New Clinical and Biomarker Data Validate Immune Design’s Lead Programs and Discovery Platforms
May 17 2017 - 4:35PM
Data from CMB305 and G100 to be Presented
at ASCO Annual Meeting in June 2017
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company
focused on oncology, reported new clinical and biomarker data today
from CMB305 and G100 monotherapy studies. The American Society of
Clinical Oncology (ASCO) is publishing three abstracts today
relating to these new data. A broader set of data will be presented
at the ASCO 2017 Annual Meeting, providing further clinical
validation of the company’s lead product candidates and discovery
platforms.
CMB305 Monotherapy in Patients with Soft Tissue
Sarcoma
- Most recent patient survival data meaningfully exceed published
survival outcomes for standard of care therapy in comparable soft
tissue sarcoma (STS) patients with recurrent metastatic disease.
- With a median follow up exceeding 18 and 11 months for LV305
and CMB305, respectively, median overall survival (mOS) has not yet
been reached in recurrent metastatic STS patients.
- Durable disease control was observed in more than half of STS
patients, including durable tumor growth arrest in patients who had
evidence of disease progression prior to CMB305 therapy.
- CMB305’s safety profile consisted mostly of mild to moderate
adverse events, with therapy being well tolerated by patients.
- Anti-NY-ESO-1 immune biomarkers identify cancer patients who
may be more likely to have prolonged survival following therapy
with CMB305
- Anti-NY-ESO-1 immune responses were observed in more than half
of the patients who received CMB305 therapy.
- Induction of anti-NY-ESO-1 immunity in patients treated with
CMB305 or LV305 was associated with better clinical outcomes,
including survival.
- Immune biomarkers pre-treatment may guide regulatory strategy
via the selection of patients more likely to respond to CMB305
therapy.
G100 Intratumoral Monotherapy with Radiation in Patients
with Low-grade Follicular NHL (FL)
- More than 40% of the FL patients experienced objective
responses based on WHO criteria (at least a 50% tumor reduction),
including substantial tumor shrinkage in untreated, unirradiated
distal (abscopal) lesions.
- Safety profile remains favorable at higher doses than those
previously reported in Merkel cell carcinoma patients.
- G100 resulted in favorable tumor microenvironment changes.
- An increased intratumoral expression of inflammatory
cytokines/chemokines, T cell infiltration, and an increased
frequency of clonal tumor infiltrating lymphocytes, were
observed.
“The ability to identify patients who are likely
to benefit from antigen-targeted immunotherapy has been an elusive
goal. We believe the results highlighted here should be considered
as we aim to maximize the chance of success of these novel
modalities, including CMB305 and future product candidates from our
ZVex platform.” said Carlos Paya, M.D., Ph.D., President and Chief
Executive Officer of Immune Design. “During the second half of the
year, we hope to have the opportunity to build on these positive
clinical and biomarker data for CMB305 and G100 monotherapy with
the results from ongoing trials evaluating each agent in
combination with anti-PD-1/PD-L1 inhibitors.”
Presentations at American Society of Clinical Oncology
Annual Meeting
Data underlying the topline releases above were
published online today by the American Society of Clinical Oncology
(ASCO) in abstracts accepted for presentation at ASCO’s 2017 Annual
Meeting in June (presentation information set forth below). The
abstracts reflect an analysis performed on or before February 2017;
additional data will be presented at the Annual Meeting.
ORAL PRESENTATION
Immune response, safety, and survival impact from CMB305 in
NY-ESO-1+ recurrent soft tissue sarcomas (STS)
Abstract #
11006 |
Session
Title: Sarcoma |
Date: Friday,
June 2, 2017 |
Time: 3 p.m.
— 6 p.m. CT (oral session) |
Location:
S100bc |
Presenter:
Neeta Somaiah, M.D., Department of Sarcoma Medical Oncology, The
University of Texas MD Anderson Cancer Center |
POSTER PRESENTATIONS
The Association of CMB305 or LV305-induced and baseline
anti-NY-ESO-1 immunity with survival in recurrent cancer
patients
Abstract #
3090 |
Session
Title: Developmental Therapeutics—Immunotherapy |
Date: Monday,
June 5, 2017 |
Time: 8 a.m.
— 11:30 a.m. CT |
Location:
Hall A |
Presenter:
Seth M. Pollack, M.D., Fred Hutchinson Cancer Research Center |
Intratumoral G100 to induce systemic immune responses and
abscopal tumor regression in patients with follicular lymphoma
Abstract #
7537 |
Session
Title: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic
Leukemia |
Date: Monday,
June 5, 2017 |
Time: 8 a.m.
— 11:30 a.m. CT |
Location:
Hall A |
Presenter:
Christopher Flowers, M.D., Department of Hematology and Medical
Oncology, Emory University School of Medicine |
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 STS patients in ongoing
Phase 1 monotherapy and 2 combination studies with the anti-PD-L1
antibody, Tecentriq® (atezolizumab), pursuant
to a collaboration with Genentech. 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 G100
G100 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. It leverages the activation of both innate and
adaptive immunity, including dendritic cells, in the tumor
microenvironment to create an immune response against the tumor's
preexisting diverse set of antigens. G100 is being evaluated as
both a monotherapy (with XRT) and in combination with Merck's
anti-PD-1 agent, Keytruda® (pembrolizumab), pursuant to a
clinical collaboration with Merck, in a randomized Phase 1/2 trial
in patients with follicular non-Hodgkin's lymphoma. The FDA has
granted Orphan Drug Designation for G100 for the treatment of
follicular non-Hodgkin's lymphoma.
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 its 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, 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,”
“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 enrolment 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
Shari.Annes@immunedesign.com
650-888-0902
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