Idera Pharmaceuticals Reports Promising Data from Ongoing Phase 1 Dose Escalation in Clinical Trial of Intra-tumoral IMO-2125 in Combination with Ipilimumab in Patients with PD-1 Refractory Metasta...
(Thomson Reuters ONE) -
3 Patients with PD-1 Refractory Cutaneous Melanoma are Responders Including One
Complete Response (CR)
Driven by Increased Prioritization of IMO-2125 Clinical Development, Company
Suspends Development of IMO-8400 for B-Cell Lymphomas
CAMBRIDGE, Mass. and EXTON, Pa., Sept. 26, 2016 (GLOBE NEWSWIRE) -- Idera
Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company
developing Toll-like receptor and RNA therapeutics for patients with cancer and
rare diseases, is reporting initial clinical data from its ongoing Phase 1/2
clinical trial of intra-tumoral IMO-2125, a Toll-like receptor (TLR) 9 agonist.
In this arm of the Phase 1 portion of the trial, IMO-2125 is being evaluated in
combination with ipilimumab for treatment of patients with metastatic melanoma
who have failed prior PD-1 therapy. These early results indicate that IMO-2125
is demonstrating promising clinical activity and is being well tolerated in a
patient population with minimal options and low expectation of clinical response
with ipilimumab treatment alone. Further clinical information from the ongoing
dose escalation portion of the trial, as well as detailed information on the
translational results, will be presented during an oral session at the 2016
Society for Immunotherapy of Cancer Annual Meeting beginning November 9th in
Maryland.
"We have completed extensive pre-clinical work in a broad scope of tumor types
to test the hypothesis of intra-tumoral administration of IMO-2125 inducing a
meaningful effect on the tumor microenvironment and potentiating local and
systemic tumor regression in patients. This work gave us confidence to test the
ability of IMO-2125, beginning with this current study in PD-1 refractory
metastatic melanoma patients," stated Vincent Milano, Idera's Chief Executive
Officer.
"We are energized by the early results from this ongoing trial and have been
solidifying our plans to accelerate the program as we believe there is a clear
path to bring IMO-2125 to melanoma patients who have not benefited from
checkpoint inhibition alone and open an opportunity to establish IMO-2125 as the
agent of choice to activate the tumor microenvironment and potentially improve
outcomes for patients," Milano added. "Following a full strategic review, we
have decided to prioritize the IMO-2125 program and explore strategic options
for IMO-8400 in B-cell lymphoma."
Current Data Analysis
Safety
* 10 patients in 3 dosing cohorts (4mg, 8mg and 16mg) have been dosed and are
assessable for safety, as of the September 19, 2016 cutoff date;
* IMO-2125 in combination with ipilimumab is being generally well tolerated at
all 3 dose levels studied to date;
* Immune related adverse events have been observed in 3 subjects: 2 responding
patients have experienced hypophysitis and 1 patient has discontinued the
study due to a recurrence of immune related hepatitis previously observed on
prior therapy with ipilimumab;
* No dose limiting toxicities (DLTs) have been identified to date and the
study is currently enrolling at the highest (32mg) dosing cohort in
combination with ipilimumab.
Clinical activity
* 6 patients treated in the first 2 dosing cohorts (4mg and 8mg) are
assessable for initial clinical activity, as of the September 19, 2016
cutoff date;
* 3 of the 4 patients with cutaneous melanoma are responders with one Complete
Response (CR) and 2 Partial Responses (PR);
* 2 patients with mucosal melanoma experienced Progressive Disease (PD).
Translational observations
* Translational data seen through the first two dosing cohorts is promising
relative to the induction of immune responses;
* Detailed information on the translational findings from biopsies taken in
the first 2 dosing cohorts and the relationship of these to clinical
response is the subject of an accepted oral presentation on November
11, 2016 at the 2016 Society for Immunotherapy of Cancer (SITC) Annual
Meeting by Cara Haymaker, Ph.D., University of Texas, MD Anderson Cancer
Center.
"The degree of activity we've seen so far in this trial is very exciting as
these patients are very unlikely to respond to other therapies. All three
responses that we've seen are clinically meaningful, and these patients continue
to do well following treatment," stated Adi Diab, M.D., Assistant Professor,
Department of Melanoma Medical Oncology, Division of Cancer Medicine, University
of Texas, MD Anderson Cancer Center.
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
given intravenously. Following determination of the recommended Phase 2 dose
(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. The primary objective of the
Phase 2 portion is to assess the clinical activity of IMO-2125 in combination
with ipilimumab at the respective RP2D in patients. 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, M.D., 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.
Business Update
Idera is also reporting that the company has chosen to suspend the clinical
development of IMO-8400 for B-cell lymphomas, including studies in Waldenstroms
Macroglobulinemia (WM) and Diffuse Large B-Cell Lymphoma (DLBCL), and will
explore strategic options in these indications. This decision was based upon
the prioritization of the clinical development plans for IMO-2125 and our
assessment that the level of clinical activity seen in the WM trial does not
support monotherapy, the very slow enrollment rate in DLBCL and our commercial
assessment. No safety concerns have been observed with IMO-8400 in the B-cell
Lymphoma program. The development of IMO-8400 in dermatomyositis continues and
is not impacted by this decision.
Investor Event and Webcast
Idera will host a conference call and live webcast on Monday, September 26 at
9:00 A.M. EST to review the data being presented along with a discussion of the
next steps for the IMO-2125 development program in melanoma. To participate in
the conference call, please dial (844) 882-7837 (domestic) and (574) 990-9824
(international). The webcast can be accessed live or in archived form in the
"Investor's" section of the company's website at www.iderapharma.com. The
company has also posted a slide presentation to the Idera corporate website in
the "Investors" section which will be referenced during the conference call.
Additionally the company has updated its corporate presentation which has also
been posted to the Idera corporate website in the "Investors" section.
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 agonist, IMO-2125 has been created using the company's proprietary
chemistry-based discovery platform. IMO-2125 has been shown 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 Melanoma
Melanoma 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 using a TLR-targeting
technology, to design synthetic oligonucleotide-based drug candidates to act by
modulating the activity of specific TLRs. In addition to its TLR programs, Idera
has created a third generation antisense technology platform using its
proprietary technology to inhibit 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 the 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 June 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(at)iderapharma.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Idera Pharmaceuticals, Inc. via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 26.09.2016 - 13:00 Uhr
Sprache: Deutsch
News-ID 496993
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