On April 6, 2021 Bioniz Therapeutics, Inc., ("Bioniz"), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, reported the European Commission (EC) has granted orphan designation to BNZ-1 for the treatment of cutaneous T-cell lymphoma (CTCL), a rare skin cancer (Press release, Bioniz Therapeutics, APR 6, 2021, View Source [SID1234577646]). BNZ-1 has previously been granted orphan drug designation by the U.S. Food and Drug Administration (FDA). Bioniz recently completed a phase 2 study of BNZ-1 in CTCL in the United States and intends to initiate a phase 3 clinical trial of BNZ-1 for the treatment of patients with relapsed or refractory CTCL (rCTCL). Bioniz expects the phase 3 to begin enrolling the second half of 2021.
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"The currently approved therapies to treat CTCL are not ideal given the limited efficacy and safety concerns and are typically tolerated by patients only for a limited time due to many side effects that are associated with these treatments," said Nazli Azimi, Pharm.D., Ph.D., Founder, President, and CEO of Bioniz Therapeutics. "With our lead product candidate, BNZ-1, we have completed several significant milestones, including positive efficacy data from our phase 2 study, guidance from the FDA on our phase 3 trial design, and now orphan designation in the U.S. and EU. BNZ-1 has the potential to be a significant treatment for CTCL."
Orphan designation from the EC provides incentives for companies to develop medicines intended for the treatment, prevention, or diagnosis of a disease that is life-threatening or chronically debilitating and where no satisfactory treatment is currently authorized. The prevalence of the condition must not exceed more than five in 10,000 people in the European Union (EU). In addition to being eligible for a 10-year period of marketing exclusivity in the EU upon product approval, orphan designation provides fee waivers, protocol assistance, and eligibility for marketing authorization under the centralized procedure granting approval in all EU countries.
About Refractory Cutaneous T-cell Lymphoma (rCTCL)
Cutaneous T-cell lymphomas (CTCLs) are a rare, aggressive, heterogeneous group of non-Hodgkin’s lymphomas that manifest primarily in the skin. Although a wide array of therapeutic options are available for early-stage CTCL, not all patients respond, resulting in refractory CTCL (rCTCL) with limited treatment options and a poor prognosis.
About BNZ-1
The company’s lead product candidate, BNZ-1, is a selective inhibitor of cytokines IL-2, IL-9, and IL-15, which are potent T-cell growth factors and key disease drivers in CTCL and autoimmune diseases. Bioniz is also planning a phase 2 study of BNZ-1 for the treatment of alopecia areata, which is also driven by unregulated T-cell biology.