- Available Translational Data Continue
to Demonstrate Correlation between Proliferation and Clonal
Expansion of T-Cells to Clinical Responses -
Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage
biopharmaceutical company developing toll-like receptor and RNA
therapeutics for patients with rare cancers and rare diseases,
today announced updated translational data from the ongoing Phase
1/2 study of intratumoral IMO-2125 in combination with ipilimumab
for the treatment of anti-PD-1 refractory metastatic melanoma.
These data will be presented at 4:45 P.M. E.T. on Saturday,
November 11th in Maryland Ballroom A at the Gaylord National Hotel
& Conference Center as part of Concurrent Session 207: Clinical
Trials: Novel Combinations at the 2017 Society for Immunotherapy of
Cancer Annual Meeting being held in National Harbor, MD.
In the oral presentation entitled, “TLR9 agonist harnesses
innate immunity to drive tumor-infiltrating T-cell expansion in
distant lesions in a Phase 1/2 study of intratumoral IMO-2125 plus
ipilimumab in anti-PD-1 refractory melanoma patients,” Cara
Haymaker, Ph.D., from The University of Texas, MD Anderson Cancer
Center, will present an update of the essential translational
findings from the Ongoing Phase 1/2 trial of IMO-2125. Adults
with anti-PD-1 refractory, unresectable stage III/IV melanoma were
enrolled. IMO-2125, escalating from 4 – 32 mg is administered under
image guidance, intratumorally on weeks 1, 2, 3, 5, 8, and 11 with
standard ipilimumab. Biopsies were obtained in both the injected
and distant tumor at baseline, 1 day and 8 weeks (W8) post
injection. Immune analyses included phenotypic, activation,
and functional characterization of DC subsets and T cells. T-cell
repertoire diversity was evaluated by high-throughput CDR3
sequencing and changes in gene expression signatures were assessed
by nanoString.
Key Highlights to be Presented Include:
- IMO-2125 induces a strong Type 1 interferon gene signature,
macrophage influx and robust dendritic cell (DC) maturation
post-injection;
- Combination therapy induces CD8+ T-cell proliferation and
activation that is preferential to the tumor;
- The hallmark of observed tumor shrinkage appears to be the
presence of Ki67+ CD8+ T-cell effector cells in the
distant/un-injected tumor;
- Major T-cell clones expanding on therapy in responding patients
are shared between local/injected and distant/un-injected lesions,
indicating that priming/reactivation is to a shared antigen;
- Additionally, the company announced that since the last
clinical data update provided at the European Society of Medical
Oncology Conference in September, an additional (5th) unconfirmed
RECIST v.1.1 response has been observed in the 10th evaluable
patient to date.
“These important translational findings continue to strengthen
our understanding of the critical role of intratumoral IMO-2125
therapy in the priming of T-cells and activation of the tumor
microenvironment to produce durable tumor shrinkage when
administered with ipilimumab in patients with anti PD-1 refractory
metastatic melanoma,” stated Joanna Horobin, M.B., Ch.B.,
Idera’s Chief Medical Officer. “Our team at Idera is driving
this program forward with purpose and rigor in order to bring this
approach to patients rapidly. I look forward to the
initiation of the phase 3 study in the first quarter of 2018.”
A copy of the oral presentation as well as a related poster will
be available Saturday, November 11, 2017 at 4:45 P.M. E.T. on
Idera’s corporate website at
http://www.iderapharma.com/our-approach/key-publications/.
About the Phase 1/2 trial of IMO-2125 in combination
with ipilimumab (NCT02644967)Study 2125-204 is a Phase 1/2
open-label study of intratumoral IMO-2125 given in combination with
either ipilimumab or pembrolizumab to patients with PD-(L)1
refractory melanoma with a planned enrollment of approximately 90
patients. IMO-2125 is given in escalating dosages from 4 to 32 mg
combined with either ipilimumab (3 mg/kg i.v. every 3 weeks for 4
doses) or pembrolizumab (2 mg/kg i.v. every 3 weeks). Study
endpoints are safety, tumor response, pharmacodynamics, and
pharmacokinetics. Serial biopsies of both the injected and a
distant tumor are being performed for translational immunologic
studies. Preliminary data, presented at SITC 2016, ASCO-SITC
2017, AACR 2017, and CRI-CIMT-EATI-AACR 2017 are available on
Idera’s website
(http://www.iderapharma.com/our-approach/key-publications/).
About IMO-2125 IMO-2125 is a toll-like
receptor (TLR) 9 agonist that received orphan drug designation from
the FDA in 2017 for the treatment of melanoma Stages IIb to IV. It
signals the immune system to create and activate cancer-fighting
cells (T-cells) to target solid tumors in refractory melanoma
patients. Currently approved immuno-oncology treatments for
patients with metastatic melanoma, specifically check-point
inhibitors, work for some but not all, as many patients’ immune
response is missing or weak and thus they do not benefit from the
checkpoint therapy making them so-called “refractory”. The
combination of ipilimumab and IMO-2125 appears to activate an
immune response in these patients who have exhausted all options.
Intratumoral injections with IMO-2125 is designed to selectively
enable the T-cells to recognize and attack cancers that remained
elusive and unrecognized by the immune system exposed to checkpoint
inhibitors alone, while limiting toxicity or impact on healthy
cells in the body.
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 the lymphatic system (metastatic
disease). Because melanoma occurs in younger individuals, the years
of life lost to melanoma are also disproportionately high when
compared with other cancers. Although melanoma is a rare form
of skin cancer, it comprises over 75% of skin cancer deaths.
The American Cancer Society estimates that there were approximately
76,000 new invasive melanoma cases and 10,000 deaths from the
disease in the USA in 2016. Additionally, according to the
World Health Organization, about 132,000 new cases of melanoma are
diagnosed around the world every year.
About Idera PharmaceuticalsHarnessing the
approach of the earliest researchers in immunotherapy and the
company’s vast experience in developing proprietary immunology
platforms, Idera’s lead development program is focused on priming
the immune system to play a more powerful role in fighting cancer,
ultimately increasing the number of people who can benefit from
immunotherapy. Idera continues to invest in research and
development, and is committed to working with investigators and
partners who share the common goal of addressing the unmet needs of
patients suffering from rare, life-threatening diseases. 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 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 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 IMO-2125 will
successfully advance 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 on form 10K for the period ended December
31, 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 ContactRobert DoodyVice
President, Investor Relations and Corporate CommunicationsOffice:
617-679-5515Mobile: 484‐639‐7235rdoody@iderapharma.com
Theresa DolgeChief Media Relations OfficerTonic Life
CommunicationsOffice:
215-928-2748Theresa.dolge@toniclc.com
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