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 – Yahoo Finance

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 – Yahoo Finance

Seviprotimut-L is in clinical development as a potential adjuvant treatment for patients 60 years and younger with Stage IIB or IIC melanoma

Polynoma’s recently published clinical data from MAVIS in JITC supports further study of seviprotimut-L in Stage IIB/IIC melanoma, especially in younger patients and those with ulcerated melanomas

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.

Final analysis of Part B1 data from Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) was recently published in the Journal for ImmunoTherapy of Cancer (JITC). A subgroup analysis of patients receiving seviprotimut-L with AJCC Stage IIB/IIC melanoma, under age 60 with a median follow-up time of 45.8 months (3.8 years), showed clinically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 68% (HR=0.32; 95% CI, 0.121, 0.864) compared to patients receiving placebo. Additionally, RFS was more favorable in patients under age 60 with ulcerated melanomas (HR 0.21; 95% CI: 0.065-0.702), and there was a trend toward improved overall survival (OS) (HR 0.34; 95% CI: 0.117, 0.975) for patients that received seviprotimut-L compared to those receiving placebo. Seviprotimut-L was extremely well tolerated, with adverse events (AEs) similar to patients that received placebo; there were no immune-mediated AEs or other treatment-related serious AEs observed.

“Vaccination with seviprotimut- L has an advantage of having very low toxicity, without significant immune-related adverse events and no significant increase in toxicity over placebo,” said Craig L. Slingluff, Jr., MD, Professor of Surgery and Director of the Human Immune Therapy Center and lead author of the JITC research paper on MAVIS. “If definitive evaluation of this vaccine therapy confirms clinical benefit in patients with Stage IIB/IIC melanoma, particularly those aged 60 and younger, the low toxicity of this approach will be a valuable option for these patients.”

“This SPA agreement with the U.S. FDA for our planned pivotal trial provides important guidance for the regulatory path towards approval of seviprotimut-L as an adjuvant treatment in Stage IIB/IIC melanoma,” said Alan Yu, Chairman of Polynoma and Vice President & Chief Executive Officer at CK Life Sciences. “We believe results from this trial will support seviprotimut-L as the first choice in treating younger patients with localized melanoma.”

About FDA Special Protocol Assessment
The SPA process is a procedure by which the FDA provides a clinical trial sponsor with an official evaluation and written guidance on the design of a proposed protocol intended to form the basis for a new drug application. A SPA does not ensure the receipt of marketing approval …….

Source: https://finance.yahoo.com/news/polynoma-receives-special-protocol-assessment-140000128.html

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