Olema Oncology, a clinical-stage biopharmaceutical company focused on developing new therapies for breast cancer, has just received clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial for its new drug candidate, OP-3136.
This development paves the way for the company to test the drug’s safety and efficacy in humans, marking a significant step towards potentially bringing a new treatment option to patients with breast cancer and other solid tumors ( including mCRPC).

OP-3136 is a potent and selective small molecule inhibitor of KAT6. KAT6 is an epigenetic target that has been shown to be dysregulated in breast and other cancers. By inhibiting KAT6, OP-3136 aims to disrupt the growth and spread of cancer cells.

This clearance means that the FDA has reviewed the company’s preclinical data and determined that the drug is safe enough to be tested in humans. The Phase 1 clinical trial, set to begin in early 2025, will evaluate the drug’s safety, dosage, and preliminary efficacy in a small group of patients.

The company’s pipeline of novel therapies is built on its deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance.

Source.