Olema Pharmaceuticals, Inc. - OLMA STOCK NEWS

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About Olema Pharmaceuticals, Inc.

Olema Pharmaceuticals, Inc. (Nasdaq: OLMA), also known as Olema Oncology, is a clinical-stage biopharmaceutical company dedicated to transforming the standard of care for women living with cancer. Headquartered in San Francisco, California, with additional operations in Cambridge, Massachusetts, Olema focuses on the discovery, development, and commercialization of innovative targeted therapies for endocrine-driven cancers, particularly breast cancer.

Core Focus and Product Pipeline

Olema’s lead product candidate, palazestrant (OP-1250), is a novel, orally available small molecule with dual activity as a complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD). Designed to address both wild-type and ESR1-mutant forms of estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, palazestrant aims to overcome resistance mechanisms that limit the efficacy of existing endocrine therapies. Palazestrant has demonstrated promising anti-tumor activity, favorable tolerability, CNS penetration, and combinability with other targeted agents, including CDK4/6 inhibitors, in clinical studies. It has received FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer, underscoring its potential to address critical unmet medical needs.

In addition to palazestrant, Olema is advancing OP-3136, a potent and selective inhibitor of KAT6, an epigenetic target implicated in breast and other cancers. Preclinical studies have shown that OP-3136 exhibits significant anti-proliferative activity both as a monotherapy and in combination with palazestrant and CDK4/6 inhibitors. OP-3136 is expected to enter Phase 1 clinical trials in early 2025, further diversifying Olema’s pipeline.

Clinical Trials and Strategic Collaborations

Olema has an active clinical development program, including the pivotal Phase 3 OPERA-01 trial, which evaluates palazestrant as a monotherapy for ER+/HER2- metastatic breast cancer. The company is also conducting Phase 1/2 combination studies with CDK4/6 inhibitors (ribociclib and palbociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). These studies aim to establish palazestrant’s efficacy in combination regimens that could redefine treatment paradigms for metastatic breast cancer.

In 2024, Olema announced a significant clinical trial collaboration and supply agreement with Novartis to support the Phase 3 OPERA-02 trial. This trial will evaluate palazestrant in combination with ribociclib as a frontline treatment for ER+/HER2- metastatic breast cancer. The collaboration underscores Olema’s commitment to advancing innovative combination therapies.

Scientific Expertise and Industry Leadership

Olema leverages its deep understanding of endocrine-driven cancers, nuclear receptor biology, and mechanisms of acquired resistance to develop therapies that address critical gaps in cancer treatment. The company’s research efforts are supported by a team of experienced scientists, accomplished board members, and partnerships with leading healthcare investors and pharmaceutical companies. Olema’s robust preclinical and clinical data have been featured in prominent scientific journals and conferences, further establishing its reputation as a leader in oncology innovation.

Commitment to Patients

Olema’s mission is to improve outcomes for women living with cancer by delivering next-generation endocrine therapies. By focusing on precision medicine and leveraging cutting-edge science, Olema aims to transform the standard of care and provide hope to patients facing limited treatment options.