PMD-026 is a first-in-class and best-in-class pan-RSK inhibitor
Favorable mPFS demonstrated in Phase 1/1b as a monotherapy in RSK2-high metastatic breast cancer patients.
SAN DIEGO and VANCOUVER, British Columbia, Feb. 20, 2025 (GLOBE NEWSWIRE) — Phoenix Molecular Designs (PhoenixMD), a female-founded clinical-stage precision oncology company focused on developing precise cancer therapeutics, today announced the dosing of the first patient in their Phase 2 clinical trial, Dauntless-1. The Dauntless-1 trial will evaluate the therapeutic potential of PMD-026 (a first-in-class oral pan-RSK inhibitor) in combination with fulvestrant, and clinical efficacy in +HR/HER2-/ RSK2-high patients with locally advanced or metastatic breast cancer.
This trial will enroll second-line HR+/HER2-/RSK2-high metastatic breast cancer patients who have been treated previously with a CDK4/6 inhibitor and have developed resistance to it. Among these patients, 70% will express high levels of nuclear RSK2. Fulvestrant, a selective estrogen receptor degrader (SERD), is a commonly prescribed second-line endocrine therapy. However, its therapeutic effect is often limited to ~2-3 months as a single agent, thus creating a need for additional therapeutic options. Notably PMD-026 is highly synergistic with fulvestrant in preclinical models, including those models with an acquired resistance to CDK4/6 inhibitors. PhoenixMD will evaluate its targeted agent, PMD-026, in combination with fulvestrant and is prospectively enrolling RSK2-high patients to receive this combination therapy in its Phase 2 Dauntless-1 trial.
“We are especially excited about our Phase 2 trial because PMD-026 has the potential to overcome CDK4/6 resistance based on pre-clinical and early clinical studies” said Sandi Dunn, PhD, Founder and CEO of Phoenix Molecular Designs. “In our Phase 1/1b monotherapy study, PMD-026 demonstrated favorable tolerability, with no peripheral neuropathy, hair loss, or hyperglycemia. Moreover, PMD-026 demonstrated a median progression free survival (mPFS) of 4.8 months in patients with RSK2-high tumors versus only 1.3 months in patients with RSK2-low tumors in a subset analysis of patients who had no more than five prior therapies. We believe that PMD-026 as a combination therapy represents a promising new approach to treating advanced breast cancer.”
Early clinical data shows PMD-026’s potential efficacy in specific breast cancer populations, with pre-clinical data supporting enhanced effects in combination with fulvestrant. “Achieving the first patient dosed in the Phase 2 cohort with the combination of PMD-026 and fulvestrant marks a key milestone for Phoenix Molecular Designs,” said Brian Barnett, M.D., Chief Medical Officer. “We are enthusiastic about PMD-026’s clinical development and the potential to address an area of significant clinical unmet medical need in breast cancer patients with advanced HR+/HER2- breast cancer who have previously been treated with a CDK4/6 inhibitor by providing a novel targeted therapy in combination with a standard of care endocrine therapy.”
“We remain steadfast in advancing breast cancer care,” Dunn continued. “With our Dauntless-1 clinical trial underway, our journey continues toward potentially making significant strides for metastatic breast cancer patients. Dauntless-1 builds on the promising Phase 1/1b results and PMD-026’s synergy with fulvestrant. Our team is dedicated to pushing cancer care boundaries.”
For more information about the Dauntless-1 study, please visit https://clinicaltrials.gov/study/NCT04115306
About Phoenix Molecular Designs
PhoenixMD is a privately held clinical-stage biopharmaceutical company focused on developing first-in-class inhibitors against RSK, for cancer and inflammation. Their lead candidate, PMD-026, shows promise for the treatment of breast and prostate cancers, as well as melanoma and more recently myelofibrosis and AML. The company’s leadership team boasts previous expertise in developing FDA-approved and marketed drugs for multiple cancers specifically including breast cancer. To learn more, visit our website PhoenixMD or follow us on LinkedIn.
Media contact
Morgan Consaul
Marketing and Communications Manager
Phoenix Molecular Designs
[email protected]
604 762-6443
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