Vical was incorporated in April 1987 to research and develop proprietary lipid chemistry. The company founders – former executives from Hybritech and researchers from the University of California-San Diego – were initially focused on developing liposomes for extended release of AZT, a treatment for patients with AIDS.
In a series of experiments in 1989, Vical researchers and collaborators at the University of Wisconsin-Madison were evaluating lipid-based delivery of DNA. A key was that muscle tissues could take up DNA directly, without the lipid formulations. Confirmation and refinement of this discovery led to Vical’s core DNA delivery patents, which form the basis of its current product portfolio.
Merck became the first licensee of Vical’s DNA delivery technology in 1991 and began initial research toward the development of DNA vaccines for influenza. The companies have renegotiated targets and terms several times over the years, and Merck’s latest focus with Vical’s technology is on cancer vaccines.
Vical completed its initial public offering of 2,000,000 shares of common stock in March 1993. Since its inception, Vical has raised total net proceeds of approximately $370.0 million from the sale of equity securities.
Allovectin-7®, Vical’s first cancer immunotherapy product candidate, entered Phase 1 clinical trials in 1994 for evaluation in treating a variety of solid tumors. The product concept originated through a collaboration with Dr. Gary Nabel at the University of Michigan, a scientific advisor to the company who later became the Director of the Dale and Betty Bumpers Vaccine Research Center at the National Institute of Allergy and Infectious Diseases. Allovectin-7® has advanced through full enrollment in a pivotal Phase 3 trial in patients with metastatic melanoma and is positioned to become the company’s first independent product.
The first U.S. patent on Vical’s core DNA delivery technology was issued in December 1996 and formed the cornerstone of the company’s comprehensive patent portfolio in the United States and in key foreign markets.
Vijay Samant joined Vical in late 2000 and began assembling a new management team. A subsequent comprehensive evaluation of the company’s technologies and resources led to a new focus on infectious disease vaccines with initial targets of anthrax and CMV. Allovectin-7® was the only program continued from the prior administration, and remains the company’s lead independent program.
Phase 1 testing of CMV vaccine candidates began in 2004, and the resulting TransVax™ vaccine, designed to prevent reactivation of CMV in transplant patients, is the company’s most advanced infectious disease vaccine program. A second candidate, the CyMVectin™ vaccine, is designed to prevent CMV infection before and during pregnancy, thereby preventing the possibility of transmitting CMV to the fetus.
Apex®-IHN, a vaccine developed by the Aqua Health division of Novartis to protect farm-raised salmon against a deadly virus carried by wild salmon, was approved by the Canadian Food Inspection Agency in 2005, marking the first approval of a product based on Vical’s technology. Vical entered into an agreement with AnGes for the Collategene™ angiogenesis gene therapy.
Vical entered into an agreement with AnGes for development of Allovectin-7® in 2006 and initiated an AnGes-funded Phase 3 trial in metastatic melanoma.
In the first human tests of Vical’s novel Vaxfectin® adjuvant in 2008, the company’s Vaxfectin®-formulated DNA vaccines against H5N1 avian-origin influenza elicited breakthrough human immunogenicity data in the same range as conventional vaccines.
ONCEPT™, a vaccine developed by the world’s largest animal health company Merial to prevent the recurrence of melanoma in dogs, received full approval from the U.S. Department of Agriculture in 2009.
During the H1N1 swine-origin influenza pandemic of 2009, Vical was the first company to produce a vaccine against the newly emerged pathogen and initiate animal testing. The vaccine advanced to proof-of-concept human testing in 2010 with funding from the U.S. Navy.
In July 2011, Astellas Pharma Inc. licensed exclusive rights to develop and commercialize TransVax™, Vical’s therapeutic vaccine designed to control cytomegalovirus (CMV) reactivation in transplant recipients.