Oncorus, Inc. (Nasdaq: ONCR), an RNA medicines company focused on
developing intravenously administered, self-amplifying RNA to
transform outcomes for cancer patients, and Daewoong Pharmaceutical
Co., Ltd. (KRX: 069620), a leading South Korean pharmaceutical
company, today announced a research collaboration for the discovery
and development of novel lipid nanoparticle (LNP) formulations for
mRNA drug candidates.
Under the terms of the collaboration, Oncorus and Daewoong will
conduct joint research to identify and evaluate formulations of
Daewoong’s mRNAs encapsulated in Oncorus’ proprietary LNPs. Oncorus
will develop formulated drug candidates at its state-of-the-art
manufacturing facility in Andover, Massachusetts. Subject to the
parties’ satisfaction with the formulations and the achievement of
certain study milestones specified in the research plan, Oncorus
and Daewoong have agreed to commence negotiations of
a potential future license and supply arrangement for the
formulated product.
“This collaboration is important validation for our proprietary
LNP platform, which is comprised of both novel ionizable amines and
cleavable PEG lipids for both intravenous and intramuscular
administration, and we are excited to develop novel LNP
formulations for Daewoong’s RNA-based programs,” said Theodore
(Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer
of Oncorus. “With our optimized LNPs and manufacturing
capabilities, Oncorus is uniquely positioned to partner with
companies like Daewoong that are developing novel, RNA-based
therapeutics that would benefit from optimized LNP formulations. We
look forward to working closely with the Daewoong team on the first
of hopefully many similar partnerships to come.”
“mRNA is now known to be a powerful tool in our ability to fight
many diseases,” said Sengho Jeon, Chief Executive Officer of
Daewoong. “Oncorus offers a robust solution to enabling mRNA
delivery through the pairing of its proprietary LNP technology and
in-house process development, with the capacity to manufacture a
successful mRNA/LNP formulation on both clinical and commercial
scales. We are excited to work with Oncorus to optimize our mRNA
drug delivery as we work to improve the quality of life for
patients around the world.”
Oncorus’ LNP platform leverages proprietary ionizable and
polyethylene glycol (PEG) lipids for multiple nucleic acid cargos
and possesses other desirable physiochemical properties. In
multiple preclinical models involving repeat intravenous (IV)
dosing, Oncorus’ formulations have demonstrated improved
tolerability, an enhanced therapeutic window and consistent
pharmacokinetics compared to approved formulations. Similar studies
incorporating Oncorus’ LNP formulations have demonstrated low
immunogenicity along with other desirable attributes, including
tunable pharmacokinetics with different compositions and stable
pharmacokinetics following repeat dosing. The platform is designed
to efficiently deliver nucleic acids, including large cargos up to
14 kilobases. This delivery strategy is intended to address many of
the complications associated with anti-PEG antibodies interfering
with the effective IV delivery of RNA and other nucleic acid-based
medicines and can also be leveraged for vaccine applications.
About Oncorus
At Oncorus, we are focused on driving innovation in RNA
medicines by developing next-generation immunotherapies to
stimulate the immune system and transform outcomes for cancer
patients. Our self-amplifying RNA immunotherapy platform improves
upon key characteristics of this therapeutic class to enhance
systemic activity. ONCR-021, our lead product candidate for
non-small cell lung and other cancers, is an IV-administered RNA
encoding an optimized Coxsackievirus 21A (CVA21) genome,
encapsulated within an LNP for non-small cell lung and other
cancers.
Please visit www.oncorus.com to learn more.
About
Daewoong Pharmaceutical
Established in 1945, Daewoong Pharmaceutical Co., Ltd. is a
leading South Korean pharmaceutical company that develops,
manufactures, and commercializes pharmaceuticals for both domestic
and international markets. With a strong and innovative in-house
R&D and advanced manufacturing facilities, Daewoong provides a
total healthcare solution to customers across the globe. Continuing
on their course of building a strong global healthcare company,
Daewoong has broadened international operations by establishing
branch offices and research centers throughout Asia and the United
States. Daewoong has also expanded strategic partnerships in more
than 100 countries worldwide.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, implied and
express statements regarding Oncorus’ plans to develop formulated
drug in accordance with the research collaboration with Daewoong;
the parties plans to commence negotiation of a subsequent license
and manufacturing and supply arrangement for the formulated drug;
the promise of LNP-based delivery mechanisms; and the opportunity
for future partnerships relative to Oncorus’ LNP platform. The
words “may,” “might,” “will,” “could,” “would,” “should,” “expect,”
“plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,”
“seek,” “predict,” “future,” “project,” “potential,” “continue,”
“target” and similar words or expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Any forward-looking
statements in this press release are based on management’s current
expectations and beliefs and are subject to a number of risks,
uncertainties and important factors that may cause actual events or
results to differ materially from those expressed or implied by any
forward-looking statements contained in this press release,
including, without limitation, risks associated with: Oncorus’
ability to successfully demonstrate the safety, tolerability and
efficacy of its product candidates and obtain regulatory approval
thereof; the adequacy of Oncorus’ existing capital resources and
availability of financing on commercially reasonable terms;
Oncorus’ ability to obtain the requisite components for its product
candidates manufactured in accordance with regulatory requirements;
the expansion of Oncorus’ in-house manufacturing capabilities and
its ability to manufacture product at clinical and commercial
scales; the impact of COVID-19 on Oncorus’ operations and the
timing and anticipated results of its ongoing and planned clinical
trials; the accuracy of the Oncorus’ estimates regarding expenses,
future revenue, capital requirements and needs for additional
financing; and Oncorus’ ability to obtain, maintain and protect its
intellectual property. These and other risks and uncertainties are
described in greater detail in the section entitled “Risk Factors”
in Oncorus’ Annual Report on Form 10-K for the year ended December
31, 2021, filed with the Securities and Exchange Commission (“SEC”)
on March 9, 2022, and Oncorus’ Quarterly Reports on Form 10-Q for
the quarters ended March 31, 2022, June 30, 2022 and September 30,
2022, filed with the SEC on May 4, 2022, August 4, 2022 and
November 2, 2022, respectively, as well as discussions of potential
risks, uncertainties, and other important factors in the other
filings that Oncorus makes with the SEC from time to time. These
documents are available under the “SEC filings” page of the
Investors section of Oncorus’ website at
http://investors.oncorus.com. Any forward-looking statements
represent Oncorus’ views only as of the date of this press release
and should not be relied upon as representing its views as of any
subsequent date. Oncorus explicitly disclaims any obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by law.
No representations or warranties (expressed or implied) are made
about the accuracy of any such forward-looking statements.
Oncorus Investor Contact:Stern Investor
Relations Julie SeidelJulie.seidel@sternir.com
Daewoong Pharmaceutical Investor
Contact:Thierry Uhthierryur@daewoong.co.kr
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