| • | | Observed responses in injected lesion(s) andnon-injected distant lesions, including visceral metastases in the liver and lung |
| • | | Response rates appeared similar regardless ofPD-L-1 status |
| • | | AEs related toSD-101 treatment were transient, mild to moderateflu-like symptoms at both the£ 2mg and the 8 mg dosing levels |
| • | | No increase in the frequency of immune-related adverse events over individual monotherapies reported in other studies1,2 nor evidence of any new safety signals |
Dynavax Conference Call and Webcast
Dynavax will host a conference call and webcast on Sunday at 1:00pm EDT (7:00 PM CEST). The live webcast can be accessed in the “Investors and Media” section of the company’s website atwww.dynavax.com. The conference call can be accessed by dialing (866)420-4066 in the U.S. or (409)217-8237 internationally, using the conference ID 2036717. A replay of the webcast will be available following the live event.
AboutSYNERGY-001(KEYNOTE-184)
SYNERGY-001, previously referred to asMEL-01, is the dose-escalation and expansion study ofSD-101 in combination with KEYTRUDA which includes patients with histologically or cytologically confirmed unresectable Stage IIIC/IV melanoma. The primary endpoints of the trial are safety and preliminary efficacy of intratumoralSD-101 in combination with KEYTRUDA.
AboutSD-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), ananti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights toSD-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], was approved by the United States Food and Drug Administration in November 2017 for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. 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, visitwww.dynavax.com.
Forward Looking Statement
This press release contains “forward-looking” statements, including statements regarding the conduct of clinical trials ofSD-101, including results from the Phase 1b/2 trial, and potential value ofSD-101 across multiple tumor types. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether we can timely provide adequate clinical supplies; initiation, enrollment and completion of clinical trials ofSD-101; whether interim and final results of current and future clinical trials will support the initiation or continuation of subsequent trials; issues arising in the regulatory process; the ability to successfully develop and commercializeSD-101; and whether or not Dynavax and parties with whom we are collaborating may reach any future agreement on further studies or a more extensive collaboration beyond the clinical trials contemplated under the existing agreements, as well as other risks detailed in the “Risk Factors” section of our Annual Report on Form10-K for the fiscal year ended December 31, 2017 and in Quarterly