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Preclinical Data Support Potential Combinations for Allovectin(R) With Emerging Immunotherapies

11/08/2012


SAN DIEGO, Nov. 8, 2012 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced the release of animal data at a melanoma conference documenting the benefits of combining the company's Allovectin® immunotherapy with anti-CTLA-4, anti-PD-1, and anti-PD-L1 antibodies, which are emerging immunotherapies for metastatic melanoma. The company also announced a new publication1 supporting Allovectin®'s proposed mechanisms of action.

The company's poster presentation at the 9th International Congress of the Society for Melanoma Research (Hollywood, CANovember 8-11) summarizes the results of studies in melanoma mouse models evaluating the combination of Allovectin® with emerging antibody immunotherapies. Conclusions from these studies are:

  • Allovectin® produces a marked anti-tumor effect in the mouse melanoma model stronger than that produced by any of the evaluated antibodies;
  • Combination approaches using Allovectin® with each of the antibodies produce additive to synergistic effects; the best results in the mouse melanoma model are with the combination of Allovectin® and anti-CTLA-4 antibody; and
  • The data, which support the distinct but complementary mechanisms of action of these immunotherapies, warrant further evaluation in humans.

An article published in the advance online issue of Cancer Gene Therapy in October compiles preclinical and clinical data supporting Allovectin®'s three proposed mechanisms of action:

  • Induction of adaptive cytotoxic T-cell responses against a novel allogeneic target;
  • Restoration of major histocompatibility class I expression; and
  • Induction of inflammatory and innate immune responses.

These mechanisms have been shown to work together to drive both local and systemic immunotherapeutic activity against tumor cells. The article specifically addresses the contributions of each component of Allovectin® to immune system recognition and destruction of cancer cells in both injected and noninjected metastatic melanoma lesions.

A Phase 3 trial, initiated in January 2007, is evaluating Allovectin® as first-line therapy in patients with Stage III or IV recurrent metastatic melanoma. Vical completed enrollment in February 2010 of 390 chemo-naive patients randomized on a 2:1 basis: 260 for treatment with Allovectin® and 130 for treatment with either dacarbazine or temozolomide. The company expects to release top-line data from the Phase 3 trial in mid-2013.

Allovectin® is a novel gene-based immunotherapeutic with unique mechanisms of action that are fundamentally different from currently approved treatments. Because the mechanisms of action for Allovectin® are not melanoma-specific, it has the potential to be used in other types of solid tumors. AnGes MG, Inc., has licensed rights to commercialize Allovectin® in specified Asian countries, and is primarily interested in developing Allovectin® as a treatment for head and neck cancer, which presents a significant unmet medical need in Asia. Allovectin® is still available for licensing in North America, Europe and other regions.

John Doukas, Ph.D., Vical's Senior Director of Pre-clinical Safety and Efficacy, is scheduled to present a poster, "Preclinical Studies in Support of a Combination Immunotherapy Approach to Melanoma Treatment Using Allovectin® with Anti-CTLA-4, Anti-PD-1, or Anti-PD-L1 Antibodies," during the Society for Melanoma Research Congress. Dr. Doukas also is the lead author of the Cancer Gene Therapy article.

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include whether Vical or others will continue developing Allovectin®; whether the Phase 3 trial will meet its primary endpoint or any other trial endpoints; whether Allovectin® will be approved as first-line treatment for metastatic melanoma in the United States or any other countries; whether any patients will derive benefit from treatment with Allovectin®; whether Allovectin® will be successfully developed and commercialized for other solid tumor indications; whether AnGes will develop or commercialize Allovectin-7® in Asia for head and neck cancer or any other indication; whether results in animal models will be duplicated in human testing; whether Vical or others will evaluate combinations of Allovectin® with antibodies in human clinical trials; whether combinations of Allovectin® with antibodies will provide additive or synergistic effects in humans, if any; whether any product candidates will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

1 Doukas J & Rolland A. Mechanisms of action underlying the immunotherapeutic activity of Allovectin in advanced melanoma. Cancer Gene Therapy 2012; doi: 10.1038/cgt.2012.69.

CONTACT: Alan R. Engbring
         (858) 646-1127
         Website:  www.vical.com

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