The immune system is the key to preventing and treating disease
We are leaders in utilizing the innate immune system on behalf of patients to address unmet clinical needs. We are committed to a rigorous approach to drug development in the field of TLR biology and immune system modulation to attack the challenges of infectious and inflammatory diseases and cancer.
Our corporate values are the collective ideals and ethical standards that we hold dear. They provide the foundation of our culture and how we operate as a company.
Driven to make a difference
We are innovating immunology to discover new treatment options to improve patients' lives.
Respect for patients and for our science
Our belief in scientific excellence anchors the choices we make in drug development which enables us to bring forth meaningful products to patients.
Committed to doing what is right
We approach all that we do with integrity and quality to ensure we maintain trust and credibility with patients, employees, and all other stakeholders.
Working together as one team
We are collaborative, open-minded and leverage our strengths and expertise, and those of our scientific partners, to drive advancement in TLR based immunology.
Carving our path with innovation
We take pride in our ability to identify opportunities and advance our technology to achieve success in our business.
Eddie Gray: CEO and Director
Mr. Gray joined Dynavax as Chief Executive Officer and was appointed to our Board in May 2013. Most recently, Mr. Gray served as the President of Pharmaceuticals Europe at GlaxoSmithKline plc (GSK) since 2008 and as Senior Vice President and General Manager of Pharmaceuticals UK from 2001 through 2007. Prior to the formation of GSK, Mr. Gray was with SmithKline Beecham from 1988 through 2000 serving in various positions of increasing responsibility, including Vice President and Director of Anti-Infectives Marketing in the US, Vice President and Director of the Vaccines Business Unit in the US, and Vice President and General Manager of Pharmaceuticals in Canada. Mr. Gray received a Bachelor of Science degree in Chemistry and Management Studies from the University of London and an MBA from the Cranfield School of Management in the UK.
Dr.Robert L.Coffman PhD
Senior Vice President and Chief Scientific Officer
Robert L. Coffman, PhD, is Senior Vice President and Chief Scientific Officer of Dynavax Technologies Corporation in Berkeley, CA. Prior to joining Dynavax in 2000, Dr. Coffman was a founding member of the DNAX Research Institute in Palo Alto, CA. Dr. Coffman has authored over 200 scientific publications, is a member of the National Academy of Sciences and the American Academy of Microbiology, and has received a number of prestigious awards for his work. With colleague Dr. Tim Mosmann, he defined the two principal subtypes of helper T cells, termed Th1 and Th2 cells, and demonstrated the central relationship between their differences in cytokine expression and function. Dr .Coffman defined basic mechanisms of T-cell regulation in asthma and infectious and parasitic diseases, and demonstrated the central role of regulatory CD4+ T cells in preventing inflammatory bowel disease. At Dynavax, Dr. Coffman has pioneered the development of agonists and antagonists for Toll-like receptors, key recognition receptors in innate immunity.
Chief Medical Officer and Vice President Clinical Development
Dr. Janssen was appointed Chief Medical Officer and Vice President, Clinical Development in July 2013. He most recently served as Dynavax's Vice President, Medical Affairs since November 2012 and was previously Senior Director, Clinical Development at Dynavax from 2010 through 2012, during which time he was extensively involved with Phase 3 clinical development of HEPLISAV-B and its US and European licensing applications. Prior to joining Dynavax, Dr. Janssen was Vice President, Medical Affairs at Gilead from 2008 to 2010 where he was responsible for oversight of physician and health care provider education focused on HIV and hepatitis B therapies. Until 2008, Dr. Janssen spent 23 years at the US Centers for Disease Control and Prevention (CDC), most recently as the Director of the Division of HIV/AIDS Prevention from 2000 to 2008. Under his leadership, CDC first explored HIV treatment as a mode of HIV prevention and launched several of the earliest Phase 3 trials of pre-exposure prophylaxis for HIV. Dr. Janssen received a Bachelor of Arts degree with Honors in Humanities from Stanford University and his M.D. degree from the University of Southern California. He is a neurologist with training in virology at the University of Pennsylvania. Dr. Janssen has been the beneficiary of numerous honors and awards during his career. He has published over 130 scientific articles in a variety of journals and has served as a reviewer for leading scientific journals.
Senior Vice President, Operation and Quality
Mr. Novack joined Dynavax in March 2013 as Senior Vice President, Operations and Quality. Mr. Novack was formerly with Novartis Vaccines & Diagnostics where he served since 2009 as the Global Head of Technical Operations and Supply Chain for Diagnostics and previously from 2007 to 2009 as the Global Head of Vaccine Manufacturing Strategy. Prior to Novartis, Mr. Novack was the Vice President, Business Development for Vaxin, Inc., a vaccine company. From 1993 until 2004, Mr. Novack worked at MedImmune, serving in several capacities including business development, manufacturing, contract operations and supply chain operations. Mr. Novack received a B.S. in Biology from State University of New York and an M.B.A. from Columbia University.
Vice President, Chief Financial Officer, Chief Business Officer and General Counsel
Mr. Ostrach joined Dynavax in 2006 as Vice President, Chief Business Officer and General Counsel and became Principal Financial Officer in 2013 and Chief Financial Officer in 2015. From 2005 to 2006, he was Chief Operating Officer, Chief Financial Officer and General Counsel at Threshold Pharmaceuticals. From 1997 to 2004, Mr. Ostrach was at Kosan Biosciences, most recently as President and Chief Operating Officer. Mr. Ostrach began his corporate career at Cetus Corporation, where he served in several capacities between 1981 and 1991, initially as general counsel and finally as Senior Vice President of corporate affairs and General Counsel. Following the acquisition of Cetus by Chiron Corporation in 1991, Mr. Ostrach became President of Chiron Technologies. He holds a B.A. from Brown University and a J.D. from Stanford Law School.
Ms. Vitug has been our Vice President of Human Resources since October 2006. She previously served as Senior Director of Human Resources and Director of Human Resources since joining us in June 2000. From 1997 to 2000, Ms. Vitug was employed by Collagen Aesthetics, Inc., where she was Director of Human Resources, Payroll and Administrative Services. Ms. Vitug brings to Dynavax more than 20 years of human resources and administrative services experience, including positions at Somatix Therapy Corporation, Chiron Corporation, and Wells Fargo Bank.
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Vice President, Clinical Operations
Ms. Ibarra joined Dynavax in 2010 and is our Vice President, Clinical Operations. She most recently served as Dynavax's Senior Director, Clinical Operations. From 2007 to 2010, Ms. Ibarra was Senior Director, Clinical Operations at Comentis, Inc. Prior to Comentis, she consulted for various companies focused in neurology, ophthalmology, oncology and infectious disease. Ms. Ibarra also held numerous roles in clinical operations and program management at InterMune, Corgentech, Fibrogen, Gilead Sciences and Chiron Corporation from 1996 through 2006. Ms. Ibarra holds a B.A. in Biology from the University of California at Berkeley and a M.S. in Biological Science from Stanford University.
BOARD OF DIRECTORS:
Arnold Oronsky Ph. D
Dr. Oronsky has been a member of our Board since November 1996 and became Chairman in February 2006. Dr. Oronsky is a managing director with InterWest Partners, a venture capital firm. Prior to joining InterWest Partners in 1994, Dr. Oronsky was Vice President of Discovery Research for the Lederle Laboratories division of American Cyanamid, a pharmaceutical company. From 1973 until 1976, Dr. Oronsky was head of the inflammation, allergy and immunology research program at Ciba-Geigy Pharmaceutical Company. Dr. Oronsky also serves as a senior lecturer in the Department of Medicine at The Johns Hopkins Medical School. Dr. Oronsky has won numerous grants and awards and has published over 125 scientific articles. He received his Ph.D. from Columbia University, College of Physicians and Surgeons and his A.B. from New York University.
Ms. Brege has been a member of our Board since February 2015. She is President and Chief Executive Officer of Nodality Inc. She has over 20 years of executive management experience in the pharmaceutical, biotechnology and venture capital industries. Prior to joining Nodality in 2012, Ms. Brege held several senior-level positions at Onyx Pharmaceuticals, Inc., including Executive Vice President and Chief Operating Officer. While at Onyx she led multiple functions, including commercialization, strategic planning, corporate development, and medical, scientific and government affairs. Prior to Onyx, Ms. Brege was a General Partner at Red Rock Capital Management, a venture capital firm specializing in early stage financing for technology companies. Previously Ms. Brege was SVP and Chief Financial Officer at COR Therapeutics, helping build the company from an early stage R&D company through commercial launch of a successful cardiovascular product. Earlier in her career, she served as Chief Financial Officer at Flextronics, Inc. and Treasurer of The Cooper Companies. She serves on the Board of Directors of Acadia Pharmaceuticals, Inc., Aratana Therapeutics, Inc. and Pacira Pharmaceuticals, Inc. Ms. Brege earned her undergraduate degrees from Ohio University (Honors Tutorial College) and her MBA degree from the University of Chicago.
Francis R.Cano Ph. D
Dr. Cano was appointed to our Board in November 2009. Dr. Cano is President and Founder of Cano Biotech Corp., a consulting firm focusing on the vaccine business, and also serves on the boards of Biomerica, Inc., a developer and manufacturer of diagnostic products, and Arbor Vita Corporation, a biopharmaceutical company. From 1993 to 1996, Dr. Cano was President and Chief Operating Officer for Aviron, a biopharmaceutical company, which was later acquired by MedImmune in 2001. As a Co-Founder of Aviron, he completed two rounds of venture financing, a licensing agreement with SmithKline Biologicals and in-licensed Flu-Mist influenza vaccine from the National Institutes of Health. For 21 years, Dr. Cano worked with the Lederle Laboratories Division of American Cyanamid, most recently as Vice President and General Manager of the Biologicals unit. He earned a Ph.D. in Microbiology from Pennsylvania State University, served as a Research Associate at Rutgers Institute of Microbiology, and holds a M.S. in Microbiology and a B.S. in Biology from St. John's University.
Dr. Dennis Carson
Dr. Carson has been a member of our Board since December 1997. Dr. Carson is a noted researcher in the fields of autoimmune and immunodeficiency diseases and is co-discoverer with Dr. Eyal Raz of the immunostimulatory sequences (ISS) that form the basis of our technology. He has played key roles in the founding of Vical, Inc., a gene therapy company, IDEC Pharmaceuticals, a biopharmaceutical company, and Triangle Pharmaceuticals, a pharmaceutical company. Dr. Carson is a director of Biomerica, Inc. Dr. Carson is director of the Rebecca and John Moores Cancer Center at the University of California, San Diego and has been a professor in the Department of Medicine at the University of California, San Diego since 1990. He is a member of the National Academy of Sciences, the American Academy of Arts and Sciences, and the Institute of Medicine, as well as the American Association for Cancer Research, the American Society for Clinical Investigation, the American Society of Hematology and the Association of American Physicians. He received his M.D. from Columbia University and his B.A. from Haverford College. Dr. Carson completed his residency in internal medicine and a postdoctoral fellowship at the University of California, San Diego.
Dr Daniel Kisner
Dr. Kisner has been a member of our Board since July 2010. He most recently served as a partner at Aberdare Ventures and prior to that as President and CEO of Caliper Technologies, leading its evolution from a start-up focused on microfluidic lab-on-chip technology to a publicly traded, commercial organization. Prior to Caliper, he was the President and Chief Operating Officer of Isis Pharmaceuticals, Inc., a biomedical pharmaceutical company. Previously, Dr. Kisner was Division Vice President of Pharmaceutical Development for Abbott Laboratories and Vice President of Clinical Research and Development at SmithKline Beckman Pharmaceuticals. In addition, he held a tenured position in the Division of Oncology at the University of Texas, San Antonio School of Medicine and is certified by the American Board of Internal Medicine in Internal Medicine and Medical Oncology. Dr. Kisner serves as Chairman of the board for Tekmira Pharmaceuticals, a biopharmaceutical company. He holds a B.A. from Rutgers University and an M.D. from Georgetown University.
Ms. Phillips has been a member of our Board since August 2006. Ms. Phillips currently also serves on the board of directors of Portola Pharmaceuticals, a biopharmaceutical company, and she served on the board of Western Wireless, a cellular network operator, from 2004 until the acquisition of the company by Alltel in mid-2005. From 2003 until 2011, Ms. Phillips served on the Board of the Naval Academy Foundation. From 1996 until 2002, she served on the board of directors of Immunex Corporation, a biotechnology company, and, from 1999, she served as the Chief Operating Officer until the company was acquired by Amgen in 2002. During her career at Immunex, she held positions of increasing responsibility in research, development, manufacturing, sales and marketing. As senior vice president for pharmaceutical development and general manager for Enbrel®, she was responsible for clinical development and regulatory affairs as well as the launch, sales and marketing of the product. Prior to joining Immunex, Ms. Phillips worked at Miles Laboratories. Ms. Phillips holds a B.S. and a M.S. in microbiology from the University of Idaho.
Stanley A. Plotkin Ph D
Dr. Plotkin has been a member of our Board since August 2005. Dr. Plotkin is Emeritus Professor of the University of Pennsylvania. Until 1991, he was Professor of Pediatrics and Microbiology at the University of Pennsylvania and Professor of Virology at the Wistar Institute and, at the same time, Director of Infectious Diseases and Senior Physician at the Children's Hospital of Philadelphia. In 1991, Dr. Plotkin left the University to join the vaccine manufacturer Pasteur-Mérieux-Connaught (today, Sanofi Pasteur), where for seven years he was Medical and Scientific Director, based at Marnes-la-Coquette, outside Paris. Until 2011, he was an Executive Advisor to Sanofi Pasteur. Dr. Plotkin's career included internship at Cleveland Metropolitan General Hospital, residency in pediatrics at the Children's Hospital of Philadelphia and the Hospital for Sick Children in London and three years in the Epidemic Intelligence Service of the Centers for Disease Control of the U.S. Public Health Service. He has been chairman of the Infectious Diseases Committee and the AIDS Task Force of the American Academy of Pediatrics, liaison member of the Advisory Committee on Immunization Practices and Chairman of the Microbiology and Infectious Diseases Research Committee of the National Institutes of Health.
Natale "Nat" Ricciardi
Mr. Ricciardi was appointed to our Board in June 2013. Mr. Ricciardi spent his entire 39-year biopharmaceutical career at Pfizer Inc, retiring in 2011 as a member of the Pfizer Executive Leadership Team. While holding the positions of President, Pfizer Global Manufacturing, and Senior Vice President of Pfizer Inc, Nat was directly responsible for all of Pfizer's internal and external supply organization, a global enterprise that grew to more than 100 manufacturing facilities supplying small and large molecule pharmaceuticals, vaccines, consumer, nutrition and animal health products. Mr. Ricciardi maintained responsibility for global manufacturing activities from 2004 through 2011. Previously, from 1999 to 2004, he had oversight for Pfizer's US manufacturing operations and from 1995 to 1999 was Vice President of Manufacturing for Pfizer's Animal Health Group. Mr. Ricciardi served on the boards of the National Association of Manufacturers and Mediacom Communications Corporation until its privatization in 2011. He is currently a member of the board of the 21st Century Foundation of The City College of New York. Nat earned a degree in Chemical Engineering from The City College of New York and an MBA in Finance and International Business from Fordham University.
--Heplisav-B ( Hepatitis Vaccine )
--SD-101 ( Cancer Immunotherapy )
--AZD1419 ( Asthma )
--DV1179 ( TLR 7/9 Inhibitor )
--DV230-NANOPARTICLE ( 2nd Generation Adjuvant )
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative therapeutic products to treat and prevent infectious diseases, allergies, and cancer. Our versatile, proprietary approaches alter specific immune responses by activating a unique receptor called Toll-Like Receptor 9 (TLR9) found on certain immune system cells. To target TLR9, we are using immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation.
Our clinical development pipeline includes: HEPLISAV™, a hepatitis B vaccine in Phase 3 clinical trials; a hepatitis B therapy in a Phase 1 trial; and a cancer therapy for non-Hodgkin's lymphoma (NHL) in a Phase 2 trial and for metastatic colorectal cancer in a Phase 1 trial. Our preclinical program in asthma and chronic obstructive pulmonary disease (COPD) is partnered with AstraZeneca. Our preclinical work on an influenza vaccine is funded in part by the National Institutes of Health (NIH), while our colorectal cancer clinical trial and preclinical hepatitis C therapeutic program are funded by Symphony Dynamo, Inc. While the NIH and Symphony provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization.
On December 17th, 2008, GlaxoSmithKline signed an agreement with Dynavax (DVAX) in which Dynavax received $10 million, with the potential for $800 million in payments from GlaxoSmithKline under a deal to develop autoimmune and inflammatory disease treatments. The agreement gives GlaxoSmithKline an exclusive option on four Dynavax programs focused on diseases including lupus, psoriasis and rheumatoid arthritis. Along with the agreement Dynavax will conduct research and early clinical development at which point, GlaxoSmithKline can exercise its exclusive option and license each program going forward. When the deal was announced shares of Dynavax (DVAX) surged higher going from $0.26 on December 16th to a high of $1.74 on December 17th on almost fifty-times Dynavax's normal trading volume, suggesting investor appetite and approval for the deal going forward. However, as the global economy and capital markets went into basic free-fall starting late December, investors seem to have forgotten about Dynavax (DVAX), their agreement with GlaxoSmithKline, and the potential the stock offers. As of Wednesday Dynavax was trading at for $0.59 cents per share, had a current market capitalization of $23.5 million dollars, $64.26 million dollars in cash sitting in the bank and no debt on its balance sheet, which equates to roughly $1.62 in cash per share---282% lower than were the stock is currently trading for. Currently, Dynavax has 6 drugs in their pipeline: 1) Heplisav: Dynavax's key hepatitis drug which showed positive results in phase III testing. 2) HCV: Hepatitis C drug which is in phase I testing. 3) HBV: Hepatitis B drug which is in phase I testing 4) Flu Vaccine: Which is in preclinical testing 5) Asthma: Which is in preclinical testing 6) Autoimmunity/Inflammation: Which is in preclinical testing. Half of Dynavax's drugs are focused on the Hepatitis market, which reinforces GlaxoSmithKline's efforts to improve the company's product offering to the Hepatitis market going forward. Additionally, GlaxoSmithKline also owns www.hepatitisbhelp.com which is one of the largest hepatitis based websites in the world. On March 18th 2008 Dynavax dropped north of 50% after the FDA put a clinical hold on a late-stage trial for its Hepatitis B vaccine Heplisav. Dynavax and its co-partner Merck (MRK) said that one patient out of a twenty-five hundred person study outside of the U.S. was diagnosed with an uncommon disease causing blood vessel inflammation. The study did indeed met its final endpoint goals, showing that Dynavax's Heplisav had a 95.1% positive result, compared with 81.1% with Engerix-B---a leading hepatitis drug in the space. It is important to point out here, that the FDA halted the trial because of one single patent out of 2,500, and that Dynavax more than adequately met its endpoint goals. Dynavax, which believes it already has the additional information the FDA is requesting will likely file the data shortly, with an FDA review sometime in 2009.
Press Release http://investors.dynavax.com/releasedetail.cfm?ReleaseID=900088 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=899071 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=898970 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=897338 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=895205 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=890873 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=888957 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=886709 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=886460 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=885172 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=881636 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=881581 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=880513 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=875727 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=875022 http://investors.dynavax.com/releasedetail.cfm?ReleaseID=871814 Recent Developments
On April 15, 2014, we announced the initiation of a new Phase 3 clinical trial of HEPLISAV-B (known as HBV-23). This safety and immunogenicity study was designed to address the Complete Response Letter regarding the HEPLISAV-B Biologics License Application that was issued to Dynavax by the U.S. Food and Drug Administration in February, 2013. This study is intended to significantly increase the number of vaccinated subjects and provide a sufficiently-sized safety database for the FDA to make a final determination regarding the safety and immunogenicity of the product. The study is a Phase 3, observer-blinded, randomized, active-controlled, multicenter trial at approximately 40 sites in the U.S. Approximately 8,250 adult subjects between the ages of 18 and 70 will be randomized in a 2:1 ratio to receive a 2-dose series of HEPLISAV-B or a 3-dose series of a control vaccine, Engerix-B. Enrollment will be stratified by site, age group and type 2 diabetes mellitus status.
The co-primary objectives of the study are: (1) to evaluate the overall safety of HEPLISAV-B with respect to clinically significant adverse events and (2) to demonstrate the noninferiority of the seroprotection rate ("SPR") induced by HEPLISAV-B compared with Engerix-B at week 28 in subjects with type 2 diabetes mellitus. All subjects will be evaluated for safety through study week 56. All potential autoimmune events will be reviewed by a Safety Evaluation and Adjudication Committee and overall safety will be monitored by a Data and Safety Monitoring Board. We expect that all study subjects will be enrolled by the end of 2014 and all follow-up will be completed by the fourth quarter of 2015. We estimate the external costs of the study to be in the range of $50-55 million.
On August 7, 2014, we announced safety and pharmacodynamic results from clinical studies of our asthma drug candidate partnered with AstraZeneca and our systemic lupus erythematosus (SLE) drug candidate partnered with GlaxoSmithKline, as follows:
In a Phase 1 study, 4 weekly doses of a TLR9 agonist, AZD1419, or placebo were delivered by inhalation to 45 healthy volunteers. Ascending doses up to 15.4 mg/week for 4 weeks were well tolerated and no serious adverse events were observed in treated subjects. Secondary endpoints assessing pharmacodynamics were met, with dose-dependent induction of interferon-regulated genes in sputum and blood cells. Based on these results, Dynavax and its collaboration partner, AstraZeneca, are evaluating protocols for a clinical trial in patients with asthma.
In a Phase 1b/2a study, the safety and pharmacodynamics of a bifunctional TLR7 and TLR9 inhibitor, DV1179, were assessed in 52 SLE patients screened for elevated expression of interferon-regulated genes. DV1179 did not meet the primary or secondary pharmacodynamic endpoints related to reduction in interferon alpha-regulated genes. Doses up to 60 mg/week for 8 weeks were well tolerated. The most common adverse events were injection site reactions. GSK will review the data package and determine whether to exercise its option to license DV1179.