Oncorus, Inc. (Nasdaq: ONCR), an RNA medicines company focused on
developing IV administered, self-amplifying RNA to transform
outcomes for cancer patients, today announced that it is
reprioritizing its pipeline to focus on its lead viral RNA (vRNA)
immunotherapy product candidate, ONCR-021. In addition, the company
is discontinuing the development of ONCR-177, reducing its
workforce and burn rate and reiterating guidance for its cash
runway into early 2024.
“Oncorus’ mission is now focused on realizing the full promise
of IV-administered, self-amplifying RNA medicines to transform
outcomes for cancer patients through our lead program, ONCR-021,
which we plan to evaluate in patients with non-small cell lung and
other cancers,” said Theodore (Ted) Ashburn, M.D., Ph.D.,
President, and Chief Executive Officer of Oncorus. “As part of this
reprioritization, we are discontinuing the Phase 1 trial of
ONCR-177 to focus our resources on ONCR-021. We would like to
express our deep gratitude to all the patients and their families,
investigators and collaborators who participated in the ONCR-177
study. We believe that we are now well positioned to execute on our
goals and progress our novel, first-of-its-kind self-amplifying
vRNA immunotherapy candidate, ONCR-021, into the clinic for cancer
patients.”
Oncorus will present the results of the Phase 1 study of
ONCR-177 in patients with advanced disease in conjunction with a
scientific congress in 2023. In addition, Oncorus has reduced its
workforce by 20%, with its remaining workforce solely focused on
the clinical development of ONCR-021, its first self-amplifying RNA
product candidate. With this re-prioritization and workforce
realignment, Oncorus has reduced its burn rate and continues to
expect its current cash, cash equivalents and investments will be
sufficient to fund its operating expenses into early 2024.
ONCR-021 Program Highlights and Upcoming
Milestones
ONCR-021 is Oncorus’ lead candidate from its self-amplifying RNA
platform intended to allow for intravenous (IV) administration.
ONCR-021 is comprised of vRNA encoding for the genome of an
optimized strain of the Coxsackievirus A21 (CVA21) formulated in a
proprietary lipid nanoparticle (LNP). This technology enables RNA
self-amplification via multiple transcription cycles in tumor cells
and further amplification via viral spread to neighboring tumor
cells. The company is planning to submit an investigational new
drug application (IND) for this program in mid-2023 to evaluate
ONCR-021 in patients with non-small cell lung cancer (NSCLC), renal
cell carcinoma (RCC), melanoma and hepatocellular carcinoma
(HCC).
In October 2022, Oncorus published preclinical data in Nature
Communications highlighting the potential of its self-amplifying
RNA platform as a novel approach to treating cancer by enabling
repeat IV administration. The data demonstrate that the delivery of
RNA encoding for the genome of a replication competent virus
encapsulated in an LNP enables 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. These RNA constructs were
well-tolerated in preclinical models and elicited tumor-specific in
situ production of oncolytic virions, broad 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, these constructs were well-tolerated
after a single or multiple IV doses in both mice and non-human
primates. These results support the potential of this modality to
safely and effectively kill tumor cells while stimulating multiple
arms of the immune system to better fight cancer.
Additional Development Programs
Further development of ONCR-788, the company’s second
self-amplifying RNA product candidate, which encodes for a modified
genome of the Seneca Valley Virus (SVV) for the treatment of small
cell lung cancer (SCLC), neuroendocrine prostate cancer and other
neuroendocrine tumors, and ONCR-719, an armed HSV-1 engineered for
viral entry via the EGFR receptor for the treatment of glioblastoma
multiforme, is dependent on additional financing.
Conference Call and Webcast Information
Oncorus will host a live conference and webcast today, November
30, 2022, at 8:00 a.m. ET to discuss these company updates. To
access the conference call, please register here. The live webcast
can be accessed under the “Events & Presentations” section of
Oncorus’ website at www.oncorus.com. A webcast replay will also be
available on the corporate website at the conclusion of the
call.
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.
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 Oncorus’ plans to focus its efforts
and resources on the development of ONCR-021 and its
self-amplifying RNA platform along with ONCR-021's ability to
improve outcomes for cancer patients; Oncorus’ plans to submit an
IND for ONCR-021 by mid-2023; Oncorus’ plans to evaluate ONCR-021
in patients with non-small cell lung and other cancers; Oncorus’
belief that, following reprioritization, it will be better
positioned to deliver on its strategic goals; Oncorus’ plans to
discontinue the further clinical development of ONCR-177 and its
plans to present full data in 2023; and Oncorus’ expectations that
its cash and cash equivalents will be sufficient to fund its
operations into early 2024.. 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’ 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
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