Development of OP-1250.
Entering the Clinic
Our investigational drug, OP-1250, is an estrogen receptor antagonist. It was developed to compete with estrogen for binding to the receptor and keep it in a completely inactive state.
Now that preclinical studies support advancing OP-1250 into the clinic, the clinical exploration of OP-1250’s potential has begun.
Target Patient Population
First Clinical Phases of OP-1250
Olema has completed discovery and preclinical studies of OP-1250 required to file an IND and is currently in the Phase 1/2 development stages with OP-1250 as a single-agent treatment for estrogen receptor-positive, HER2-negative metastatic breast cancer (ER+, HER2- MBC). Initial data is anticipated in the second half of 2021.
Metastatic Breast Cancer
ER+, HER2- MBC (with and without CNS metastases)
ER+, HER2- MBC(1) (combination with CDK4/6i)(1, 2)
ER+, HER2- MBC with PIK3CA mutated (combination with PIK3αi)(1, 2)
ER+ with ESR1 mutation(1)
Programs and Biology Complementary to OP-1250
Olema is anticipating initiating clinical studies in ER+, HER2- MBC in combination with other therapies; in ER+ pre-menopausal MBC, and in ER+ MBC with ESR1 mutation during 2021. A clinical study in ER+, HER2+ MBC with CNS metastases is expected to begin in 2022.
HER2+ Metastatic Breast Cancer with CNS mets
ER+, HER2+ MBC with CNS metastases
Other Women’s Cancers
Clinical studies of OP-1250 in endometrial cancer in 2021 and other gynecologic malignancies.
Gynecology — Oncology