- Companies
Aim to Bring Together LinearDNA™ and Spindle Biotech’s Proprietary
Engineered RNA Polymerase to Develop a Next-Generation, Cell-Free
mRNA Production Platform -
Applied DNA Sciences,
Inc. (NASDAQ: APDN) (the
“Company”), a leader in cell-free, enzymatic DNA production, and
Spindle Biotech Inc. (“Spindle Biotech”), a company focused on the
development of a novel, high yield, and low-cost RNA production
systems, today announced that the two companies have executed a
non-binding letter of intent (“LOI”) that outlines the terms of a
collaborative research agreement (the “Definitive Agreement”) to
investigate the feasibility of utilizing the Company’s LinearDNATM
platform to produce chemically modified DNA templates for use in
Spindle Biotech’s proprietary, high yield RNA manufacturing system.
The companies believe the combination of their respective platforms
provides for a simplified, high yield, and 100% cell-free workflow
that is differentiated from current mRNA production that uses
plasmid DNA (pDNA). In addition to increased speed and purity, the
use of LinearDNA as an IVT template for mRNA production removes
several complex manufacturing steps necessitated by
pDNA.
The companies believe that
Spindle Biotech’s proprietary, high yield, and engineered RNA
polymerase, which requires a chemically modified DNA template, is
particularly well suited to leverage the unique advantages of
Applied DNA’s PCR-based LinearDNA platform. Under the proposed
Definitive Agreement terms, Applied DNA will produce specialized
IVT DNA templates for RNA transcription using Spindle Biotech’s RNA
polymerase. Following initial validation work, the companies intend
to explore the commercialization of an mRNA production system that
leverages the benefits of the companies’ respective
platforms.
Dr. James A. Hayward,
president and CEO of Applied DNA, stated, “We believe that
Spindle’s mRNA manufacturing approach is a very good fit for our
LinearDNA platform, which excels at the efficient production of
chemically modified DNA constructs. As demand for mRNA therapeutics
grows, Spindle Biotech and we are pursuing a simplified and
efficient method to produce mRNAs with potential advantages in
terms of cost, complexity, and production time versus standard pDNA
methods to produce mRNA.”
Added Aaron Chung, CEO of
Spindle Biotech, “Our preliminary studies suggest that a chemically
modified LinearDNA-based IVT construct transcribed with our
engineered RNA polymerase can offer at least five to ten-fold
improvement in yield compared to conventional mRNA production
methods using a wild-type T7 RNA polymerase. We believe that the
increase in yield coupled with the speed and simplicity of the
LinearDNA platform offers compelling advantages over legacy mRNA
production methods. Combining Applied DNA’s LinearDNA production
technology and Spindle's proprietary RNA synthesis technology, the
two companies can provide tremendous value to the mRNA community
with a complete package of high-quality, scalable, and rapid mRNA
manufacturing with minimal change to customers' existing mRNA
production pipeline.”
Completion of the Definitive
Agreement is subject to the negotiation and successful execution of
the Agreement by both companies. Accordingly, there can be no
assurance that the Definitive Agreement will be entered into by the
parties.
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary,
large-scale polymerase chain reaction ("PCR")-based manufacturing
platform that allows for the large-scale cell-free production of
specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in
vitro diagnostics and preclinical nucleic acid-based drug
development and manufacturing market. The platform is used to
manufacture DNA for customers as components of in vitro diagnostic
tests and for preclinical nucleic acid-based drug development in
the fields of adoptive cell therapies (CAR T and TCR T therapies),
DNA vaccines (anti-viral and cancer), RNA therapies, clustered
regularly interspaced short palindromic repeats (CRISPR) based
therapies, and gene therapies.
The LinearDNA platform also has non-biologic applications, such
as supply chain security, anti-counterfeiting and anti-theft
technology. Key end-markets include textiles, pharmaceuticals and
nutraceuticals, and cannabis, among others.
Leveraging its deep expertise in nucleic acid-based
technologies, the Company has also established safeCircle™, a high-
turnkey solution for population-scale COVID-19 testing. safeCircle
is designed to look for infection within defined populations or
communities utilizing high throughput testing methodologies that
increase testing efficiencies and provide for rapid
turn-around-times.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list.
The Company's common stock is listed on NASDAQ under the ticker
symbol 'APDN,' and its publicly traded warrants are listed on OTC
under the ticker symbol 'APPDW.'
Applied DNA is a member of the Russell Microcap® Index.
About Spindle Biotech Inc.
Spindle Biotech Inc. is commercializing a proprietary RNA
polymerase for large-scale mRNA vaccine production. Recent advances
in mRNA technology have shown the growing importance of synthetic
RNA in biological systems due to its desirable transient property.
Typical mRNA vaccine companies spend up to 60% of their cost of
goods on raw materials such as enzymes and DNA templates. Spindle's
platform provides a unique solution in producing high-quality RNA
on-demand and in high yield, significantly reducing the cost of
goods for mRNA production. The company will initially focus on
commercializing mRNA production, then on other biomolecules
syntheses, such as protein or antibody, for broader biological
applications.
Forward-Looking Statements
The statements made by Applied DNA in this press release may be
“forward-looking” in nature within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and the Private Securities Litigation Reform Act of
1995. Forward-looking statements describe Applied DNA’s future
plans, projections, strategies, and expectations, and are based on
assumptions and involve a number of risks and uncertainties, many
of which are beyond the control of Applied DNA. Actual results
could differ materially from those projected due to, its history of
net losses, limited financial resources, limited market acceptance,
the uncertainties inherent in research and development, future
clinical data and analysis, including whether any of Applied DNA’s
or its partner’s therapeutic candidates or manufacturing platforms
will advance further in the preclinical research or clinical trial
process, including receiving clearance from the U.S. Food and Drug
Administration (FDA), United State Department of Agriculture (USDA)
or equivalent foreign regulatory agencies to conduct clinical
trials and whether and when, if at all, they will receive final or
conditional approval from the FDA, USDA or equivalent foreign
regulatory agencies, the unknown outcome of any applications or
requests to FDA, USDA or equivalent foreign regulatory agencies,
whether results from preclinical studies will be predictive of the
results of later preclinical studies and clinical trials, the
unknown ability to manufacture therapeutic grade DNA in large
quantities, the fact that there has never been a commercial drug
product utilizing PCR-produced DNA technology approved for
therapeutic use, and various other factors detailed from time to
time in Applied DNA’s SEC reports and filings, including our Annual
Report on Form 10-K filed on December 9, 2021, its Quarterly Report
on Form 10-Q filed on February 10, 2022 and other reports it files
with the SEC, which are available at www.sec.gov. Applied DNA
undertakes no obligation to update publicly any forward-looking
statements to reflect new information, events, or circumstances
after the date hereof or to reflect the occurrence of unanticipated
events, unless otherwise required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20220314005242/en/
For Applied DNA: Investor Relations Contact:
Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com Program
Contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
Web: www.adnas.com Twitter: @APDN
For Spindle Biotech: Program Contact: Aaron Chung,
226-978-2879, aaronchung@spindle.bio Web:
https://spindle.bio/
Applied DNA Sciences (NASDAQ:APDN)
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