Dynavax to Present New Data for SD-101 in Combination with KEYTRUDA® (pembrolizumab) at the 2018 American Society for Clinic...
May 16 2018 - 4:15PM
Abstract Data Show Overall Response Rate of 60%
in 25 Advanced Melanoma Patients Naïve to Anti-PD-1 Therapy
Dynavax Technologies Corporation (NASDAQ:DVAX) announced today that
data will be presented from its 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). Data on patients with advanced melanoma who are
naïve to anti-PD-1 therapy is the subject of a poster presentation
and will be highlighted in a poster discussion session at the 2018
American Society for Clinical Oncology (ASCO) Annual Meeting, being
held June 1-5, 2018 in Chicago, IL.
The abstract for the poster titled “Phase 1b/2, open label,
multicenter, study of the combination of SD-101 and pembrolizumab
in patients with advanced melanoma who are naïve to anti-PD1
therapy” has been posted on the 2018 ASCO Annual Meeting website,
here. The abstract summarizes efficacy data on 25 patients that
were available at the time of abstract submission in early February
and shows an overall response rate (ORR) of 60%. The
combination reported low rates of Grade 3-4 treatment-related
adverse events and no evidence of an increased rate of
immune-related adverse events. The poster at ASCO in June will
present efficacy data from over 50 patients comparing two doses of
SD-101, 2mg in 1-4 lesions versus 8mg in a single lesion.
The details of the poster presentation and discussion session
are as follows:
Phase 1b/2, open label, multicenter, study of the
combination of SD-101 and pembrolizumab in patients with advanced
melanoma who are naïve to anti-PD-1 therapy
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Session
Title: Melanoma/Skin Cancers |
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Abstract: 9513 |
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Poster
Board: 340 |
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Poster Session
Date/Time: Monday, June 4, 2018, 1:15 PM - 4:45 PM
CDT |
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Poster Session
Location: McCormick Place South, Hall A, Advanced Disease
Poster Section |
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Discussion
Session Date/Time: Monday, June 4, 2018, 4:45 PM - 6:00 PM
CDT |
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Discussion
Session Location: McCormick Place Lakeside Center, Level 4
- E451 |
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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 safety and preliminary efficacy of intratumoral SD-101 in
combination with KEYTRUDA. In addition, biomarkers are being
evaluated.
About SD-101SD-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 advanced 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 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’s first
commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], 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.
Forward Looking StatementThis press release
contains "forward-looking" statements, including statements
regarding the conduct of clinical trials of SD-101. 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;
the results of clinical trials and the impact of those results on
the initiation or continuation of subsequent trials and issues
arising in the regulatory process; the ability to successfully
develop and commercialize SD-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 current periodic reports with the SEC. 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.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc.
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Contact: David BurkeDirector, IR & Corporate
Communications510.665.7269dburke@dynavax.com |
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Media
Contact:Rachel St. MartinW2O wcg 646.894.5757
rstmartin@w2ogroup.com |
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