The clinical development of targeted therapies for difficult-to-treat hematological diseases and malignancies is based on our peptide-drug conjugate platform, PDC.
In November 2021, Oncopeptides decided to refocus the clinical development program with melflufen and reduce the number of studies to support the marketing authorization process in Europe, and strengthen the company´s cash position.
- OCEAN study continues with long-term follow-up and documentation. The study is planned to close in Q1, 2023.
- The PORT and BRIDGE studies have been closed with relevant scientific data sets.
- ANCHOR closed without the last 10 planned patients in the bortezomib + melflufen study arm. Data sets will be large enough to draw relevant scientific conclusions.
- ASCENT, and COAST have been closed with incomplete number of patients. It will not be possible to draw any relevant scientific conclusions from these data sets.
- LIGHTHOUSE study was closed with incomplete number of patients. Topline data was presented in October 2022.
Effective July 8, 2021, FDA has requested a partial clinical hold of the clinical development program in the US.