Replimune Presents Updated Interim Results from the ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients with Skin Cancers During Oral Presentation at the 38th Annual Meeting of the Society for Immunotherapy
November 03 2023 - 7:30PM
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage
biotechnology company pioneering the development of a novel
portfolio of oncolytic immunotherapies, today announced updated
interim results from ARTACUS, a Phase 1/2 clinical trial evaluating
RP1 monotherapy for the treatment of skin cancers in patients who
have had solid organ or hematopoietic cell transplants. The data
were presented today by Dr. Michael R. Midgen of the University of
Texas MD Anderson Cancer Center during an oral session (Abstract
#777) at the 38th Annual Meeting of the Society for Immunotherapy
of Cancer (SITC) in San Diego.
Treatment with RP1 monotherapy led to an overall response rate
(ORR) of 34.8 percent (8 of 23 evaluable patients, including 5
complete responses and 3 partial responses). Of the 23 evaluable
patients, 20 had cutaneous squamous cell carcinoma (CSCC) and 3 had
merkel cell carcinoma (MCC) with responses observed in 6 CSCC
patients and 2 patients with MCC. One patient treated for CSCC also
had a complete response of a new primary basal cell carcinoma which
appeared post baseline that was treated with RP1. Most responses
were ongoing as of the data cutoff date of September 18, 2023.
There was no evidence of allograft rejection including of hepatic
and lung allografts. RP1 monotherapy was well tolerated, and the
safety profile was similar to the profile in non-immunocompromised
patients with advanced skin cancers. The slides are available on
the Replimune website under presentations.
“These data demonstrating an overall response rate of nearly 35
percent with good durability of benefit to date show that RP1
monotherapy has clinically meaningful anti-tumor activity in a
difficult to treat patient population receiving chronic
immunosuppressive treatment and where systemic immunotherapy may
not be a viable option,” said Robert Coffin, President and Chief
Research and Development Officer of Replimune. “Patients receiving
organ transplants are highly susceptible to skin cancer at a rate
which is far higher than in the general population. Based on the
data to date, we believe that RP1 monotherapy may potentially
provide a safe and effective option for patients that currently
have a limited number of treatments available.”
About ARTACUSARTACUS is a multicenter,
open-label, two-part Phase 1b/2 study evaluating RP1 as monotherapy
for the treatment of locally advanced or metastatic cutaneous
malignancies in patients who underwent a kidney, liver, heart,
lung, or other solid organ transplant, or hematopoietic cell
transplantation, who are on chronic immunosuppressive treatment, in
whom systemic immunotherapy is typically contra-indicated.
Researchers will assess the safety of RP1 and also evaluate its
ability to shrink tumors.
About RP1RP1 is Replimune’s lead product
candidate and 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.
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 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 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.
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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