Galinpepimut-S granted FDA orphan drug designation

On 9 May 2018, SELLAS Life Sciences (SLS) announced that its therapeutic vaccine, Galinpepimut-S (GPS), has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of multiple myeloma (MM). GPS targets the Wilm’s Tumor-1 (WT-1) protein, a known tumor antigen which, along with an adjuvant, stimulates the immune system to fight back. It has been suggested that this could prove highly beneficial if given in combination with other immunomodulatory drugs.  

The vaccine is currently licensed from the Memorial Sloan Kettering Cancer Center, where the research has been carried out, including a phase II trial in which 19 patients with high-risk disease were immunized with GPS following autologous stem cell transplant (ASCT). A median progression-free survival (PFS) of 23.6 months was reported, an 11-month increase compared to data from a comparative trial with a similar sub-group of high-risk patients. An 88% overall survival (OS) of 18 months was also recorded.

A study to assess the clinical benefit of the vaccine in high-risk patients was conducted by Guenther Koehne and presented at the 44^th Annual Meeting of the European Society for Blood and Marrow Transplantation earlier this year – see previous MM Hub article.