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Olema Oncology Announces New Preclinical Data for OP-3136 Demonstrating Anti-Tumor Activity in Multiple Solid Tumor Models at AACR 2025

1. OP-3136 shows anti-tumor activity in multiple cancer models beyond breast cancer. 2. Phase 1 trial for OP-3136 is actively recruiting participants for solid tumors. 3. Promising preclinical data presented at the 2025 AACR Annual Meeting. 4. OP-3136 demonstrates tumor growth inhibition and sustained regression in ovarian cancer models. 5. Combination treatments with OP-3136 show enhanced anti-tumor activity.

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Why Bullish?

The positive preclinical results and ongoing trials indicate strong potential for OP-3136. Historical precedents show that successful clinical trial data can boost stock prices significantly in biotech firms.

How important is it?

The ongoing development of OP-3136 and its expanded applications are crucial to Olema's portfolio and stock performance. This advancement signals the company's innovation and potential market capture in oncology.

Why Long Term?

The data showcased may lead to further clinical trials and eventual drug approval, impacting long-term growth. Previous developments in similar clinical-stage biotechs often lead to significant stock appreciation over the years following successful trials.

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April 25, 2025 13:00 ET  | Source: Olema Oncology Activity in preclinical models of ovarian, prostate, and non-small cell lung cancer supports potential utility of OP-3136, a KAT6 inhibitor, in indications beyond breast cancerPatient recruitment ongoing in Phase 1 trial of OP-3136 as a monotherapy and in combination regimens in multiple solid tumor typesData to be presented at 2025 AACR Annual Meeting SAN FRANCISCO, April 25, 2025 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced preclinical data demonstrating the anti-tumor activity of OP-3136, a novel small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), in prostate, ovarian, and non-small cell lung cancer (NSCLC) models. These findings are being presented in a late-breaking poster session at the American Association for Cancer Research (AACR) Annual Meeting taking place April 25-30 in Chicago, Illinois. “These data showcase the potential of OP-3136 for the treatment of challenging cancers beyond breast cancer,” said David C. Myles, Ph.D., Chief Discovery and Non-Clinical Development Officer of Olema Oncology. “OP-3136 has shown inhibition across all models explored, and we were excited to observe potent tumor growth inhibition and sustained tumor regression with OP-3136 as a monotherapy in ovarian cancer models. We are actively recruiting the Phase 1 trial of OP-3136 in multiple solid tumor types and will continue to explore its potential in other indications of high unmet need.” Poster Presentation Details Title: OP-3136, a selective KAT6 inhibitor, demonstrates anti-tumor activity in prostate, ovarian, and non-small cell lung cancer preclinical models Poster/Abstract: LB166Session: Late-Breaking Research: Tumor Biology 2Date/Time: April 28, 2025, from 9:00am-12:00pm CT / 10:00am-1:00pm ETPresenter: Dr. Gopinath S. Palanisamy, DVM, Ph.D. Key findings include: OP-3136 showed potent anti-proliferative activity in multiple ovarian, NSCLC, and prostate cell lines in vitro.OP-3136 showed activity that was independent of KAT6 amplification or over expression.OP-3136 monotherapy demonstrated anti-tumor activity in in vivo xenograft models of ovarian (OVCAR3), NSCLC (LCLC-97TM1), and prostate (22Rv1) cancers. In the OVCAR3 model, OP-3136 monotherapy demonstrated sustained tumor regression across the 28-day study period and robust tumor growth inhibition.In the LCLC-97TM1 model, OP-3136 monotherapy demonstrated tumor growth inhibition comparable to ribociclib and, when combined with ribociclib, demonstrated synergy and enhanced anti-tumor activity.In the 22Rv1 model, OP-3136 inhibited tumor growth in a dose-dependent manner and, when combined with docetaxel, resulted in enhanced anti-tumor activity. These data indicate OP-3136 may be effective in treating ovarian, lung, and prostate cancer indications in addition to breast cancer. A copy of this poster is available on the Publications page of Olema’s website. Additional information can be found on the AACR Annual Meeting website, including abstracts. About OP-3136OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies, including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical trial. About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), currently in a Phase 3 clinical trial called OPERA-01. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical trial. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com. Media and Investor Relations ContactCourtney O’KonekVice President, Corporate CommunicationsOlema Oncologymedia@olema.com

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