Business
Olema Oncology Provides Clinical Update Reflecting Strong Progress Across OP-1250 Development Program
Favorable tolerability with no grade 3/4 neutropenia and encouraging anti-tumor activity across Phase 1b monotherapy expansionCombinability with CDK4/6i
About this update from Olema Pharmaceuticals, Inc.
[{"type":"text","content":"Favorable tolerability with no grade 3/4 neutropenia and encouraging anti-tumor activity across Phase 1b monotherapy expansionCombinability with CDK4/6i palbociclib demonstrated across initial dose escalation cohorts, including no dose limiting toxicities and no induced metabolism of palbociclibRapidly advancing the development of OP-1250 for ER+ / HER2- breast cancer with pivotal monotherapy study planned for 2023 initiation SAN FRANCISCO, June 09, 2022 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA) today announced clinical development progress for OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD) in development for the treatment of metastatic breast cancer. “We are extremely pleased with the emerging clinical profile of OP-1250 and the encouraging progress achieved over the last six months. High investigator enthusiasm has led to rapid enrollment across the development program. In our Phase 1b monotherapy dose expansion, we have seen favorable tolerability and encouraging early anti-tumor activity. In the Phase 1b combination trial with palbociclib, two initial cohorts have completed the dose limiting toxicity evaluation period and we have demonstrated combinability for OP-1250 with no induced metabolism of palbociclib,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “We are entering an exciting period with the selection of our Recommended Phase 2 Dose later this month, followed by enrollment in our Phase 2 cohorts and plans to initiate an additional Phase 1b combination trial with each of ribociclib and alpelisib. We expect these datasets will further validate OP-1250’s clinical profile and lay the foundation for our planned pivotal monotherapy study to begin next year.” Olema continues to be well capitalized with sufficient cash to fund our planned research and development operations into the second half of 2024. As of June 1, 2022, Olema reported the following clinical updates and anticipated milestones for the OP-1250 development program: Phase 1b Monotherapy Expansion Successfully achieved 30 patient targeted enrollment (N=15 each for 60 and 120 mg dose cohorts).Favorable tolerability demonstrated, with no grade 3/4 neutropenia and no adverse events that led to discontinuation.Encouraging ...