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May 26, 2022, 5:16 p.m. EDT

Replimune To Present at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

Presentations include recently updated results from the skin cancer cohort of IGNYTE, an ongoing Phase 1/2 study of RP1 combined with Opdivo(R) (nivolumab), and trial-in-progress updates across the RP1, RP2 and RP3 programs

WOBURN, May 26, 2022 (GLOBE NEWSWIRE via COMTEX) -- WOBURN, Mass., May 26, 2022 (GLOBE NEWSWIRE) -- Replimune Group, Inc. /zigman2/quotes/203971249/composite REPL +2.15% , a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced multiple presentations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL from June 3 to June 7, 2022.

Details for the presentations are as follows:

Data presentation

Updated results from the skin cancer cohorts from an ongoing Phase 1/2 multi-cohort 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 PM-4:15 PM CDT

  • Location: McCormick Place, Exhibit Hall A, Poster 146

  • Abstract: 9553

Trial in progress 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 PM-4:15 PM CDT

  • Location: McCormick Place, Exhibit Hall A, Poster 184a

  • Abstract: TPS9593

An open-label, multicenter, phase 1b/2 study of RP1, a first-in-class, enhanced potency 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 PM-4:15 PM CDT

  • Location: McCormick Place, Exhibit Hall A, Poster 187a

  • Abstract: TPS9597

A phase 1 trial of RP2, a first-in-class, enhanced potency oncolytic HSV expressing an anti-CTLA-4 antibody as a single agent and combined with nivolumab in patients with advanced solid tumors

  • Session Title: Developmental Therapeutics Immunotherapy

  • Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT

  • Location: McCormick Place, Exhibit Hall A, Poster 339b

  • Abstract: TPS2704

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

  • Session Title: Developmental Therapeutics Immunotherapy

  • Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT

  • Location: McCormick Place, Exhibit Hall A, Poster 340a

  • Abstract: TPS2705

About CERPASS
CERPASS is Replimune's registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo [(R)] alone versus a combination of Libtayo and Replimune's investigational oncolytic immunotherapy RP1. The clinical trial is enrolling 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naive 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.

About IGNYTE
IGNYTE is Replimune's multi-cohort Phase 1/2 trial of RP1 plus Opdivo [(R)] . 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 naive 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.

About RP1
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.

About RP2 & RP3
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 toxicity.

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 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, 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, the escalating Russian-Ukrainian conflict and related global economic environment, 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 Brinzey
Westwicke, an ICR Company
339.970.2843
chris.brinzey@westwicke.com

Media Inquiries
Lissette Steele
Verge Scientific Communications
202.930.4762 x 409
lsteele@vergescientific.com


COMTEX_407815878/2471/2022-05-26T17:15:47

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/zigman2/quotes/203971249/composite
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Volume: 107,266
Nov. 25, 2022 1:00p
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