Interim Results from the ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients with Skin Cancers Presented During Oral Presentation at the American Association of Cancer Research (AACR) 2024 Annual Meeting
April 07 2024 - 4:00PM
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage
biotechnology company pioneering the development of a novel
portfolio of oncolytic immunotherapies, today announced the
presentation of 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, by Michael R. Midgen, M.D., of the University of Texas
MD Anderson Cancer Center during an oral session at the AACR 2024
Annual Meeting in San Diego. The results were initially presented
late last year at the 38th Annual Meeting of the Society for
Immunotherapy of Cancer (SITC).
In the study, treatment with RP1 as monotherapy, for up to 25
doses, resulted in an overall response rate (ORR) of 34.8 percent
(8 of 23 evaluable patients, including 5 complete responses and 3
partial responses) with most responses ongoing as of the data
cutoff date of September 18, 2023. In the evaluable patient
population (n=23), 20 had cutaneous squamous cell carcinoma (CSCC)
and three had merkel cell carcinoma. Of note, a patient treated
with RP1 for CSCC also had a complete response of a new primary
basal cell carcinoma which appeared post baseline. 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. Additional biomarker data
collected showed an increase in CD+8 T, a type of immune cell, and
an increase in the expression of PD-L1, after treatment suggesting
immune activation. The slides are available on the Replimune
website under presentations.
“Organ transplant recipients are at a higher risk for skin
cancer when compared to the broader population and have access to a
limited number of treatment options given that systemic
immunotherapy is typically contra-indicated,” said Sushil Patel,
Ph.D., CEO of Replimune. “These data show RP1 as monotherapy has
clear anti-tumor activity and may be a safe and effective treatment
option for these patients with an overall response rate of nearly
35 percent with good durability of benefit to date.”
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. ARTACUS is currently recruiting patients.
To learn more, contact clinicaltrials@replimune.com or
+1-781-222-9570.
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 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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