Dynavax Announces Publication of Two Papers in Leading Oncology Journal Highlighting Data From Clinical Studies of Its TLR9 A...
August 28 2018 - 6:30AM
Dynavax Technologies Corporation (NASDAQ: DVAX) today announced
that two peer-reviewed papers reporting clinical studies of SD-101
have been published by Cancer Discovery, a journal publication from
American Association of Cancer Research (AACR). The investigators
report clinical activity and broad immune activation in the tumor
microenvironment when SD-101 is administered in combination with
either low dose radiation in patients with indolent lymphoma or in
combination with PD-1 blockade in patients with unresectable or
metastatic melanoma. Top-line results from these studies have
previously been presented at major oncology conferences.
“Promising data from multiple trials studying intratumoral
administration of TLR9 agonists indicate that stimulating the
innate immune system through the TLR9 pathway can enhance the
adaptive immune response to both injected and non-injected tumors,”
said Antoni Ribas, M.D., Ph.D., Director of the Tumor Immunology
Program at the Jonsson Comprehensive Cancer Center. “TLR9 agonists
are showing potential as an important component of combination
immuno-therapy for the treatment of cancer. With further research
we hope to realize the full value that this approach can create for
immuno-oncology.”
Dr. Ribas is the lead author for the paper titled SD-101 in
Combination with Pembrolizumab in Advanced Melanoma: Results of a
Phase 1b, Multicenter Study. This trial evaluated 22 patients who
received intratumoral SD-101, a synthetic CpG-oligonucleotide that
stimulates Toll-like receptor 9 (TLR9), in combination with a PD-1
inhibitor in patients with unresectable or metastatic malignant
melanoma. The combination was well tolerated and the most common
adverse events related to SD-101 were injection site reactions and
transient, mild-to-moderate “flu-like” symptoms. Durable tumor
responses were seen in both peripheral and visceral lesions.
Among the 9 patients naïve to anti-PD-1 therapy, the overall
response rate (ORR) was 78%. The estimated 12 month progression
free survival (PFS) rate was 88%, and overall survival (OS) rate
was 89%. Among 13 patients having prior anti-PD-1 therapy, the ORR
was 15%. These clinical responses were supported by biomarker data
indicating the induction of broad immune activation in the tumor
microenvironment, including increased NK cells, cytotoxic cells,
dendritic cells, B cells and CD8+ T cells and T cell infiltration.
Increases in CD4+ and CD8+ T cells generally correlated with tumor
responses. The paper can be found online here.
Ronald Levy, M.D., Robert K. and Helen K. Summy Professor in the
School of Medicine at Stanford University, is the lead author of
the paper titled In situ vaccination with a TLR 9 agonist and local
low dose radiation induces systemic responses in untreated indolent
lymphoma. It reports on a phase 1/2 multicenter study in which 29
patients received 4 Gy of radiation followed by five weekly
intratumoral injections of SD-101 at a single tumor site. The paper
can be found online here.
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], 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, visit
www.dynavax.com.
Forward-Looking Statements This press release
contains "forward-looking" statements, including statements
regarding conduct of clinical trials of SD-101, including results
from the Phase 1b/2 trials, and the potential of SD-101 in the
treatment of cancer. Actual results may differ materially from
those set forth in this press release due to the risks and
uncertainties inherent in our business, including 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 Annual Report
on Form 10-K for the fiscal year ended December 31, 2017 and in
Quarterly Report on Form 10-Q for the quarter ended June 30, 2018,
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: Ryan SpencerVP, Corporate Strategy
& Communications510.665.4618
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