ProNAi Therapeutics Will Develop Oncology-Focused Compounds Utilizing Its Proprietary DNAi Technology Combined With Marina Biotech's Novel SMARTICLES(R) Liposomal Delivery Technology
BOTHELL, WA and ANN ARBOR, MI, Mar 14, 2012 (MARKETWIRE via COMTEX) --Marina Biotech, Inc. (OTCQX: MRNA), a leading nucleic acid-based
drug discovery and development company, and ProNAi Therapeutics, Inc.
(ProNAi), a privately-held biotechnology company pioneering DNA
interference (DNAi) therapies for cancer, announced today that the
Companies have entered into an Exclusive License Agreement regarding
the development and commercialization of DNAi-based therapeutics
utilizing Marina Biotech's novel SMARTICLES(R) liposomal delivery
technology. ProNAi will have full responsibility for the development
and commercialization of any products arising under the Agreement.
Under terms of the Agreement, Marina Biotech could receive up to $14
million for each gene target in total upfront, clinical and
commercialization milestone payments, as well as royalties on sales,
with ProNAi having the option to select any number of additional gene
targets. For example, if ProNAi licenses five products over time
under this Agreement, Marina Biotech could receive up to $70 million
in total milestones, plus royalties. Further terms of the Agreement
were not disclosed.
"We are pleased that twenty-two patients have been dosed with PNT2258
in our Phase I clinical trial in advanced solid tumor patients to
evaluate safety and tolerability, maximum tolerated dose,
pharmacokinetics and pharmacodynamics. PNT2258 is our first DNAi
oligonucleotide targeted against the anti-apoptotic bcl-2 oncogene
and encapsulated in Marina's SMARTICLES(R) technology. This novel
delivery technology offers protection for the DNAi oligonucleotide
during systemic administration with good circulation times and
extrahepatic tumor exposure. DNAi are short single-strand unmodified
oligonucleotides designed to silence genes by interfering with DNA.
The DNAi silencing approach is differentiated from that of RNAi,
antisense or miRNA in that it targets genomic sequences within the
noncoding region of DNA disrupting transcription. The progress and
delivery validation in the clinic this past year on the novel
DNAi-SMARTICLES(R) formulation gives us confidence to bring forward
more first-in-class drug candidates alone or with partners. ProNAi is
now positioned to advance additional cancer therapies from its
pre-clinical leads targeting other oncogenes such as c-myc and k-ras
while also exploring other disease targets in areas such as
inflammation and genetics diseases," said Charles L. Bisgaier, Ph.D.,
President and CEO of ProNAi Therapeutics.
"We are extremely pleased to have entered into a relationship with a
company like ProNAi that is developing a first-in-class nucleic acid
therapeutic," stated J. Michael French, President and CEO of Marina
Biotech. "In addition, we are excited to see the continued
advancement of oligonucleotide-based therapeutics using our
SMARTICLES(R) technology. Besides advancements within our own
internal research programs, we have now been able to establish two
license agreements broadening the application of the SMARTICLES(R)
technology to the systemic administration of both single- and
double-stranded oligonucleotide therapeutics. We look forward to the
rapid advancement of ProNAi Therapeutics' clinical pipeline and the
opportunity to bring novel therapeutics to patients in need."
ProNAi is conducting an open-label, single arm, Phase I
dose-escalation study of PNT2258 in patients with advanced solid
tumors for which no standard therapy exists at START in San Antonio,
Texas. PNT2258 is ProNAi's first drug candidate from the DNAi drug
platform. Patients receive PNT2258 as an intravenous infusion once
daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3
weeks). ProNAi plans to report the results of this Phase I study at
oncology conferences later this year and initiate the next Phase I/II
safety and efficacy studies in select cancer patients based upon the
safety and dose findings from this Phase I study.
About Marina Biotech, Inc.
Marina Biotech is a biotechnology company
focused on the development and commercialization of
oligonucleotide-based therapeutics utilizing multiple mechanisms of
action including RNA interference (RNAi) and messenger RNA
translational blocking. The Marina Biotech pipeline currently
includes a clinical program in Familial Adenomatous Polyposis (a
precancerous syndrome) and two preclinical programs -- in bladder
cancer and malignant ascites. Marina Biotech entered into an
exclusive agreement with The Debiopharm Group for the development and
commercialization of the bladder cancer program. In addition, Marina
Biotech has entered into an agreement with Mirna Therapeutics to
license Marina Biotech's SMARTICLES(R) technology for the delivery of
microRNA mimics. Marina Biotech's goal is to improve human health
through the development of RNAi- and oligonucleotide-based compounds
and drug delivery technologies that together provide superior
therapeutic options for patients. Additional information about Marina
Biotech is available at http://www.marinabio.com.
About ProNAi Therapeutics, Inc.
ProNAi Therapeutics, Inc. is a
venture backed, clinical stage, biotech company pioneering a new
class of targeted drugs based on utilizing single strands of
unmodified DNA oligonucleotides to target genomes responsible for
complex, proliferative diseases initially in cancer. The Company's
lead drug candidate, PNT2258, has demonstrated safety and in vivo
efficacy in a variety of preclinical tumor xenograft models. The
Company has successfully raised over $20 million from Apjohn
Ventures, Grand Angels, the State of Michigan, Biosciences Research
and Commercialization Center (BRCC), Amherst Fund and private
investors. Additional information about ProNAi Therapeutics is
available at http://www.pronai.com.
Statements made in this news release may
be forward-looking statements within the meaning of Federal
Securities laws that are subject to certain risks and uncertainties
and involve factors that may cause actual results to differ
materially from those projected or suggested. Factors that could
cause actual results to differ materially from those in
forward-looking statements include, but are not limited to: (i) the
ability of Marina Biotech to obtain additional funding; (ii) the
ability of Marina Biotech to attract and/or maintain manufacturing,
research, development and commercialization partners; (iii) the
ability of Marina Biotech and/or a partner to successfully complete
product research and development, including preclinical and clinical
studies and commercialization; (iv) the ability of Marina Biotech
and/or a partner to obtain required governmental approvals; and (v)
the ability of Marina Biotech and/or a partner to develop and
commercialize products prior to, and that can compete favorably with
those of, competitors. Additional factors that could cause actual
results to differ materially from those projected or suggested in any
forward-looking statements are contained in Marina Biotech's most
recent periodic reports on Form 10-K and Form 10-Q that are filed
with the Securities and Exchange Commission. Marina Biotech assumes
no obligation to update and supplement forward-looking statements
because of subsequent events.
Statements made in this news release may be forward-looking
statements within the meaning of Federal Securities laws that are
subject to certain risks and uncertainties and involve factors that
may cause actual results to differ materially from those projected or
suggested. Factors that could cause actual results to differ
materially from those in forward-looking statements include, but are
not limited to: (i) the ability of ProNAi to obtain additional
funding; (ii) the ability of ProNAi Therapeutics to attract and/or
maintain manufacturing, research, development and commercialization
partners; (iii) the ability of ProNAi and/or a partner to
successfully complete product research and development, including
preclinical and clinical studies and commercialization; (iv) the
ability of ProNAi Therapeutics and/or a partner to obtain required
governmental approvals; and (v) the ability of ProNAi Therapeutics
and/or a partner to develop and commercialize products that can
compete favorably with those of competitors.
Marina Biotech, Inc.
Interim Chief Financial Officer
ProNAi Therapeutics, Inc.
Wendi Rodrigueza, Ph.D.
Vice President, Product Development
SOURCE: Marina Biotech, Inc.