Galena Biopharma will merge with biopharma company SELLAS Life Sciences Group combing both companies’ competences in novel cancer treatments.
The combined company will be renamed SELLAS Life Science Group.
It will feature a late-stage pipeline led by novel immunotherapies targeting a broad range of indications in haematology and solid tumours.
SELLAS licenses the rights to its lead asset, galinpepimut-S, a novel WT1 antigen-targeting immunotherapy.
GPS is initially being developed for the treatment of acute myeloid leukemia and is Phase 3-ready in this setting.
SELLAS has also successfully completed a Phase 2 study of GPS in malignant pleural mesothelioma, and its end-of-Phase 2 meetings with the US FDA for GPS in both indications.
For both AML and MPM, SELLAS has been granted orphan drug designation from the FDA and the European Medicines Agency and been given FDA fast track status.
In addition, SELLAS is currently conducting two Phase 2 trials of GPS in multiple myeloma, as well as a combination trial in ovarian cancer with nivolumab.
It is also currently preparing for additional combination trials for GPS in combination with another checkpoint inhibitor.
Galena’s lead immunotherapy program, NeuVax, is currently in three, Phase 2, investigator-sponsored clinical trials in breast cancer, and these trials will remain ongoing.
Galena’s other development programs, GALE-401, a controlled release version of anagrelide that is Phase 3-ready, and GALE-301/GALE-302, an earlier stage cancer immunotherapy program targeting folate binding protein, are currently being evaluated for potential internal development or strategic partnership.