Replimune Presents Positive Data from RP1 and RP2 Clinical Programs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
03 6월 2024 - 9:00PM
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage
biotechnology company pioneering the development of a novel
portfolio of oncolytic immunotherapies, today presented two oral
presentations highlighting promising clinical data from its RP1 and
RP2 programs at the 2024 American Society of Clinical Oncology
(ASCO) Annual Meeting taking place May 31-June 4 in Chicago.
“The strength of the RP1 and RP2 data being presented at ASCO in
two hard-to-treat tumor types further validates the potential of
the RPx platform,” said Sushil Patel, Ph.D., CEO of Replimune. “In
the IGNYTE trial, the investigator-assessed 12-month results show
an overall response rate of 32.7% that was highly durable, and the
combination provided a favorable safety profile, all consistent
with previous data. The data with RP2 as monotherapy and in
combination with nivolumab in refractory patients highlights a
strong and durable overall response rate of nearly 30 percent in
uveal melanoma where treatment options are limited.”
Key findings are outlined below.
Oral Presentation: Efficacy and Safety of RP1
Combined with Nivolumab in Patients with anti-PD-1-Failed Melanoma
from the IGNYTE Clinical Trial (Session: Melanoma/Skin Cancers;
June 3, 2024, 10:57AM CDT; Location: S406;
Abstract: 9517)
- The data continues to show that the combination of RP1 and
nivolumab in anti-PD-1 failed melanoma (n=156) provides deep and
durable responses with an "on-target" safety profile with generally
transient grade 1/2 adverse events, indicative of systemic immune
activation.
- Approximately one third of patients experienced a response,
with an overall response rate (ORR) by investigator assessment of
32.7%.
- In the 94 patients who had primary resistance to their
immediate prior anti-PD-1 therapy, the ORR was 34%.
- In the 66 patients who progressed on prior anti-PD-1 combined
with anti-CTLA-4 therapy, the ORR was 27.3%.
- All responses lasted greater than six months from enrollment,
with a median duration of response exceeding 36 months.
- Clinically meaningful activity was observed across all enrolled
subgroups, with over half of patients experiencing either a
complete response (CR), partial response (PR) or stable disease
(SD).
Primary analysis results by independent central review from the
IGNYTE anti-PD-1 failed melanoma cohort are expected later in Q2
2024 with the Company on track to submit a biologics license
application (BLA) for RP1 to the U.S. Food and Drug Administration
(FDA) in 2H 2024. The Company also has agreed on a protocol for a
Phase 3 confirmatory study with the FDA (IGNYTE-3; NCT06264180;
poster TPS9603, ASCO 2024) and expects to initiate the trial prior
to the RP1 BLA in anti-PD-1 failed melanoma being submitted.
“The findings shared for the IGNYTE clinical trial underscore
the promising effects of RP1 shown to date, including overall
response rate, durability and safety,” said Michael Wong, M.D.,
Ph.D., Professor of Melanoma Medical Oncology at The University of
Texas MD Anderson Cancer Center and presenter of the study. “RP1
plus nivolumab provides an attractive risk-benefit profile for
melanoma patients who have progressed on PD1 based treatment,
particularly when compared with other therapies. For this
population – the unmet need is significant as there are limited
options with only about half of patients with melanoma responding
to first line treatment.”
Oral Presentation: Safety, Efficacy, and
Biomarker Results from an Open-Label, Multicenter, Phase 1 Study of
RP2 Alone or Combined with Nivolumab in a Cohort of Patients with
Uveal Melanoma (Session: Melanoma/Skin Cancers,
June 3, 2024, 9:57AM CDT; Location: S406;
Abstract: 9511)
- The data suggest that RP2, which expresses an anti-CTLA-4
antibody, dosed both alone and in combination with an anti-PD-1
agent in metastatic uveal melanoma patients (n=17), including those
with both liver and extra-hepatic metastases, had a favorable
safety profile and durable anti-tumor activity.
- RP2 administered as monotherapy or in combination with
nivolumab demonstrated an ORR of 29.4%, with a disease control rate
(DCR) of 58.8%.
- Biomarker data indicate immune cell infiltration and increased
PD-L1 expression in tumors, together with changes in the systemic T
cell repertoire following RP2 plus nivolumab.
- Based on the encouraging ORR observed amongst a patient
population with historically poor treatment outcomes, Replimune is
currently finalizing the protocol for a registration-directed study
based on FDA input.
Both presentations will be available on the Company website
under Events and Presentations.
About RP1RP1 is Replimune’s lead
product candidate and is based on a proprietary strain of herpes
simplex virus engineered 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 RP2RP2 is based on a proprietary
strain of herpes simplex virus engineered 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. 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
activity 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. The RPx product candidates are 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 StatementsThis 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 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, 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 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 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.
Investor InquiriesChris BrinzeyICR
Westwicke339.970.2843chris.brinzey@westwicke.com
Media InquiriesArleen
GoldenbergReplimune917.548.1582media@replimune.com
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