Bioniz - Pipeline

BNZ-1

BNZ-1: An IL-2, IL-9, IL-15 Inhibitor

The Company’s lead development candidate, BNZ-1, is a selective and simultaneous inhibitor of cytokines IL-2, IL-9 and IL-15. BNZ-1 is currently in Phase 1 studies.

T-cell Malignancies

Cytokines IL-2, IL-9 and IL-15 are potent T-lymphocyte growth factors and key disease drivers in multiple T-cell leukemias. T-cell leukemias, including Large Granular Lymphocyte (LGL) Leukemia and Cutaneous T-cell Lymphoma (CTCL), are a group of rare and often aggressive leukemias with no or limited treatment options resulting in a poor prognosis.

BNZ-1 inhibition of IL-15 prevents the proliferation of IL-15-dependent leukemic cells, while IL-2 & IL-9 blockade reduces the number and activity of Treg cells that enables a more robust immune system attack against malignant cells.

Bioniz plans to initiate a Phase 2 study with BNZ-1 in LGL leukemia and CTCL in 2017.

Alopecia Areata

Alopecia areata (AA) is a common autoimmune disease (~2% lifetime incidence), driven by T-cell attacks on hair follicles that have lost their immune privilege, which results in partial or complete loss of hair on the scalp and body. The onset of the disease can occur throughout life and equally affects both women and men. AA has been found to be associated with concurrent autoimmune disorders (e.g., vitiligo, atopy) and with serious psychological consequences, including anxiety and depression.

There are currently no pharmaceutical products approved by the U.S. Food and Drug Administration (FDA) for the treatment of AA. Broad-acting, intralesional steroids are the most commonly used therapy for AA, with varying degrees of success. Progress in developing effective, rationally targeted therapies has been historically limited by a lack of mechanistic understanding of the underlying key T-cell inflammatory pathways in AA. However, it has recently been demonstrated that IL-2, IL-9, and IL-15 are upregulated in AA lesions and are key drivers of the pathologic cytotoxic T-cell and natural killer cell activity in AA (Xing et al., 2014; Suarez-Farinas et al., 2015).

Following completion of multiple-dose studies in healthy volunteers, Bioniz plans to initiate a Phase 2 trial with BNZ-1 in AA in 2018.