Oncorus Presents Preclinical Data on ONCR-021 and ONCR-788 Supporting Selectively Self-Amplifying vRNA Immunotherapy Platform at AACR Annual Meeting
April 08 2022 - 1:00PM
Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapy company focused
on driving innovation to transform outcomes for cancer patients,
today announced its presentation of preclinical data for both
ONCR-021 and ONCR-788 in two e-posters at the American Association
for Cancer Research (AACR) Annual Meeting 2022, taking place April
8-13 in New Orleans, Louisiana, supporting the company’s
selectively self-amplifying viral RNA (vRNA) Immunotherapy
Platform.
“The preclinical data presented on ONCR-021 and ONCR-788 at AACR
are an important step forward for Oncorus’ novel approach of
selectively self-amplifying vRNA immunotherapies formulated in
lipid nanoparticles. We are incredibly pleased to see these vRNA
drug candidates’ potent efficacy in preclinical tumor models, after
intravenous administration of the nanoparticle formulation even in
the presence of neutralizing antibodies,” said Ted Ashburn, M.D.,
Ph.D., President and Chief Executive Officer of Oncorus. “These
data further bolster our confidence in our vRNA platform’s ability
to deliver the RNA genome of oncolytic viruses to tumors
intravenously and to circumvent the common limitation of existing
IV-administered oncolytic viral cancer therapies. We look forward
to advancing this next-generation approach of selectively
self-amplifying vRNA, furthering our goal of realizing the full
potential of systemically active viral immunotherapies to transform
outcomes for cancer patients.”
Oncorus’ vRNA Immunotherapy Platform encapsulates the genomes of
RNA viruses known to kill cancer cells within an LNP, producing a
living oncolytic and immunostimulatory viral infection in the tumor
to destroy cancer cells and stimulate the immune system. In
preclinical studies, Oncorus’ IV-administered vRNA immunotherapies
demonstrated efficacy in multiple tumor models, avoiding the
challenges seen in previous studies incorporating IV administration
of RNA-based oncology therapeutics.
In a poster titled, “ONCR-021 as a systemic intravenous
synthetic RNA virus immunotherapy for the repeat treatment of
cancer,” Oncorus highlighted:
- ONCR-021, Oncorus’ lead vRNA immunotherapy product candidate,
is an LNP formulation of Coxsackievirus A21 (CVA21) vRNA, which
encodes an optimized strain of CVA21.
- ONCR-021 demonstrated greater in vitro and in vivo oncolysis
compared to previously described CVA21 Kuykendall strain.
- IV administration of ONCR-021 vRNA resulted in rapid initiation
of viral replication, oncolysis and potent anti-tumor efficacy
driven by CVA21 amplification in situ after delivery to tumor
cells.
- Preclinical data support the potential clinical development of
ONCR-021 in non-small cell lung cancer (NSCLC), renal cell
carcinoma (RCC) and melanoma based on viral tropism.
Oncorus plans to submit an investigational new drug (IND)
application for ONCR-021 with the U.S. Food and Drug Administration
(FDA) in mid-2023.
In a poster titled, “Development of ONCR-788, a
synthetic oncolytic virus based on Seneca Valley Virus for the
treatment of neuroendocrine tumors,” Oncorus
highlighted:
- ONCR-788, Oncorus’ second vRNA immunotherapy product candidate,
encodes an optimized version of the Seneca Valley Virus (SVV).
- Systemic IV administration of ONCR-788 led to potent anti-tumor
efficacy, even in the presence of oncolytic virus neutralizing
antibodies within the bloodstream.
- vRNA delivery, viral replication, spread and lysis of tumor
cells were observed after administration of ONCR-788.
- Robust anti-tumor efficacy was observed across a diverse set of
neuroendocrine tumor models, including tumor CDX and PDX
xenografts, lung orthotopic and GEMM-derived models.
- Enhanced T cell recruitment and activation, increased
expression of PD-L1 on tumor cells and myeloid cells and M2 to M1
macrophage conversion were observed.
- ONCR-788 in combination with an anti-PD1 resulted in improved
anti-tumor activity as compared to ONCR-788 monotherapy.
Oncorus plans to submit an IND for ONCR-788 with the FDA
following the IND submission for ONCR-021.
The posters presented at AACR are available on the “Publications
& Presentations” section of the Oncorus website at
www.oncorus.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
Herpes Simplex Virus (HSV) and selectively self-amplifying viral
RNA 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, 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 selectively self-amplifying vRNA Immunotherapy Platform,
highlighted by our product candidates ONCR-021 and ONCR-788,
involves a highly innovative, novel combination of RNA and
oncolytic virus-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 the timing of IND submissions for
ONCR-021 and ONCR-788 and the therapeutic potential of Oncorus’
vRNA Immunotherapy Platform, its ability to deliver potent and
sustained tumor efficacy even in the presence of neutralizing
antibodies and its ability to address challenges associated with
the IV administration of RNA-based oncology therapeutics. 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 ONCR-177, ONCR-021, ONCR-788 and ONCR-GBM and obtain
regulatory approval thereof; the impact of COVID-19 on Oncorus’
operations and the timing and anticipated results of its ongoing
and planned clinical trials; 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 adequacy of Oncorus’
existing capital resources and availability of financing on
commercially reasonable terms; 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 on March 9, 2022, 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, 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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