JNJ-9968 / J&J - LARVOL DELTA

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=100 ➔ 220

CALR • Enrollment change • First-in-human • Essential Thrombocythemia • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Thrombocytosis

Discovery of JNJ-88549968, a Novel, First-in-Class CALRmutxCD3 T-Cell Redirecting Antibody for the Treatment of Myeloproliferative Neoplasms (ASH 2023) - "Taken together, JNJ-88549968 is a novel first-in-class bispecific T-cell redirection antibody investigated for the treatment of CALRmut MPN. JNJ-88549968 is currently being advanced for clinical investigation in patients with MPN."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myeloproliferative Neoplasm • Oncology • CALR • CD34 • JAK2

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2026 ➔ Dec 2027

First-in-human • Trial completion date • Essential Thrombocythemia • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Thrombocytosis

Novel Therapies in Essential Thrombocythemia and Polycythemia Vera (SOHO 2025) - P1, P1/2, P2, P3 | "In PV, recommended cytoreductive options include hydroxyurea, pegIGN, ropeginterferon-alpha-2b (ropeginterferon), and ruxolitinib...A novel fully human IgG1 monoclonal antibody against mutant CALR (INCA033989) has demonstrated promising preclinical activity...Another phase 1 trial evaluating JNJ-88549968, a novel bispecific antibody that binds to both mutant CALR and T cells to enhance cytotoxicity, 10 is also enrolling both CALR -mutated ET and MF patients (NCT06150157)...12 A phase 2 trial of bomedemstat in high-risk ET patients who were resistant or intolerant to hydroxyurea demonstrated that 94% (34/36) of patients met hematologic response criteria after a median of 8 weeks, with stable hemoglobin levels and improved white blood cell counts...Novel Therapies in Polycythemia Vera Rusfertide and Hepcidin Mimetics Maintenance of a hematocrit <45% is a core aspect of PV therapy, which can be accomplished with a combination of therapeutic phlebotomy..."

IO biomarker • Chronic Myeloid Leukemia • Essential Thrombocythemia • Hematological Malignancies • Leukemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Polycythemia Vera • CALR • JAK2 • KLK7 • MPL • TMPRSS6

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2026 ➔ Dec 2026 | Trial primary completion date: Oct 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Essential Thrombocythemia • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Thrombocytosis

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2026 ➔ Sep 2026

Trial completion date • Essential Thrombocythemia • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Thrombocytosis

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Nov 2026 ➔ Jun 2026

Trial completion date • Essential Thrombocythemia • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Thrombocytosis

T-CELL PHENOTYPING SUPPORTS THE USE OF T-CELL ENGAGING ANTIBODIES FOR TREATMENT OF CALRETICULIN MUTATED MYELOPROLIFERATIVE NEOPLASMS (EHA 2024) - P1 | "Phenotyping and functional assessment of T cells from CALRmut patients in the presence of JNJ-88549968confirmed that CALRmut MPN T cells are functional and can mediate cytotoxicity to CALRmut MPN clone. Taken together, these data validate TCE as a novel therapeutic modality for CALRmut MPN patients. Phase 1clinical trial of JNJ-88549968, a novel first-in-class CALRmutxCD3 TCE, is ongoing (NCT06150157)."

IO biomarker • Hematological Disorders • Hematological Malignancies • Myeloproliferative Neoplasm • Oncology • CALR • CD34 • CD8 • GZMB • IFNG • PD-1 • TNFA

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Essential Thrombocythemia • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Thrombocytosis

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P1 trial • Essential Thrombocythemia • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Thrombocytosis