- 3 Patients with PD-1 Refractory
Cutaneous Melanoma are Responders Including One Complete Response
(CR) –
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 UpdateIdera 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 WebcastIdera
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 ProgramToll-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 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 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 StatementsThis
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@iderapharma.com
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