- ILLUMINATE 204 Data
selected as subject of a poster discussion session
to be held on Monday, June 4, 2018 at 4:45 PM CT –
Idera Pharmaceuticals, Inc. (Idera) (NASDAQ:IDRA), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel oligonucleotide therapeutics for
oncology and rare diseases, today announced the acceptance of three
abstracts related to the ILLUMINATE clinical development program at
the upcoming ASCO meeting being held June 1-5, 2018 in Chicago. The
abstracts include a clinical data update from the ILLUMINATE 204
trial in anti-PD-1 refractory melanoma provided by lead
investigator Adi Diab, MD from the University of Texas MD Anderson
Cancer Center; this abstract will also be featured in a poster
discussion session at the meeting.
The company plans to hold an investor/analyst event at the ASCO
Annual Meeting on Monday, June 4, 2018, which will feature a
presentation by ILLUMINATE 204 lead investigator Adi Diab, MD as
well as Q&A with attendees. As a convenience to those
unable to attend in person, the event will be webcast. Full event
details will be provided closer to the meeting.
Additionally, the Phase 3 ILLUMINATE 301 trial in anti-PD-1
refractory melanoma has opened to enrollment during the first
quarter of 2018.
Accepted Abstracts for ASCO 2018:
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Title (1): |
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A phase 2 study to
evaluate the safety and efficacy of Intratumoral (IT)injection of
the TLR9 agonist IMO-2125 (IMO) in combination withipilimumab (ipi)
in PD-1 inhibitor refractory melanoma. |
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Abstract Number: |
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9515 |
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Poster Display
Session: |
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Melanoma/Skin Cancers |
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Date: |
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June 4, 2018, 1:15 – 4:45
PM CT |
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Location: |
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Hall A |
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Presenter: |
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Adi Diab, MD, MD Anderson
Cancer Center |
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Poster Discussion
Session: |
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Melanoma Skin Cancers |
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Date: |
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June 4, 2018 4:45 – 6:00
PM CT |
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Location: |
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E451 |
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Title (2): |
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Preliminary
safety of deep/visceral (D/V) image guided (IG)
intratumoralinjection (ITI) of IMO-2125. |
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Abstract NumberFor
Publication: |
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e15150 |
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Author: |
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Hani Babiker, MD,
University of Arizona Cancer Center |
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Title (3): |
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Right tumor, right time:
Systematic methodology for fiducial markerplacement to achieve
reliable and reproducible image guided (IG)delivery of intratumoral
immunotherapy into deep/visceral (D/V) lesionsand target-lesion
imaging follow-up. |
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Abstract NumberFor
Publication: |
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e24137 |
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Author: |
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Gregory John Woodhead, MD,
PhD, University of Arizona Cancer Center |
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About Tilsotolimod (IMO-2125)Tilsotolimod is a
TLR 9 agonist that received Fast Track Designation from the US Food
and Drug Administration (FDA) in 2017 for the treatment of PD-1
refractory melanoma, in combination with ipilimumab as well as
orphan drug designation from the FDA 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. Currently approved immuno-oncology treatments,
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. Intratumoral injections
with tilsotolimod are 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 ILLUMINATE-204The Illuminate 204 study
(2125-204) is for patients who have metastatic melanoma for whom
treatment with an anti-PD-1 drug like Keytruda® (pembrolizumab) or
Opdivo® (nivolumab) has failed. Melanoma is the most dangerous type
of skin cancer. When it is metastatic, it means that the melanoma
has spread to different parts of the body. Illuminate 204 is
a multi-center, two-arm Phase 1/2 study that tests the safety and
effectiveness of tilsotolimod in combination with either ipilimumab
(Yervoy®) or pembrolizumab (Keytruda®) for the treatment of
patients with PD-1 refractory metastatic melanoma.
For additional details about Illuminate 204, please go to
clinicaltrials.gov and search for study identifier NCT02644967.
About ILLUMINATE-301The Illuminate 301 study
(2125-MEL-301) is for patients who have metastatic melanoma for
whom treatment with an anti-PD-1 drug like Keytruda®
(pembrolizumab) or Opdivo® (nivolumab) has failed. Illuminate
301 is a multi-center, randomized Phase 3 study that compares the
effectiveness and safety between two treatment groups: IMO-2125
combined with ipilimumab (Yervoy®) versus ipilimumab given
alone.
For additional details about Illuminate 301, please go to
clinicaltrials.gov and search for study identifier NCT03445533.
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 Harnessing 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 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, clinical trials, 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 the
company’s cash resources will be sufficient to fund the company’s
continuing operations and the further development of the company’s
programs for the period anticipated; 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 results 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 when anticipated or at all or
warrant submission for regulatory approval; whether such products
will receive approval from the U.S. Food and Drug Administration or
equivalent foreign regulatory agencies; whether, if the company's
products receive approval, they will be successfully distributed
and marketed; whether the company's collaborations will be
successful; and such other important factors as are set forth under
the caption "Risk factors" in the company’s Annual Report filed on
Form 10-K for the period ended December 31, 2017. 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.
Idera Pharmaceuticals
Contact:
Robert A. Doody, Jr.VP, Investor Relations &
CommunicationsPhone (484) 639-7235rdoody@iderapharma.com
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