Bioniz Therapeutics gets EC orphan drug status for BNZ-1 for CTCL

Bioniz Therapeutics has secured orphan drug designation for BNZ-1 from the European Commission (EC) for the treatment of cutaneous T-cell lymphoma (CTCL), a rare type of skin cancer.

Previously, BNZ-1 was given orphan drug designation by the US Food and Drug Administration (FDA).

Recently, Bioniz Therapeutics wrapped up a phase 2 study of BNZ-1 in cutaneous T-cell lymphoma in the US. The California-based biopharma company is planning to launch a phase 3 clinical trial of BNZ-1 in patients having relapsed or refractory form of the rare type of skin cancer (rCTCL).

Bioniz Therapeutics is likely to start enrolment in the phase 3 clinical trial in the latter half of this year.

Bioniz Therapeutics gets EC orphan drug status for BNZ-1 for cutaneous T-cell lymphoma.

Bioniz Therapeutics gets EC orphan drug status for BNZ-1 for cutaneous T-cell lymphoma. Photo courtesy of Dimitris Vetsikas from Pixabay.

BNZ-1 has been designed to selectively block the IL-2, IL-9, and IL-15 cytokines, which are potent T-cell growth factors and main disease drivers in cutaneous T-cell lymphoma and autoimmune diseases.

Nazli Azimi – Founder, President, and CEO of Bioniz Therapeutics said: “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.

“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.”

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