Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company
focused on driving innovation to transform outcomes for cancer
patients, today announced the nomination of its first Synthetic
viral RNA (vRNA) immunotherapy clinical candidates, ONCR-021 and
ONCR-788. Oncorus’ pioneering intravenous (IV)-administered
approach involves encapsulating the genomes of RNA viruses known to
kill cancer cells (i.e., oncolytic viruses, or OVs) in a lipid
nanoparticle (or LNP), creating a Synthetic vRNA immunotherapy.
ONCR-021 encodes an optimized strain of Coxsackievirus A21 (CVA21),
and ONCR-788 encodes for a modified version of the Seneca Valley
Virus (SVV). Both CVA21 and SVV have extensive clinical experience
and favorable safety profiles when administered IV. Oncorus’ novel
Synthetic vRNA approach holds the potential for IV-administration
and avoids the challenge of neutralizing antibodies seen in
previous approaches with IV-administered OVs. Oncorus plans to
investigate its novel Synthetic vRNA immunotherapies in multiple
histologies including cancers of the lung both as monotherapy and
in combination with immune checkpoint inhibitors and other cancer
treatments.
“There has been a notable rise in the development and approval
of RNA-based vaccines, most prominently for COVID-19, and
therapeutics for certain rare diseases. To date, however, there are
no approved RNA-based cancer therapies. Simultaneously, the
therapeutic benefit of viral immunotherapy has been limited to
intratumoral (iTu) administration, restricting broader applications
of this modality. In addition, past investigational programs that
utilized IV-administered natural OVs faced the challenge of
neutralizing antibodies which likely hinders the clinical efficacy
of later doses. Our proprietary Synthetic vRNA Immunotherapy
Platform involves a highly innovative, novel combination of RNA-
and OV-based modalities and, in doing so, holds the potential to
create a new pillar in cancer therapy,” said Theodore (Ted)
Ashburn, M.D., Ph.D., President and CEO of Oncorus.
LNP-encapsulated IV-administered vRNA to create a “living
immunostimulatory drug”Developing IV-administered RNA medicines for
cancer requires addressing two primary technological hurdles:
first, getting adequate concentrations of the RNA-based drug
candidate to all tumor cells, and second, limiting exposure to
normal tissue throughout the body.
OVs, through rapid, self-amplification of their genomes in
permissive cells and their ability to infect nearby cancer cells,
are a potential answer to the challenge of the suboptimal LNP
delivery of cargo RNA to tumor cells. In addition, OVs are selected
or engineered to replicate more robustly in cells with deficiencies
in antiviral responses, as is the case for cancer cells. OVs’
selectivity for tumors ensures that their genomes, when delivered
by LNP, are minimally or not at all replicating in healthy tissues,
thus potentially providing a large therapeutic window for Oncorus’
Synthetic vRNA immunotherapy candidates. Furthermore, the
immunogenic cell death triggered by OVs, and the release of tumor
antigens in an inflamed tumor microenvironment, are expected to
broadly stimulate the immune system in its fight against
cancer.
“Taken together, the oncolytic and immunogenic properties of
OVs, combined with the broad tissue distribution enabled by
IV-administered LNPs and the tumor selective self-amplification
afforded by vRNA, opens the door to the successful application of
IV-administered RNA medicines in cancer,” explained Dr. Ashburn.
“This approach holds the promise of improving outcomes for patients
across multiple types of cancer, in particular those with cancers
of the lung.”
Christophe Quéva, Ph.D., Oncorus’ Chief Scientific Officer,
said, “We are proud of our team’s work to advance both our
oncolytic Herpes Simplex Virus and Synthetic Viral RNA
Immunotherapy Platforms. With this dual-platform strategy, we are
building a versatile pipeline of iTu-administered and
IV-administered viral immunotherapy product candidates that will
potentially enable the treatment of a broad range of cancer
settings. We continue to advance our lead oHSV candidate, ONCR-177,
through Phase 1 study, and we are working diligently to progress
our lead synthetic candidates, ONCR-021 and ONCR-788, into the
clinic.”
ONCR-021 and ONCR-788 Clinical Development and In-House GMP
Manufacturing
Oncorus plans to file an investigational new drug (IND)
application for ONCR-021 in the first half of 2023 to enable
clinical development for non-small cell lung cancer and other
cancers such as hepatocellular carcinoma, clear cell renal cell
carcinoma and melanoma, both as a single agent and in combination
with immune checkpoint inhibitors. Following the IND filing for
ONCR-021, Oncorus plans to file an IND for ONCR-788 to enable its
development in small cell lung cancer, neuroendocrine prostate and
other neuroendocrine cancers, both as a single agent and in
combination with immune checkpoint inhibitors and other cancer
treatments. In the process of developing ONCR-021 and ONCR-788,
Oncorus also developed and optimized a proprietary LNP platform for
delivery of large nucleic acids, with efficient endosomal escape.
Oncorus will manufacture ONCR-021 and ONCR-788 at its 88,000 square
foot state-of-the-art process development and Good Manufacturing
Practices (GMP) manufacturing facility in Andover, Mass. With the
site buildout underway, Oncorus plans to initiate process
development activities at the facility in the second half of 2021
and anticipates this facility will be operational for GMP
manufacturing in first half of 2023.
Link here to a white paper on Oncorus’ Synthetic vRNA
Immunotherapy Platform and lead candidates.
Upcoming Synthetic vRNA Immunotherapy-Focused Investor Event
Oncorus will host a virtual investor event on Monday, June 21,
2021 from 1:00 pm to 3:30 pm ET to discuss details surrounding
these Synthetic vRNA programs, including preclinical data
supporting the ONCR-021 and ONCR-788 candidate nominations and
planned clinical studies. Leena Ghandi, M.D., Ph.D., Director,
Center for Cancer Therapeutic Innovation at the Dana-Farber Cancer
Institute, will be a featured speaker. For more information or to
RSVP for the event, please contact Josh Rauch at
jrauch@soleburytrout.com.
About Oncorus
At Oncorus, we are focused on driving innovation to deliver
next-generation viral immunotherapies to transform 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
oncolytic Herpes Simplex Virus (oHSV) and Synthetic viral RNA
(vRNA) Immunotherapy Platforms.
Designed to deliver next-generation viral immunotherapy impact,
our oHSV platform improves upon key characteristics of this
therapeutic class to enhance systemic activity. Our lead oHSV
program, 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 we believe could potentially limit
systemic toxicities. Our pioneering Synthetic vRNA Immunotherapy
Platform involves a highly innovative, novel combination of RNA-
and oncolytic virus-based modalities to realize the potential of
RNA medicines for cancer. Our lead IV-administered Synthetic vRNA
clinical candidates, ONCR-021 and ONCR-788, are both currently in
IND-enabling studies.
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 the preclinical and clinical
development of ONCR-021 and ONCR-788, including expectations
regarding timing for filing INDs, as well as the product
candidates’ therapeutic potential and clinical benefits and the
utility and potential of Oncorus’ Synthetic vRNA Immunotherapy
Platform; and expectations regarding the buildout timeline of its
viral immunotherapy clinical manufacturing facility. 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: the impact of
COVID-19 on Oncorus’ operations and the timing and anticipated
results of its ongoing and planned clinical trials; the risk that
the results of preclinical studies and clinical trials may not be
predictive of future results in connection with future clinical
trials; Oncorus’ ability to successfully demonstrate the safety and
efficacy of ONCR-021 and ONCR-788; Oncorus’ ability to secure
adequate quantities of viral immunotherapies manufactured in
accordance with regulatory requirements; the expansion of Oncorus’
in-house manufacturing capabilities; the adequacy of Oncorus’ cash
resources and availability of financing on commercially reasonable
terms; 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, 2020, filed with the Securities and
Exchange Commission on March 10, 2021, as well as
discussions of potential risks, uncertainties, and other important
factors in the other filings that Oncorus makes with
the Securities and Exchange Commission 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.
No representations or warranties (expressed or implied) are made
about the accuracy of any such forward-looking statements.
Investor Contact: |
Media
Contact: |
Alan Lada |
Liz Melone |
Solebury Trout |
liz.melone@oncorus.com |
617-221-8006 |
|
alada@soleburytrout.com |
|
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