Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage
biopharmaceutical company developing toll-like receptor and RNA
therapeutics for patients with cancer and rare diseases, today
announced that new data from the Phase 1/2 clinical trial for
intratumoral IMO-2125, a TLR9 agonist, being evaluated for the
treatment of late-stage metastatic melanoma, will be presented at
the 2016 Society for Immunotherapy of Cancer (SITC) Annual Meeting
in National Harbor, MD, November 9-13, 2016.
Oral Presentations
Date: Wednesday, November 9, 2016, Presentation Time: 11:15 AM
E.T.Session Title: Clinical New Agents in DevelopmentPresentation
Title: IMO-2125, An Investigational Intratumoral Toll-Like
Receptor 9 Agonist, Modulates the Tumor Microenvironment to Enhance
Anti-Tumor ActivityPresenter: Mark J. Cornfeld, M.D. M.P.H., Vice
President, Oncology Medical Lead, Idera PharmaceuticalsLocation:
Gaylord National Hotel & Convention Center, Cherry Blossom
Ballroom
Date: Friday, November 11, 2016, Presentation Time: 3:15 PM
E.T.Session Title: State of the Art Immunotherapies: Challenges and
OpportunitiesPresentation Title: Reactivating the anti-tumor immune
response by targeting innate and adaptive immunity in a phase I/II
study of intratumoral IMO-2125 in combination with systemic
ipilimumab in patients with anti-PD-1 refractory metastatic
melanomaPresenter: Presenter: Cara Haymaker, Ph.D., Instructor, The
University of Texas MD Anderson Cancer CenterLocation: Gaylord
National Hotel & Convention Center, Maryland Ballroom
Poster PresentationDate: Saturday, November 12,
2016: Presentation Time: 11:45 AM E.T. – 1:00 PM E.T.Session
Title: ImmunotherapyPoster Number: 216Presentation Title:
Reactivating the anti-tumor immune response by targeting innate and
adaptive immunity in a phase I/II study of intratumoral IMO-2125 in
combination with systemic ipilimumab in patients with anti-PD-1
refractory metastatic melanomaPresenter: Cara Haymaker, Ph.D.,
Instructor, The University of Texas MD Anderson Cancer
CenterLocation: Gaylord National Hotel & Convention Center,
Prince George’s Exhibition Hall AB
A copy of the slides from Dr. Cornfeld’s presentation will be
made available on Idera’s corporate website at
http://www.iderapharma.com/our-approach/key-publications/ on
Wednesday, November 9 at 11:15 AM E.T. Copies of Dr.
Haymaker’s presentation and related poster will be also be made
available on Idera’s corporate website on Friday, November 11 at
3:15 PM E.T., in accordance with the embargo policies set forth by
SITC.
“As we noted in late September, we are extremely excited by the
initial clinical outcomes we have generated with intratumoral
IMO-2125, in combination with ipilimumab,” stated Joanna Horobin,
M.B., Ch.B., Idera’s Chief Medical Officer. “The
translational data from this trial is adding to our understanding
of how IMO-2125 positively modulates the tumor microenvironment and
enabling previously cold tumors an opportunity for regression and
ultimately successful outcomes for patients. The
translational research from this trial is critical to further this
understanding as well as to help guide the direction of IMO-2125’s
development.”
These early results are from the phase 1 portion of study
IMO-2125-204 (NCT02644967) in which cohorts of patients with
metastatic melanoma unresponsive to PD-1 inhibitor therapy are
being administered escalating doses of IMO-2125 ranging from 4
mg/kg through 32 mg/kg. IMO-2125 is injected intra-tumorally into a
designated tumor lesion together with a standard dosing regimen of
ipilimumab. The trial has recently been amended to also study the
combination of IMO-2125 and pembrolizumab given intravenously.
Following determination of the recommended phase 2 doses (RP2D)
additional patients will be treated in an expansion phase 2 portion
of the study. The primary objective of the phase 1 portion of the
trial is to characterize the safety and determine a RP2D of
IMO-2125 when administered intra-tumorally in combination with
ipilimumab or pembrolizumab. The primary objective of the
phase 2 portion is to assess the clinical activity of IMO-2125 in
each combination at the respective RP2Ds. Assessment will be
based on the immune-related response criteria (irRC) and
additionally the traditional RECIST criteria. Serial biopsies
are being taken of selected injected and non-injected tumor lesions
to assess immune changes and correlate with clinical response
assessments. The trial will enroll approximately 60
patients. The study is being conducted at The University of
Texas MD Anderson Cancer Center and is being led by Adi Diab, MD,
Assistant Professor, Department of Melanoma Medical Oncology,
Division of Cancer Medicine, MD Anderson as part of a strategic
research alliance announced by Idera and MD Anderson in 2015.
About Toll-like Receptors and Idera's Immuno-Oncology
Research Program
Toll-like receptors (TLRs) play a central role in the innate
immune system, the body's first line of defense against invading
pathogens, as well as damaged or dysfunctional cells including
cancer cells. The innate immune system is also involved in
activating the adaptive immune system, which marshals highly
specific immune responses to target pathogens or tissue. Cancer
cells may exploit regulatory checkpoint pathways to avoid being
recognized by the immune system, thereby shielding the tumor from
immune attack. Checkpoint inhibitors such as agents targeting CTLA4
or programmed cell death protein 1 (PD1) are designed to enable the
immune system to recognize tumor cells. In this setting,
intra-tumoral TLR9 agonist administration may increase the
tumor-infiltrating lymphocytes (TILs), and thereby potentiate
anti-cancer activity of checkpoint inhibitors in the injected tumor
as well as systemically.
Idera’s TLR9 agonists, IMO-2125 and IMO-2055, have been created
using the company's proprietary chemistry-based discovery
platform. IMO-2125 has been shown in various scientific
presentations and publications to activate dendritic cells and
induce interferon. Idera selected IMO-2125 to advance into clinical
development in combination with checkpoint inhibitors based on this
immunological profile. In previously completed clinical
trials, subcutaneous administration of IMO-2125 was generally well
tolerated in about 80 patients with hepatitis C. Idera has
conducted further preclinical research evaluating the potential of
IMO-2125 to enhance the anti-tumor activity of other checkpoint
inhibitors in cancer immunotherapy with data being presented at
several medical conferences during the past twelve months.
The posters from these presentations can be found at
http://www.iderapharma.com/our-approach/key-publications.
About Metastatic MelanomaMelanoma is a type of
skin cancer that begins in a type of skin cell called
melanocytes. As is the case in many forms of cancer, melanoma
becomes more difficult to treat once the disease has spread beyond
the skin to other parts of the body such as by through the
lymphatic system (metastatic disease). Melanoma accounts for
only one percent of skin cancer cases, but causes a large majority
of skin cancer deaths. The American Cancer Society estimates
that in 2016, there will be 76,380 new cases of melanoma in the
U.S., and about 10,130 will die of this disease.
About Idera
Pharmaceuticals
Idera Pharmaceuticals is a clinical-stage biopharmaceutical company
developing novel nucleic acid-based therapies for the treatment of
certain cancers and rare diseases. Idera’s proprietary technology
involves designing synthetic oligonucleotide-based drug candidates
to modulate the activity of specific TLRs. In addition to its TLR
programs, Idera has used its proprietary knowledge to create a
third generation antisense technology platform which inhibits the
production of disease-associated proteins by targeting RNA. To
learn more about Idera, visit www.iderapharma.com.
Forward Looking
Statements
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
All statements, other than statements of historical fact, included
or incorporated in this press release, including statements
regarding the Company's strategy, future operations,
collaborations, intellectual property, cash resources, financial
position, future revenues, projected costs, prospects, plans, and
objectives of management, are forward-looking statements. The words
"believes," "anticipates," "estimates," "plans," "expects,"
"intends," "may," "could," "should," "potential," "likely,"
"projects," "continue," "will," and "would" and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Idera cannot guarantee that it will actually achieve the plans,
intentions or expectations disclosed in its forward-looking
statements and you should not place undue reliance on the Company's
forward-looking statements. There are a number of important factors
that could cause Idera's actual results to differ materially from
those indicated or implied by its forward-looking statements.
Factors that may cause such a difference include: whether interim
results from a clinical trial, such as preliminary results reported
in this release, will be predictive of the final results of the
trial, whether results obtained in preclinical studies and clinical
trials such as the preclinical data described in this release will
be indicative of the results that will be generated in future
clinical trials, including in clinical trials in different disease
indications; whether products based on Idera's technology will
advance into or through the clinical trial process on a timely
basis or at all and receive approval from the United States Food
and Drug Administration or equivalent foreign regulatory agencies;
whether, if the Company's products receive approval, they will be
successfully distributed and marketed; and such other important
factors as are set forth under the caption "Risk Factors" in the
Company's Annual Report and on Form 10-Q for the period ended
September 30, 2016. Although Idera may elect to do so at some point
in the future, the Company does not assume any obligation to update
any forward-looking statements and it disclaims any intention or
obligation to update or revise any forward-looking statement,
whether as a result of new information, future events or otherwise.
Investor and Media Contact
Robert Doody
Vice President, Investor Relations and Corporate Communications
Office: 617-679-5515
Mobile: 484‐639‐7235
rdoody@iderapharma.com
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