Dynavax Technologies and Quantum Leap Healthcare Collaborative Announce Selection of SD-101 Combined with KEYTRUDA® (pembrol...
October 15 2018 - 6:00AM
Dynavax Technologies Corporation (NASDAQ:DVAX) and Quantum Leap
Healthcare Collaborative™ (QLHC) announced today that the
immunotherapy combination of Dynavax’s proprietary investigational
compound SD-101 and KEYTRUDA® (pembrolizumab) will be evaluated in
a new randomized, investigational treatment arm for the ongoing
I-SPY 2 TRIAL™ for neoadjuvant treatment of locally advanced breast
cancer.
SD-101 is an intratumoral TLR9 agonist that modulates the tumor
microenvironment and optimally primes T cells to generate a
systemic anti-tumor response. SD-101 is expected to augment
responses to anti-PD-1 therapy as has been reflected in early
clinical studies of other tumor types. The combination will be
added to standard of care in a new I-SPY 2 TRIAL treatment arm.
“The I-SPY TRIAL is designed to evaluate multiple emerging new
agents simultaneously with the goal of getting effective and
potentially less toxic treatments to patients much more quickly. We
are excited to add SD-101 into I-SPY 2, and combine it with
pembrolizumab with the goal of extending responses previously
observed with pembrolizumab alone,” stated Dr. Laura J. Esserman,
MD, MBA, Principal Investigator of I-SPY 2 and Director of the
Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family
Comprehensive Cancer Center.
“We are excited SD-101 has been chosen to be included in the
I-SPY 2 trial and see this as an excellent opportunity to
potentially expand its use into the emerging field of neoadjuvant
immunotherapy,” stated Eddie Gray, chief executive officer of
Dynavax.
The I-SPY 2 TRIAL, sponsored by QLHC, is a standing phase 2
randomized, controlled, multicenter study with an innovative
Bayesian adaptive design aimed to rapidly screen and identify
promising new treatments in specific subgroups of women with
newly-diagnosed, high-risk (high likelihood of recurrence),
locally-advanced breast cancer (Stage II/III). Dynavax will provide
funding and SD-101; Merck will provide pembrolizumab. KEYTRUDA® is
a registered trademark of Merck Sharp & Dohme Corp., a
subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About the I-SPY TRIALsThe I-SPY TRIAL
(Investigation of Serial studies to Predict Your Therapeutic
Response with Imaging And moLecular analysis) was designed to
rapidly screen promising experimental treatments and identify those
most effective in specific patient subgroups based on molecular
characteristics (biomarker signatures). The trial is a unique
collaborative effort by a consortium that includes the Food and
Drug Administration (FDA), industry, patient advocates,
philanthropic sponsors, and clinicians from 16 major U.S. cancer
research centers. Under the terms of the collaboration agreement,
Quantum Leap Healthcare Collaborative is the trial sponsor and
manages all study operations. For more information, visit
www.ispytrials.org.
About Quantum Leap Healthcare
CollaborativeQuantum Leap Healthcare Collaborative (QLHC)
is a 501C(3) charitable organization established in 2005 as a
collaboration between medical researchers at University of
California, San Francisco and Silicon Valley entrepreneurs. Our
mission is to integrate high-impact research with clinical
processes and systems technology, resulting in improved data
management and information systems, greater access to clinical
trial matching and sponsorship, and greater benefit to providers,
patients, and researchers. Quantum Leap provides operational,
financial, and regulatory oversight to I-SPY. For more information,
visit www.quantumleaphealth.org.
About SD-101SD-101, Dynavax’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 clinical studies to
assess its safety and activity, including a Phase 2 study in
combination with KEYTRUDA® (pembrolizumab), Merck’s 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 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, visit
www.dynavax.com.
Contact: Ryan SpencerVP Corporate Strategy and
Communications510.665.4618 |
Media Contact:Rachel St. MartinW2O 646.894.5757
rstmartin@w2ogroup.com |
Dynavax’s Forward-Looking Statements This
press release contains "forward-looking" statements, including
statements regarding conduct of clinical trials of SD-101 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 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.
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