- Key findings presented in poster
discussion demonstrate clear abscopal effect of intratumoral
tilsotolimod -
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical-stage
biopharmaceutical company focused on the development and ultimate
commercialization of drug candidates for both oncology and rare
disease indications characterized by small, well-defined patient
populations with serious unmet needs, today presented data from the
ongoing ILLUMINATE-204 trial investigating tilsotolimod, Idera’s
intratumorally-delivered toll-like receptor 9 (TLR9) agonist, in
combination with ipilimumab (Yervoy®*) at the 2018 European Society
for Medical Oncology (ESMO) Congress.
The poster, which was selected for a poster discussion session,
highlighted additional analyses of data for 21 patients for whom
efficacy and safety analysis were originally presented at the 2018
American Society of Clinical Oncology Annual Meeting this past June
(data cut-off May 9th).
The new analyses address the potential of intramural
tilsotolimod to induce an antitumor response in combination with
ipilimumab in injected tumors as well as uninjected tumors via an
abscopal effect. As previously reported the overall response rate
(ORR, by RECIST 1.1) for these 21 patients was 39%. Notably, in 7
of the 8 responders tumor shrinkage was observed in both the
injected and uninjected tumors. Tumor shrinkage at uninjected
lesions was observed in an additional four patients who had not met
the criteria for RECIST v.1.1 response status as of this
analysis.
Clinical responses were seen in patients whose HLA-ABC RNA (MHC
class I) expression is low at baseline. Rodig and colleagues1 have
recently shown that robust MHC class I expression is required for
anti-CTLA-4 activity. Our findings suggest that combining
tilsotolimod with ipilimumab may overcome this resistance
mechanism, and therefore, enhance clinical activity and increase
the overall response rate compared to that expected with ipilimumab
monotherapy.
The ILLUMINATE-204 trial is enrolling two distinct patient
populations, both patients who are naïve to ipilimumab therapy
(N=40; Primary Efficacy Endpoint Population) and patients who have
prior ipilimumab experience (N=Up to 20; Secondary Efficacy
Endpoint Population). Of the initial 21 patients available for
efficacy evaluations 6 of 17 patients from the Primary Efficacy
Endpoint Population and 2 of 4 patients from the Secondary Efficacy
Endpoint Population achieved RECIST v.1.1 responses, further
demonstrating a signal that tilsotolimod has the potential to help
overcome prior ipilimumab resistance.
“The data presented at ESMO demonstrate that in patients with
melanoma progressing on or after PD-1 inhibitor therapy, injecting
a single tumor lesion with tilsotolimod, in combination with
ipilimumab, produced tumor shrinkage in distant uninjected lesions
in nearly all patients with reported responses by RECIST v1.1
criteria,” stated Adi Diab, M.D., Lead Trial Investigator,
Assistant Professor, Department of Melanoma Medical Oncology,
Division of Cancer Medicine, The University of Texas, MD Anderson
Cancer Center. “Moreover, clinical responses were seen in tumors
where MHC class I expression was low at baseline. In a recent
clinical study in melanoma, it was shown that robust MHC class I
expression is required for anti-CTLA-4 activity. Our findings
suggest that combining tilsotolimod with ipilimumab may overcome
this mechanism of resistance to anti-CTLA-4 monotherapy.”
“The clear demonstration of tumor shrinkage in uninjected tumors
following the injection of a single tumor lesion with tilsotolimod,
provides clinical confirmation of our translational data and
addresses an important frequently asked question,” stated Joanna
Horobin, Idera’s Chief Medical Officer. “Additionally, the
new observation that tilsotolimod may overcome the requirement for
MHC class 1 expression for effective anti-tumor therapy with
ipilimumab in patients otherwise unlikely to respond, is a very
exciting finding and addresses another important question regarding
the contribution of tilsotolimod when given in combination with
ipilimumab.”
The poster discussion is scheduled for Saturday, October 20,
2018 at 2:45 PM CEST (8:45 AM EST) in Room ICM-14b at the Messe
Munchen Congress Center in Munich, Germany.
In addition to the poster discussion, the company also presented
a Trials in Progress (TiPS) poster on the trial design for the
ongoing ILLUMINATE-301 Phase 3 clinical trial of the combination of
tilsotolimod and ipilimumab for unresectable or metastatic melanoma
following failure of PD-1 inhibitor treatment. This poster
will be on display on Sunday, October 21, 2018 from 12:45 – 1:45 PM
CEST (6:45 – 8:45 AM EST) in Hall A3 at the Messe Munchen Congress
Center in Munich, Germany.
Copies of these poster presentations are currently available on
Idera’s corporate website at
http://www.iderapharma.com/our-approach/key-publications/.
4th Quarter Clinical Efficacy and Safety
UpdateBased on the timing of disease assessment visits,
the company plans an additional data cut later this quarter for the
ILLUMINATE-204 trial to provide an update on clinical efficacy and
safety data for up to 35 patients, including overall response rate
(ORR) for all patients as well as for the Primary and Secondary
Efficacy Patient Populations.
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
anti-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 anti-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 global, 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, liver or
other visceral organs (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 also continues to focus on the acquisition,
development and ultimate commercialization of drug candidates for
both oncology and rare disease indications characterized by small,
well-defined patient populations with serious unmet needs. 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 and the Company’s
Quarterly Report filed on Form 10-Q for the period ended March 31,
2018. 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.
*Yervoy (ipilimumab) and Opdivo (nivolimumab) are registered
trademarks of Bristol-Myers Squibb.
**Keytruda (pembrolizimab) is a registered trademark of Merck
& Co., Inc.
1 Rodig, S., et al., MHC proteins confer differential
sensitivity to CTLA-4 and PD-1 blockade in untreated metastatic
melanoma. Sci. Transl. Med. 10, eaar3342 (2018).
IDERA PHARMACEUTICALS CONTACT:Robert A. Doody, Jr.VP, Investor
Relations & CommunicationsPhone (484)
639-7235rdoody@iderapharma.com
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