Replimune to Present at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Rhea-AI Summary

Replimune Group, a clinical-stage biotech firm, is set to present at the 2024 ASCO Annual Meeting from May 31-June 4 in Chicago. The company will showcase data from two significant trials: the IGNYTE trial of RP1 combined with nivolumab in anti-PD-1 failed melanoma, and a Phase 1 trial of RP2 combined with nivolumab in advanced uveal melanoma. Additional highlights include three trial-in-progress posters for RP1 and RP2. Oral presentations will feature updated 12-month data and new biomarker results, with key sessions scheduled on June 3.

Positive

• Replimune is presenting multiple studies at a prestigious event, indicating scientific recognition.
• Updated 12-month data from the IGNYTE trial of RP1 may provide robust insights, potentially boosting investor confidence.
• Inclusion of multiple abstracts suggests a broad and active clinical pipeline.
• Positive safety and efficacy data from Phase 1 trial of RP2 could signal promising therapeutic potential.

Negative

• Data updates and presentations are interim; final results and impacts on clinical outcomes remain uncertain.
• The RP2 data involves only Phase 1 results; further trials are needed, which could entail higher costs and extended timelines.

WOBURN, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced multiple presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from May 31-June 4, 2024.

The Company has two abstracts selected for oral presentation, including an updated presentation of investigator-assessed 12-month data from the IGNYTE clinical trial of RP1 (vusolimogene oderparepvec) plus nivolumab in anti-PD-1 failed melanoma, and another presentation showcasing data from the Phase 1 trial of RP2 combined with nivolumab in advanced uveal melanoma. In addition, RP1 and RP2 are also featured in three trial-in-progress posters.

Details for the presentations are as follows:

Oral data presentations

Abstract Title: Efficacy and safety of RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma from the IGNYTE clinical trial. Data included in the presentation will be 12-month investigator-assessed data with a cutoff date of March 8, 2024, as compared to the abstract which includes 6-month investigator-assessed data. As previously disclosed, the topline 12-month primary analysis results by independent central review are expected later in Q2 2024.

• Session Title: Melanoma/Skin Cancers
• Date: June 3, 2024; 10:57-11:03 AM CDT
• Location: S406
• Abstract: 9517

Abstract Title: Safety, efficacy, and biomarker results from an open-label, multicenter, phase 1 study of RP2 alone or combined with nivolumab in a cohort of patients with uveal melanoma.

• Session Title: Melanoma/Skin Cancers
• Date: June 3, 2024; 9:57-10:03 AM CDT
• Location: S406
• Abstract: 9511

Trial-in-progress poster presentations

Abstract Title: A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec (VO) combined with nivolumab vs treatment of physician’s choice in patients with advanced melanoma that has progressed on anti-PD-1 and anti-CTLA-4 therapy (IGNYTE-3).

• Poster Session Title: Melanoma/Skin Cancers
• Date: June 1, 2024, 1:30 PM-4:30 PM CDT
• Location: Hall A, Poster Board 385b
• Abstract: TPS9604

Abstract Title: An open-label, multicenter study investigating RP2 oncolytic immunotherapy in combination with second-line systemic atezolizumab combined with bevacizumab in patients with locally advanced unresectable or metastatic hepatocellular carcinoma

• Poster Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
• Date: June 1, 2024, 1:30 PM-4:30 PM CDT
• Location: Hall A, Poster Board 165b
• Abstract: TPS4191

Abstract Title: IST: Trial in progress: A phase 1/2 study of Vusolimogene oderparepvec in primary melanoma (mel) to reduce the risk of sentinel lymph node (SLN) metastasis.

• Poster Session Title: Melanoma/Skin Cancers
• Date: June 1, 2024, 1:30 PM-4:30 PM CDT
• Location: Hall A, Poster Board 390b
• Abstract: TPS9614

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary 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 RP2
RP2 is based on a proprietary 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. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP-R- and GM-CSF. RP2 is 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 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 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 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 Brinzey
Westwicke, an ICR Company
339.970.2843
chris.brinzey@westwicke.com

Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com

FAQ

What is Replimune presenting at the 2024 ASCO Annual Meeting?

Replimune is presenting data from the IGNYTE clinical trial of RP1 combined with nivolumab in anti-PD-1 failed melanoma, and a Phase 1 trial of RP2 combined with nivolumab in advanced uveal melanoma.

When will the Replimune presentations at ASCO 2024 take place?

The presentations are scheduled between May 31 and June 4, 2024, with key sessions on June 3.

What types of cancers are covered in Replimune's ASCO presentations?

The presentations cover melanoma, uveal melanoma, and hepatocellular carcinoma.

What is the significance of the 12-month data from the IGNYTE trial?

The 12-month data offers updated insights into the efficacy and safety of RP1 combined with nivolumab, important for assessing the treatment's potential in anti-PD-1 failed melanoma.

Which Replimune candidates are featured in trial-in-progress posters at ASCO 2024?

RP1 and RP2 are featured in several trial-in-progress posters at the event.