Oncorus, Inc. (Nasdaq: ONCR), a clinical stage biopharmaceutical
company developing next-generation viral immunotherapies to
transform outcomes for cancer patients, announced today that it has
signed a 15-year lease to build a state-of-the-art, 88,000 square
foot Good Manufacturing Practice (GMP) viral immunotherapy clinical
manufacturing facility in Andover, Mass.
Oncorus is advancing a portfolio of intratumorally and
intravenously administered viral immunotherapies for multiple
cancer indications with significant unmet needs based on its
oncolytic Herpes Simplex Virus (oHSV) Platform and Synthetic Virus
Platform. The company is currently conducting a Phase 1 clinical
trial of its lead product candidate, ONCR-177, an intratumorally
administered oHSV viral immunotherapy being developed for multiple
solid tumor indications. The company anticipates reporting interim
data from this Phase 1 trial in the second half of 2021 through the
second half of 2022. Oncorus plans to nominate its first
intravenously administered synthetic virus clinical candidates
(coxsackievirus A21 and Seneca Valley Virus programs) in the first
half of 2021 and its second intratumorally administered oHSV
clinical candidate, which will specifically target brain cancer,
including glioblastoma multiforme, in the second half of 2021.
“Last year was a year of tremendous progress for Oncorus. We
initiated a first-in-human study of our lead viral immunotherapy
program, ONCR-177, signed a clinical collaboration agreement and
supply agreement with Merck for ONCR-177, made strides advancing
multiple earlier stage programs, successfully completed an IPO, and
continued to strengthen our team,” said Theodore (Ted) Ashburn,
M.D., Ph.D., President and CEO at Oncorus. “Now we’re thrilled to
announce that we’ve signed a lease for our planned manufacturing
facility, which will play a central role in enabling us to advance
our mission to realize the full promise of viral immunotherapy for
cancer patients. Operational and manufacturing scale-up will be a
strategic priority for Oncorus going forward.”
The facility is intended to provide a comprehensive solution for
Oncorus’ Chemistry, Manufacturing and Controls (CMC) development
needs, enabling the manufacture, quality, control and supply of
clinical-grade viral immunotherapies for investigational new drug
(IND)-enabling studies and clinical studies. Oncorus anticipates
the first phase of the facility’s buildout will be completed in
late 2021, including process development and quality control, with
GMP multi-product manufacturing capabilities and full operation
commencing in early 2023. Oncorus plans to continue partnering with
contract manufacturing organizations to provide additional support
and capacity.
“The investment in this manufacturing facility demonstrates our
commitment to growth and innovation,” said Steve Harbin, Chief
Operations Officer and Chief of Staff at Oncorus. “In addition to
ramping up GMP activities to support our near-term development
needs, we also plan to build robust process development and
scale-up infrastructure, which is critical for future efforts,
including potential commercial launch support. This facility
will give us control over quality and output and enhanced
flexibility as we develop our multiple oHSV- and synthetic
virus-based viral immunotherapy programs."
Mr. Harbin, who recently joined Oncorus, is responsible for
guiding operations and manufacturing at the company in addition to
its Talent and Culture function. Previously, he held senior
executive manufacturing and operations leadership roles in the U.S.
and globally with Moderna, Inc., bioMérieux SA, and Eli Lilly and
Company.
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 and
intravenously administered viral immunotherapies for multiple
indications with significant unmet needs based on our oncolytic
Herpes Simplex Virus (oHSV) Platform and Synthetic Virus Platform.
Designed to deliver next-generation viral immunotherapy impact, our
oHSV Platform improves upon key characteristics of this therapeutic
class to enhance potency without sacrificing safety, including
greater capacity to encode transgenes to drive systemic
immunostimulatory activity, retention of full replication
competency to enable high tumor-killing potency, and orthogonal
safety strategies to restrict viral activity in tumor cells. Our
lead oHSV program, ONCR-177, is designed to be directly
administered into a tumor, resulting in high local concentrations
of the therapeutic agent, as well as low systemic exposure to the
therapy, which we believe could potentially limit systemic
toxicities. Please visit us at 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 with respect to Oncorus’
ability to advance its clinical and pre-clinical pipelines,
including statements regarding the clinical development of ONCR-177
and timing of reporting interim data, expectations regarding
upcoming milestones for its other potential product candidates, as
well as the therapeutic potential and clinical benefits of Oncorus’
product candidates; Oncorus’ expectations with respect to its
continued growth, including its ability to expand its
infrastructure and organization and its ability to scale-up its
platforms, buildout its manufacturing capabilities, including the
anticipated timing for completion of the initial buildout phase and
full operating capacity at Oncorus’ newly leased manufacturing
facility, and secure additional manufacturing capacity; the ability
of the leadership team to execute Oncorus’ strategy and support its
future growth; and statements regarding the accomplishments,
experience and capabilities of individual members of Oncorus’
leadership team and the ability of such qualities to drive Oncorus’
success. 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 development of its manufacturing capabilities and progression
of its product candidates into the operational scale-up phase; the
risk that the results of a clinical trial may not be predictive of
future results in connection with future clinical trials; Oncorus’
ability to successfully demonstrate the safety and efficacy of
ONCR-177 and obtain regulatory approval; 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’ Quarterly Report on
Form 10-Q for the quarter ended September 30, 2020, which was
filed with the Securities and Exchange Commission
on November 12, 2020, 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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