Investigational Cancer Vaccine Galinpepimut-S Receives Orphan Drug Status in EU for Multiple Myeloma

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by Alice Melão |

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Fast track designation

SELLAS Life Sciences’ lead therapy candidate galinpepimut-S (GPS) received orphan medicinal product designation from the European Medicines Agency for the treatment of multiple myeloma patients, according to a press release.

The decision is expected to support and expedite the clinical development and regulatory review of galinpepimut-S. It provides several benefits, including protocol design assistance, reduced regulatory fees, and 10 years of market exclusivity across the European Union.

This designation follows orphan drug status and fast track designation granted to galinpepimut-S by the U.S. Food and Drug Administration for the treatment of multiple myeloma.

“The innovative nature and unique mechanism of action for GPS provide a promising potential addition to the current arsenal of therapies in this indication,” Angelos Stergiou, MD, president and CEO of SELLAS, said in the release.

GPS is an investigational anti-cancer vaccine composed by mixing four small man-made proteins derived from the Wilms tumor (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.

Licensed from the Memorial Sloan Kettering Cancer Center, the immunotherapy is designed to have a broad application, with the ability to induce a strong immune response to any cancer cell positive for the WT1 protein in a variety of tumors.

GPS is being explored as a maintenance therapy in an ongoing Phase 2 trial (NCT01827137), which enrolled 19 high-risk multiple myeloma patients who had achieved at least stable disease after a stem cell transplant. Despite the transplants’ success, all patients had residual disease, with cancer cells in their blood or bone marrow.

GPS treatment significantly extended the time patients lived without cancer recurrence. While patients with high-risk multiple myeloma usually experience cancer recurrence in less than a year, those who received the vaccine had a median progression-free survival time of 23.6 months — a significant 2.5 times increase.

In addition, 18 months after receiving the vaccine, 88% of patients were still alive.

“The results from our open-label Phase 2 study reinforce the potential of GPS to serve as a therapy for high-risk multiple myeloma patients in the post-autotransplant maintenance setting,” Stergiou said. “We continue to work closely with the FDA and EMA, as well as multiple myeloma key opinion leaders to further advance the clinical development of GPS in this malignancy and look forward to gaining further insights on the potential therapeutic role of GPS in high-risk multiple myeloma patients.”