Clinical-stage biopharma Olema Oncology’s (Nasdaq:OLMA) lead product candidate is OP-1250, an orally-available small molecule that recently won FDA Fast Track Designation for the treatment of ER+/HER2– metastatic breast cancer.
OP-1250 is a complete estrogen receptor antagonist with combined activity as a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD).
The drug candidate competes with estrogen for binding to the estrogen receptor to ensure it remains in an inactive state. It thus differs from drugs such as tamoxifen that do not completely inactivate the receptor.
The Fast Track Designation specifically covers human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has progressed after patients receive at least one line of endocrine therapy. In addition, patients should receive at least one line of therapy with a cyclin-dependent kinase (CDK) 4/6 inhibitor.
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