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Olema Oncology Announces Expansion of Collaboration Agreement with Novartis
Amended clinical collaboration and supply agreement increases the palazestrant/ribociclib combination Phase 1/2 clinical study size to approximately 60
About this update from Olema Pharmaceuticals, Inc.
[{"type":"text","content":"Amended clinical collaboration and supply agreement increases the palazestrant/ribociclib combination Phase 1/2 clinical study size to approximately 60 patients Expanded study supports the potential late-stage development of palazestrant in first-line advanced or metastatic breast cancer in combination with ribociclib SAN FRANCISCO, Oct. 10, 2023 (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 women’s cancers, today announced an amendment to our existing clinical collaboration and supply agreement with Novartis Institutes for BioMedical Research, Inc. (“Novartis”) to increase the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib to approximately 60 patients. “The amendment announced today significantly increases the size of our ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib, in collaboration with Novartis,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “With the Phase 1b dose escalation portion now successfully completed, we are currently in Phase 2 dose expansion at the 120 mg dose of palazestrant in combination with 600 mg of ribociclib. We believe that this expanded study now has the potential to generate a clinical dataset sufficient to support the regulatory pathway for a first-line pivotal trial.” Olema first signed a clinical collaboration and supply agreement with Novartis in July 2020, the agreement was amended and restated in January 2022, and focuses on the evaluation of the safety, tolerability and efficacy of palazestrant in combination with Novartis’ proprietary cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor ribociclib and/or Novartis’ proprietary phosphatidylinositol 3-kinase (PI3Ka) inhibitor alpelisib in patients with metastatic ER+ breast cancer. The amendment adds approximately 30 patients to be enrolled in the cohort expansion phase of the palazestrant clinical study in combination with ribociclib. About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidat...