Vical to collaborate with AnGes MG on cancer therapeutic Allovectin-7

By E. Janene Geiss and Jennifer Lanning Drey

Philadelphia, May 30 - Vical Inc. and AnGes MG, Inc. announced Tuesday a collaborative agreement that will fund phase 3 clinical trials of Vical's Allovectin-7 cancer immunotherapeutic in the United States.

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, according to a company news release.

Through a scheduled series of cash payments and equity investments totaling $22.6 million, including an initial equity investment of $6.9 million, AnGes said it 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 completed with the Food and Drug Administration.

"We are excited about this collaboration which allows us to move forward with the phase 3 clinical trial for melanoma with minimal financial risk," said Vijay Samant, president and chief executive officer for Vical, during a conference call on Tuesday.

"If the trial endpoints are met, Vical will move rapidly forward with regulatory approval and commercialization in the United States," he said.

Under the collaboration agreement, 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.

"We believe this agreement meets the priority goals of both companies, and for Vical combines the ability to complete the phase 3 pivotal trial with minimal financial risk while maintaining maximum flexibility for commercialization," said Dr. Robin Jackman, vice president, business development for Vical, during the conference call.

AnGes said it will pay Vical royalties on product sales in the specified Asian countries, plus the above-mentioned milestones as defined sales levels are achieved.

Vical said it will pay AnGes tiered royalties based on defined sales levels in the United States and fixed royalties on rest-of-world sales.

The royalty structure would also be applied to future uses of Allovectin-7, which is currently being tested on metastatic melanoma but is not melanoma specific. The treatment has also undergone early stage trials targeting other cancers, Jackman said Tuesday.

Each company will be responsible for obtaining regulatory approvals in any countries where it plans to market Allovectin-7, and either company can work independently or with a commercialization partner in their respective countries under the agreement, he added.

Vical preparing to begin testing

Vical will supply product for the upcoming phase 3 clinical trial, and Vical employees will manage the program with oversight by a joint steering committee of representatives from both companies, Jackman said.

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 that is scheduled for June 2 through June 6 in Atlanta.

The company's goal is to eventually recruit 40 to 50 sites, according to Samant.

AnGes plans to use the clinical data package from the United States trial, along with a small clinical trial in Japan, to advance its program in Japan and other Asian countries, Samant said.

May augment immune response

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 tumor lesions may augment the immune response against both local and distant metastatic tumors, officials said.

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 phase 3 randomized, multi-center, open-label trial calls for enrollment of about 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. About 250 patients will be treated with Allovectin-7 and about 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.

Vical, based in San Diego, researches and develops biopharmaceutical products based on its patented DNA delivery technologies.

AnGes MG is an Osaka, Japan, biopharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.