Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company
focused on oncology, today announced updated clinical and biomarker
data for its lead immuno-oncology product candidates, CMB305 and
G100. The data are being presented at the American Society of
Clinical Oncology (ASCO) 2017 Annual Meeting in Chicago.
CMB305 Monotherapy in Soft Tissue Sarcoma Patients:
Clinical Benefit, Safety and Patient Selection
Data in an oral presentation last Friday by Neeta Somaiah, M.D.,
Department of Sarcoma Medical Oncology, The University of Texas MD
Anderson Cancer Center, highlight the results of 25 soft tissue
sarcoma (STS) patients with recurrent disease treated with
CMB305:
- Patient characteristics: 92% metastatic, 56% progressing upon
trial entry, and 52% with ≥2 prior lines of chemotherapy
- Survival: median overall survival (mOS) has still not yet been
reached.• The overall survival rate at 12 and 18 months was 83% and
76%, respectively.• These new data compare favorably to mOS for
approved second line and later sarcoma agents, which is only
12.4-13.5 months, as well as a published mOS of 11.7 months for
synovial sarcoma patients specifically; the largest patient
population enrolled in this trial.
- Disease control: a disease control rate (CDR) of 64% (16/25)
was observed, including durable tumor growth arrest in patients who
had evidence of disease progression at study entry.
- Safety: CMB305 was well tolerated, with only one related Grade
3 adverse event (AE).
- Immune response: CMB305 generated a strong and broad
anti-NY-ESO-1 immune response in >50% of the patients, with 32%
patients experiencing an integrated response (T cells and
antibodies).
- Antigen spreading: induction of an immune response against
other tumor antigens not targeted by CMB305 was detected in 33% of
evaluable patients following CMB305 therapy.
In a related presentation today, Seth M. Pollack, M.D. of the
Fred Hutchinson Cancer Research Institute, will present data
examining the relationship between immune response against NY-ESO-1
and clinical benefit in a combined set of CMB305 and LV305 patients
(n=64) with various tumor types. LV305 is the vector only, “prime”
component of CMB305, and was the subject of a separate Phase 1
study:
- NY-ESO-1 specific “public” T cell receptor (pTCR): three
NY-ESO-1-specific T-cell receptor sequences isolated from a patient
responding to therapy were found to be shared by approximately 50%
of all study patients, as well as healthy blood donors, tested.
These pTCR sequences indicate a low level of pre-existing
anti-NY-ESO-1 immunity which appear to be expanded by CMB305.
- Immune response: the induction of an integrated anti-NY-ESO-1
immune response (antibodies and T-cells) was observed in more than
30% of the patients who received therapy.
- Biomarker (immune response) vs. Survival: the induction of an
anti-NY-ESO-1 immune response by these agents is associated with
improved patient survival, particularly in patients with
pre-existing anti-NY-ESO-1 immunity.
- Patient selection: these immune biomarkers, including novel
bio-markers derived from pTCRs, may guide regulatory strategy via
the selection of patients more likely to have survival benefit on
CMB305 therapy.
G100 Monotherapy in Follicular NHL (FL) Patients:
Clinical Benefit, Safety and Changes to the Tumor Microenvironment
(TME)
In a poster presentation today, Christopher Flowers, M.D.,
Department of Hematology and Medical Oncology, Emory University
School of Medicine, will present results of 9 patients with FL
treated with escalating doses of G100 monotherapy (with local
radiation (XRT)).
- Patient characteristics: of the 9 FL patients enrolled, 45%
were treatment-naïve and 56% were relapsed/refractory, and most had
Stage III and IV disease (56% and 33%, respectively). Additionally,
55% of patients had received at least two prior therapies and 78%
had progressive disease upon study entry.
- Disease control:• Objective responses were observed at all
three dose levels tested.• 44% of the patients achieved a partial
response (PR) based on WHO criteria (at least a 50% tumor
reduction).• Some patients had tumor shrinkage over a prolonged
period, e.g., continuing up to 8+ months, and a duration of
response exceeding 4 months in some patients.• DCR of 100% of
patients (44% PR, 56% SD).• 50% of evaluable patients experienced
shrinkage of untreated distal (abscopal) lesion.
- Safety: G100 was well tolerated, with no related Grade 3/4 AEs
in all three dose levels tested.
- Tumor microenvironment: G100 resulted in favorable tumor
microenvironment changes• Tumor biopsies showed increased
inflammatory responses and T cell infiltrates in abscopal,
non-treated tumors.
“These data demonstrate that both CMB305 and
G100, our lead cancer immunotherapy product candidates, are capable
of activating patients’ immune systems in ways that have a direct
effect on patients’ tumor growth, whether it is tumor-growth arrest
on CMB305 therapy and subsequent survival benefit, or ORR and
systemic tumor shrinkage after local therapy with G100,” said
Sergey Yurasov, MD, PhD, Senior Vice President and Chief Medical
Officer at Immune Design. “Also, importantly, we are evaluating
immune biomarkers that may identify patients who are likely to
benefit the most from CMB305 therapy. We plan to present these
clinical data to regulatory agencies in planning for a pivotal
trial that may lead to subsequent regulatory approval, and enable
us to bring these novel, safe immunotherapies to cancer
patients.”
ASCO Presentation Details
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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