Dynavax Presents Phase 1b Data on Inhaled DV281 TLR9 Agonist at the 2019 AACR Annual Meeting
April 02 2019 - 1:00PM
Dynavax Technologies Corporation (NASDAQ:DVAX), a fully-integrated
biopharmaceutical company focused on discovering and developing
novel vaccines and immuno-oncology therapeutics, today announced
results from the ongoing Phase 1b clinical study evaluating the
safety of DV281, a novel toll-like receptor (TLR) 9 agonist in
combination with nivolumab in patients with advanced or metastatic
non-small cell lung cancer (NSCLC). The results were presented
today in a poster session at the 2019 American Association for
Cancer Research (AACR) Annual Meeting 2019 (Exhibit Hall B, Poster
Section 17, Poster Board Number: #18, 1:00 pm. – 5:00 p.m. ET).
DV281 is Dynavax's proprietary investigational
TLR9 agonist designed specifically for focused delivery to
tumor-burdened lungs for the treatment of primary lung tumors and
lung metastases.
“We are very encouraged by what we've seen with
the TLR9 agonist DV281 in this safety study, including a favorable
safety profile and evidence of target engagement,” said Edward B.
Garon, MD, associate professor of medicine at the David Geffen
School of Medicine at the University of California, Los Angeles,
and principal investigator for the trial. “Lung cancer is the most
common cause of cancer-related death, and new options are needed
for this difficult disease. These preliminary results support
additional evaluation of inhaled DV281 as a unique treatment option
to stimulate the body’s immune system to fight lung cancer.”
The Phase 1b clinical study (NCT03326752) is
ongoing. Dynavax is currently studying DV281 in this open label,
multicenter study to assess the safety and pharmacodynamic activity
of inhaled DV281 in combination with nivolumab in patients with
advanced or metastatic NSCLC. As of March 5, 2019, 23 heavily
pre-treated anti-PD-1/L1 experienced (87% of whom were PD-1/PD-L1
resistant) or naïve advanced NSCLC patients were enrolled in
second-line or third-line treatment using a 3+3 design in five dose
cohorts.
Key highlights from the clinical data
presentation include:
- In this safety study, two doses of DV281 monotherapy followed
by combination with nivolumab was well tolerated. No immune-related
adverse events such as pneumonitis have been reported.
- Inhalation of DV281 leads to dose-dependent target engagement
as measured by induction of IFN-regulated genes at all evaluated
dose levels.
- DV281 plus nivolumab demonstrates early signs of antitumor
activity in heavily pretreated patients (87% received a prior
checkpoint inhibitor +/- chemotherapy.)
- Dramatic clinical improvement and clear tumor shrinkage at day
50 in a patient treated at 25 mg who was progressing on
pembrolizumab.
- Prolonged stable disease (4 to 8 months) has been observed in
all cohorts that have sufficient duration of follow-up.
- Clear control of target lesions as measured on CT scans and
slowing down of tumor growth with significantly extended tumor
doubling time.
- The dose escalation phase of the study is ongoing.
“In this safety study in heavily pre-treated
patients with advanced lung cancer, we were pleased to see that
combination of DV281 and nivolumab was well tolerated and exhibited
dose-dependent target engagement,” said Robert Janssen, M.D., chief
medical officer of Dynavax. “We were further encouraged by signs of
anti-tumor activity, including patients with prolonged stable
disease. In addition, we were pleased to see results demonstrating
that the combination slowed tumor growth and significantly extended
tumor doubling time.”
Activation of dendritic cells through TLR9 in
the presence of tumor antigens generates potent T cell-mediated
anti-tumor immunity and can substantially improve the response to
PD-1 blockade in mouse tumor models.
The combination of an inhaled TLR9 agonist with
systemic PD-1 blockade can induce complete clearance of lung tumors
as well as distant metastases and provide a long-term survival
benefit in mouse models of lung cancer.
The poster titled “Phase Ib, open label,
multicenter study of inhaled DV281, a Toll-like receptor 9 agonist,
in combination with nivolumab in patients with advanced or
metastatic non-small cell lung cancer (NSCLC)” is available on
Dynavax’s website at
http://investors.dynavax.com/events-presentations
About DV281 DV281 is Dynavax's
proprietary investigational TLR9 agonist designed specifically for
focused delivery to primary lung tumors and lung metastases. DV281
is similar in biological activity and mechanism of action to
Dynavax's Phase 2 immunotherapy candidate, SD-101, but has been
optimized for administration as an inhaled therapy. Both SD-101 and
DV281 activate plasmacytoid dendritic cells which then stimulate T
cells specific for antigens released from dying tumor cells. TLR9
agonists such as DV281 and SD-101 have been shown to stimulate
potent Type 1 interferon induction along with maturation of
dendritic cells to effective antigen-presenting cells; both
activities are important for the induction of effective anti-tumor
immunity.
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 U.S. 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 Dynavax compound DV281. These statements are
subject to a number of risks and uncertainties that could cause
actual results to differ materially, including whether early
clinical study results for DV281 will support further development
of the compound. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of Dynavax in general, see risks detailed
in the "Risk Factors" section of our most recent current periodic
report filed with the SEC. These statements represent our estimates
and assumptions only as of the date of this press release. We do
not undertake any obligation to update publicly any such
forward-looking statements, 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
Communicationshrowe@dynavax.com 510-665-7269
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