Pipeline

Our pipeline of immune-modulating, clinical-stage product candidates are based on strong biologic rationale or validated mechanisms, target underserved conditions and offer the potential for differentiation.

Program & Target Therapeutic Area Preclinical Phase 1 Phase 2 Phase 3 Mkt Rights
Rilonacept IL-1α & IL-1β Recurrent Pericarditis
(breakthrough therapy designation)*
Mid Phase 3
Worldwide (excluding the Middle East and North Africa)
Mavrilimumab GM-CSFRα Giant Cell Arteritis Phase 2
Worldwide
CAR T Induced Cytokine Release Syndrome** End Phase 1
Worldwide
COVID-19 Pneumonia & Hyperinflammation End Phase 1
Worldwide
Vixarelimab OSMRβ Prurigo Nodularis Phase 2
Worldwide
Diseases Characterized by Chronic Pruritus Phase 2
Worldwide
KPL-404 CD40 T-Cell Dependent, B-Cell–Mediated Indications Phase 1
Worldwide
*Data from RHAPSODY, a pivotal Phase 3 trial of rilonacept in recurrent pericarditis, were reported in June 2020. Per the license agreement with Regeneron Pharmaceuticals, Inc, ownership of the rilonacept BLA will transfer to Kiniksa. Kiniksa expects to file an sBLA with the FDA by the end of 2020.
**Clinical collaboration with Kite, a Gilead Company, in relapsed or refractory large B-cell lymphoma. Phase 2 trial expected to start in the second half of 2020. Kite will be the sponsor of the trial and will be responsible for its conduct.
Active IND with the U.S. FDA for a global placebo-controlled Phase 2/3 clinical trial of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation.

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