Following past challenges and restructuring, Olema Oncology has plans to start the pivotal trial of its lead candidate OP-1250 in estrogen receptor (ER)+/HER- metastatic breast cancer in H2 2023, said CEO Sean Bohen. The San Francisco, California-headquartered company is on track to meet this target, having already selected an undisclosed CRO for the global study and some clinical sites, confirmed Bohen in an interview with Pharmaceutical Technology.
The biotech is in the implementation phase of the trial where it has selected some clinical sites and is in the midst of planning the selection of other locations, explained Bohen. Additionally, the company has finished preparing the drug’s formulation with its CMO partner. While Olema previously studied the drug in a capsule formulation, this upcoming trial will test the treatment in a tablet form, he added.
The study will test out Olema’s OP-1250 as a monotherapy in the second-line and third-line setting in ER+/HER- metastatic breast cancer patients. Olema’s trial will include a design that echoes that of the Phase III EMERALD trial (NCT03778931), which was featured in the successful application of Menarini Group’s drug Orserdu (elacestrant) to the US Food and Drug Administration (FDA), noted Bohen. The study will look at the progression free survival as the primary efficacy endpoint and coul enroll over 400 patients, said Bohen. The trial will likely take approximately two and a half years to readout, the CEO added.
The upcoming Phase III trial will be global and will likely include sites in Europe and North America, said Bohen. Additionally, the trial will also feature sites in Asia, Australia and South America, he added.
OP-1250 functions as both a complete estrogen receptor antagonist (CERAN) and selective ER degrader (SERD). Last year proved as a challenge to the SERD pipeline in breast cancer, and companies such as Roche and Sanofi have both experienced negative developments with their own candidates. Nevertheless, in January, Orserdu became the first oral drug of its class to be approved for ER+/HER- ESR1-mutated metastatic breast cancer.
Tough business environment
In March, Olema announced a corporate restructuring and a portfolio prioritisation towards OP-1250. The restructuring included layoffs, with the company reducing its workforce by 25%, per the March update.
The bear market has been a challenge and there are companies that are not making it through, said Bohen. At the same time, the company’s past capital raises in 2020 allowed it to weather through the storm, he added.
This also means that the equity markets are not favourable enough for the company to start a first-line trial of OP-1250 in this indication, said Bohen. The company forecasts that it would need funding in the range of a “couple of $100 million” to power the study, which means the company would be looking to collaborate here with larger pharma players, he added.
The current environment has not been receptive to clinical stage companies when it comes to developing their pipelines, said Bohen. However, Olema hopes to provide an update either at the end of the year or the start of the next on its other efforts, he noted.