Replimune Presents Initial RP1 Data from the ARTACUS Clinical Trial at the 2023 American Transplant Congress (ATC) Meeting
06 6월 2023 - 11:00PM
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage
biotechnology company pioneering the development of a novel class
of tumor-directed oncolytic immunotherapies, today announced
initial data from ARTACUS, a Phase 1/2 trial evaluating RP1 for the
treatment of cutaneous malignancies in patients who have had a
kidney, liver, heart, lung, and/or a hematopoietic cell transplant.
This data from the ARTACUS trial will be presented at the ATC 2023
Meeting being held in San Diego.
“Cutaneous cancer represents the most common post-transplant
malignancy in highly immuno-compromised solid organ transplant
patients. The challenge treating this high-risk population is that
the use of anti-PD1 therapies can lead to organ transplant
rejection in these patients,” said Robert Coffin, President and
Chief Research & Development Officer of Replimune. “We are
pleased with the interim data from the ARTACUS study that
demonstrates a compelling overall response rate and complete
response rate of 27.3% with strong durability to date that makes
RP1 a potentially safe and effective treatment for these
patients.”
Initial results from the Phase 1b/2 ARTACUS study of RP1
oncolytic immunotherapy in solid organ and hematopoietic cell
transplant recipients with advanced cutaneous
malignancies
ARTACUS is Replimune’s multicenter, open-label, 2-part Phase
1b/2 study evaluating RP1 for the treatment of locally advanced or
metastatic cutaneous malignancies (to skin, soft tissue, or lymph
nodes) in solid organ transplant recipients. This initial analysis
includes kidney transplant recipients.
- This is the first clinical trial
assessing single-agent RP1 in immunocompromised patients.
- No immune-mediated adverse events
or evidence of allograft rejection were observed.
- RP1 monotherapy was well tolerated,
and the safety profile was similar to non-immunocompromised
patients with advanced skin cancers (IGNYTE study)
- RP1 monotherapy showed clear
anti-tumor activity, with a preliminary overall response rate (ORR)
for the 11 evaluable patients with cutaneous squamous cell
carcinoma (N=10) and Merkel cell carcinoma (N=1) of 27.3%, with 3
patients (27.3%) achieving a confirmed complete response (CR). One
of the non-evaluable patients also showed a clear reduction in
tumor size before death due to COVID-19–related pneumonia at 7
weeks following initiation of RP1 (i.e. prior to the first formal
efficacy assessment).
The poster is part of a poster session at ATC
and can be found at Replimune’s website under Presentations.
- Presenter: Dr. Michael Migden
- Poster Session D – Transplant Oncology
- Presentation Time: Tuesday, June 6, 2023 from 9:45–10:25 AM PT
and 3:00–3:30 PM PT
About ARTACUSARTACUS is Replimune’s Phase 1B/2
clinical trial to study the effects of the investigational
oncolytic immunotherapy RP1 for the treatment of cutaneous
malignancies in patients who underwent either a kidney, liver,
heart, lung, or other solid organ transplant, or hematopoietic cell
transplantation. Researchers will study the safety of this
treatment in patients 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
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.
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 Inquiries Chris BrinzeyWestwicke, an
ICR Company339.970.2843chris.brinzey@westwicke.com
Media InquiriesArleen
GoldenbergReplimune917.548.1582media@replimune.com
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