On November 20, 2019 Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, reported that it has dosed the first patient in its Phase 1/1b study of PMD-026, the company’s lead product candidate (Press release, PhoenixMD, NOV 20, 2019, View Source [SID1234551545]). PMD-026 is a proprietary first-in-class orally-available RSK (kinase) inhibitor for the potential treatment of patients with metastatic breast cancer and, more specifically, triple-negative breast cancer (TNBC).

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"Dosing the first patient in this newly initiated clinical trial is a paramount milestone for PhoenixMD," said Andrew Dorr, M.D., chief medical officer of Phoenix Molecular Designs. "We believe PMD-026 to be a promising new approach to treat advanced breast cancer and we look forward to building upon this momentum in the pursuit of a potential treatment option for individuals living with advanced forms of breast cancer."

The company’s Phase 1/1b clinical trial will be conducted at leading medical centers across United States and it will evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with metastatic breast cancer in the dose escalation as well as in women with TNBC in Phase 1b. Importantly, this trial will include a CAP/CLIA (College of American Pathologists/Clinical Laboratory Improvement Amendments) certified companion diagnostic (CDx) designed to detect RSK2 activation in breast tumors and to then correlate it with response to PMD-026. Activated RSK2 is prevalent in breast cancer as it is highly expressed in 89 percent of primary tumors and is found in metastatic disease. In TNBC, early data indicates that approximately 42 percent of patients have extremely high levels of RSK2 activation. Targeting of RSK2, which drives breast cancer proliferation, by PMD-026 creates a distinct precision medicine approach to treating breast cancer.

"Metastatic breast cancer, including TNBC, is a devastating disease with poor prognosis and few impactful treatment options," said Murali Beeram, M.D., lead investigator of South Texas Accelerated Research Therapeutics (START). "Our team is eager to evaluate RSK2 inhibition in advanced breast cancers and play an integral role, alongside PhoenixMD, in the exploration of new medicines for patients."

About PMD-026
PhoenixMD’s lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase, out of 519 kinases, that drives the growth of this breast cancer subtype. Preclinical data shows the potential for PMD-026 to be effective alone or in combination with conventional chemotherapies. It has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future. PMD-026 is currently in Phase 1/1b testing.