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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Dynavax Technologies Corp | NASDAQ:DVAX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.02 | 0.17% | 11.74 | 11.46 | 12.95 | 12.06 | 11.71 | 11.87 | 1,817,398 | 05:00:07 |
“To consistently see an overall response rate above 70% among advanced melanoma patients, which has historically been a difficult population to treat, is very encouraging and exciting,” said Robert Janssen, M.D., chief medical officer of Dynavax. “Additionally, in response to treatment, we have seen immunologically cold tumors reach similarly high levels of immune cell activation as immunologically hot tumors.”
The Phase 1b/2 clinical study (NCT02521870) in patients with advanced melanoma is ongoing. In the study, SD-101 is administered intratumorally with 8 mg in 1 lesion or 2 mg in 1–4 lesions combined with intravenous administration of 200 mg of pembrolizumab.
Key highlights from the clinical data presentation include:
A table accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d03e76d2-86e7-4675-ae1d-8a29251f5101
In addition, the company presented data from the Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced/metastatic melanoma resistant to anti-PD-1/PD-L1 therapy.
Key highlights from the clinical data presentation include:
In addition, a poster titled: “Overcoming genetically based resistance mechanisms to PD-1 blockade” (Abstract No: 2584) was presented. The goal of the preclinical study was to assess mechanism-based strategies to overcome resistance to anti-PD1 therapy. Results demonstrated that even in the extreme setting of genetic resistance to PD-1 blockade by JAK1/2 LoF, resistance can be overcome by SD-101, a TLR9 agonist.
About SYNERGY-001 (KEYNOTE-184)SYNERGY-001, previously referred to as MEL-01, is a Phase 1b/2 SYNERGY-001/KEYNOTE-184 trial in combination with KEYTRUDA which includes patients with histologically or cytologically confirmed unresectable Stage IIIC/IV melanoma. The primary endpoint of the trial is objective response rate assessed by RECIST v1.1. The secondary endpoints are safety and tolerability, progression-free survival and duration of response, with an exploratory endpoint of immunophenotype of the tumor microenvironment.
About SD-101SD-101 is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating SD-101 in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA® (pembrolizumab) in advanced melanoma and metastatic or recurrent head and neck squamous cell cancer in collaboration with Merck, and in high risk breast cancer in collaboration with I-SPY 2. Dynavax maintains all commercial rights to SD-101.
About DynavaxDynavax 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 is currently exploring strategic alternatives for its immuno-oncology portfolio. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. For more information, visit www.dynavax.com.
Forward-Looking Statements (update)This press release contains "forward-looking" statements, including statements regarding the conduct of clinical trials of SD-101, including results from the Phase 1b/2 trial, and potential value of SD-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 of SD-101; whether interim and final results of current and future clinical trials will support the initiation or continuation of subsequent trials by us or another party; issues arising in the regulatory process; the ability to successfully develop or pursue strategic alternatives for SD-101, including the funding of future studies as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.
Contact: Heather Rowe Vice President, Investor Relations & Corporate Communications hrowe@dynavax.com 510-665-7269
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