Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), a clinical stage
biopharmaceutical company developing a novel therapeutic approach for
the treatment of autoimmune diseases and genetically defined forms of
B-cell lymphoma, today announced that it has strengthened its clinical
development expertise through the addition of two industry veterans with
track records of success in bringing novel therapeutic products to
market.
Lou Brenner, MD, has joined the company as Senior Vice President and
Chief Medical Officer, building on more than a decade of leadership
experience that has encompassed clinical development strategy,
regulatory affairs, medical affairs, and product commercialization. Dr.
Brenner joins Idera from Radius Health, where he served as Senior Vice
President and Chief Medical Officer. He had earlier served in key roles
at AMAG Pharmaceuticals and Genzyme.
Dr. Brenner has designed, planned, and directed successful clinical
trials at all stages and in multiple indications, including managing the
late stage development and regulatory submission for Feraheme®, an
FDA-approved product for the treatment of iron deficiency anemia in
adult patients with chronic kidney disease. At Radius, he led the
conduct of a large, ongoing Phase 3 trial of a novel candidate for the
treatment of osteoporosis. Previously at Genzyme, he led global
commercial planning for the launch of Renvela®, a next-generation
phosphate binder for patients with chronic kidney disease, and also led
the business development efforts for the Renal and Transplant Business
Units. Dr. Brenner holds an MD from Duke University and an MBA from
Harvard Business School, and completed his residency in Internal
Medicine at Brigham and Women’s Hospital, as well as a Fellowship in
Nephrology at Brigham and Women’s Hospital and Massachusetts General
Hospital. Dr. Brenner holds a clinical appointment at Brigham and
Women’s Hospital.
“We are pleased to welcome Lou to the Idera team, further strengthening
our management depth at a time when we are advancing multiple clinical
stage programs,” said Sudhir Agrawal, D. Phil., Chief Executive Officer
of Idera Pharmaceuticals. “Lou’s breadth of experience in clinical
design and development, regulatory strategy and commercial preparedness
will be a strong asset for us as we work to advance clinical development
of our candidates in genetically defined forms of B-cell lymphomas and
orphan autoimmune diseases.”
Newly-appointed Board Member Mark Goldberg, MD, has served as Senior
Vice President for Medical and Regulatory Affairs at Synageva BioPharma
since September 2011. Before joining Synageva, he served in management
capacities of increasing responsibility at Genzyme from 1996 to 2011,
including most recently as Senior Vice President for Clinical
Development and Global Therapeutic Group Head for Oncology and
Personalized Genetic Health. While at Genzyme, Dr. Goldberg played a key
role in the development and approval of four successful orphan
therapies: Fabrazyme®, Aldurazyme®, Myozyme® and Lumizyme®.
Prior to joining Genzyme, he was a full-time staff physician at Brigham
and Women's Hospital and the Dana-Farber Cancer Institute, where he
still holds appointments. Dr. Goldberg is a board-certified medical
oncologist and hematologist and has published more than 50 papers.
In welcoming Dr. Goldberg to the Idera Board of Directors, Chairman Jim
Geraghty said, “Mark is a recognized industry leader in the development
of novel therapies for oncology and orphan diseases, and has been a
driving force behind multiple clinically and commercially important
products. His appointment brings new depth to the Idera Board, and will
help guide both the execution of our ongoing programs and the strategic
prioritization of the many additional clinical opportunities currently
before us.”
The strengthening of Idera’s senior management team comes at a time of
strong progress and momentum for the company, which recently announced
the initiation of clinical development of its Toll-like receptor (TLR)
antagonist IMO-8400 in Waldenström’s macroglobulinemia. The Company’s
program is targeted to patients with the L265P oncogenic mutation of the
MYD88 gene, which is highly characteristic of Waldenström’s
macroglobulinemia and is reportedly influenced by TLR activation.
IMO-8400 blocks the activation of the TLR signaling pathway and
represents a novel approach to the treatment of these patients.
In addition to its clinical development in Waldenström’s
macroglobulinemia, Idera plans to submit a protocol to the FDA this
quarter to conduct a Phase 1/2 trial in patients with diffuse large
B-cell lymphoma (DLBCL). The L265P mutation of the MYD88 gene has been
identified in approximately 30% of patients with the activated
B-cell-like (ABC) type of DLBCL.
In its autoimmune disease program, the Company is conducting a
randomized, double-blind, placebo-controlled Phase 2 trial of IMO-8400
in patients with moderate-to-severe plaque psoriasis. The Company
expects to report data from this trial in the first half of 2014. In
addition, Idera has begun a strategic review of orphan autoimmune
indications with unmet needs that it believes are suited to Toll-like
receptor (TLR) antagonist therapy, and expects to identify priority
indications in early 2014.
About Idera Pharmaceuticals, Inc.
Idera's technology platform involves creating novel synthetic RNA- and
DNA-based compounds to modulate immune responses. Idera has applied this
platform to develop proprietary Toll-like receptor (TLR) antagonists as
immunomodulatory drug candidates. Toll-like receptor antagonists block
the over-activation of immune factors which can cause a range of
pathological effects. Idera is conducting clinical development of TLR
antagonists in autoimmune and inflammatory diseases, and in certain
genetically defined forms of B-cell lymphoma. More information on Idera
is available at www.iderapharma.com.
Forward Looking Statements
This press release includes statements concerning Idera Pharmaceuticals,
Inc. and its future expectations, plans and prospects that constitute
forward-looking statements within the meaning of The Private Securities
Litigation Reform Act of 1995 and that involve a number of risks and
uncertainties. For this purpose, any statements contained herein that
are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the words
"believes," "anticipates," "plans," "expects," "estimates," "intends,"
"should," "could," "will," "may," and similar expressions are intended
to identify forward-looking statements. There are a number of important
factors that could cause Idera's actual results to differ materially
from those indicated by such forward-looking statements, including
whether results obtained in early research, preclinical studies and
clinical trials will be indicative of the results that will be generated
in future preclinical and clinical studies; whether regulatory
submissions will be made when anticipated; whether products based on
Idera's technology will advance into or through the clinical trial
process on a timely basis or at all and receive approval from the FDA 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 Idera's Quarterly Report on Form 10-Q for the
period ended September 30, 2013, which important factors are
incorporated herein by reference. Idera disclaims any intention or
obligation to update any forward-looking statements.
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