Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel nucleic acid-based therapeutics for
oncology and rare diseases, today reported its financial and
operational results for the first quarter ended March 31, 2017.
Since January 1, 2017, the Company:
• Completed enrollment in the dose escalation cohorts of the
ipilimumab combination arm of the ongoing Phase 1/2 clinical trial
of intratumoral IMO-2125 in PD-1 refractory metastatic
melanoma;
- No dose-limiting toxicity reported in studied dose
levels; MTD not reached; and
- Durable responses of over a year have been observed;
• Commenced enrollment of the Phase 2 portion of the clinical
trial of 8mg intratumoral IMO-2125 in combination with ipilimumab
in PD-1 refractory melanoma;
- 21 patients planned for evaluation, with 9 already enrolled;
and
- Overall Response Rate (ORR) data expected to be available in
first quarter of 2018;
• Continued enrollment into the dose escalation cohorts of the
pembrolizumab combination arm of the Phase 1/2 clinical trial of
intratumoral IMO-2125 in PD-1 refractory metastatic melanoma;
• Commenced and will continue to engage in discussions with
global regulatory authorities regarding the path to registration
for IMO-2125 in combination with ipilimumab in PD-1 refractory
metastatic melanoma;
• Activated first site for Phase 1 clinical trial of
intratumoral IMO-2125 monotherapy in multiple tumor types;
• Continued accruing patients into the IMO-8400 Phase 2 clinical
trial in dermatomyositis which is being conducted at 22 sites both
in the U.S. and abroad and is expected to complete enrollment in
2017 with data planned for the first half of 2018; and
• Continued all pre-clinical and IND-enabling activities for
IDRA 008, Idera’s first clinical candidate from the Third
Generation Antisense (3GA) technology platform, with expected IND
filing and initiation of human proof-of-concept clinical trial in
the first half of 2018.
“We are very focused on bringing the first
treatment option to PD1 refractory metastatic melanoma
patients. Having selected our phase 2 dose earlier than we
planned is good example of this focus,” stated Vincent Milano,
Idera’s Chief Executive Officer. “We set very clear
objectives in the beginning of this year for each of our programs,
and I am very pleased with the output and progress through the
first several months of 2017.”
Research and Development Program
UpdatesIMO-2125 and IMO-8400 are the Company’s lead
clinical development drug candidates. IMO-2125 is an
oligonucleotide-based agonist of Toll-like receptor (TLR) 9.
IMO-8400 is an oligonucleotide-based antagonist of TLRs 7, 8, and
9. The Company also announced, in early 2017, the selection
of the first development target from its proprietary 3GA technology
platform. The company plans to disclose the specific target,
disease and clinical pathway in the second half of 2017. The
Company plans to take the first 3GA candidate into human proof of
concept studies in 2018.
Toll-like Receptor (TLR) Agonism
Immuno-Oncology ProgramIdera’s development program
in immuno-oncology is based on the rationale that intra-tumoral
injections of IMO-2125, a TLR9 agonist, will activate dendritic
cells and modulate the tumor microenvironment to potentiate the
anti-tumor activity of checkpoint inhibitors and other
immunotherapies. This rationale is supported by pre-clinical
data in multiple tumor types.
Idera is currently conducting a Phase 2 clinical
trial of intratumoral IMO-2125 in combination with ipilimumab, a
CTLA4 antibody, and in a separate arm exploration of the
combination of intratumoral IMO-2125 with pembrolizumab, an
anti-PD1 antibody. The Phase 1 dose exploration portion of
the trial was conducted at the University of Texas MD Anderson
Cancer Center and the Phase 2 portion of the trial is being
conducted at multiple centers. This trial is being conducted
in patients with relapsed or refractory metastatic melanoma who
have failed prior PD-1 therapy. In the second half of 2016, the
Company announced positive preliminary clinical data from the
initial dosing cohorts in the ipilimumab arm of the dose escalation
portion of the trial. The company has completed the dose
escalation of intratumoral IMO-2125 in the ipilimumab arm of the
trial and the combination appears generally well tolerated across
all doses explored, without any dose-limiting toxicity and without
reaching a maximally tolerated dose. The company selected the
8mg dose for Phase 2 and enrollment is underway. The company has
also continued enrollment into the pembrolizumab combination arm of
the trial.
Additionally, the company has begun and will
continue to engage in discussions with regulatory authorities
regarding the path to registration for IMO-2125 in combination with
ipilimumab in PD-1 refractory metastatic melanoma patients.
Also during the first quarter of 2017, the phase 1
trial of intratumoral IMO-2125 monotherapy in multiple tumor types
has been activated and the first patient is expected to enroll
early in the second quarter of 2017.
At the 2017 ASCO-SITC Clinical Immuno-Oncology
Symposium held February 23 through February 25, in Orlando, FL,
Marc Uemura, M.D. of MD Anderson Cancer Center, presented an update
of the ongoing IMO-2125 clinical trial in combination with
ipilimumab in PD-1 refractory melanoma.
At the 2017 American Academy of Cancer Research
(AACR) Annual Meeting held, April 1 through April 5, in Washington,
DC, Dr. Cara Haymaker of MD Anderson Cancer Center presented an
update on the translational data outcomes in a poster presentation
entitled, “Translational evidence of reactivated innate and
adaptive immunity with intratumoral IMO-2125 in combination with
systemic checkpoint inhibitors form a Phase 1/2 study in patients
with anti-PD-1 refractory metastatic melanoma.”
Additionally, on the same day, Daqing Wang, Ph.D.,
Principal Scientist, Idera Pharmaceuticals presented new IMO-2125
pre-clinical data in a poster entitled, “Local treatment with novel
TLR9 agonist IMO-2125 demonstrates anti-tumor activity in
preclinical models of pancreatic cancer.”
Third Generation Antisense Platform
(3GA)Idera’s proprietary third-generation antisense (3GA)
platform technology is focused on silencing the mRNA associated
with disease causing genes. Idera has designed 3GA
oligonucleotides to overcome specific challenges associated with
earlier generation antisense technologies and RNAi technologies
such as immunotoxicities and less than optimal therapeutic
index.
Over the past two years, Idera has generated 22
unique compounds developed to target specific genes across a wide
variety of therapeutic areas such as rare diseases, oncology,
autoimmune disorders, metabolic conditions and diseases driven by a
single point mutation. The company is currently conducting
activities ranging from cell culture through IND-enabling
toxicology. The current portfolio is designed to create both
internal development candidates as well as partnering opportunities
for disease areas outside of Idera’s stated focus.
The first partnering endeavor is demonstrated
through Idera’s collaboration with GSK developing an undisclosed
3GA gene target for renal conditions. Idera and GSK entered
into the collaboration in late 2015 and GSK’s stated goal is to
achieve selection of clinical development candidate in the first
quarter of 2018.
Additionally, in January of 2017, Idera announced
selection of its first internal candidate to enter clinical
development. For strategic and competitive purposes, Idera is
withholding naming the specific target until the second half of
2017. Idera has selected a well-established liver target,
with available, validated pre-clinical animal models,
well-understood clinical endpoints, which has the potential for
both rare and broader disease applications. Idera is
currently conducting the IND-enabling toxicology for this program
and expects to file and IND and enter the clinic in 2018.
Toll-like Receptor (TLR)
Antagonism Dermatomyositis Clinical Development
ProgramIn late 2015, Idera announced the initiation of a
Phase 2 clinical trial of IMO-8400 in patients with
dermatomyositis, a rare auto-immune condition, which negatively
affects skin and may result in debilitating muscle weakness. TLRs
have been reported to play an important role in the pathogenesis of
the disease. This randomized, double-blind, placebo
controlled Phase 2 trial is expected to enroll 36 patients and is
being conducted at 22 clinical sites worldwide. The Company
plans to complete enrollment of this trial by the end of 2017 and
have clinical data available in 2018.
Financial Results
First Quarter ResultsNet loss
applicable to common stockholders for the three months ended March
31, 2017 was $15.1 million, or $0.10 per basic and diluted share,
compared to a net loss applicable to common stockholders of $12.8
million, or $0.11 per basic and diluted share, for the same period
in 2016. Research and development expenses for the three months
ended March 31, 2017 totaled $11.5 million compared to $9.3 million
for the same period in 2016. General and administrative expense for
the three months ended March 31, 2017 and March 31, 2016 were $4.1
million and $3.9 million, respectively.
As of March 31, 2017, our cash, cash equivalents
and investments totaled $91.3 million. We currently
anticipate our cash position is capable of funding our operations
into the second quarter of 2018.
About Idera Pharmaceuticals,
Inc.Idera Pharmaceuticals is a clinical-stage
biopharmaceutical company developing novel nucleic acid-based
therapies for the treatment of certain cancers and rare diseases.
Idera’s proprietary technology involves using a TLR-targeting
technology, to design synthetic oligonucleotide-based drug
candidates to act by modulating the activity of specific TLRs. In
addition to its TLR programs, Idera has created a third generation
antisense technology platform using its proprietary technology to
inhibit the production of disease-associated proteins by targeting
RNA. 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, 2016 and the Quarterly
Report on Form 10-Q for the period ended March 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,
Inc. Condensed Statements of Operations (In thousands, except per
share data) |
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
March 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
Alliance Revenue |
$ |
378 |
|
|
$ |
294 |
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
Research &
Development |
|
11,485 |
|
|
|
9,296 |
|
|
|
|
|
|
|
General &
Administrative |
|
4,081 |
|
|
|
3,916 |
|
|
|
|
|
|
|
Total Operating
Expenses |
|
15,566 |
|
|
|
13,212 |
|
|
|
|
|
|
|
Loss from
Operations |
|
(15,188 |
) |
|
|
(12,918 |
) |
|
|
|
|
|
|
Other Income (Expense),
Net |
|
131 |
|
|
|
95 |
|
|
|
|
|
|
|
Net Loss |
$ |
(15,057 |
) |
|
$ |
(12,823 |
) |
|
|
|
|
|
|
Basic and diluted net
loss per common share applicable to common stockholders |
$ |
(0.10 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
Shares used in
computing basic and diluted net loss per common share applicable to
common stockholders |
|
149,100 |
|
|
|
121,284 |
|
|
|
|
|
|
|
|
|
|
|
|
Idera Pharmaceuticals,
Inc.Condensed Balance Sheet Data(In thousands) |
|
|
|
|
|
|
|
|
|
|
At March 31 |
|
At December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
Cash, Cash Equivalents
& Investments |
$ |
91,262 |
|
|
$ |
109,014 |
|
|
Other Assets |
|
6,311 |
|
|
|
4,217 |
|
|
Total Assets |
$ |
97,573 |
|
|
$ |
113,231 |
|
|
|
|
|
|
|
Total Liabilities |
$ |
7,382 |
|
|
$ |
9,882 |
|
|
Total Stockholders'
Equity |
|
90,191 |
|
|
|
103,349 |
|
|
Total Liabilities &
Stockholders' Equity |
$ |
97,573 |
|
|
$ |
113,231 |
|
IDERA PHARMACEUTICALS Contact:
Robert A. Doody, Jr.
VP, Investor Relations & Communications
Phone (617) 679-5515
RDOODY@IDERAPHARMA.COM
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