Follow the Money: Dynavax Technologies Corporation

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Follow the Money highlights a newly funded bio/pharmaceutical company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities.

Dynavax Technologies Corp. is a U.S. public pharmaceutical company that develops products based on immunostimulatory sequences for the treatment of allergies, inflammation-mediated diseases, infectious diseases, and cancer. As reported in the July 30, 2015 issue of the PharmSource Lead Sheet, Dynavax expects to raise $125 million in the completion of a secondary public offering.

Corporate Highlights

  • Dynavax was incorporated in California in August 1996.
  • Corporate Headquarters: Berkeley, CA – approximately 55,200 square feet of laboratory and office space.
  • Facility: Düsseldorf, Germany– approximately 5,600 square feet of laboratory and office space.
  • As of December 31, 2014, Dynavax had 197 employees, including 107 employees located in Berkeley, CA and 90 employees in Düsseldorf, Germany.

Sourcing Opportunities

  • Dynavax plans to use the proceeds to support its HEPLISAV-B program, including the ongoing Phase III HBV-23 study; the seeking of US regulatory approval and preparation for potential commercial launch. In addition, proceeds will support continuing clinical development of the investigational cancer immunotherapeutic product candidate, SD-101.
  • The company contracts with Contract Research Organizations to conduct clinical trials.
  • Dynavax operates a manufacturing facility in Düsseldorf, Germany and also relies on third parties to perform the processes involved in manufacturing TLR agonist and inhibitors, antigens, and combinations of these components.
  • Dynavax has no commercialization experience, nor do they have marketing or distribution capabilities. If their lead product, HEPLISA V-B, is approved, Dynavax will need third party providers for these services.

Business Relationships

  • In September 2006, Dynavax entered into a three year research collaboration and license agreement with AstraZeneca for the discovery and development of TLR9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease.
  • In October 2011, Dynavax entered into an agreement with AstraZeneca to conduct the initial clinical development of AZD1419, a second generation TLR9 agonist. Dynavax received a $3 million initial payment in 2011, an additional $2.6 million in 2012 for the preclinical toxicology studies of AZD1419, and $6 million in the fourth quarter of 2012 for the Phase 1 clinical trials.
  • In December 2014, Dynavax and AstraZeneca signed an amendment to the existing research agreement stating that Dynavax will conduct a Phase 2a clinical trial of AZD1419 that would be fully funded by AstraZeneca. Dynavax intended to initiate the Phase 2a study in the first half of 2015. In this amendment, Dynavax will receive all royalties on worldwide sales of any approved products from the collaboration, and a remaining potential milestone payment of $100 million.
  • In June 2015, Dynavax entered into a research collaboration agreement with Merck to investigate the potential synergistic effects of immunotherapies from both companies’ pipelines: Merck’s KEYTRUDA (pembrolizumab) and MK-1966, with Dynavax’s TLR9 agonist, SD-101. The terms of the agreement include provisions for each party to agree to extend the collaboration to include a Phase 3 clinical trial. Additional details were not disclosed.

Pipeline

Product Candidate Indication Dosage Form Status Next Anticipated Step
DV230-NANOPARTICLE Adjuvant technology N/A Preclinical TBA
AZD1419 Asthma Inhalation Phase 1 TBA
SD-101 Cancer immunotherapy Injection (Intratumoral) Phase 1/ Phase 2 TBA
DV1179 Autoimmune and inflammatory diseases Parenteral Phase 2 TBA
HEPLISAV-B Hepatitis B Injection (Intramuscular) Phase 3 Plans to complete Phase 3 by October, 2015

 

Finances

(In $ thousands) 2014 2013
Revenues
11,032
11,251
R&D Expenditures
84,580
50,870
General & Administrative Expenditures
17,377
25,943
Total Operating Expenses
102,343
77,739

Contact Information

Dynavax Technologies Corporation Key Officers
2929 Seventh Street, Suite 100 Eddie Gray, CEO
Berkeley, CA 94710 USA Robert L. Coffman, PhD, VP & CSO
Phone: 510-848-5100 Robert Janssen MD, CMO & Clinical Development
Fax: 510-848-1327 Lani Ibarra, VP, Clinical Operations
Web: www.dynavax.com Ceclia Vitug, VP, Human Resources

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Scotty is a Research Analyst at PharmSource. He holds a BS degree in Biology from George Mason University and an MPH degree from Eastern Virginia Medical School. He’s experienced in data collection, analysis and management, and has done laboratory analysis and safety program development.

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