Full Press Release Details
Provides 2021 Year End Review and Overview of Expected 2022 Milestones
CERPASS clinical trial with RP1 in CSCC on track
to complete enrollment mid-year with the primary analysis trigger six months thereafter
anti-PD1 failed melanoma, evaluating RP1 in combination with Opdivo
on track to release interim data in late 2022
Phase 2 development plan for RP2/3 to be presented
in the first quarter of 2022
Replimune to provide corporate update at the 40th
Annual J.P. Morgan Healthcare Conference on January 10, 2022
Woburn, MA, January 10, 2022 - Replimune Group, Inc. (Nasdaq:
REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies,
today provided a corporate update, highlighting the progress of key programs.
"Data with RP1 in various high-value skin
cancer indications has continued to mature in 2021," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "We
have been thrilled to see the clear trends in safety and efficacy persist, with durability data that suggests RP1 has the profile to
provide many patients with transformative long-term benefit. With our objective of establishing a broad skin cancer franchise with RP1,
which has progressed to commercial planning, we have begun to validate the potential of our RP2 and RP3 oncolytic immunotherapies beyond
skin cancers, including in tumor types that commonly metastasize to the liver. Replimune continues to build towards an exciting, data
rich 2022, beginning later this quarter with a number of clinical updates, and visibility into the RP2/RP3 Phase 2 clinical development
Anticipated Key Milestones for 2022
CERPASS - Registration-directed Phase 2 clinical trial in
cutaneous squamous cell carcinoma (CSCC)
IGNYTE - Multi-cohort Phase 2 clinical trial of RP1 combined
with Opdivo (nivolumab)
ARTACUS - Phase 1b/2 clinical trial of RP1 as monotherapy
in solid organ transplant recipients with CSCC
J.P. Morgan Conference Presentation and Webcast
As previously announced, the Company will be present at the virtual
meeting of the 40th Annual J.P. Morgan Healthcare Conference on Monday, Jan. 10 at 7:30 a.m. PT. A simultaneous webcast of
the presentation will be available in the Investors section of Replimune's website at www.replimune.com. A replay will be available
for 30 days following the conference.
CERPASS is Replimune's registration-directed randomized, global
Phase 2 clinical study to compare the effects of Libtayo . alone versus a combination of Libtayo and Replimune's
investigational oncolytic immunotherapy RP1. The clinical trial is enrolling enroll 180 patients with locally advanced or metastatic cutaneous
squamous cell carcinoma (CSCC) who are na ve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and
overall response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response,
progression-free survival (PFS), and overall survival (OS) as secondary endpoints. The study is being conducted under a clinical trial
collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo
is being jointly developed by Regeneron and Sanofi.
Libtayo is a registered trademark of Regeneron.
IGNYTE is Replimune's multi-cohort Phase 1/2 trial of RP1 plus
Opdivo . There are 4 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in
anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical
trial of approximately 30 patients with melanoma. The additional cohorts are in non-melanoma skin cancers which includes both na ve
and anti-PD-1 failed CSCC, in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors and anti-PD(L)-1 failed non-small
cell lung cancer, or NSCLC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb Company.
Opdivo is a registered trademark of Bristol-Myers Squibb Company.
RP1 is Replimune's lead product candidate and is based on a proprietary
new strain of herpes simplex virus engineered and genetically armed to maximize tumor killing potency, the immunogenicity of tumor cell
death, and the activation of a systemic anti-tumor immune response.
RP2 and RP3 are derivatives of RP1 that express additional immune-activating
proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating
proteins CD40L and 4-1BBL. RP2 and RP3 are 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
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 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 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, the potential impact of the global coronavirus
pandemic and the global economy on our operations and milestones, 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
Verge Scientific Communications