Oncorus Announces Publication in Nature Communications Highlighting the Development of its Intravenously Administered Synthetic vRNA/LNP Platform for the Treatment of Cancer
October 07 2022 - 9:00AM
Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company
focused on stimulating the immune system to transform outcomes for
cancer patients, today announced the publication of preclinical
data in Nature Communications highlighting the potential of its
synthetic viral RNA (vRNA)/lipid nanoparticle (LNP) platform as a
novel approach to treating cancer by enabling repeat intravenous
(IV) administration of viral immunotherapy. Data published today
demonstrate vRNA/LNP delivery and selective replication, virus
assembly, spread and lysis of tumor cells, leading to potent
anti-tumor efficacy even in the presence of virus neutralizing
antibodies in the bloodstream.
The article describes the design and development of Oncorus’
synthetic RNA viruses for the systemic treatment of cancer. The IV
delivery of viral RNA genomes for two picornaviruses, Seneca Valley
Virus (SVV) and Coxsackievirus A21 (CVA21), was formulated in LNPs.
By encapsulating vRNA in LNPs, Oncorus was able to recapitulate
oncolytic viral therapy in various tumor cells and avoid
neutralizing antibodies. The vRNA/LNP constructs were well
tolerated and elicited tumor-specific in situ production of
oncolytic virions, immune cell recruitment and tumor destruction.
Efficacy was observed across multiple cancer models, including
xenografts, PDX, GEMM and syngeneic models, with survival benefit
observed in an orthotopic small cell lung cancer (SCLC) tumor
model. Overall, synthetic RNA viruses were well tolerated after a
single or multiple IV dose in mice and non-human primates. These
results support the potential of this modality to expose all tumor
lesions within a patient to a potently living drug that can both
kill tumor cells and stimulate the immune system to fight cancer
more effectively.
“Oncorus has made great strides in the development of viral RNA
encapsulated within LNPs, and this publication is an important
first step in realizing the potential of our platform as we
progress this highly innovated approach into the clinic. We are
focused on overcoming the neutralizing antibodies seen in previous
studies incorporating IV-administration of RNA-based oncolytic
therapeutics which has likely limited their effectiveness today and
believe that our data supports the ability our self-amplifying
vRNA/LNP constructs to overcome these challenges,” said Theodore
(Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer
of Oncorus. “As demonstrated in animal models outlined here, we’ve
established a way to simultaneously cause direct tumor cell killing
in addition to broad immune stimulation in multiple tumors through
an IV-administered self-amplifying RNA encapsulated within an LNP.
We look forward to progressing our first candidate from this
platform, ONCR-021, in patients with non-small cell lung cancer,
renal cell carcinoma, melanoma and hepatocellular carcinoma. We
plan to submit an IND with the U.S. FDA for this program in
mid-2023,” said Matthew Kennedy, Ph.D., Vice President of Research
at Oncorus and the lead author on this paper.
Oncorus has built a pioneering platform addressing significant
unmet needs in cancer immunotherapy treatment. This novel
IV-administered approach involves encapsulating the RNA genomes of
viruses known to kill cancer cells in an LNP, resulting in a
vRNA/LNP immunotherapy. Oncorus’ LNP delivery strategy is intended
to be less immunogenic than a natural viral capsid and is designed
to overcome the challenges caused by neutralizing antibodies. Using
its platform, Oncorus has developed two vRNA/LNP immunotherapy
programs, ONCR-021 and ONCR-788, which are based on CVA21 and SVV,
respectively. The Company plans to submit an investigational new
drug (IND) application with the U.S Food and Drug Administration
(FDA) for ONCR-021 in mid-2023.
About Oncorus
At Oncorus, we are focused on driving innovation to deliver
next-generation viral immunotherapies to stimulate the immune
system to outcomes for cancer patients. We are advancing a
portfolio of intratumorally (iTu) and intravenously (IV)
administered viral immunotherapies for multiple indications with
significant unmet need based on our Herpes Simplex Virus (HSV) and
self-amplifying viral RNA/LNP Immunotherapy Platforms.
Designed to deliver next-generation viral immunotherapy impact,
our HSV Platform improves upon key characteristics of this
therapeutic class to enhance systemic activity. Our lead HSV
program which currently in the clinic, ONCR-177, is designed to be
directly administered into a tumor, resulting in high local
concentrations of the therapeutic agent and its five encoded
transgenes, as well as low systemic exposure to the therapy, which
could limit systemic toxicities. Our pioneering self-amplifying
vRNA/LNP Platform, highlighted by our product candidates ONCR-021
and ONCR-788, involves a highly innovative, novel combination of
RNA and LNP-based modalities designed to realize the potential of
RNA medicines for cancer.
Please visit www.oncorus.com to learn more.
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 expectations regarding timing for submitting
an IND for ONCR-021, as well as the product candidate’s therapeutic
potential and clinical benefits and the utility and potential of
Oncorus’ synthetic viral RNA (vRNA)/lipid nanoparticle (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; 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’
subsequent Quarterly Reports on Form 10-Q, 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.
Investor Contact:Stern Investor
Relations Julie SeidelJulie.seidel@sternir.com
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