Olema Oncology Announces New Preclinical Data for OP-3136 Demonstrating Anti-Tumor Activity in Multiple Solid Tumor Models at AACR 2025
Rhea-AI Summary
Olema Oncology (OLMA) has revealed promising preclinical data for OP-3136, their novel KAT6 inhibitor, demonstrating significant anti-tumor activity across multiple solid tumor types. The data, presented at AACR 2025, showed effectiveness in ovarian, prostate, and non-small cell lung cancer (NSCLC) models.
Key findings include potent anti-proliferative activity in various cell lines and notable results in xenograft models:
- OVCAR3 (ovarian) model showed sustained tumor regression over 28 days
- LCLC-97TM1 (NSCLC) model demonstrated tumor inhibition comparable to ribociclib
- 22Rv1 (prostate) model exhibited dose-dependent tumor growth inhibition
The company is currently recruiting patients for a Phase 1 trial of OP-3136 as both monotherapy and in combination regimens for multiple solid tumor types.
Positive
- Demonstrated sustained tumor regression in ovarian cancer models over 28 days
- Showed comparable efficacy to established drug ribociclib in NSCLC models
- Exhibited synergistic effects when combined with existing treatments
- Demonstrated activity independent of KAT6 amplification or overexpression
- Successfully expanded potential therapeutic applications beyond breast cancer
Negative
- Still in early Phase 1 trials with no human efficacy data available
- Results to preclinical models only
News Market Reaction – OLMA
On the day this news was published, OLMA declined 3.73%, reflecting a moderate negative market reaction.
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- 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 cancer
- Patient recruitment ongoing in Phase 1 trial of OP-3136 as a monotherapy and in combination regimens in multiple solid tumor types
- Data 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: LB166
Session: Late-Breaking Research: Tumor Biology 2
Date/Time: April 28, 2025, from 9:00am-12:00pm CT / 10:00am-1:00pm ET
Presenter: 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-3136
OP-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 Oncology
Olema 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 Contact
Courtney O’Konek
Vice President, Corporate Communications
Olema Oncology
media@olema.com
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