Vical

= Vical =

General Information
toc 10390 Pacific Center Court San Diego, California 92121-4340 USA || Jill M. Broadfoot - Senior Vice President, Chief Financial Officer and Secretary Alain P. Rolland, Pharm. D., Ph.D. - Executive Vice President, Product Development Kevin R. Bracken - Vice President, Manufacturing Richard T. Kenney, M.D. - Vice President, Clinical Development Larry R. Smith, Ph.D. - Vice President, Vaccine Research || __Corporate Partners - Inlicensing:__ Bioject Medical Technologies, Inc. and CytRx Corporation. __Government Collaborators:__ CRADAS and NIH Vaccine Research Center __Academic Research Institutions:__ Wisconsin Alumni Research Foundation; University of Michigan; University of Massachusetts; The Wistar Institute and Academic Licenses ||
 * ~ Company Name || Vical ||
 * ~ Year founded || 1987 ||
 * ~ Headquarters ||  Vical Incorporated
 * ~ Number of Locations || 1 ||
 * ~ Management || Vijay B. Samant - President and Chief Executive Officer
 * ~ Partnership Programs || __Corporate Partners - Outlicensing:__ Anges MG, Inc.; Sanofi-aventis Group; Merck & Co.; Aqua Health Ltd.; Merial Ltd. and Invitrogen Corporation.
 * = **Employees** || 113 ||
 * ~ website || [] ||

In 1989 Vical discovered DNA delivery technology which they patented. Since then, Vical engages in the research and development of biopharmaceutical products based on this patented for the prevention and treatment of serious or life-threatening diseases. Potential applications of this 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.

DNA delivery technology consists in inserting DNA or RNA in the cell, without viral components or other delivery vehicles, and subsequently the expression of the proteins encoded by that genetic material. In order to achieve this typically involves the design and construction of plasmids which have genetic material encoding for: protein of interest, control of protein expression and the plasmid’s replication. Therefore, since the discovery of DNA delivery technology, Vical has improved the design of their plasmids increasing efficiency of gene expression and immunogenicity.

Research and development of other formulation and delivery technologies other than plasmids are ways to enhance DNA expression or increase the immune response in DNA vaccine applications such as: lipid molecules, synthetic polymers – poloxamers and needle-free injection.

(*) - Immunotherapy is a technique that teaches the immune system to fight cancer cells, this process is morose for that reason patients must be healthy enough and live long enough to allow the immune system to be trained. Through immunotherapy better results can be obtained.

History

 * **April 1987 -** Incorporated to research & develop proprietary lipid chemistry
 * **1989 -** Discovered DNA delivery technology and filed patent applications
 * **1991 -** Merck licensed DNA delivery technology for infectious disease vaccines
 * **1994 -** Merck expanded the license
 * -** Aventis Pasteur licensed DNA delivery technology for infectious disease vaccines
 * **1995 -** Merial licensed DNA vaccines for veterinary applications
 * **1996 -** First patent issued from 1989 filing on core DNA delivery technology
 * **1997 -** Merck licensed DNA delivery technology for therapeutic vaccines against infectious diseases
 * -** other patents for DNA delivery applications
 * **1998 -** Patent issued for lipid-mediated DNA delivery
 * **1999 -** Pfizer licensed gene delivery technology for animal health applications
 * -** Merck initiated DNA HIV vaccine trial
 * -** Merial selected targets for animal health DNA vaccines
 * **2000 -** Enteres strategic partnership with Human Genome Sciences
 * **2001 -** Appointed prestigious Scientific Advisory Board
 * -** Issuance of key DNA vaccine patent
 * -** Issuance of key University of Michigan patent, licensed to Vical
 * -** Acess to DNA delivery enhancing technologies
 * **2002 -** Issuance of broad patent covering DNA delivery of proteins
 * -** Awarded first manufacturing contract for Vaccine Research Center of NIH
 * **2003 -** Moved to new facility to consolidate operations and upgrade manufacturing capacity
 * **2005 -** Aqua Health (Novartis) vaccine for salmon received approval in Canada
 * -** Established angiogenesis collaboration with AnGes MG
 * **2008 -** AnGes filed for Japanese appoval of its Collategene TM angiogenesis product
 * **2009 - ** Merial's ONCEPT TM canine melanoma DNA vaccine was approved in the USA.

Products
This was Vical’s first researched and developed product in 1994. Recently phase 3 was completed and currently they are collecting data which will be available in mid 2011. This product consists of a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and B2 microglobulin, which together form a major histocompatibility complex (MHC) class I. Thus, when Allovectin-7 ® is injected directly into tumor lesions it triggers an immune response against metastatic tumors through several mechanisms. viral reactivation and disease after transplant.  The development status: phase 2 was completed and at present they are collecting and auditing all patients’ data. This product is a bivalent DNA vaccine containing plasmids encoding CMV phosphoprotein 65 (pp65) and glycoprotein B (gB) which induce cellular and humoral immune responses. TransVaxTM is formulated with a poloxamer-based delivery system.  Still in preclinical phase. This product consists of encoding the glycoprotein B (gB) in a plasmid.
 * In addition to the plasmids and cationic lipids Vical has others products or potential products: **
 * **Allovectin-7 ® cancer immunotherapeutic** - first-line treatment for metastatic melanoma.
 * **TransVax™ therapeutic vaccine for cytomegalovirus (CMV), a herpes virus - Prevents **
 * **CyMVectin™ prophylactic vaccine for cytomegalovirus (CMV), a herpes virus -** Prevents infection before and during pregnancy to preclude fetal transmission.
 * **Vaxfectin ® -** is a cationic lipid formulation (a mixture of a cationic lipid, VC1052, and neutral co-lipid, DPyPE) optimized by Vical to increase the antibody and T-cell immune response of plasmid DNA (pDNA) vaccines. It can be use with an adjuvant for pDNA vaccine and immunotherapeutics.
 * **Prophylactic vaccine for H5N1 pandemic influenza virus -** Protects against infection, disease, and/or viral shedding.

Phase 1 completed. This vaccine probably will be composed of a plasmid encoding nucleoprotein (NP), an ion channel protein (M2) (two highly-conserved influenza virus proteins) and H5 hemagglutinin avian influenza virus surface protein. It’s formulated with Vaxfectin® adjunvant.
 * **Prophylactic vaccine for H1N1 pandemic influenza virus -** Protects against infection, disease, and/or viral shedding.

The development status: preclinical. This vaccine encodes for H1 hemagglutinin from swine type influenza virus with Vaxfectin® adjuvant.
 * **Therapeutic vaccine for herpes simplex type 2 virus (HSV-2) -** Prevents recurring flare-ups to reduce viral shedding and transmission.

In research. This vaccine will also be tested with Vaxfectin® adjuvant.

Vical has others products with partnership programs. The next table summarizes their corporate and government collaborations.


 * Table** **1** **–** Summary  of corporate and government collaborations adapted from []

Product ** ||= ** Objective ** ||= ** Development status ** ||= ** Lead Developer ** ||
 * = **Partnership Programs** ||= **

Induces local growth of blood vessels to restore blood flow to limbs affected by ischemia || NDA filed in Japan; Phase 2 completed in the USA ||
 * Corporate collaborations ** ||
 * Collategene** **TM** - DNA encoding Hepatocyte Growth Factor (HGF), a human protein that helps hepatic cells multiply and angiogenesis when injected in areas of restricted blood flow. ||

AnGes || Hepatocyte Growth Factor (HGF), a great angiogenic and antifibrotic factor. || Induces local angiogenesis to restore blood flow to ischemic hearts || Phase 1 completed in the USA || AnGes ||
 * ^  || **Temusi®** - Encodes Fibroblast Growth Factor 1 (FGF-1), an angiogenic growth factor || Induces local angiogenesis to restore blood flow to limbs affected by ischemia, reducing risk of amputation. || Phase 3 - enrollment completed || Sanofi-aventis ||
 * ^  ||   **Angiogenic therapy** - Encodes
 * ^  ||   **Therapeutic vaccine** - encodes human telomerase reverse transcriptase, a subunit of the enzyme telomerase that maintains telomere ends   || Treats non-small cell lung, breast or prostate cancer, melanoma, or carcinomas of the upper GI tract, colon, kidney, or bladder. || Phase 1 || Merk ||
 * ^  ||   **Prophylactic and/or therapeutic hepatitis C vaccine**   || Prevents and/or treats infection, disease, and/or viral shedding || Research || Merk ||
 * ^  || **Apex-IHN® prophylactic vaccine for infectious hematopoietic necrosis (IHN) virus** - Encodes IHN virus glycoprotein || Protects farm-raised salmon from infection and disease when exposed to infected wild salmon || Approved in Canada || Aqua Health (Novartis) ||
 * ^  || **ONCEPT** **TM** **therapeutic cancer vaccine** - encodes human tyrosinase. The difference between the human and canine tyrosinase activates a strong immune response against self-tumor. || Adjunct treatment to increase survival time of dogs with oral melanoma || Approved in the USA || Merial ||
 * ** Government collaboration ** || **Prophylactic and/or therapeutic HIV vaccine** || Prevents and/or treats infection, disease, and/or viral shedding || Phase 2 || NIH ||

The different development status is according to the description in Vical’s web-page: “Research” indicates exploration and/or evaluation of a potential product candidate in a nonclinical laboratory setting. “Preclinical” indicates that a specific product candidate in a nonclinical setting has shown functional activity that is relevant to a targeted medical need, and is undergoing toxicology testing in preparation for filing an Investigational New Drug (IND) application. “Phase 1” clinical trials are typically conducted with a small number of patients or healthy subjects to evaluate safety, determine a safe dosage range, identify side effects, and, if possible, gain early evidence of effectiveness. “Phase 2” clinical trials are conducted with a larger group of patients to evaluate effectiveness of an investigational drug for a defined patient population, and to determine common short-term side effects and risks associated with the drug. “Phase 3” clinical trials involve large scale, multi-center, comparative trials that are conducted with patients afflicted with a target disease to evaluate the overall benefit-risk relationship of the investigational drug and to provide an adequate basis for product labeling ( []).

** Financial Information **
In 2009, reported financial results said that Vical had cash and investments of approximately $53 million at year-end 2009. The company raised approximately $33 million of net proceeds from the sale of equity securities during 2009, and approximately $3 million of additional net proceeds from the sale of equity securities to date in 2010. In comparison with 2008, financially, Vical generated higher revenues and reduced expenses, and they ended the year with sufficient cash to last the next two years. Operationally, Vical made extended progress and they hope for continued advancement through the achievement of key milestones in their independent and partnered product development programs throughout 2010.

On April 16 th 2010, the Market Cap was $207,3 million, the Volume was $367,3 thousand and the average volume (10 D) was $274,2 thousand. (http://investing.businessweek.com/research/stocks/snapshot/snapshot.asp?ticker=VICL:US)

Bibliography
 * 1) []
 * 2) http://www.ceocfointerviews.com/interviews/VICL-Vical10.htm (last visited April 17th 2010)
 * 3) http://ir.vical.com/releasedetail.cfm?ReleaseID=380055 (last visited April 17th 2010)
 * 4) http://ir.vical.com/releasedetail.cfm?ReleaseID=352421(last visited April 17th 2010)
 * 5) http://www.docstoc.com/docs/24743307/DNA-Vaccines-for-IHNV-and-IPNV (last visited April 17th 2010)
 * 6) http://ir.vical.com/releasedetail.cfm?ReleaseID=453573 ((last visited April 17th 2010)
 * 7) Vical 2009 Annual Report (http://www.vical.com/assets/pdfs/09AR.pdf)
 * 8) <span style="font-family: Arial,Helvetica,sans-serif; font-size: 11px; line-height: 17px;">http://www.ceocfointerviews.com/interviews/PR-Vical021110.htm (last visited April 17th 2010)

Last update April 17 th 2010

Elisabete M. Ribeiro nº.: 68455 MBiotec

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