CAMBRIDGE, Mass. and
EXTON, Pa., Sept. 10, 2017 /PRNewswire/ -- 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 final results from the dose-selection phase of an
ongoing Phase 1/2 trial investigating IMO-2125, Idera's
intratumorally-delivered Toll-like Receptor (TLR) 9 agonist, in
combination with ipilimumab (Yervoy®), manufactured by
Bristol-Myers Squibb. These data were presented at the 2017
European Society for Medical Oncology Congress (ESMO) in
Madrid,
Spain.
The IMO-2125-ipilimumab dose-selection phase included 18
patients, all but one of whom had progressed on nivolumab or
pembrolizumab. Patients were treated with up to 6 doses of
intratumoral IMO-2125 at doses ranging from 4 to 32 mg, along with
standard dosing of ipilimumab. No dose-limiting toxicities
were seen and the maximum tolerated dose (MTD) was not
reached. No previously unreported immune-related toxicities
were observed. The 8 mg IMO-2125 dose was selected for
further development in combination with ipilimumab based upon
acceptable safety, clinical activity, and evidence for target
engagement on serial biopsies of the injected tumor and a distant
(non-injected) metastasis.
Key Findings
- Nine patients were treated at the Recommended Phase 2 Dose
(RP2D) of 8 mg IMO-2125 (in combination with ipilimumab)
- Confirmed RECIST v1.1 responses (including 1 Complete Response
(CR) ≥ 1 year) were observed in 4 of these 9 subjects (44%);
- Overall 6 patients out of 9 treated at the RP2D (67%)
experienced disease control (CR, PR, or durable SD);
- A RECIST v1.1 PR of > 1 year duration is ongoing in a
patient treated with IMO-2125 4 mg (in combination with
ipilimumab);
- IMO-2125 in combination with ipilimumab is tolerable at all
dose levels studied
- IMO-2125 was safely administered via deep injection (using
interventional radiology guidance) in patients lacking
superficially accessible disease for injection
- Dose escalation with IMO-2125 and pembrolizumab is ongoing; one
patient has an ongoing PR by RECIST (v1.1), and;
- An abstract highlighting translational findings from the trial
has been accepted as an oral presentation for the upcoming Society
for Immunotherapy of Cancer (SITC) meeting in November.
"The majority of patients with solid tumors do not respond to
anti-PD-1 therapy and the published response rate to ipilimumab
alone in anti-PD-1 refractory melanoma is only10-13%; to be seeing
6 out of 9 patients experiencing clear disease control is extremely
exciting," stated Adi Diab, M.D.,
Lead Trial Investigator, Assistant Professor, Department of
Melanoma Medical Oncology, Division of Cancer Medicine,
University of Texas, MD Anderson Cancer
Center.
"Based on these positive and encouraging response data in
anti-PD-1 refractory melanoma, where the greatest need exists, we
have expanded the target number of patients in the ongoing Phase 2
expansion, including broadening eligibility to patients who have
received prior ipilimumab, including the ipilimumab/PD-1
inhibitor combination," stated Joanna
Horobin, M.B., Ch.B., Idera's Chief Medical Officer.
"We plan to start a Phase 3 trial in patients with PD-1 refractory
melanoma in the first quarter of 2018. Preparations are
well-underway for this global initiative which is addressing a
major unmet need in melanoma. We are very encouraged by the
enthusiasm of investigators to participate in the Phase 3
study."
A copy of the poster presentation is currently available 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/).
Investor Event and Webcast
Idera will host a
conference call and live webcast on Monday,
September 11 at 9:00 A.M. EST
to review the data being presented along with discussion of next
steps for the IMO-2125 development program. 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 "Investors" section of the
company's website at www.iderapharma.com. The company plans
to post a slide presentation on Monday,
September 11, 2017 to the Idera corporate website in the
"Investors" section which will be referenced during the conference
call.
About IMO-2125
IMO-2125 is a toll-like
receptor (TLR) 9 agonist that received orphan drug designation from
the US Food and Drug Administration (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 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 Metastatic Melanoma
Melanoma 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 Pharmaceuticals
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, 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 and on form 10-Q
for the period ended June 30, 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.
Yervoy is a registered trademark of Bristol-Myers Squibb.
Investor and Media Contact
Robert Doody
Vice President, Investor Relations and Corporate Communications
Office: 617-679-5515
Mobile: 484‐639‐7235
rdoody@iderapharma.com
Theresa Dolge
Chief Media Relations Officer
Tonic Life Communications
Office: 215-928-2748
Theresa.dolge@toniclc.com
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