Kiniksa Pharmaceuticals focuses on developing immune-modulating therapies aimed at addressing critical therapeutic needs in underserved conditions. Their pipeline includes clinical-stage product candidates such as ARCALYST® (rilonacept), which targets interleukin-1α and interleukin-1β and is currently approved for recurrent pericarditis and other conditions. The company is also advancing Mavrilimumab, which targets the granulocyte macrophage colony-stimulating factor receptor alpha (GM-CSFRα) and is in Phase 1 trials for rare cardiovascular diseases. Additionally, Kiniksa is developing KPL-404, which targets CD40/CD154 and is in Phase 2 trials for rheumatoid arthritis, showcasing their commitment to addressing autoimmune diseases.

Kiniksa's approach is characterized by a sense of urgency, as they strive to make every moment count for patients living with debilitating diseases. Their focus on differentiation in treatment options is evident in their strategic development of therapies that have received significant designations from regulatory bodies, such as Breakthrough Therapy designation and Orphan Drug exclusivity for ARCALYST. This reflects Kiniksa's dedication to not only advancing innovative treatments but also ensuring that they meet the pressing needs of patients who often face uncertainty in their health journeys.

United States

Kiniksa is a publicly traded biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines designed for patients suffering from debilitating immunological diseases with significant unmet medical need.

We have a pipeline of product candidates across various stages of development, focused on autoinflammatory and autoimmune conditions. We are relentless and focused on patients and strive to develop life-changing medicines.

We are focused on hiring and retaining a highly skilled team that has extensive experience and specific skill sets relating to the selection, development, and commercialization of transformative therapies. Whether in development, research, manufacturing, technical operations, or general / administrative functions, we depend on a brilliant team to support our mission of building a global, generational company.


Infectious Diseases

Kiniksa Pharmaceuticals

Heart disease

Inflammatory disease

Recurrent pericarditis

Inhibitor of interleukin-1α (IL-1α) and interleukin-1β (IL-1β).
Rilonacept is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks IL-1α and IL-1β signaling. Rilonacept was discovered and developed by Regeneron and is approved by the FDA under the brand name ARCALYST® for the treatment of CAPS, specifically Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome. Rilonacept for the treatment of DIRA is currently under FDA review following the submission of an sBLA in June 2020. Rilonacept in recurrent pericarditis is an investigational drug. The FDA granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to rilonacept for the treatment of pericarditis in 2020.

ARCALYST (Rilonacept) (IL-1α & IL-1β)

Autoimmune disease

Rheumatoid arthritis

KPL-404 is an investigational humanized monoclonal antibody that is &nbsp;designed to inhibit CD40-CD40 ligand (CD40L) interaction, a key T-cell &nbsp;co-stimulatory signal critical for B-cell maturation and immunoglobulin &nbsp;class switching and Type 1 immune responses. Kiniksa believes disrupting &nbsp;the CD40-CD40L interaction is an attractive approach for multiple &nbsp;autoimmune disease pathologies such as rheumatoid arthritis, Sjogren’s &nbsp;syndrome, Graves’ disease, systemic lupus erythematosus and solid organ &nbsp;transplant. Kiniksa owns or controls the intellectual property related &nbsp;to KPL-404.
<a href="https://investors.kiniksa.com/news-releases/news-release-details/kiniksa-highlights-corporate-priorities-and-expected-2021">Source</a>

Abiprubart (KPL-404) (CD40)

Prurigo nodularis

Skin disease/disorder

Vixarelimab is an investigational fully-human monoclonal antibody that targets OSMRβ, which mediates signaling of interleukin-31 (IL-31) and oncostatin M (OSM), two key cytokines implicated in pruritus, inflammation and fibrosis. Kiniksa believes vixarelimab to be the only monoclonal antibody in development that targets both pathways simultaneously.

Vixarelimab (OSMRβ) (KPL-716)

KPL-387 is an independently developed, investigational, fully human IgG2 monoclonal antibody that binds to IL-1R1, inhibiting the signaling of the cytokines IL-1α and IL-1β.

Kiniksa believes KPL-387 could expand the treatment options for patients with recurrent pericarditis by enabling dosing with a single monthly subcutaneous (SC) injection in a convenient liquid formulation.

KPL-387

Giant cell arteritis

Mavrilimumab is an investigational fully-human monoclonal antibody that targets GM-CSFRα. Mavrilimumab was dosed in over 550 patients with rheumatoid arthritis through Phase 2b clinical studies in&nbsp;Europe&nbsp;and achieved prospectively-defined primary endpoints of efficacy and safety. Kiniksa’s lead indication for mavrilimumab is GCA, a rare inflammatory disease of medium-to-large arteries. Kiniksa is also evaluating mavrilimumab in COVID-19 pneumonia and hyperinflammation. The FDA granted Orphan Drug designation to mavrilimumab for the treatment of GCA in 2020.

Mavrilimumab (GM-CSFRa)

COVID-19

Pneumonia

Mavrilimumab is an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα). Kiniksa’s lead indication for mavrilimumab is giant cell arteritis (GCA), an inflammatory disease of medium-to-large arteries. The company completed enrollment in a Phase 2 proof-of-concept trial in GCA and expects data in the fourth quarter of 2020.&nbsp;Mavrilimumab was dosed in over 550 patients with rheumatoid arthritis through Phase 2b clinical studies in&nbsp;Europe&nbsp;and achieved prospectively-defined primary endpoints of efficacy and safety. Additionally, Kiniksa and Kite, a Gilead company, have a clinical collaboration to evaluate mavrilimumab in combination with Yescarta® (axicabtagene ciloleucel) (which is a CAR-T cell therapy) in patients with relapsed or refractory large B-cell lymphoma. Kiniksa also has an active investigational new drug (IND) application with the&nbsp;U.S. Food and Drug Administration&nbsp;(FDA) for a Phase 2/3 clinical trial evaluating mavrilimumab in severe COVID-19 pneumonia and hyperinflammation.

Kiniksa Pharmaceuticals

Company Details