Vical Incorporated and AnGes MG, Inc. announced a collaborative agreement for Vical's Allovectin-7 cancer immunotherapeutic.

Under the agreement, AnGes will provide up to $100 million in ongoing clinical trial funding and future sales-based milestones as Allovectin-7 is successfully commercialized. Vical retains exclusive marketing rights for Allovectin-7 in the United States and the rest of the world outside of specified Asian countries, for which AnGes received exclusive rights, a company release said.

Through a scheduled series of cash payments and equity investments totalling $22.6 million, including an initial equity investment of $6.9 million, AnGes will fund the Phase 3 pivotal trial of Allovectin-7 to be conducted by Vical in the United States in accordance with a Special Protocol Assessment (SPA) completed with the US Food and Drug Administration (FDA). Vical has made significant preparations for timely initiation of the Phase 3 trial, and will be actively recruiting additional clinical sites at the annual meeting of the American Society of Clinical Oncology June 2 through 6 in Atlanta, Georgia.

AnGes will pay Vical royalties on product sales in the specified Asian countries, plus the above-mentioned milestones as defined sales levels are achieved. Vical will pay AnGes tiered royalties based on defined sales levels in the United States, and fixed royalties on rest-of-world sales. Each company will be responsible for obtaining regulatory approvals in any countries where it plans to market Allovectin-7.

"We established a mutually beneficial relationship last year with AnGes in the angiogenesis field," said Vijay Samant, president and chief executive officer of Vical," and we believe the Allovectin-7 agreement expands our opportunities for success. Now that we can advance this key program mitigating the financial risk of independent development, we are eager to begin the Phase 3 trial of Allovectin-7 as soon as possible."

"We have been pleased in our ongoing relationship with Vical and being able to further strengthen the strategic relationship between us in the field of gene therapy," said Ei Yamada, president and CEO of AnGes MG, "and through this new arrangement we see great potential to bring Allovectin-7 into the Asian market for melanoma and other cancer indications. We believe our new partnership will yield further collaboration and substantial benefits for both parties in the future."

Allovectin-7 is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and beta-2 microglobulin, which together form a Class I Major Histocompatibility Complex, or MHC-I antigen. Injection of Allovectin-7 directly into tumour lesions may augment the immune response against both local and distant metastatic tumours. Vical conducted a large Phase 2 trial evaluating high-dose, 2 mg, Allovectin-7 immunotherapeutic as a single agent for patients with Stage III or IV metastatic melanoma, who have few other treatment options. Based on advice from clinical experts and detailed guidance received from the FDA in End-of-Phase 2 meetings, Vical successfully completed a SPA with the FDA for a Phase 3 trial of high-dose, 2 mg, Allovectin-7 for certain patients with metastatic melanoma. The SPA specifies the trial objectives and design, clinical endpoints, and planned analyses expected to be needed for product approval.

The Phase 3, randomized, multi-centre, open-label trial calls for enrolment of approximately 375 patients with recurrent metastatic melanoma. Patients may have been treated with surgery, adjuvant therapy, and/or biotherapy, but cannot have been treated with chemotherapy. The patients will be randomized on a 2:1 basis: approximately 250 patients will be treated with Allovectin-7(R) and approximately 125 will be treated with their physician's choice of either of two chemotherapy agents, dacarbazine or temozolomide. The primary endpoint is a comparison of objective response rates at 24 weeks or more after randomization.