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Replimune will present at the American Society of 2022

WOBURN, Mass., May 26, 2022 (GLOBE NEWSWIRE) — Replimune Group, Inc. (Nasdaq: REPL), a clinical-stage biotechnology company pioneering the development of a new class of tumor-directed oncolytic immunotherapies, today announced several presentations at the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held in Chicago, Illinois, June 3-7, 2022.

The details of the presentations are as follows:

Presentation of data

Updated Results from Skin Cancer Cohorts of an Ongoing Multi-Cohort Phase 1/2 Study of RP1, an Enhanced Potency Oncolytic HSV, Combined with Nivolumab (IGNYTE)

  • Session title: Melanoma/Skin cancers
  • Session date and time: Monday, June 6, 2022, 1:15-4:15 p.m. CDT
  • Location: McCormick Place, Exhibit Hall A, Poster 146
  • Summary: 9553

Ongoing trial presentations

A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab ± RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma (CERPASS)

  • Session title: Melanoma/Skin cancers
  • Session date and time: Monday, June 6, 2022, 1:15-4:15 p.m. CDT
  • Location: McCormick Place, Exhibit Hall A, Poster 184a
  • Summary: TPS9593

An Open-Label, Multicenter, Phase 1b/2 Study of RP1, a First-in-Class Potency-Enhanced Oncolytic Virus, in Solid Organ Transplant Recipients With Advanced Cutaneous Malignancies (ARTACUS)

  • Session title: Melanoma/Skin cancers
  • Session date and time: Monday, June 6, 2022, 1:15-4:15 p.m. CDT
  • Location: McCormick Square, Exhibit Hall A, Poster 187a
  • Summary: TPS9597

A Phase 1 Trial of RP2, a First-in-Class Enhanced Potency Oncolytic HSV Expressing Anti-CTLA-4 Antibody as a Single Agent and Combined with Nivolumab in Patients With Advanced Solid Tumors

  • Session title: Developmental therapy Immunotherapy
  • Session date and time: Sunday, June 5, 2022, 8:00 a.m. to 11:00 a.m. CDT
  • Location: McCormick Place, Exhibit Hall A, Poster 339b
  • Summary: TPS2704

An open-label, multicenter, phase 1 study of RP3 as monotherapy and in combination with nivolumab in patients (pts) with solid tumors

  • Session title: Developmental therapy Immunotherapy
  • Session date and time: Sunday, June 5, 2022, 8:00 a.m. to 11:00 a.m. CDT
  • Location: McCormick Place, Exhibit Hall A, Poster 340a
  • Summary: TPS2705

CERPASS is Replimune’s registration-led global randomized Phase 2 clinical study to compare the effects of Libtayo® alone versus a combination of experimental oncolytic immunotherapy RP1 from Libtayo and Replimune. The clinical trial is enrolling 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (SCCC) who have never received anti-PD-1 therapy. The clinical trial will assess complete response rate (CR) and overall response rate (ORR) as its two primary efficacy endpoints assessed by independent review, along with 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 trial costs are shared and full commercial rights are retained by Replimune. Libtayo is 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 specific cohorts of tumors currently enrolled in this clinical trial, including a cohort of 125 patients with cutaneous melanoma in anti-PD-1 failure. This cohort was launched after completing enrollment in a previous Phase 2 cohort in the same clinical trial of approximately 30 melanoma patients. Additional cohorts are for non-melanoma skin cancers, which include both naïve CSCC and anti-PD-1 failures, high microsatellite instability anti-PD1 failures, or MSI-H/dMMR tumors and anti-PD(L)-1 failures of 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.

About RP1
RP1 is Replimune’s lead product candidate and is based on a novel proprietary strain of the herpes simplex virus engineered and genetically engineered to maximize tumor killing potency, tumor cell death immunogenicity, and tumor cell activation. a systemic anti-tumor immune response.

About RP2 and RP3
RP2 and RP3 are derivatives of RP1 that express additional immunoactivating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 further expresses the immune costimulation pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to immune response initiation sites in the tumor and draining lymph nodes, with the aim of focusing systemic immune efficacy on tumors and limiting the off-target toxicity.

About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with a mission to transform cancer treatment by paving the way for the development of novel tumor-directed oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a powerful HSV-1 backbone with added payloads to maximize immunogenic cell death and induction of a systemic anti-tumor immune response. The RPx platform has a unique local and systemic dual mechanism of action (MOA) consisting of direct selective destruction of the tumor via a virus, resulting in the release of tumor-derived antigens and modification of the tumor microenvironment (TME) to trigger a strong and lasting action. systemic response. This mode of action 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 on its own or combined with a variety of other options. treatment. For more information, 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 regarding the design and the progress of our clinical trials, the timing and sufficiency of the results of our clinical trials to support the potential approval of any of our product candidates, our goals for developing and commercializing our product candidates, registrations of patients in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could”, “expect”, “intend”, “may”, “plan”, “potential”, “should”, “fly”, “would” or similar expressions and the negatives of these 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 these 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 regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify other product candidates, global political and macroeconomic factors, including the impact of the coronavirus as a global pandemic and the related public health issues, the escalation of the Russian-Ukrainian conflict and the related global economic environment, and other risks which may be detailed from time to time in our Form 10-K annual reports and Form 10-K quarterly reports 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described or implied by these 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 requests
Chris Brinzey
Westwicke, an ICR company
[email protected]

Media inquiries
Steele lisette
Verge Scientific Communications
202.930.4762 ext. 409
[email protected]