California-based precision medicine developer Rain Oncology has outlined new strategic priorities after its lead candidate failed to best standard of care chemotherapy in a phase 3 liposarcoma trial.
Rain plans to "streamline internal resources," which will include reducing full-time employees by approximately 65% and saying goodbye to its current chief medical officer, Richard Bryce.
Milademetan is an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53. Rain was studying the treatment in patients with dedifferentiated liposarcoma (DDLPS), which is one of the five subtypes of liposarcoma — a malignancy of fat cells. DDLPS occurs when a low grade tumor changes and newer cells with higher grade arise in the tumor.
Rain, which was founded in 2017, added milademetan to its pipeline of targeted cancer therapies in a 2020 deal with Daiichi Sankyo. At the time, Rain was banking that the treatment, with a differentiated tolerability profile, would enable longer-term therapy as compared to other MDM2 programs in development.
Last week, Rain reported that the phase 3 MANTRA trial did not meet its primary endpoint of progression free survival (PFS) by blinded independent central review compared to the standard of care chemotherapy — Janssen Pharmaceuticals’ Yondelis. The median PFS for milademetan was 3.6 months vs. 2.2 months for Yondelis.
Now, as the company continues to evaluate the phase 3 data, it will suspend enrollment in the ongoing milademetan phase 2 MANTRA-2 basket trial and terminate plans for its phase 1/2 MANTRA-4 combination trial.
Rain hopes its actions will extend its cash runway to year-end 2026.
