Replimune Presents Updated Data on RP2 in Uveal Melanoma during Plenary Session at the 20th International Congress of the Society for Melanoma Research
November 08 2023 - 9:10AM
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage
biotechnology company pioneering the development of a novel
portfolio of oncolytic immunotherapies, today announced updated
data from a cohort of metastatic uveal melanoma patients enrolled
in the open-label, multicenter, Phase 1 study of RP2 as a single
agent and in combination with nivolumab. The data were presented by
Dr. Joseph Sacco during a Plenary Session at the 20th International
Congress of the Society for Melanoma Research in Philadelphia.
Treatment with RP2 led to an overall response rate (ORR) of 29.4
percent (5 of 17 patients; one of the responding patients was
treated with RP2 monotherapy and four of the responding patients
were treated with RP2 combined with nivolumab), including responses
in patients with liver, lung, and bone metastases. The median
duration of response (DOR) at the data cutoff was 11.47 months
(range of 2.78 to 21.22 with responses ongoing). Nearly all
patients (15 of 17, 88.2%) in the study had progressed on or after
immunotherapy with 12 of 17 patients (70.6%) having received both
prior anti-PD1 and anti-CTLA-4 therapy, including four of the
responding patients. The slides are available on our website under
presentations.
RP2 was generally well tolerated both as monotherapy and in
combination with nivolumab with no additive adverse events
observed. The most common grade 1 or 2 treatment related adverse
events (TRAEs) overall in both cohorts were pyrexia, chills,
fatigue, hypotension and pruritis. Six patients had grade 3 TRAEs,
including two cases of hypotension. There were no grade 4 or 5
TRAEs.
“Metastatic uveal melanoma is an immunologically cold tumor type
with few effective treatment options,” said Joseph Sacco, MBChB,
PhD, FRCP, University of Liverpool and Clatterbridge Cancer Centre,
UK. “In fact, single-agent and combination immune checkpoint
inhibitor therapies, including ipilimumab combined with nivolumab,
exhibit low response rates in patients with this disease, with
combination therapies associated with significant toxicity. The
data from this study are compelling given the rate of durable
responses seen combined with a favorable safety profile, including
in patients who had both liver and extra-hepatic metastases,
further supporting the potential of RP2 in this patient
population.”
Uveal melanoma is the most common form of intraocular primary
malignancy and accounts for approximately 90 percent of all cases
of ocular melanoma and up to 5 percent of all melanomas.
Approximately 50 percent of patients will develop distant
metastases, with about 90 percent of such patients manifesting
liver metastases. Once the disease metastasizes, median overall
survival is less than one year.
“These data from the trial cohort evaluating RP2 as monotherapy
and in combination with nivolumab in metastatic uveal melanoma are
highly promising,” said Robert Coffin, President and Chief Research
& Development Officer at Replimune. “We are currently assessing
the potential registrational path forward for RP2 in advanced uveal
melanoma now that the Phase 1 development of RP2 in this disease is
nearly complete. Metastatic uveal melanoma is a disease with
significant unmet medical need where treatments remain limited, and
no current standard of care options provide the potential for long
term survival, other than in a minority of patients.”
About RP2RP2 is a derivative of RP1,
Replimune’s lead product candidate that is based on a proprietary
new strain of herpes simplex virus engineered and genetically armed
with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor
killing potency, the immunogenicity of tumor cell death and the
activation of a systemic anti-tumor immune response. RP2
additionally expresses an anti-CTLA-4 antibody-like molecule, as
well as GALV-GP-R- and GM-CSF. RP2 is intended to provide targeted
and potent delivery of these proteins to the sites of immune
response initiation in the tumor and draining lymph nodes, with the
goal of focusing systemic-immune-based efficacy on tumors and
limiting off-target toxicity.
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 a
novel portfolio of oncolytic immunotherapies. Replimune’s
proprietary RPx platform is based on a potent HSV-1 backbone
intended to maximize immunogenic cell death and the induction of a
systemic anti-tumor immune response. The RPx platform is designed
to have 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 to ignite a strong and durable systemic
response. This MOA is expected to be synergistic with most
established and experimental cancer treatment modalities, leading
to the versatility to be developed alone or combined with a variety
of other treatment options. For more information, please visit
www.replimune.com.
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 our cash runway, the
design and advancement of our clinical trials, the timing and
sufficiency of our clinical trial outcomes to support potential
approval of any of our product candidates, our goals to develop and
commercialize our product candidates, patient enrollments in our
existing and planned clinical trials 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 product
candidates, the costs and timing of operating our in-house
manufacturing facility, the timing and scope of regulatory
approvals, the availability of combination therapies needed to
conduct our clinical trials, changes in laws and regulations to
which we are subject, competitive pressures, our ability to
identify additional product candidates, political and global macro
factors including the impact of the coronavirus as a global
pandemic and related public health issues and the Russian-Ukrainian
and Israel-Hamas political and military conflicts, 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
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Investor Inquiries Chris BrinzeyWestwicke, an
ICR Company339.970.2843chris.brinzey@westwicke.com
Media InquiriesArleen
GoldenbergReplimune917.548.1582media@replimune.com
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