Initial study in the neoadjuvant setting
designed to assess RP1 in combination with the small molecule, oral
PD-L1 inhibitor, INCB99280
Replimune Group, Inc. (NASDAQ:REPL), a clinical stage
biotechnology company pioneering the development of a novel
portfolio of tumor-directed oncolytic immunotherapies, and Incyte
(NASDAQ:INCY), a global biopharmaceutical company, today announced
a clinical trial collaboration and supply agreement to study RP1,
Replimune’s lead product candidate, in combination with INCB99280,
Incyte’s small molecule oral PD-L1 inhibitor.
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“We are excited to enter into this collaboration with Incyte to
explore the use of RP1 prior to surgery as we believe that our
tumor-directed oncolytic immunotherapies could have a great impact
in the neoadjuvant setting both in cutaneous squamous cell
carcinoma (CSCC) and in other cancer types, given the high rates of
complete responses we’ve seen to date, and data indicating RP1 is
generally very well tolerated,” said Robert Coffin, Chief Research
and Development Officer of Replimune. “The unique potential of the
RPx platform to induce a patient-specific anti-tumor immune
response with an off-the-shelf treatment speaks to the practicality
and broad potential utility of the approach, and exploring its use
with Incyte’s oral PD-L1 inhibitor has the potential to improve the
patient experience further.”
“We look forward to collaborating with Replimune on this study
evaluating INCB99280 and RP1 in patients with CSCC. Our oral PD-L1
program has shown promising safety and efficacy in early studies
thus far, and we look forward to adding to the growing body of
evidence for INCB99280 and learning more about its potential to
improve clinical outcomes,” said Lance Leopold, M.D., Group Vice
President, Clinical Development Hematology and Oncology,
Incyte.
Under the terms of the agreement, Incyte will initiate and
sponsor the clinical trial of INCB99280 and RP1 in patients with
high risk, resectable cutaneous squamous cell carcinoma (CSCC),
with the clinical trial expected to initiate in early 2024.
Replimune will supply Incyte with RP1 for the study and share
equally in the costs of the study.
About RP1
RP1 is Replimune’s lead oncolytic immunotherapy product
candidate and is based on a proprietary new strain of herpes
simplex virus engineered for robust tumor selective replication and
genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF,
intended to maximize tumor killing potency, the immunogenicity of
tumor cell death, and the activation of a systemic anti-tumor
immune response.
About INCB99280
INCB99280 is a potent and selective small molecule oral PD-L1
inhibitor, which has demonstrated promising clinical activity and
safety in patients with solid tumors. INCB99280 is being evaluated
in multiple Phase 2 studies as monotherapy and in combination with
other antitumor agents.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded
in 2015 with the mission to transform cancer treatment by
pioneering the development of novel tumor-directed oncolytic
immunotherapies. Replimune’s proprietary RPx platform is based on a
potent HSV-1 backbone with payloads added to maximize immunogenic
cell death and the induction of a systemic anti-tumor immune
response. The RPx platform has a unique dual local and systemic
mechanism of action (MOA) consisting of direct selective
virus-mediated killing of the tumor resulting in the release of
tumor derived antigens and altering of the tumor microenvironment
(TME) to ignite a strong and durable systemic response. This MOA is
expected to be synergistic with most established and experimental
cancer treatment modalities, and, with an attractive safety profile
the RPx platform has the versatility to be developed alone or
combined with a variety of other treatment options. For more
information, please visit www.replimune.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Replimune Forward-looking Statements
This press release contains forward looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, including statements regarding our expectations about the
design and advancement of our clinical trials, those of our
collaboration partners or the combined clinical trials with our
collaboration partners, the timing and sufficiency of our clinical
trial outcomes to support potential approval of any of our RPx
product candidates or those of, or combined with, our collaboration
partners, our goals to develop and commercialize our RPx product
candidates alone or with our collaboration partners, patient
enrollments in our planned clinical trials, alone or with our
collaboration partners, and the timing thereof, and other
statements identified by words such as “could,” “expects,”
“intends,” “may,” “plans,” “potential,” “should,” “will,” “would,”
or similar expressions and the negatives of those terms.
Forward-looking statements are not promises or guarantees of future
performance, and are subject to a variety of risks and
uncertainties, many of which are beyond our control, and which
could cause actual results to differ materially from those
contemplated in such forward-looking statements. These factors
include risks related to our limited operating history, our ability
to generate positive clinical trial results for our RPx product
candidates, alone or with our collaboration partners, changes in
laws and regulations to which we are subject, political and global
macro factors, and other risks as may be detailed from time to time
in our Annual Reports on Form 10-K and Quarterly Reports on Form
10-Q and other reports we file with the Securities and Exchange
Commission. Our actual results and the actual results of our
collaboration partners and/or the combined results with our
collaboration partners could differ materially from the results
described in or implied by such forward-looking statements.
Forward-looking statements speak only as of the date hereof, and,
except as required by law, we undertake no obligation to update or
revise these forward-looking statements.
Incyte Forward-looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding the potential of INCB99280 and/or RP1 to treat patients
with cutaneous squamous carcinoma or for any other indication,
contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on Incyte’s current
expectations and are subject to risks and uncertainties that may
cause actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays; further
research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials;
determinations made by regulatory authorities; Incyte’s dependence
on its relationships with its collaboration partners; the efficacy
or safety of Incyte’s products and the products of Incyte’s
collaboration partners; the acceptance of Incyte’s products and the
products of Incyte‘s collaboration partners in the marketplace;
market competition; sales, marketing, manufacturing and
distribution requirements; and other risks detailed from time to
time in Incyte’s reports filed with the Securities and Exchange
Commission, including its annual report and its quarterly report on
Form 10-Q for the quarter ended March 31, 2023. Incyte disclaims
any intent or obligation to update these forward-looking
statements.
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Replimune Contacts:
Media Arleen Goldenberg Replimune
media@replimune.com Tel 917.548.1582
Investors Chris Brinzey Westwicke, an ICR Company
chris.brinzey@westwicke.com Tel 339.970.2843
Incyte Contacts:
Media Catalina Loveman cloveman@incyte.com Tel
302.498.6171
Investors Greg Shertzer gshertzer@incyte.com Tel
302.498.4779
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