Immune Design Announces New CMB305 + Checkpoint Inhibitor Topline Data from an Upcoming Presentation at the ESMO 2017 Congre...
August 30 2017 - 6:42PM
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company
focused on oncology, today announced positive topline data from its
interim analysis of the ongoing, randomized Phase 2 trial
evaluating CMB305 in combination with atezolizumab
(TECENTRIQ
®) or atezolizumab alone in 88 soft
tissue sarcoma patients. The data will be presented in a poster
discussion session at the European Society of Medical Oncology
(ESMO) 2017 Congress, September 8-12, 2017 in Madrid, Spain.
“The two main goals of this study are (1) to
determine whether combining a next-generation vaccine like CMB305
with a checkpoint inhibitor (such as an anti-PD-L1 antibody)
provides improved clinical benefit compared to that of the
checkpoint inhibitor alone, particularly in a PD-L1-low or
-negative tumor, and (2) in a randomized setting, to determine the
biological activity of CMB305,” said Carlos Paya, M.D., Ph.D.,
President and Chief Executive Officer of Immune Design. “We believe
these interim data constitute the first steps towards answering
both questions in a favorable manner.”
Data to be presented at ESMO build upon those
data on the first 36 patients summarized in the abstract, and
include a greater number of patients enrolled.
- Clinical Benefit: Data from the larger patient
population show that patients receiving CMB305 and atezolizumab
experienced greater clinical benefit in the form of Disease Control
Rate (including objective responses), Progression Free Survival and
Time to Next Treatment than those receiving atezolizumab
alone.
- Immune Response: Patients who received the
combination of CMB305 and atezolizumab demonstrated an increased
frequency of induced immune responses to NY-ESO-1, including
NY-ESO-1-specific T cells, NY-ESO-1 antibodies, and antigen
spreading, in comparison to patients who received atezolizumab
alone
- Biomarkers: In an exploratory analysis, a
trend towards improved overall survival was observed in patients in
the CMB305 and atezolizumab combination arm who had pre-existing
and treatment-induced anti-NY-ESO-1 immunity, compared to the
atezolizumab alone arm. Pre-treatment tumor biopsy analysis showed
negligible levels of PD-L1 expression.
- Safety: No new safety signals have been
observed in either arm.
The fully enrolled trial is evaluating the
safety, immunogenicity and efficacy of CMB305 in combination with
atezolizumab, or atezolizumab alone, in a total of 88 patients with
locally advanced, relapsed, or metastatic NY-ESO-1+ synovial
sarcoma or myxoid/round-cell liposarcoma. Atezolizumab is a
monoclonal antibody designed to target and bind to a protein called
PD-L1 (programmed death ligand-1) and is being developed by
Genentech, a member of the Roche Group. The trial is being
conducted pursuant to a clinical collaboration with Genentech.
Immune Design intends to present survival data in 2018 once all
patients have at least one year of follow up (current data are
preliminary: median duration of observation <six months).
The ESMO Poster Discussion session presentation details are as
follows:
A Phase 2 Study of CMB305 and Atezolizumab in NY-ESO-1+
Soft Tissue Sarcoma: Interim Analysis of Immunogenicity, Tumor
Control and SurvivalAbstract # 1480PDSession
Title: Sarcoma Poster Discussion SessionDate: Monday, Sept.
11, 2017Time: 11 a.m. – 12:30 p.m. Location: Bilbao
AuditoriumPoster Presenter: Dr. Sant ChawlaPoster Discussant: Dr.
Robert Maki
About CMB305
CMB305 is a prime-boost vaccine approach
against NY-ESO-1-expressing tumors, designed to generate an
integrated, anti-NY-ESO-1 immune response in vivo via a
targeted, specific interaction with dendritic cells, a mechanism of
action Immune Design believes differs from traditional cancer
vaccines. CMB305 is being evaluated in soft tissue sarcoma patients
in ongoing Phase 1 monotherapy and 2 combination studies. Immune
Design has received Orphan Drug Designation for CMB305 from the
U.S. Food and Drug Administration (FDA) for the treatment of soft
tissue sarcoma, as well as from the FDA and European Medicines
Agency for each of the components of CMB305 for the treatment of
soft tissue sarcoma.
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 primary foci
of Immune Design's ongoing immuno-oncology clinical programs, are
products of its two synergistic discovery platforms, ZVex and
GLAAS, the fundamental technologies of which were licensed from the
California Institute of Technology and the Infectious Disease
Research Institute (IDRI), respectively. Immune Design has
offices in Seattle and South San Francisco. For more information,
please visit www.immunedesign.com.
TECENTRIQ® (atezolizumab) is a registered
trademark of Genentech, a member of the Roche Group.
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,"
"anticipate," "estimate," "intend" 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 progress, 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,
clinical trial site activation or enrollment rates that are lower
than expected, 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 Contact
Julie Rathbun
Rathbun Communications
julie@rathbuncomm.com
206-769-9219
Investor Contact
Shari Annes
Annes Associates
sannes@annesassociates.com
650-888-0902
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