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Olema Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced a new clinical trial collaboration and supply agreement with Novartis in frontline metastatic breast cancer.
Olema Pharmaceuticals,Inc.是一家临床阶段的生物制药公司,专注于乳腺癌等靶向治疗的发现,开发和商业化,今天宣布与诺华在一线转移性乳腺癌方面达成新的临床试验合作和供应协议。
Olema has also entered into a securities purchase agreement for the private placement of approximately $250.0 million of common stock and pre-funded warrants to purchase common stock with new and existing institutional and accredited investors (the “Private Placement”).'We are now fully enabled to initiate our planned pivotal Phase 3 clinical trial, OPERA-02, for palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer.
Olema还签订了一份证券购买协议,以私募约2.5亿美元的普通股和预先融资的认股权证,与新的和现有的机构和合格投资者购买普通股(“私募”)我们现在完全能够启动我们计划的关键性3期临床试验OPERA-02,用于palazestrant联合ribociclib治疗一线ER+/HER2转移性乳腺癌。
Our new agreement with Novartis, which includes sufficient ribociclib drug supply for the planned approximately 1,000 patient trial, is a major milestone. When combined with our Private Placement of $250.0 million of common stock and pre-funded warrants with high-quality, long-term investors, Olema now expects to have the necessary resources to execute OPERA-02, the Phase 1/2 study of OP-3136, and the ongoing Phase 3 OPERA-01 monotherapy trial,” said Sean P.
我们与诺华的新协议是一个重要的里程碑,其中包括为计划的约1000名患者试验提供足够的ribociclib药物供应。当我们与高质量的长期投资者一起私募2.5亿美元的普通股和预先出资的认股权证时,Olema现在预计将拥有必要的资源来执行OPERA-02、OP-3136的1/2期研究以及正在进行的3期OPERA-01单药治疗试验,”Sean P说。
Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “We remain on track to share topline data from OPERA-01 in 2026 and we are excited to present our latest data from the ongoing Phase 1b/2 study of palazestrant in combination with ribociclib at the San Antonio Breast Cancer Symposium (SABCS) next week.”New Clinical Trial Collaboration and Supply Agreement Enables Phase 3 OPERA-02 TrialUnder the terms of the agreement, Novartis will provide Olema with ribociclib drug supply for the planned, Olema-sponsored, Phase 3 OPERA-02 trial of pala.
博恩,医学博士,博士,Olema Oncology总裁兼首席执行官。“我们仍将在2026年分享OPERA-01的主要数据,我们很高兴下周在圣安东尼奥乳腺癌研讨会(SABCS)上展示正在进行的palazestrant与ribociclib联合1b/2期研究的最新数据。”新的临床试验合作和供应协议使OPERA-02第三阶段试验成为可能。根据协议条款,诺华将为Olema计划的Olema赞助的OPERA-02第三阶段试验提供ribociclib药物供应。