Profile: Vical Inc (VICL.O)

Vical Incorporated, incorporated in 1987, researches and develops biopharmaceutical products based on its deoxyribonucleic acid (DNA) delivery technologies for the prevention and treatment of serious or life-threatening diseases. The Company has three active independent development programs in the areas of infectious disease and cancer. These are a Phase III clinical trial using its Allovectin-7 immunotherapeutic in patients with metastatic melanoma; a Phase II clinical trial using its cytomegalovirus (CMV) DNA vaccine in hematopoietic cell transplant patients, and a Phase I clinical trial using its H5N1 pandemic influenza DNA vaccine formulated with its Vaxfectin adjuvant. The Company has licensing and collaboration arrangements, such as its licensing arrangements with Merck & Co., Inc. (Merck), the sanofi-aventis Group (sanofi-aventis), AnGes, Aqua Health Ltd. of Canada (Aqua Health), an affiliate of Novartis Animal Health, and Merial Limited, a joint venture of Merck and sanofi-aventis and AnGes, among other biopharmaceutical companies.

Cytomegalovirus Vaccine

During the year ended December 31, 2008, the Company’s CMV program included a DNA-based therapeutic vaccine to prevent viral reactivation and disease after transplant, which is in a Phase II clinical trial and a DNA-based preventive vaccine to prevent infection before and during pregnancy to preclude fetal transmission, which is in preclinical development. Results from the Phase I trial indicated that its CMV vaccine was safe and well tolerated by a majority of subjects, with temporary injection site pain. The vaccine induced antibody and T-cell immune responses at both dose levels and both dosing schedules tested. Based on these results, the Company designed a Phase II CMV clinical trial was designed to evaluate the safety, immunogenicity, and clinical benefit of a CMV immunotherapeutic vaccine in patients undergoing bone marrow transplants. In November 2008, the Company announced that it had completed enrollment of 80 subjects in the Phase II trial.

Pandemic Influenza Vaccine

In 2008, the Company completed its Phase I pandemic influenza study. Pandemic influenza is virulent human influenza that causes a global outbreak, or pandemic, of serious illness. A pandemic could begin if the H5N1 virus or another avian influenza virus strain changes to a form that can spread easily from person to person.

Allovectin-7

Allovectin-7 is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and ß2 microglobulin, which together form a major histocompatibility complex (MHC), class I. The Phase III trial is being conducted at more than 100 clinical sites worldwide. The Phase III trial calls for enrollment of approximately 375 patients with metastatic melanoma. Patients may have been previously treated with surgery, adjuvant therapy, and/or biotherapy, but cannot have been previously treated with chemotherapy.

The Company competes with sanofi-aventis, Novartis, GlaxoSmithKline plc, MedImmune, Inc., Merck, Pfizer Inc., Medarex Inc. and Wyeth.