Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company
focused on oncology, today presented data from the randomized Phase
2 trial of its investigational intratumoral TLR4
agonist G100 plus low-dose radiation (G100 Monotherapy) with
or without KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in
follicular non-Hodgkin's lymphoma (FL) patients. The G100
Monotherapy and pembrolizumab combination resulted in a 39%
objective response rate (ORR), with a 57% ORR in those patients who
expressed a potential predictive biomarker. These data were
presented at the 59th American Society of Hematology (ASH) Annual
meeting in Atlanta, Georgia on Sunday, December 10, 2017.
“We have been developing two immuno-oncology
platforms in parallel: an intratumoral immunization approach with
G100 as the lead therapeutic candidate, and novel cancer vaccines
from the Dendritic cell-targeting RNA vector platform, ZVex. We
believe these data presented at ASH confirm that G100 is an active
and safe agent that results in systemic tumor responses, which are
further enhanced in combination with KEYTRUDA,” said Carlos Paya,
M.D., Ph.D., President and Chief Executive Officer of Immune
Design. “In light of the fact that some inhibitors of the anti-PD-1
class are viewed to have limited activity in this type of
hematological malignancy, these positive data support further
investigation of the potential synergy of G100 with anti-PD-1/L1
agents and the use of TLR4 expression as a potential predictive
biomarker.”
The randomized Phase 2 trial was designed to
examine intratumoral (IT) administration of G100 Monotherapy vs.
G100 Monotherapy + pembrolizumab (G+P) in either treatment naïve or
recurrent/refractory FL patients (13 patients/arm). Highlights from
the study include:
- Clinical Benefit
- Patients receiving G+P showed a 39% ORR, as compared to 15% in
the G100 Monotherapy arm.
- Pembrolizumab monotherapy in a similar recurrent/refractory FL
study showed 11% ORR (Ding, ASH 2017 abstract).
- Patients receiving G+P also had more frequent and deeper
abscopal tumor shrinkage and a trend toward a better progression
free survival (PFS).
- Safety: Adverse events considered possibly
related to G100 were Grade 1 or 2, with no related serious adverse
events. The safety experience in the G+P arm did not suggest any
unexpected or worsening toxicity compared to what has been reported
previously with pembrolizumab alone.
- Potential Predictive Biomarker: A strong
association between baseline tumor TLR4 expression and objective
clinical response was observed. Reported ORR in patients with a
>50% TLR4 expression by IHC (TLR4high) receiving G+P increased
to 57%, including patients with recurrent/refractory disease.
- Potential Further Development: Because
clinical responses were observed in patients with
recurrent/refractory disease, treatment failure <2 years after
rituximab-containing chemotherapy, and high-risk patients based on
GELF criteria, G+P may provide a therapeutic option in this unmet
medical need population. Enrichment of patients more likely to
respond may be attained by selecting for high expression of
TLR4.
Additional subtypes of indolent lymphomas with
injectable lesions are known to express TLR4, which expands the
potential of this combination of G100 and pembrolizumab in
hematological malignancies beyond FL. Likewise, many solid tumors
are known to express TLR4.
G100 has been granted orphan drug designation by
the U.S. Food and Drug Administration and the European Medicines
Agency for the treatment of FL.
Conference Call Information
Immune Design will hold a conference call on
Monday, December 11, 2017 at 8:00 a.m. EST. Ahmad S Halwani, MD,
Assistant Professor of Medicine, Huntsman Cancer Institute,
University of Utah, and a Principal Investigator on the trial, will
join the call.
The live call may be accessed by dialing
844-266-9538 for domestic callers and 216-562-0391 for
international callers. The audience passcode is 3258589. A live
webcast of the call will be available online from the investor
relations section of the company website at
http://ir.immunedesign.com/events.cfm and will be archived there
for 30 days. A telephone replay of the call will be available for
five days by dialing 855-859-2056 for domestic callers or
404-537-3406 for international callers and entering the conference
code: 3258589.
ASH Presentation Details:
Intratumoral G100 Induces Systemic Immunity and
Abscopal Tumor Regression in Patients with Follicular Lymphoma:
Results of a Phase 1/2 Study Examining G100 Alone and in
Combination with Pembrolizumab (Abstract # 2771)
Presenter: Christopher R. Flowers, M.D.Session Name: 623. Mantle
Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical
Studies: Poster II Poster Discussion: Sunday, December 10, 2017,
6:00 PM - 8:00 PM EasternLocation: Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2
About G100
G100 is a product candidate from Immune Design's
GLAAS® discovery platform. It contains a potent synthetic
small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl
Lipid A (GLA), and is the lead product candidate in Immune Design's
Antigen Agnostic approach. G100 activates innate and adaptive
immunity in the tumor microenvironment to generate an immune
response against the tumor's preexisting diverse set of antigens. A
growing set of clinical and preclinical data have demonstrated the
ability of G100 to activate tumor-infiltrating lymphocytes,
macrophages and dendritic cells, and promote antigen-presentation
and the recruitment of T cells to the tumor. The induction of
local and systemic immune responses has been shown in preclinical
studies to result in local and abscopal (shrinking of tumors
outside the scope of the localized treatment) tumor control.
About Follicular Non-Hodgkin’s
Lymphoma
Follicular lymphoma is a malignancy affecting
the lymph nodes and may spread to the bone marrow or spleen. The
most common type of slow-growing (indolent) non-Hodgkin’s lymphoma
(NHL), it represents approximately 20% of all NHL cases. Despite
advances in treatment options in recent decades, FL is considered
incurable. Currently, patients who do not respond to initial
treatment or whose disease progresses within two years of diagnoses
after treatment have a worse survival prognosis and may constitute
an unmet medical need population. In 2017, it is estimated that
more than 14,000 new cases of FL will be diagnosed in the United
States alone.
About Immune Design
Immune Design is a clinical-stage immunotherapy
company employing next-generation in vivo approaches to enable the
body's immune system to fight disease. The company's technologies
are engineered to activate the immune system's natural ability to
generate and/or expand antigen-specific cytotoxic T cells, while
also enhancing other immune effectors, to fight cancer and other
chronic diseases. CMB305 and G100, the two leading product
candidates focused in cancer immunotherapy, are the first products
from Immune Design’s two separate discovery platforms targeting
dendritic cells in vivo, ZVex® and GLAAS®. Both ZVex and
GLAAS also have potential applications in infectious disease and
allergy as demonstrated by ongoing pharmaceutical
collaborations. Immune Design has offices in Seattle and
South San Francisco. For more information, please visit
www.immunedesign.com.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as "may," "will," "expect," "plan,"
"intend", "believe", "appear", "trend" and similar expressions (as
well as other words or expressions referencing future events,
conditions or circumstances) are intended to identify
forward-looking statements. These forward-looking statements are
based on Immune Design's expectations and assumptions as of the
date of this press release. Each of these forward-looking
statements involves risks and uncertainties that could cause our
clinical development programs, future results or performance to
differ significantly from those expressed or implied by the
forward-looking statements. Forward-looking statements contained in
this press release include, but are not limited to, statements
about the timing, scope and results of clinical trials, the
association of data with treatment outcomes, and the timing and
likelihood of obtaining regulatory approval of Immune Design’s
product candidates. Many factors may cause differences between
current expectations and actual results including unexpected safety
or efficacy data observed during preclinical or clinical studies,
changes in expected or existing competition, changes in the
regulatory environment, the uncertainties and timing of the
regulatory approval process, and unexpected litigation or other
disputes. Other factors that may cause Immune Design's actual
results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
Immune Design's filings with the U.S. Securities and Exchange
Commission, including the "Risk Factors" sections contained
therein. Except as required by law, Immune Design assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
Media ContactJulie
RathbunRathbun Communicationsjulie@rathbuncomm.com
206-769-9219
Investor ContactShari
AnnesAnnes Associatessannes@annesassociates.com650-888-0902
IMMUNE DESIGN CORP. (NASDAQ:IMDZ)
Historical Stock Chart
From Mar 2024 to Apr 2024
IMMUNE DESIGN CORP. (NASDAQ:IMDZ)
Historical Stock Chart
From Apr 2023 to Apr 2024