Interim Data from this Cutaneous T-Cell Lymphoma Trial is Looking Promising

According to a story from BioSpace, the biopharmaceutical company Bioniz Therapeutics, Inc., has recently announced the release of interim results from its phase 1/2 clinical trial. This trial is investigating its investigational product candidate BNZ-1 as a treatment for refractory cutaneous T-cell lymphoma, a rare blood cancer. So far, the findings from the trial are looking promising. Bioniz is focused on the development of peptide medications that inhibit multiple cytokines for the treatment of cancers and immuno-inflammatory diseases.

About Cutaneous T-Cell Lymphoma

Cutaneous T-cell lymphomas are cancers that affect a type of white blood cell called T-cells. Though classified as a type of non-Hodgkin lymphoma, it differs from most other types because it affects T-cells instead of B-cells. In these diseases, the affected T-cells attack the skin. The cause of cutaneous T-cell lymphoma remains unknown, nor is it well understood why the cells attack skin. Symptoms of the disease include skin that is red or itchy. In some cases, round patches of scaly skin may appear. Some areas may appear lighter in color. Other symptoms include enlarged lymph nodes, lumps on the skin, hair loss, and thickened skin on the hands and feet. There are many types of this lymphoma, including Sézary syndrome and mycosis fungoides. Treatment for these diseases may include certain medications, light therapy, bone marrow transplant, extracorporeal photopheresis, and radiation therapy. Treatment and the rate of disease progression varies depending on the sub-type. To learn more about cutaneous T-cell lymphoma, click here.

About the Ongoing Trial

The trial evaluated BNZ-1 on its own as a systemic therapy for the cancer in patients that had failed to benefit from other available treatments. The investigators monitored both safety and therapeutic characteristics of the drug at dose levels of 0.5, 1, 2, and 4 mg/kg with the primary endpoint being safety following a month of treatment; a 3 month extension of the treatment period followed to further evaluate longer term effects.

The study initially included a total of 15 patients but the 2 mg/kg cohort ultimately included 19 patients. While signs of treatment response were present at all dose levels, this cohort was enlarged because it appeared to be the most favorable in initial response. 

  • 5 percent of patients showed a complete response.
  • Around 50 percent saw a partial response
  • More than 80 percent saw improvement in tumor burden based on modified severity weighted assessment tool (mSWAT) score
  • Mean response duration was 9.2 months at the end of data collection cutoff

While these are still only interim findings, they nevertheless are encouraging and indicate that the investigation of BNZ-1 as a treatment for cutaneous T-cell lymphoma should continue.


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