Olema Oncology Unveils Promising Data for Oral SERD Palazestrant Ahead of Phase III Trials

New Data Presentation:
Olema Oncology has unveiled new data from a Phase 1b/2 breast cancer trial for its oral selective estrogen receptor degrader (SERD), palazestrant, at the San Antonio Breast Cancer Symposium (SABCS)13.

Clinical Trial Collaboration:
Olema has entered into a clinical trial collaboration and supply agreement with Novartis to initiate the pivotal Phase 3 clinical trial, OPERA-02, for palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer3.

Funding:
Olema has secured $250.0 million through a private placement of common stock and pre-funded warrants to support the Phase 3 OPERA-02 trial and other clinical development activities3.

Differentiation:
Palazestrant is distinguished by its dual mechanism of action, both antagonizing and degrading the estrogen receptor, unlike traditional SERDs25.

Development Timeline:
The company expects to share topline data from the OPERA-01 monotherapy trial in 2026 and is on track to initiate the OPERA-02 trial34.

Preclinical Data:
Olema has also presented compelling preclinical data demonstrating anti-tumor activity for OP-3136, a novel KAT6 inhibitor, which enhances the activity of palazestrant combinations4.

Clinical Study Initiation:
The IND submission for OP-3136 is expected before the end of 2024, with the clinical study to initiate early in 20254.

Sources:

1. https://endpts.com/sabcs24-olema-makes-case-for-its-oral-serd-with-fresh-cut-from-phase-1b-2-breast-cancer-trial/

2. https://www.oncologypipeline.com/apexonco/olema-takes-its-antagonistdegrader-concept-phase-3

3. https://ir.olema.com/node/10156/pdf

4. https://ir.olema.com/news-releases/news-release-details/olema-oncology-reports-third-quarter-2024-financial-results-and

5. https://ir.olema.com/news-releases/news-release-details/olema-oncology-announces-complete-er-antagonist-op-1250