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 it has
entered into a clinical development support agreement with Pillar
Partners Foundation (“Pillar Partners”). Under the terms of
the agreement Pillar Partners will provide direct funding to
support three investigator initiated clinical trials to further
strategically expand the clinical research of IMO-2125, Idera’s
toll-like receptor (“TLR”) 9 agonist into broader melanoma
populations and other solid tumors. For these trials, Idera will
provide IMO-2125. Idera is currently enrolling a Phase 3
(“ILLUMINATE-301”) trial of intratumoral administration of IMO-2125
in combination with ipilimumab in patients with anti-PD-1
refractory metastatic melanoma.
The three trials within the terms of this agreement are:
- A Phase 1/2 open label study of intratumoral IMO-2125 in
combination with intratumoral ipilimumab and IV nivolumab in a
protocol open to multiple tumor types including non-small cell lung
cancer (“NSCLC”), melanoma, squamous cell carcinoma of the head and
neck and urothelial carcinoma. The principal investigator
initiating this trial is Aurélien Marabelle, MD, PhD, Clinical
Director of the Cancer Immunotherapy Program at Institut Gustave
Roussy, Villejuif, France.
- A Phase 2 study of intratumoral IMO-2125 in combination with IV
pembrolizumab in patients with NSCLC. The principal investigator
initiating this trial is Arafat Tfayli, MD, FRCP, Professor of
Clinical Medicine, Director of Research, NK Basile Cancer
Institute, American University of Beirut Medical Center, Beirut,
Lebanon.
- A Phase 2 placebo controlled study of intradermal
administration of IMO-2125 in patients with T3/T4 primary melanoma
scheduled to undergo a combined re-excision and sentinel node
biopsy procedure. The principal investigators initiating this trial
are Bas Koster, MD, Fons van den Eertwegh MD, PhD, and Tanja de
Gruijl, PhD, who is Professor of Translational Tumor Immunology and
Co-Director of the Cancer Immunology Program at the VU University
Medical Center, Cancer Center Amsterdam, The Netherlands.
“We are eager to expand our knowledge and understanding of the
various cancer types and combinations in which IMO-2125 can play a
significant role in improving outcomes beyond our current
registrational focus with our ILLUMINATE 301 program,” stated
Joanna Horobin, M.B., Ch. B., Idera’s Chief Medical Officer. “We
look forward to working with these investigators to provide the
support they need to initiate these trials before the end of the
year,” said Shah Rahimian, MD, Idera’s Oncology Medical Lead. ”
“We have long believed and understood that the mechanism for
IMO-2125 has broad potential and plays a central role in IO
combinations beyond PD-1 refractory melanoma and through this
financial grant, we are able to help light the spark to further
expand our ability to test this hypothesis in multiple tumor types
with expert clinical investigators,” stated Youssef El Zein,
Managing Partner, Pillar Invest Corporation.
About Idera Harnessing the approach of the
earliest researchers in immunotherapy and Idera’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.
About IMO-2125 IMO-2125 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 IMO-2125 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 IMO-2125 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 Pillar Partners FoundationPillar Partners
Foundation is the philanthropic arm of Pillar Partners, a private
investment group committed under the management of Youssef El Zein
and Abude Umari to the development of proprietary biotechnologies
that address large unmet medical needs. The Pillar Partners
Foundation has made numerous charitable contributions to pioneering
medical research in the fields of innate immunity and gene therapy
and to the advancement of the clinical development of
immuno-oncology, including the creation of the Pillar Chair in
Biomedical Research at the University of Massachusetts Medical
School and the Pillar Genomics Institute of Precision Medicine at
the American University of Beirut Medical Center.
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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