (AI) platform to unlock the discovery of breakthrough small molecule therapeutics against Incyte-selected targets Incyte receives exclusive rights to develop and commercialize collaboration products WILMINGTON, Del. & BURLINGAME, Calif., February 20, 2025--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) and Genesis Therapeutics, Inc. announced today that the companies have entered into a strategic collaboration focused on the research, discovery and development of novel small molecule medicines, with an initial focus on collaboration targets selected by Incyte. Genesis is pioneering generative and predictive artificial intelligence (AI) technologies to help create therapeutics for challenging targets. Utilizing Genesis' proprietary AI platform, GEMS (Genesis Exploration of Molecular Space), the partnership will pursue the discovery and optimization of small molecule compounds for the collaboration targets. Incyte is granted exclusive rights for potential clinical development and commercialization of collaboration products. "As a leader in pharmaceutical innovation, Incyte is continually seeking new technologies that can transform how new medicines are discovered and developed," said Pablo J. Cagnoni, M.D., President and Head of Research and Development at Incyte. "Partnering with Genesis Therapeutics presents a unique opportunity to leverage their AI technologies to accelerate the discovery of breakthrough small molecules for high-impact targets in our pipeline." "AI has the potential to redefine how we discover small molecule medicines, and our team is at the forefront of this revolution," said Evan Feinberg, Ph.D., Founder and Chief Executive Officer of Genesis. "We are pleased to establish this world-class partnership to combine our GEMS AI platform with Incyte's deep expertise and track record in drug discovery and development, with the shared goal of advancing critical treatments for patients with severe diseases." Terms of the Agreement Under the terms of the agreement, Genesis will receive an upfront payment of $30 million. Genesis and Incyte have agreed to collaborate on two initial targets, and Incyte will have the option to nominate an additional target for a predetermined fee. If all milestones are achieved, Genesis is eligible to receive up to $295 million in development, regulatory and commercial milestone payments per target. Genesis is also eligible to receive tiered royalties on sales of any collaboration products, once approved. About Genesis Therapeutics Genesis Therapeutics, Inc. is an AI-focused biotechnology company leveraging its generative and predictive AI platform, GEMS (Genesis Exploration of Molecular Space), for small molecule drug discovery. GEMS integrates proprietary AI methods, including language models, diffusion models and physical simulation, to generate and optimize molecules for complex targets. Genesis has raised over $300 million from leading life science, tech, and AI-focused investors, and is building a therapeutics pipeline for a variety of high-impact targets. Genesis is headquartered in Burlingame, CA, with a fully integrated laboratory in San Diego. For more information on Genesis, please visit the company's website at About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential of the products arising from the collaboration with Genesis Therapeutics, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by regulatory authorities; Incyte's dependence on its relationships with its collaboration partners; the efficacy or safety of Incyte's products and the products of Incyte's collaboration partners; the acceptance of Incyte's products and the products of Incyte's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte's reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended December 31, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements. View source version on Contacts Genesis Media Contact: Thermal for Genesispress@ Incyte Contacts: Media media@ Investors ir@
