An independent Safety Monitoring Board (SMB) has completed the third scheduled safety analysis for Vical’s phase 3 AIMM trial of Allovectin-7 in patients with metastatic melanoma and recommended to continue as per the protocol. The trial is expected to complete enrollment of the planned 375 subjects in the next few weeks.
Allovectin-7 is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and beta-2 microglobulin, which together form MHC-I antigen. Injection of Allovectin-7 directly into tumors is designed to stimulate an immune response against both local and distant metastatic tumors.
Vical has conducted a large phase 2 trial evaluating Allovectin-7 immunotherapeutic as a single agent for patients with stage III or IV metastatic melanoma. Based on advice from clinical experts and detailed guidance received from the FDA in an end-of-phase 2 meeting, Vical designed the phase 3 AIMM trial.
The company is conducting the AIMM (Allovectin-7 Immunotherapeutic for Metastatic Melanoma) trial, a phase 3 pivotal trial of the company’s Allovectin-7 cancer immunotherapeutic as first-line therapy in approximately 375 chemotherapy-naive patients with stage III or IV metastatic melanoma in accordance with a Special Protocol Assessment (SPA) agreement completed with the FDA.
Reportedly, the SPA specifies the trial objectives and design, clinical endpoints, and planned analyses expected to be needed for product approval. The AIMM trial is currently enrolling patients at clinical sites in key centers worldwide.
Under a previously announced collaborative agreement, AnGes MG is funding the AIMM trial through a series of cash payments and equity investments. Vical has received the full $22.6m committed by AnGes. In exchange for funding the trial, AnGes received exclusive marketing rights in Japan and other key Asian countries, and Vical is obligated to pay AnGes tiered royalties based on defined sales levels in the US, and fixed royalties on rest-of-world sales.
AnGes is obligated to pay Vical royalties on product sales in the specified Asian countries plus certain sales-based milestone payments, if defined sales levels are achieved. Each company will be responsible for obtaining regulatory approvals in any countries where it plans to market Allovectin-7.