Biopharmaceutical company Vical Inc. (VICL) Monday said that its late-stage AIMM trial of Allovectin-7(R) in patients with metastatic melanoma received a positive review from an independent Safety Monitoring Board. Metastatic melanoma is a serious form of skin cancer.
According to the company, the Safety Monitoring Board, or SMB, has completed the trial's third scheduled safety analysis and recommended that the trial continue per the protocol.
Allovectin-7(R), which is getting injected directly into tumors, is designed to stimulate an immune response against both local and distant metastatic tumors. The company had conducted a large mid-stage trial evaluating Allovectin-7(R) immunotherapeutic as a single agent for patients with Stage III or IV metastatic melanoma. Allovectin-7(R) has also been granted an orphan drug designation by the U.S. Food and Drug Administration, or FDA's, Office of Orphan Products Development for the treatment of invasive and metastatic melanoma.
Vical said it is conducting the AIMM, or Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma, pivotal trial as the first-line therapy in about 375 chemotherapy-naive patients with Stage III or IV metastatic melanoma. This is in accordance with a Special Protocol Assessment, or SPA, agreement completed with the U.S. FDA. The SPA specifies the trial objectives as well as design, clinical endpoints, and planned analyses to be needed for the product approval, the company noted.
Vical also said that the AIMM trial is currently enrolling patients at clinical sites in key centers worldwide. The company expects to complete the enrollment of the planned 375 subjects in the next few weeks.
Further, Vical stated that Japan's AnGes MG, Inc. is funding the AIMM trial through a series of cash payments and equity investments under a previously announced collaborative agreement. The company has received the full $22.6 million committed by AnGes.
Vical also said that in exchange for funding the trial, AnGes has received exclusive marketing rights to Allovectin-7(R) in Japan and other key Asian countries. Vical has to pay AnGes tiered royalties based on defined sales levels in the U.S., and fixed royalties on sales in rest of the world. Meanwhile, AnGes is required to pay Vical royalties on product sales in the specified Asian countries, along with certain sales-based milestone payments if defined sales levels are achieved. Additionally, each company will be responsible for obtaining regulatory approvals in any countries where it plans to market Allovectin-7(R).
VICL is trading at $3.32, up $0.57, on a volume of 801,384 shares.
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