Manish R. Patel, MD, First Author for Breast Cancer Study To Be Presented at San Antonio Breast Cancer Symposium

Advocacy Groups | <b>Florida Cancer Specialists Foundation</b>

Medical oncologist Manish R Patel, MD, a member of the clinical research team at Florida Cancer Specialists & Research Institute , LLC (FCS), first-authored a study examining dose escalation of an oral complete estrogen receptor (ER) antagonist (CERAN)/selective ER degrader (SERD) in cases of advanced and/or metastatic estrogen receptor-positive, HER2-negative breast cancer.

Fort Myers, Fla., Dec. 10, 2021 – Medical oncologist Manish R Patel, MD, a member of the clinical research team at Florida Cancer Specialists & Research Institute , LLC (FCS), first-authored a study examining dose escalation of an oral complete estrogen receptor (ER) antagonist (CERAN)/selective ER degrader (SERD) in cases of advanced and/or metastatic estrogen receptor-positive, HER2-negative breast cancer.

Entitled, “Preliminary data from a phase I/II, multicenter, dose escalation study of OP-1250, an oral CERAN/SERD, in subjects with advanced and/or metastatic estrogen receptor (ER)-positive, HER2-negative breast cancer,” the study will be shared at the San Antonio Breast Cancer Symposium being held Dec. 7 – 12, 2021.

For ER-positive, HER-2 negative metastatic breast cancer patients, the current treatment includes hormone blocking therapies, either monotherapy or in combination with a targeted agent until endocrine resistance develops. This first-in-human study evaluates the safety and dosing tolerance of the complete estrogen receptor antagonist, OP-1250, and its efficacy over the standard of care. By completely inactivating ER, OP-1250 has also shown effectiveness in degrading ER, as well. In its preclinical stage, OP-1250 demonstrated anti-cancer activity, including against brain metastases and tumors with activating mutations.

While still ongoing, the study’s analysis indicates an evolution in the standard of care, to include complete estrogen receptor antagonists. Dr. Patel and his fellow co-authors state: “Importantly OP-1250 has now demonstrated clinical activity at doses that were well tolerated and within the predicted exposure windows where maximum efficacy was observed in preclinical models.”

The study further notes, “No MTD has been identified and selection of the RP2D will be based on consideration of long-term tolerability, efficacy, and the ability to combine with targeted agents.”

To view an online version of abstract, visit: https://www.sabcs.org/Portals/SABCS2016/2021%20SABCS/SABCS21_embargoedAbstracts_111921.pdf?ver=2021-11-19-162822-303