A therapy candidate is put on a fast track by the FDA is intended to treat serious health conditions. The designation is intended to accelerate the therapy’s development and expedite its approval by providing more frequent meetings with the FDA and discussions about the development plan.
The decision was based on results from a Phase 2 trial (NCT01827137), testing galinpepimut-S as a maintenance therapy for high-risk myeloma patients. Patients in the trial had achieved at least disease stabilization after a stem cell transplant, but still had cancer cells in their blood or bone marrow.
Results presented at the 44th Annual European Society Blood and Marrow Transplantation (EBMT) Meeting in March showed that galinpepimut-S more than doubles the time to myeloma worsening compared to high-risk patients who receive no maintenance therapy after a transplant. Also, 88% of the patients were still alive 18 months after the treatment.
Galinpepimut-S is a cancer vaccine that targets the Wilms tumor 1 (WT1) protein. WT1 is found at high levels in several cancers and is considered the No. 1 target for cancer immunotherapy by the National Cancer Institute.
Importantly, galinpepimut-S was able to stimulate the immune system against WT-1 in 91% of patients.
“The designation of Fast Track for GPS [galinpepimut-S] represents important recognition by the FDA of the potential of this novel immunotherapeutic to address the significant unmet need in the treatment of patients with high-risk multiple myeloma in patients with poor-risk cytogenetics at diagnosis who still harbor minimal residual disease (MRD) after autologous stem cell transplant,” Angelos Stergiou, MD, ScD, president and CEO of SELLAS, said in a press release.
“We are fully committed to working closely with the FDA as we continue the development of our potential first-in-class novel WT1-targeting cancer vaccine for select high-risk multiple myeloma patients in the post-autotransplant maintenance setting after standard first-line treatment,” Stergiou added.
SELLAS is also studying galinpepimut-S in other cancer types, including acute myeloid leukemia, malignant pleural mesothelioma, and ovarian cancer. The treatment is being tested alone or in combination with existing therapies, such as the immune checkpoint inhibitor Keytruda (pembrolizumab).