Oncorus Announces Exclusive Licensing Agreement with Gaeta Therapeutics Ltd. for Use of Locally Delivered Interleukin-12 (IL-12) via Oncolytic Viral Expression in Combination with Immune Checkpoint Inhibitors
November 11 2021 - 7:00AM
Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company
focused on driving innovation to transform outcomes for cancer
patients, today announced that it has signed an exclusive licensing
agreement with Gaeta Therapeutics Ltd., related to the use of
locally delivered Interleukin-12 (IL-12) via oncolytic viral
expression in combination with immune checkpoint inhibitors,
including CTLA-4, PD-1 or PD-L1 checkpoint blockade. Gaeta
Therapeutics was founded by the University of Zurich in 2017 as a
vehicle for the commercialization of its immune-oncology patent
estate relating to the use of IL-12 in combination with checkpoint
inhibitors in the treatment of cancer.
“Known to activate and expand CD8, CD4 TH1 and
natural killer cells, IL-12 is a transgene of notable interest in
the immune-oncology space. IL-12 in combination with immune
checkpoint blockade has demonstrated the ability to augment
treatment response in certain patients versus immune checkpoint
inhibitor treatment alone,” said Theodore (Ted) Ashburn, M.D.,
Ph.D., President and Chief Executive Officer at Oncorus. “IL-12 is
one of five immunomodulatory payloads in our lead viral
immunotherapy product candidate, ONCR-177. This agreement with
Gaeta is a strategic addition to our IP portfolio as we continue to
advance ONCR-177 as a potential new therapeutic option for cancer
patients, including in combination with pembrolizumab and other
immunotherapies.”
Under the terms of the agreement, Gaeta will
receive an upfront payment of $0.2M and is eligible to receive up
to $7.5M in potential clinical and regulatory milestone payments on
a product-by-product and indication-by-indication basis.
“We’re pleased to enter into this agreement with
Gaeta, as it enhances our clinical development efforts for ONCR-177
and bolsters our future commercialization strategy and
opportunities for this product candidate,” said Stephanie
Duncanson, Ph.D., Vice President, Corporate Strategy and Business
Development. “We’ll continue to seek additional strategic
opportunities to differentiate our pipeline programs as we work to
drive innovation and advance our mission to realize the full
promise of viral immunotherapy for cancer
patients.”
Being developed for multiple solid tumor
indications, ONCR-177 is an intratumorally administered oncolytic
Herpes Simplex Virus (HSV)-based viral immunotherapy engineered to
induce immunogenic cancer cell death and ignite innate and adaptive
immunity to drive a lasting and systemic anti-tumor response. In
addition to IL1-12, ONCR-177’s complementary transgene payload also
includes FLT3LG, CCL4, anti-PD-1 and anti-CLTA-4. Oncorus is
currently enrolling patients in a Phase 1 open-label, dose
escalation and expansion clinical trial designed to evaluate the
safety and tolerability of ONCR-177 alone and in combination with
Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients
with advanced and/or refractory cutaneous, subcutaneous or
metastatic nodal solid tumors or with liver metastases of solid
tumors. Oncorus will present initial data from its ongoing Phase 1
clinical trial of ONCR-177 at the upcoming Society for
Immunotherapy of Cancer’s (SITC) 36th Annual Meeting, taking place
November 12–14, 2021 in Washington, D.C. and virtually.
About OncorusAt 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 (HSV) Platform and Synthetic viral RNA (vRNA) Immunotherapy
Platform.
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 Synthetic vRNA
Immunotherapy Platform involves a highly innovative, novel
combination of RNA- and oncolytic virus-based modalities designed
to realize the potential of RNA medicines for cancer. Our lead
IV-administered Synthetic vRNA Immunotherapy 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
StatementsThis 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 clinical development
of ONCR-177, including expectations regarding timing for reporting
initial data from the ongoing Phase 1 clinical trial of ONCR-177,
the product candidate’s therapeutic potential and clinical benefits
and the utility and potential of Oncorus’ HSV Platform, and the
strategic benefit of Oncorus’ license agreement with Gaeta
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 obtain, maintain and protect its
intellectual property; 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, tolerability and
efficacy of ONCR-177 and obtain regulatory approval thereof;
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; and
the adequacy of Oncorus’ cash resources and availability of
financing on commercially reasonable terms. 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.
Media
Contact: Liz
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Contact:Stern Investor Relations Julie
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