INCA033989 / Incyte - LARVOL DELTA

Incyte Reports 2024 Fourth Quarter and Year-End Financial Results, Provides 2025 Financial Guidance and Highlights 2025 R&D Milestones (Businesswire) - "Key Recent Company Updates: In December 2024, Incyte shared additional data from its BET inhibitor (INCB057643) in patients with relapsed or refractory myelofibrosis and other advanced myeloid neoplasms at the 2024 ASH Annual Meeting....Incyte plans to initiate a Phase 3 monotherapy study in the post Jakafi patient population in 2025. In December 2024, the supplemental Biologics License Application (sBLA) submission for retifanlimab (Zynyz) in advanced/metastatic squamous cell anal carcinoma was filed with the FDA with approval anticipated in the second half of 2025....The Phase 1 studies evaluating mutCALR in myelofibrosis (MF) and essential thrombocythemia (ET) and JAK2V617Fi in MF are ongoing and enrolling patients. Initial proof of concept data for both studies are anticipated in 2025."

FDA approval • FDA filing • New P3 trial • P1 data • Anal Carcinoma • Essential Thrombocythemia • Myelofibrosis • Squamous Cell Carcinoma

INCA033989: the first shot on goal for MPNs? (PubMed, Blood) - "In this issue of Blood, Reis et al1 identify a monoclonal antibody, INCA033989, that selectively targets mutant calreticulin (mutCALR) in myeloproliferative neoplasms (MPNs), inhibiting its oncogenic activity without affecting normal hematopoiesis."

Journal • Hematological Disorders • Myeloproliferative Neoplasm • Oncology • CALR

Incyte Reports 2024 Third Quarter Financial Results and Provides Updates on Key Clinical Programs (Businesswire) - "Additional Pipeline Updates: A bioequivalence study of ruxolitinib extended-release (XR) is enrolling. The data are anticipated in the first half of 2025....Trials of ruxolitinib twice daily (BID) with BETi and zilurgisertib are ongoing. Additional data for BETi and zilurgisertib are anticipated in the fourth quarter of 2024. The Phase 1 studies evaluating mCALR and JAK2V617Fi are ongoing and enrolling patients. Initial data for both studies are anticipated in 2025."

Clinical data • P1 data • Myelofibrosis • Myeloproliferative Neoplasm

Selective targeting of mutated calreticulin by the monoclonal antibody INCA033989 inhibits oncogenic function of MPN. (PubMed, Blood) - "INCA033989 reduced the pathogenic self-renewal of mutCALR-positive disease-initiating cells in both primary and secondary transplantations, illustrating its disease-modifying potential. In summary, we describe a novel mutCALR-targeted therapy for MPNs, a monoclonal antibody that selectively inhibits the oncogenic function of MPN cells without interfering with normal hematopoiesis."

Journal • Hematological Disorders • Myeloproliferative Neoplasm • Oncology • Thrombocytosis • Transplantation • CALR • CD34

Incyte Reports 2024 Second Quarter Financial Results and Provides Updates on Key Clinical Programs (Businesswire) - "Jakafi: Net product revenues for the second quarter 2024 of $706 million (+3% Y/Y): Paid demand increased 9% in the second quarter of 2024 versus the same quarter in the prior year, with growth across all indications. Year over year net product revenue growth was lower than paid demand growth due to higher channel inventory levels at the end of the second quarter of 2023 versus the same period of 2024. Channel inventory at the end of the second quarter of 2024 was within the normal range....The Phase 1 studies evaluating mCALR and JAK2V617Fi are ongoing and enrolling patients. Initial data for both studies is anticipated in 2025."

P1 data • Sales • Graft versus Host Disease • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera

EFFICACY OF INCA033989 IN CHRONIC AND ADVANCED FORMS OF CALRDEL52 AND CALRINS5 MYELOPROLIFERATIVE NEOPLASMS (MPN) MODELS (EHA 2024) - "Together, our results show INCA efficiently targets CALRdel52 and CALRins5 cells in chronic and advancedforms of MPNs, demonstrating therapeutic potential and warranting further investigation."

Clinical • Metastases • Acute Myelogenous Leukemia • Essential Thrombocythemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myeloproliferative Neoplasm • Oncology • Thrombocytosis • CALR • CD34 • HSP90AA1

Incyte to Highlight Data From its Oncology Portfolio at the 2024 ASCO Annual Meeting and EHA2024 Congress (Businesswire) - "Incyte...announced that several abstracts featuring data from its oncology portfolio will be presented at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held May 31 - June 4 in Chicago, and at the European Hematology Association 2024 (EHA2024) Congress held on June 13-16 in Madrid, Spain, and virtually."

Clinical data • Myelofibrosis • Myeloproliferative Neoplasm • Solid Tumor

A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Incyte Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • CALR

Incyte Reports 2023 Third Quarter Financial Results and Provides Updates on Key Clinical Programs (Businesswire) - "The Phase 1 study evaluating INCA033989 (mCALR) is ongoing and enrolling patients. In October, we announced the development of a new program targeting the JAK2V617F mutation, which is present in 55-60% of myelofibrosis (MF) and essential thrombocythemia (ET) patients, and in 95% of polycythemia vera (PV) patients. INCB100658 is a small molecule inhibitor, targeting the JAK2V617F mutation and we expected to file the IND by year-end 2023."

IND • Trial status • Essential Thrombocythemia • Hematological Malignancies • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Polycythemia Vera

A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=140 | Not yet recruiting | Sponsor: Incyte Corporation

New P1 trial • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • CALR

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=225 | Recruiting | Sponsor: Incyte Corporation

Combination therapy • Monotherapy • New P1 trial • Myeloproliferative Neoplasm • Oncology • CALR

Incyte Reports 2022 Fourth Quarter and Year-end Financial Results, Provides 2023 Financial Guidance and Updates on Key Clinical Programs (Businesswire) - "Parsaclisib + ruxolitinib in myelofibrosis (MF): A Phase 3 trial evaluating parsaclisib as an add-on to ruxolitinib in suboptimal responders is ongoing with results expected at the end of 2023....Zilurgisertib (ALK2) ± ruxolitinib in MF: Updated combination data with ruxolitinib are expected later this year....INCA33989 (mCALR) in MF and essential thrombocythemia (ET): INCA33989 is expected to enter the clinic later this year."

New P1 trial • P2 data • P3 data • Essential Thrombocythemia • Hematological Disorders • Hematological Malignancies • Myelofibrosis • Myeloproliferative Neoplasm • Oncology