Product Description
NCA033989, a new anti-mutant calreticulin (CALR)-targeted monoclonal antibody, represents important research milestone in myelofibrosis (MF) and essential thrombocythemia (ET). INCA033989 binds with high affinity to mutant CALR and inhibits oncogenesis, the process of cells becoming cancerous, in cells expressing this oncoprotein. As described in our presentation, INCA033989 potently antagonizes CALR oncogenic function, resulting in selective inhibition of JAK/STAT signaling only in CALR-mutated cells with no effect on normal, non-oncogenic cells. This selectivity of action with INCA033989 results in the specific killing of tumor cells harboring the mutation and is suggestive of the potential to alter the course of disease in patients with CALR-mutant MF and ET. (Sourced from: https://investor.incyte.com/news-releases/news-release-details/incytes-novel-mutant-calr-antibody-unveiled-ash-2022-plenary)
Mechanisms of Action: CALR Antagonist
Novel Mechanism: Yes
Modality: Antibody
Route of Administration: N/A
FDA Designation: Breakthrough Therapy - Thrombocytopenia *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Incyte
Company Location: Eastern America
Company CEO: Hervé Hoppenot
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Canada, Denmark, France, Germany, Italy, Japan, Spain, United Kingdom, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Incyte presented P1 Myeloproliferative Disorders results on 2025-12-08 for INCA-033989
- Clinical Outcomes Reported - Incyte presented P1 Myelofibrosis results on 2025-12-07 for INCA-033989
- Clinical Outcomes Reported - Incyte presented Unknown Thrombocythemia, Essential results on 2025-06-15 for INCA-033989
Highest Development Phases
Phase 1: Myeloproliferative Disorders|Oncology Unspecified
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05936359 |
INCA 33989-101 | P1 |
Recruiting |
Myeloproliferative Disorders |
2028-02-29 |
12% |
2024-04-11 |
Primary Endpoints|Treatments |
jRCT2031230426 |
jRCT2031230426 | P1 |
Recruiting |
Oncology Unspecified |
2028-02-29 |
|||
NCT06034002 |
INCA33989-102 | P1 |
Recruiting |
Myeloproliferative Disorders |
2028-10-29 |
50% |
2025-05-31 |
Patient Enrollment|Primary Endpoints|Treatments |