Bioniz - Pipeline


BNZ-1, a multi-cytokine inhibitor for cancer and autoimmune diseases 

BNZ-1 is the lead asset from the company’s platform of first-in-class peptide therapeutics that selectively and simultaneously inhibit multiple cytokines to treat cancer and autoimmune diseases. 

Refractory Cutaneous T-cell lymphoma (rCTCL)

Bioniz has successfully completed a Phase 1/2 clinical study demonstrating therapeutic efficacy of BNZ-1 for the treatment of refractory cutaneous T-cell lymphoma (rCTCL), a rare, aggressive cancer with limited or no treatment options resulting in a poor prognosis.

BNZ-1 is a selective and simultaneous inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in CTCL and multiple T-cell leukemias, including large granular lymphocyte leukemia. As a multi-cytokine inhibitor, BNZ-1 is a novel immuno-oncology drug that integrates inhibition of malignant cells, activation of tumor immunity, and suppression of inflammation.

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

Alopecia Areata

Bioniz is also evaluating BNZ-1 for the treatment of autoimmune diseases, including alopecia areata and vitiligo, which are also driven by unregulated T-cell biology.

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).

Clinical Trials

Patients seeking information about Bioniz clinical trials are encouraged to check for information at by clicking here. A description of the current clinical trial, “A Phase 2 dose ranging study for patients with Large Granular Lymphocytic Leukemia (LGLL) and Cutaneous T-Cell Lymphoma (CTCL)”  is available at