Polynoma Receives Special Protocol Assessment (SPA) Agreement from the U.S. FDA for a Pivotal Phase 3 Clinical Study of Seviprotimut-L, a Melanoma Cancer Vaccine

SAN DIEGO: SAN DIEGO, Jan. 11, 2022 /PRNewswire/ — Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) on a pivotal Phase 3 clinical study of seviprotimut-L, Polynoma’s melanoma cancer vaccine, for the adjuvant treatment of patients 60 years and younger with Stage IIB or IIC melanoma following definitive surgical resection to improve recurrence-free survival. Seviprotimut-L previously received Fast Track designation from the U.S. FDA.
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