Polynoma LLC, a U.S. oncology-focused biopharmaceutical company within Hong Kong-based CK Life Sciences Int’l., (Holdings) Inc., today announced the start of a Phase III clinical trial program for POL 103A, the Company’s novel melanoma vaccine. Polynoma’s global, multi-center, double-blind, placebo-controlled Melanoma Antigen Vaccine Immunotherapy Study (MAVIS) is designed to enroll a total of 1059 patients with resected Stage IIb, IIc or III melanoma. The trial is being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA).
“Initiation of our multinational Phase III clinical program is a major milestone for Polynoma, and is a strong demonstration of our commitment to rapidly advancing new treatments with broad potential impact in oncology,” stated John Chiplin, PhD, President and Chief Executive Officer of Polynoma.
Polynoma’s melanoma vaccine has an extensive clinical history, having been safely administered to over 650 patients. The current Phase III study of POL 103A has been initiated based on the results of two randomized, placebo-controlled Phase II trials that demonstrated strong efficacy in terms of significantly improved recurrence-free survival (RFS) and overall survival (OS). Additionally, POL 103A has exhibited an excellent safety profile.
Dr. Chiplin commented, “POL 103A‘s strong safety profile and tolerability have a significant advantage over Interferon, which has limited efficacy and poor tolerability despite its being the current standard of care for resected Stage IIb – III melanoma patients, for whom there are currently no other alternatives.”
Polynoma’s Phase III program consists of two stages, the first being a lead-in stage that is currently enrolling 99 patients and is designed to assess vaccine safety and bioactivity, as well as select the vaccine dose to be used in the second and final stage of the study.
The ensuing second stage is designed to assess the efficacy of POL 103A, with the goal of enrolling 960 melanoma patients randomized to POL 103A or a placebo vaccine comparator on a 2:1 basis. The study will be conducted in fourteen countries across the U.S. and Europe.
Dr. Chiplin continued, “The goal is to reach the RFS endpoint by mid-2016, another key milestone for the clinical program. Given the fact that other key oncology therapies have received approvals based on positive RFS findings, our plan is to file an early BLA submission to the FDA according to our SPA.”