Tekmira
Pharmaceuticals Corporation TKMR, a leading developer of
RNA interference (RNAi) therapeutics, today announced that its contract with
the U.S. Department of Defense (DoD) has been modified to support development
plans that integrate advancements in Tekmira's lipid nanoparticle (LNP)
formulation and manufacturing technologies, and provide for additional funding
for the TKM-Ebola program.
TKM-Ebola, an anti-Ebola viral therapeutic, is being developed under a
contract with the U.S. DoD's Joint Project Manager Transformational Medical
Technologies (JPM-TMT) Office with a total contract value of approximately
$140 million.
"We are pleased that since the initiation of the program in July 2010, our
productive collaboration with the JPM-TMT has expanded to include significant
advances in LNP formulation technology. The TKM-Ebola program will now
incorporate an LNP formulation that is more than 10 times as potent as the
previous formulation, and the most potent of all the LNP formulations
evaluated in clinical trials. Many of Tekmira's LNP technology innovations
around process development, manufacturing scale-up, and lyophilization have
been supported by JPM-TMT," said Dr. Mark J. Murray, Tekmira's President and
CEO.
Under the modification to the existing contract, funding has been increased by
$6.9 million, from $34.8 million to $41.7 million for the first phase of the
contract. The modification to the existing contract allows for the integration
of a more potent LNP formulation in the TKM-Ebola program as well as
advancements in manufacturing technology, including lyophilization. Tekmira
has initiated pre-clinical, chemistry, manufacturing and control studies that
support the use of these improvements in the program. Tekmira anticipates the
completion of these studies and a submission to the FDA in the second half of
2013 in order to support the use of the enhanced product in a Phase I clinical
trial. New data from the TKM-Ebola program will be presented at the 15^th
Annual TIDES Summit: Oligonucleotide and Peptide® Therapeutics from Research
through Commercialization taking place in Boston, MA from May 12-15, 2013.
About JPM-TMT
JPM-TMT is a component of the U.S. Department of Defense's Joint Program
Executive Office for Chemical and Biological Defense (JPEO-CBD). JPM-TMT aims
to protect the Warfighter from emerging infectious diseases, genetically
altered, and unknown biological threats. Through strategic investments and
partnerships with innovative biotech firms, pharmaceutical corporations, other
government agencies, and academic institutions, JPM-TMT facilitates the
advanced development and acquisition of adaptable platform technologies,
broad-spectrum medical countermeasures, and innovative systems to enhance our
nation's biodefense response capability. For more information, visit
www.jpmtmt.mil.
About RNAi and Tekmira's LNP
RNAi therapeutics have the potential to treat a broad number of human diseases
by "silencing" disease causing genes. The discoverers of RNAi, a gene
silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for
Physiology or Medicine. RNAi therapeutics, such as "siRNAs," require delivery
technology to be effective systemically. Tekmira believes its LNP technology
represents the most widely adopted delivery technology for the systemic
delivery of RNAi therapeutics. Tekmira's LNP platform is being utilized in
multiple clinical trials by both Tekmira and its partners. Tekmira's LNP
technology (formerly referred to as stable nucleic acid-lipid particles or
SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles
that are effective in delivering RNAi therapeutics to disease sites in
numerous preclinical models. Tekmira's LNP formulations are manufactured by a
proprietary method which is robust, scalable and highly reproducible, and
LNP-based products have been reviewed by multiple FDA divisions for use in
clinical trials. LNP formulations comprise several lipid components that can
be adjusted to suit the specific application.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on
advancing novel RNAi therapeutics and providing its leading lipid nanoparticle
delivery technology to pharmaceutical partners. Tekmira has been working in
the field of nucleic acid delivery for over a decade and has broad
intellectual property covering LNPs. Further information about Tekmira can be
found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
This news release contains "forward-looking statements" or "forward-looking
information" within the meaning of applicable securities laws (collectively,
"forward-looking statements"). Forward-looking statements are generally
identifiable by use of the words "believes," "may," "plans," "will,"
"anticipates," "intends," "budgets," "could," "estimates," "expects,"
"forecasts," "projects" and similar expressions, and the negative of such
expressions. Forward-looking statements in this news release include
statements about Tekmira's strategy, future operations, clinical trials,
prospects and the plans of management; RNAi (ribonucleic acid interference)
product development programs; the effects of Tekmira's products on the
treatment of infectious disease; the quantum and timing of potential funding
from the U.S. DoD's JPM-TMT Office; the modifications to the TKM-Ebola
contract with the U.S. DoD's JPM-TMT Office to integrate recent advancements
in LNP formulation and manufacturing technology; the expected presentation of
data at the upcoming 15^th Annual TIDES Summit; expected timing of the
completion and submission of the LNP formulation work to the FDA and the
initiation of a Phase I clinical trial for TKM-Ebola; and, the quantum and
timing of funding that may be provided to Tekmira pursuant to the TKM-Ebola
contract with the U.S. DoD's JPM-TMT Office.
With respect to the forward-looking statements contained in this news release,
Tekmira has made numerous assumptions regarding, among other things: LNP's
status as a leading RNAi delivery technology; the effectiveness of Tekmira's
products as a treatment for infectious disease, or other diseases; the
developmental milestones and approvals required to trigger funding for
TKM-Ebola from the JPM-TMT Office; results in preclinical models are
indicative of the potential effect in humans; Tekmira's research and
development capabilities and resources; FDA approval with respect to
commencing clinical trials; the timing and obtaining of regulatory approvals
for Tekmira's products; the timing and results of clinical data releases and
use of LNP technology by Tekmira's development partners and licensees; the
time required to complete research and product development activities; the
timing and quantum of payments to be received under contracts with Tekmira's
partners including the U.S. DoD's JPM-TMT Office, and others; Tekmira's
financial position and its ability to execute on its business strategy; and
Tekmira's ability to protect its intellectual property rights and not to
infringe on the intellectual property rights of others. While Tekmira
considers these assumptions to be reasonable, these assumptions are inherently
subject to significant business, economic, competitive, market and social
uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause
Tekmira's actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or
implied by the forward-looking statements contained herein. Known risk factors
include, among others: payments received from third parties may not be
sufficient to fund Tekmira's continued business plan as currently anticipated;
Tekmira's ability to obtain and protect intellectual property rights, and
operate without infringing on the intellectual property rights of others;
Tekmira's research and development capabilities and resources will not meet
current or expected demand; Tekmira's development partners and licensees
conducting clinical trial, development programs and joint venture strategic
alliances will not result in expected results on a timely basis, or at all;
anticipated payments under contracts with Tekmira's collaborative partners may
not be received by Tekmira on a timely basis, or at all, or in the quantum
expected by Tekmira; Tekmira's products may not prove to be effective in the
treatment of infectious disease or other diseases; the possibility that other
organizations have made advancements in RNAi delivery technology that Tekmira
is not aware of; the FDA will not approve the commencement of Tekmira's
planned clinical trials or approve the use of Tekmira's products and
generally, difficulties or delays in the progress, timing and results of
clinical trials; the FDA may determine that the design and planned analysis of
Tekmira's clinical trials do not adequately address the trial objectives in
support of Tekmira's regulatory submissions; future operating results are
uncertain and likely to fluctuate; competition from other pharmaceutical or
biotechnology companies; anticipated payments under contracts with Tekmira's
collaborative partners including the U.S. DoD's JPM-TMT Office, will not be
received by Tekmira on a timely basis, or at all, or in the quantum expected
by Tekmira; the U.S. Government may reduce or cancel certain defense spending,
including Tekmira's contract to develop TKM-Ebola; FDA may require additional
pre-clinical, clinical or other studies, refuse to approve TKM-Ebola, or place
restrictions on our ability to commercialize TKM-Ebola; the release of data
from the TKM-Ebola Phase 1 human clinical trial may not occur in the expected
timeframe, or at all; Tekmira may not complete the work necessary for the
submission of the new LNP formulation to the FDA in the anticipated timeframe,
or at all; Tekmira may not initiate a new TKM-Ebola Phase 1 clinical trial in
the anticipated timeframe, or at all; pre-clinical and clinical trials may be
more costly or take longer to complete than anticipated; pre-clinical or
clinical trials may not generate results that warrant future development of
the tested drug candidate; and the possibility that Tekmira has not
sufficiently budgeted for expenditures necessary to carry out planned
activities.
A more complete discussion of the risks and uncertainties facing Tekmira
appears in Tekmira's annual report on Form 20-F for the year ended December
31, 2012 (Annual Report), which is available at www.sedar.com or at
www.sec.gov/edgar.shtml. All forward-looking statements herein are qualified
in their entirety by this cautionary statement, and Tekmira disclaims any
obligation to revise or update any such forward-looking statements or to
publicly announce the result of any revisions to any of the forward-looking
statements contained herein to reflect future results, events or developments,
except as required by law.
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