Dynavax Announces Acceptance of Two Data Abstracts for SD-101 in Combination with KEYTRUDA® for Presentation at the 2018 American Association for Cancer Research (AACR) Annual Meeting

Berkeley, California, UNITED STATES

Data from Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Durability Data in Advanced Metastatic Melanoma

BERKELEY, Calif., March 15, 2018 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ:DVAX) announced today that data from an ongoing Phase 1b/2 study investigating SD-101, Dynavax's intratumoral TLR9 agonist, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada), will be presented in two posters at the 2018 American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL to be held April 14-18, 2018.

The details of the poster presentations are as follows:

Phase Ib/II, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)

Session Title: Phase II-III Clinical Trials
Abstract: CT098
Poster Board Number: 19
Date/Time: Monday Apr 16, 2018 1:00 PM - 5:00 PM CDT
Location: McCormick Place South, Hall A, Poster Section 42

Durability of responses to the combination of SD-101 and pembrolizumab in advanced metastatic melanoma: Results of a phase Ib, multicenter study

Session Title: Phase I Trials in Progress
Abstract: CT139
Poster Board Number: 22
Date/Time: Tuesday Apr 17, 2018 8:00 AM - 12:00 PM CDT
Location: McCormick Place South, Hall A, Poster Section 42

About MEL-01 (KEYNOTE-184)
The dose-escalation and expansion study of SD-101 in combination with KEYTRUDA includes patients with histologically or cytologically confirmed unresectable Stage IIIc/IV melanoma. The primary endpoints of the trial are MTD and evaluation of the safety of intratumoral SD-101 in combination with KEYTRUDA. In addition, the trial is investigating response as assessed by the investigator according to RECIST v1.1, biomarker assessments and duration of response. Patients previously treated with anti-PD-1 and other immunotherapies are included.

About SD-101
SD-101, the Company's lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with Keytruda® (pembrolizumab), an anti-PD-1 therapy, in patients with metastatic melanoma and  in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

About Dynavax
Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], a hepatitis B vaccine for adults, is approved in the United States. Dynavax's lead immunotherapy product, SD-101, is an investigational cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and its second cancer immunotherapeutic, DV281, is in Phase 1 development. For more information, visit www.dynavax.com.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


David Burke
Director, Investor Relations & Corporate Communications