Profile: Vical Inc (VICL.OQ)
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 clinical and preclinical development programs in the areas of infectious disease and cancer, including a fully enrolled Phase III clinical trial using its Allovectin immunotherapeutic in patients with metastatic melanoma; a completed preclinical program, with an allowed investigational new drug application (IND), using its CyMVectin prophylactic vaccine formulated with its Vaxfectin adjuvant to prevent cytomegalovirus (CMV), infection before and during pregnancy, and a preclinical program with therapeutic and prophylactic vaccines for herpes simplex virus type II formulated with its Vaxfectin adjuvant. The Company’s licensing arrangements with Astellas Pharma Inc. (Astellas), Merck & Co., Inc. (Merck), Sanofi, AnGes, Aqua Health Ltd. of Canada (Aqua Health), an affiliate of Novartis Animal Health, and Merial Limited (Merial), a subsidiary of Sanofi, among other biopharmaceutical companies.
Independent Programs Targeting Infectious Diseases
The Company is developing two CMV vaccines: TransVax and CyMVectin. TransVax is designed to serve the first patient population by preventing CMV reactivation or infection in transplant recipients. During 2011, it licensed the right to develop and commercialize TransVax to Astellas. CyMVectin is designed to serve the second, much larger patient population by preventing congenital infection by vaccinating women before pregnancy. TransVax is a plasmid DNA vaccine that induces both T-cell and antibody responses by expressing two antigens, phosphoprotein 65 (pp65), and glycoprotein B (gB). The tegument protein, pp65, is an antigen recognized by T cells in CMV-infected individuals. The gB protein is a surface antigen of CMV and a primary target of neutralizing antibodies. The gB protein is also a CMV antigen recognized by both CD4+ and CD8+ T cells in CMV-seropositive subjects. The vaccine is also formulated with poloxamer CRL1005, which has been shown in nonclinical studies by it and others to enhance gene expression and immune responses.
CyMVectin consists of pDNA that encodes the human CMV gB antigen with pDNA that encodes the human CMV pp65 antigen. The product is formulated with its y lipid-based adjuvant Vaxfectin. A gB protein-based vaccine, developed by others, has shown some protection against CMV infection in a Phase II clinical trial. During 2011, it completed a Phase I clinical trial of its Vaxfectin-formulated DNA vaccine against A/H1N1 pandemic influenza. The Company had developed several vaccines targeted at diseases, including malaria, anthrax, severe acute respiratory syndrome (SARS), West Nile Virus (WNV) and Ebola.
Independent Program Targeting Cancer
Allovectin is a plasmid/lipid formulation containing the DNA sequences encoding HLA-B7 and ß2 microglobulin, which together form a MHC Class I complex. In HLA-B7 negative patients, a vigorous allogeneic immune response may be initiated against the foreign MHC class I antigen. In all patients,ß2 microglobulin may reconstitute normal class I antigen presentation and/or increase tumor antigen presentation to the immune system. In any patient, an innate pro-inflammatory response may occur that induces tumor responses following intralesional injection of the pDNA/lipid complex. The goal of all three of these mechanisms is to initially cause recognition of the tumor at the local site to allow a then-sensitized immune response to recognize un-injected tumors at distant metastatic sites. The Company began a high-dose, two milligram, Phase II trial evaluating the Allovectin immunotherapeutic alone for patients with stage III or stage IV melanoma. The data showed that the trial had a total of 15 responders among the 127 patients receiving the high dose (11.8 %), with four of the patients having complete responses and 11 having partial responses.
The Company completed a special protocol assessment (SPA), with the FDA for a Phase III trial of high-dose, two milligram, Allovectin for certain patients with recurrent Stage III or Stage IV melanoma. The Phase III trial has involved more than 100 clinical sites. Patients could have been previously treated with surgery, adjuvant therapy, and/or biotherapy, but cannot have been previously treated with chemotherapy. The patients were randomized on a 2:1, basis with 260 patients treated with Allovectin and 130 treated with their physician’s choice of either of two chemotherapy agents, dacarbazine or temozolomide. The primary endpoint is overall response rate that compares the two trial arms for objective responses that are ongoing or commence at 24 weeks or more after randomization. The study will also evaluate safety and tolerability, as well as survival as secondary endpoints.
Vaxfectin is the Company’s cationic lipid formulation optimized to increase the immune response to vaccines. Vaxfectin formulations have demonstrated safety and adjuvant activity in pDNA vaccine applications in multiple animal models, including nonhuman primates, in addition to the animal and human influenza studies. Studies of Vaxfectin -formulated pDNA vaccines against CMV and measles have shown enhanced immunogenicity in rodents and nonhuman primates, respectively. Vaxfectin has also demonstrated dose-sparing attributes as an adjuvant for protein-based influenza vaccines, as well as increased T-cell responses and antitumor responses to formulated peptide-based cancer antigens. In addition to the studies, there have been a number of published non-clinical infectious disease studies utilizing Vaxfectin as an adjuvant.
The Company completed a study, which demonstrated that a measles DNA vaccine formulated with Vaxfectin adjuvant elicited sustained protective levels of neutralizing antibodies in infant (6-10 week old) nonhuman primates confirmed by complete protection following challenge one year after intradermal vaccination, with no clinical signs of disease and no culturable virus after challenge. Similar results were found in juvenile (1-2 year old) nonhuman primates. In a separate study in mice, the Company evaluated the potential of Vaxfectin to be used as a dose-sparing agent with a protein-based H5N1 pandemic influenza vaccine stockpiled by the United States Government. Vaxfectin-formulated vaccine contains a peptide from tyrosinase-related protein 2 T(RP-2), an antigen commonly expressed by several types of tumors, including glioma and melanoma, resulted in approximately a 100-fold increase in antigen-specific CD8+ T-cell responses compared with unformulated vaccine. CD8+ T cells are deployed by the immune system to identify and destroy infected or cancerous cells.
The Company competes with Sanofi, Novartis, GlaxoSmithKline plc, AstraZeneca, Merck and Pfizer Inc, Roche, AlphaVax, Bristol-Myers Squibb, Daiichi Sankyo, Amgen and Celgene.
10390 Pacific Center Court
SAN DIEGO CA 92121-4340