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BioCommunique Article

PMD-026 is the only purpose-built agent designed specifically to treat triple-negative breast cancer (TNBC).

Phoenix Molecular Designs Receives FDA Clearance to Begin Clinical Trial with PMD-026, Targeting Advanced Breast Cancer

  • 2019-09-27T19:51:00.000+0000
  • California
  • Author: Phoenix Molecular Designs

Phoenix Molecular Designs (PhoenixMD) recently received IND clearance from the FDA for their lead product candidate, PMD-026 for the treatment of metastatic breast cancer with a focus on triple-negative breast cancer (TNBC). This clearance permits PhoenixMD to begin patient enrollment into its Phase 1/1b clinical trial, which is expected to start in the United States during the fourth quarter of 2019.

“Our IND clearance marks an important developmental milestone for PhoenixMD,” said Sandra Dunn, Ph.D., chief executive officer of PhoenixMD. “To our knowledge, PMD-026 is the only purpose-built agent designed specifically to treat triple-negative breast cancer. Additionally, we will be assessing the potential of PMD-026 to extend beyond TNBC and into other forms of advanced breast cancer.”

PMD-026 is a proprietary first-in-class orally-available RSK (kinase) inhibitor being developed to treat certain forms of breast cancer. The Phase 1/1b clinical trial will evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with advanced disease and a sub-group of women with TNBC. Importantly, this trial will include a CAP/CLIA certified companion diagnostic designed to detect RSK2 activation in breast tumors and to then correlate it with response to PMD-026. This is a new approach for the treatment of cancer that hinges on precision medicine and functional kinomics.

“TNBC patients with metastatic disease have limited treatment options and new drugs have not generally been specifically developed based on the biology of this type of tumor,” said Gerrit Los, Ph.D., chief scientific officer of PhoenixMD. “We have had substantial interest from some of the top clinical oncology centers eager to participate in our upcoming trial, underscoring the need for treatment options for women with advanced disease.”

PhoenixMD is a privately-held clinical stage biopharmaceutical company designing precise cancer therapeutics and companion diagnostics by targeting kinases, a class of highly druggable enzymes to treat a wide range of oncology indications. The company is focused on developing first-in-class inhibitors against RSK, an important drug target for cancer, heart disease and inflammation. Their leadership team boasts previous expertise in developing FDA-approved and marketed drugs for breast cancer. Due to PhoenixMD’s emerging leadership in kinase inhibition, the company has entered into partnerships with well-recognized government, academic research institutions and patient advocates, including the National Cancer Institute, MD Anderson, Kyushu University (Japan), University of Tuebingen (Germany) and the Susan G. Komen Foundation –San Diego. PhoenixMD has clinical headquarters in San Diego, CA and pre-clinical operations in Vancouver, BC. For more information, visit phoenixmd.ca.