CSF-2R stimulants(Granulocyte-macrophage colony-stimulating factor receptor stimulants), GALV-GP R- modulators(GALV-GP R(-) modulators), PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesRespiratory Diseases+ [3]

Active Indication

MelanomaUnresectable MelanomaHemangiosarcoma+ [11]

Inactive Indication-

Originator Organization

Replimune Group, Inc.

Active Organization

Replimune, Inc.

Replimune Group, Inc.

Regeneron Pharmaceuticals, Inc.

+ [1]

Inactive Organization-

License Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (United States), Priority Review (United States)

Structure/Sequence

Sequence Code 1390932635

Clinical Trials associated with Vusolimogene oderparepvec

NCT06898970

/ Active, not recruitingPhase 2IIT

An Open-Label, Multicenter, Phase 2 Study With Safety Lead-In of Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab in Patients With Angiosarcoma

This is a multicenter, open-label study of Intratumoral Vusolimogene Oderparepvec (VO) to investigate safety and estimate when used in combination with pembrolizumab for treating participants with angiosarcoma. This is the first study evaluating this novel combination in participants with advanced angiosarcoma who have progressed after prior immunotherapy.

Start Date09 Jan 2026

Sponsor / Collaborator

The University of California, San Francisco

[+1]

NCT06264180

/ RecruitingPhase 3

Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment [IGNYTE-3]

This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.

Start Date11 Jul 2024

Sponsor / Collaborator

Replimune, Inc.

NCT06067061

/ TerminatedPhase 1/2IIT

"neoBREASTIM": A Phase 2 Study of Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer (TNBC)

Neoadjuvant treatment is an important part of the treatment strategy for locally advanced TNBC having established a positive and significant correlation of pathologic Complete Response (pCR) with long-term clinical benefit such as Event-Free Survival (EFS) and Overall Survival (OS) as shown via large meta-analysis. Much effort has been made to identify novel agents and new drug combinations that can improve pCR rates in this specific clinical setting, which is the leading rationale to evaluate RP1 oncolytic immunotherapy in combination with Atezolizumab.

Start Date05 Apr 2024

Sponsor / Collaborator

Institut Curie

[+2]

100 Clinical Results associated with Vusolimogene oderparepvec

100 Translational Medicine associated with Vusolimogene oderparepvec

100 Patents (Medical) associated with Vusolimogene oderparepvec

Literatures (Medical) associated with Vusolimogene oderparepvec

01 Mar 2026·Journal for ImmunoTherapy of Cancer

Effects of oncolytic immunotherapy with RP1 (vusolimogene oderparepvec) on immune cells mediate responsiveness to anti-PD-1 via STING-mediated interferon signaling

Article

Author: Mohan, Nitya ; Fernando, Winnie ; Mannion, Jonathan ; Kyula, Joan ; Goicoechea, Maria ; Melcher, Alan ; Zierhut, Christian ; Kuncheria, Linta ; Gkantalis, Jim ; Bommareddy, Praveen K ; Harrington, Kevin J ; Patin, Emmanuel Christian ; Wongariyapak, Amarin ; Layzell, Scott ; Baldock, Holly ; Coffin, Robert S ; Foo, Shane ; Roulstone, Victoria ; McLaughlin, Martin ; Pickering, Robert ; Appleton, Elizabeth ; Leslie, Isla ; Chan Wah Hak, Charleen ML ; Jones, Sylwia ; Hubbard, Lisa C ; Murano, Carmen ; Vile, Richard ; Pedersen, Malin ; Dean, Isaac ; Meier, Pascal ; Smith, Henry G ; Patrikeev, Anton ; Mansfield, David

Background:

Antitumor immune responses induced by oncolytic immunotherapy (OI) are often followed by upregulation of programmed death-ligand 1 (PD-L1). As such, the combination of OI with blockade of the programmed cell death protein-1 (PD-1)/PD-L1 axis has demonstrated therapeutic activity in preclinical and clinical trials. The purpose of this study is to understand further the immune-mediated mechanism of interaction between oncolytic viruses and anti-PD-1 therapy.

Methods:

Tumor cells and immune cells (splenocytes) were cultured separately, or in co-culture with vusolimogene oderparepvec, an oncolytic herpes simplex virus expressing the fusogenic gibbon-ape leukemia virus-fusogenic membrane glycoprotein protein (GALV) and granulocyte-macrophage colony-stimulating factor (GM-CSF), also known as RP1. Viral replication, interferon (IFN) responses and PD-L1 expression were analyzed using wild-type, IFNAR1, TNFAR1 and STING knockout splenocytes. In vivo studies evaluated immune cell infiltrates into the tumor following RP1 administration with anti-PD-1 therapy.

Results:

RP1 replication was evident in tumor cells but not splenocytes. This was also accompanied by upregulated IFN expression in cultured splenocytes that was absent in cultured tumor cells. However, when these cell types were co-cultured, splenocytes mediated an interferon response to RP1 via STING that was transmitted to tumor cells in a non-touch-dependent manner. Tumor cells responded to these input signals via upregulation of cell surface major histocompatibility complex-I and PD-L1 through tumor intrinsic JAK-STAT signaling. In vivo, an IFN signature was observed following intratumoral injection of RP1, both in injected and non-injected tumors, which was further increased when combined with anti-PD-1 therapy. Marked upregulation of PD-L1 was observed in tumors injected with RP1 accompanied by the recruitment of CD11b+Ly6G+neutrophils into the tumor microenvironment, which stained positive for PD-L1.

Conclusion:

Overall, the data demonstrate that RP1 remodels the tumor microenvironment through a combination of direct and indirect effects on both tumor and immune cells, resulting in an overall more inflamed phenotype.

27 Jan 2026·RADIATION RESEARCH

Development of an Extended-release Formulation of Radioprotectin-1 for Mitigation of Gastrointestinal Acute Radiation Syndrome

Article

Author: Shin, Yoojin ; Norman, Derek D. ; Ibrahim, Mohamed M. ; Wang, Yingzhe ; Benyó, Zoltán ; Jablonski, Monica M. ; Balázs, Louisa ; Davies, Erika W. ; Lee, Sue Chin ; Tigyi, Gábor J.

Left unmitigated, high-dose ionizing radiation causes DNA damage resulting in cell death and manifestation of the acute radiation syndrome (ARS). Activation of the lysophosphatidic acid receptor subtype 2 (LPAR2) is one mechanism by which radiation damage can be mitigated. Our laboratory has previously developed 5-chloro-2-( N -(4-(1,3-dioxo-1 H -benzo[ de ]isoquinolin-2(3 H )-yl)butyl)sulfamoyl)benzoic acid, designated as Radioprotectin-1 (RP-1), which is a potent LPAR2-specific agonist and radiation mitigator. We previously reported that an aqueous (AQ) formulation of RP-1 provides significant survival advantage in a murine gastrointestinal ARS (GI-ARS) model when given in a three-day regimen of twice-daily subcutaneous injections administered starting 24 h after irradiation. To improve the dosing formulation suitable for the field treatment of mass casualties, an extended-release dosing regimen was developed utilizing a water-in-oil-in-water (W/O/W) multilayered microemulsion (ME) formulation. The ME significantly extended plasma half-life, mean residence time, and exposure time while slowing plasma clearance compared to the AQ formulation in C57BL/6J mice as well as in non-human primates (NHP). This formulation provides a significant survival advantage in a GI-ARS model with only two subcutaneous injections at 24 and 72 h postirradiation. Additionally, RP-1 ME treatment protects intestinal crypts in irradiated mice, resulting in an increase in both total and actively regenerating crypts at day 5 postirradiation. Finally, LPAR2 activation by RP-1 leads to prolonged and sustained activation of the pro-survival kinases ERK1/2 and Akt up to 16 h postirradiation and reduces caspase-mediated apoptosis in irradiated mouse embryonic fibroblasts, providing a mechanism for RP-1 radiation mitigation.

01 Jan 2026·Transboundary and Emerging Diseases

Identification and Evaluation of Conserved Subunit Vaccine Candidates Conferring Cross-Serotype Protection Against Streptococcus suis Serotypes 2, 7, 8, and 9.

Article

Author: Kang, Shun ; Chen, Liye ; Zhu, Jinlu ; Zhuang, Hongkun ; Wu, Zongfu ; Peng, Zeren

Streptococcus suis is a major zoonotic pathogen with substantial serotype diversity and remains a serious threat to global swine production and public health. Accordingly, vaccines capable of inducing cross-serotype protection are urgently needed. Here, we integrated comparative genomics, bioinformatics, and reverse vaccinology to identify five conserved candidate antigens from four clinically important S. suis serotypes (2, 7, 8, and 9), designated rP1-rP5. The previously reported antigen PstB was included as a reference control (rP6), as it has demonstrated protective efficacy against serotypes 2, 7, and 9. All six recombinant proteins were successfully expressed and purified, and in silico analyses supported their predicted antigenic features and immunogenic potential. Following three immunizations in mice, all candidates elicited robust antigen-specific IgG responses. In opsonophagocytic assays, antisera against rP1, rP3, rP4, and rP6 displayed functional activity against serotypes 2, 7, 8, and 9. In a mouse infection model, vaccination with rP3, rP4, and rP6 reduced bacterial burdens in blood and multiple organs and conferred partial protection against all four serotypes, with rP4 producing a more pronounced reduction in tissue bacterial burdens than rP3 and rP6. Overall, rP4 and rP6 exhibited the most consistent cross-serotype protection in both bacterial burden and survival analyses, whereas rP3 showed protective efficacy, particularly against serotype 2, and may serve as a useful component of a multivalent formulation. Collectively, these findings support the rational design of broadly protective, multicomponent subunit vaccines against S. suis.

127

News (Medical) associated with Vusolimogene oderparepvec

29 Jun 2026

·www.biospace.com

Replimune Reports Fiscal Fourth Quarter and Year End 2026 Financial Results and Provides Corporate Update

WOBURN, Mass., June 29, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2026 and provided a business update. The Company recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July. “The FDA’s acceptance of our RP1 BLA resubmission marks a pivotal milestone in our mission to bring this important therapy to patients facing advanced melanoma, where the need for durable, effective treatment options remains significant,” said Sushil Patel, Ph.D., CEO of Replimune. “We are working hard to ensure we can provide access to RP1 as soon as possible pending an approval. We are equally pleased by the momentum across our clinical programs including continued strong enrollment in our IGNYTE-3 trial of RP1 in advanced melanoma and our REVEAL trial of RP2 in metastatic uveal melanoma.” Program Highlights & Milestones RP1 (vusolimogene oderparepvec) IGNYTE Trial (RP1 + Nivolumab) - 3-Year Overall Survival Analysis: In an oral presentation at the ASCO 2026 annual meeting, RP1 plus nivolumab demonstrated exceptional durability in anti-PD-1-failed melanoma patients, with 47.8% of all treated patients alive at 3 years and a median overall survival of 32.9 months - including an 83.5% 3-year survival rate among responders - representing a rare and meaningful long-term benefit in a patient population with historically limited treatment options ( Presentation ). IGNYTE-3 Confirmatory Study: The global Phase 3 trial assessing RP1 in combination with nivolumab versus physician's choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment is actively enrolling. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate. RP2 Phase 1 First-in-Human Trial (RP2) - Final Data: In an oral presentation at the ASCO 2026 annual meeting, RP2 monotherapy and in combination with nivolumab demonstrated promising efficacy across multiple advanced solid tumor types, achieving a 19% objective response rate in both arms with durable responses (median duration not reached for monotherapy), while translational analyses confirmed the intended mechanism of transforming immunologically “cold” tumors into immune-inflamed environments with systemic T-cell activation, supporting advancement to a randomized Phase 2/3 trial in metastatic uveal melanoma ( Presentation ). REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027. Financial Highlights Cash Position : As of March 31, 2026, cash, cash equivalents and short-term investments were $268.9 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans. Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations into the first quarter of calendar 2027, which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue. R&D Expenses: Research and development expenses were $52.3 million for the fiscal fourth quarter and $221.2 million for the fiscal year ended March 31, 2026, as compared to $54.0 million for the fiscal fourth quarter and $189.4 million for the fiscal year ended March 31, 2025. This year over year increase was primarily due to an increase in personnel-related costs as we scaled operations in preparation for commercial launch of RP1, as well as consulting and facility-related costs. Research and development expenses included $4.1 million in stock-based compensation expenses for the fiscal fourth quarter and $16.7 million for the fiscal year ended March 31, 2026. S,G&A Expenses: Selling, general and administrative expenses were $21.0 million for the fiscal fourth quarter and $98.7 million for the fiscal year ended March 31, 2026, as compared to $25.4 million for the fiscal fourth quarter and $72.2 million for the fiscal year ended March 31, 2025. Selling, general and administrative expenses included $4.1 million in stock-based compensation expenses for the fiscal fourth quarter and $15.5 million for the fiscal year ended March 31, 2026. Net Loss: Net loss was $73.7 million for the fiscal fourth quarter and $313.9 million for the fiscal year ended March 31, 2026, as compared to a net loss of $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025. About RP1 RP1 (vusolimogene oderparepvec) 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 intended 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 intended 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 novel 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 intended to ignite local 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 then activate 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 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 our cash runway, the status of the FDA review of our BLA for RP1 or potential approval of such BLA, 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, the regulatory review process and timing of potential product approval, 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 the outcome of FDA’s review process, 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, the availability of combination therapies needed to conduct our clinical trials, 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 a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, 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 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 ICR Healthcare 339.970.2843 chris.brinzey@icrhealthcare.com Media Inquiries Arleen Goldenberg Replimune 917.548.1582 media@replimune.com Replimune Group, Inc. Consolidated Statements of Operations (Amounts in thousands, except share and per share amounts) (Unaudited) Year Ended March 31, 2026 2025 Operating expenses: Research and development $ 221,184 $ 189,447 Selling, general and administrative 98,735 72,180 Total operating expenses 319,919 261,627 Loss from operations (319,919 ) (261,627 ) Other income (expense): Research and development incentives 1,604 1,773 Investment income 13,625 21,120 Interest expense on finance lease liability (2,063 ) (2,118 ) Interest expense on debt obligations (6,796 ) (5,775 ) Other expense (942 ) (202 ) Total other income, net 5,428 14,798 Loss before income taxes $ (314,491 ) $ (246,829 ) Income tax (benefit) provision (551 ) 468 Net loss $ (313,940 ) $ (247,297 ) Net loss per common share, basic and diluted $ (3.38 ) $ (3.07 ) Weighted average common shares outstanding, basic and diluted 92,803,711 80,564,147 Replimune Group, Inc. Condensed Consolidated Balance Sheets (Amounts in thousands, except share and per share amounts) (Unaudited) March 31, 2026 March 31, 2025 (in thousands) Consolidated Balance Sheet Data: Cash, cash equivalents and short-term investments $ 268,889 $ 483,804 Working capital 220,891 433,518 Total assets 332,388 551,328 Total stockholders' equity 166,160 415,843

Phase 3Phase 1Clinical ResultFinancial StatementImmunotherapy

26 Jun 2026

·www.biopharmadive.com

FDA accepts Replimune filing; Merck KGaA drops $11B on life sciences services

Today, a brief rundown of news involving Replimune, Revolution Medicines and Merck KGaA, as well as updates from Eli Lilly, Otsuka Pharmaceutical and Definium Therapeutics that you may have missed.On Friday, Replimune said that the Food and Drug Administration has accepted the resubmission for its cancer drug RP1, with a decision expected by Aug. 2 and an advisory committee set to convene in July to discuss the twice-rejected application. The latest move is another signal of the changing attitude of the FDA, which was accused of moving the goal post or providing conflicting feedback to companies, leading to delayed or rejected applications under the now-exited leaders Marty Makary and Vinay Prasad. Multiple other companies that faced hurdles under the prior leadership are now gaining new chances for their applications. Delilah AlvaradoRevolution Medicine outlined data from Phase 2 trials of its second RAS-blocking cancer drug, zoldonrasib, showing it can shrink or eliminate tumors in pancreatic cancer patients when combined with chemotherapy or Revolutions lead drug, daraxonrasib. In the chemo-combo trial, 82% of enrollees with RAS-mutated disease who got zoldonrasib and one type of chemotherapy regimen as a first-line treatment responded, as did 61% who got the experimental drug plus another type of chemo. In the trial that combined the two Revolution drugs in a second- or third-line setting in RAS-mutated enrollees, 50% of patients in the second-line setting and 47% in the third-line setting saw their tumors shrink or disappear. The data are scheduled for presentation at the European Society of Medical Oncology Gastrointestinal Cancers meeting next week. Revolution just began dosing patients in a Phase 3 trial with the chemo combination, and is planning to begin a daraxonrasib-zoldonrasib Phase 3 trial later this year. Jonathan GardnerGermany-based Merck KGaA is spending more than $11 billion to acquire Bio-Techne, a U.S. life-sciences analytics and diagnostics provider, the companies said Thursday. Per deal terms, German Merck will pay $73 per share in cash, a 36% premium to Bio-Technes average price over the past month. Merck KGaA executives stated the transaction will help build the companys life science business that serves drugmakers with materials and manufacturing by adding protein analysis, biomarker discovery and diagnostics capabilities. The deal is expected to close later this year, pending regulatory and shareholder approval, and Merck KGaA will finance it with a combination of cash on hand and new debt. Jonathan GardnerPsychedelic drug developer Definium Therapeutics is issuing $805 million worth of stock, proceeds from which will go toward research and development of its pipeline, and potential commercialization of its candidate DT120 against major depression. The public offering closing announced Thursday comes just a few days after the company unveiled positive late-stage results of DT120, an LSD-based oral drug. The company is still awaiting data from a second pivotal trial. Delilah AlvaradoEli Lilly is widening a research collaboration with China-based Abbisko, paying an undisclosed upfront fee and pledging up to $1.9 billion in potential payouts based on achievement of development and commercial milestones for drugs developed under the agreement, Abbisko said Tuesday. The two companies will work on multiple targets, advancing novel drug candidates with global potential, growing from work from a deal signed in 2022 on discovery, development, and potential commercialization of a novel small-molecule therapeutic. Abbisko has established deals with multiple drugmakers, including Merck KGaA and AstraZeneca, with the former company seeking FDA approval for a medicine called pimicotinib thats part of their deal. Jonathan GardnerOtsuka Pharmaceuticals experimental drug met its primary endpoint in a late-stage trial of adults with ADHD and comorbid anxiety, showcasing statistically significant and clinically relevant improvements when compared to placebo, the company said Thursday. Compared to placebo, centanafadine a norepinephrine, dopamine, and serotonin reuptake inhibitor had improved ADHD after eight weeks, as measured by a rating scale. The Phase 3b trial enrolled 315 adults. The experimental therapy is currently under regulatory review in the U.S. as a treatment for ADHD in children and adults, with a decision target of July 24. Delilah Alvarado '

Phase 3Phase 2AcquisitionClinical Trial FailureLicense out/in

26 Jun 2026

·www.biospace.com

Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma

FDA decision expected by August 2, 2026 WOBURN, Mass., June 26, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July. “We are pleased that the FDA has demonstrated urgency in reconsidering the RP1 BLA with an expeditious action date in recognition of the significant unmet need for advanced melanoma patients and support from the broader melanoma community,” said Sushil Patel, Ph.D., CEO of Replimune. “We look forward to a productive scientific and clinical discussion on the risk/benefit pro RP1 in this difficult to treat setting.” The resubmission seeks accelerated approval of RP1 in advanced melanoma based on data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an anti-PD-1 containing regimen. About Advanced Melanoma Melanoma is the fifth most common cancer in the United States, with approximately 112,000 new cases estimated in 2026 and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually. Melanoma is considered advanced when the cancer has spread beyond the primary tumor. Standard of care therapy includes immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment, leaving a significant population in need of effective therapeutic alternatives. About RP1 RP1 (vusolimogene oderparepvec) is Replimune's lead product candidate, based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R⁻) and GM-CSF. RP1 is designed 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 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 intended to ignite local 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 then activate 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 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 the status of the FDA review of our BLA for RP1 or potential approval of such BLA, 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, the regulatory review process and timing of potential product approval, 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 the outcome of FDA’s review process, 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, the availability of combination therapies needed to conduct our clinical trials, 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 a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, 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 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 ICR Healthcare 339.970.2843 chris.brinzey@icrhealthcare.com Media Inquiries Arleen Goldenberg Replimune 917.548.1582 media@replimune.com

100 Deals associated with Vusolimogene oderparepvec

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	NDA/BLA	United States	Replimune Group, Inc.	21 Nov 2024
Unresectable Melanoma	Phase 3	United States	Replimune, Inc.	11 Jul 2024
Unresectable Melanoma	Phase 3	France	Replimune, Inc.	11 Jul 2024
Unresectable Melanoma	Phase 3	Germany	Replimune, Inc.	11 Jul 2024
Unresectable Melanoma	Phase 3	Greece	Replimune, Inc.	11 Jul 2024
Unresectable Melanoma	Phase 3	Poland	Replimune, Inc.	11 Jul 2024
Unresectable Melanoma	Phase 3	Spain	Replimune, Inc.	11 Jul 2024
Unresectable Melanoma	Phase 3	United Kingdom	Replimune, Inc.	11 Jul 2024
Hemangiosarcoma	Phase 2	United States	Replimune, Inc.	09 Jan 2026
Microsatellite instability-high cancer	Phase 2	United States	Replimune, Inc.	30 Jan 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03767348 (IGNYTE, ASCO2026)	Phase 1/2	PD-L1-negative	140	RP1 + nivolumab	eedhomxxoo(ffqzzydtkr) = cggvezailv cygxebgqef (fqbxxphqnc, 66.9 - 81.9) View more	Positive	29 May 2026
NCT03767348 (IGNYTE, ASCO2026)	Phase 1/2	PD-L1-negative	140	RP1 + nivolumab (stage IVM1b-d disease)	eedhomxxoo(xgskexxwba) = mmtiupgran ndocyjkydx (nrweevnmcf, 29.4 - 51.7)	Positive	29 May 2026
NCT03767348 (IGNYTE, Pubmed \| J Clin Oncol) Manual	Phase 2	Melanoma	140	Vusolimogene oderparepvec + Nivolumab	yqeqcaeksp(yaatkovcln) = qcacfonsup scqdxjyyjr (owljxweorc, 25.2% - 41.3) View more	Positive	20 Nov 2025
NCT03767348 (IGNYTE, ESMO2025)	Phase 1/2	Skin Neoplasms	99	RP1 + nivo (MCC)	ppykswjlrr(ldzvawofjn) = etormixkeh ifppgcmzoq (tqwxxfrela ) View more	Positive	17 Oct 2025
NCT03767348 (IGNYTE, ESMO2025)	Phase 1/2	Skin Neoplasms	99	RP1 + nivo (LA/Met + CSCC)	ppykswjlrr(ldzvawofjn) = nskrbxpgtd ifppgcmzoq (tqwxxfrela ) View more	Positive	17 Oct 2025
NCT03767348 (IGNYTE, ESMO2025)	Phase 2	Acral Lentiginous Malignant Melanoma	18	RP1 + nivolumab (acral melanoma)	pknoellfoq(dpsrbxodub) = the most common TRAEs (any grade) were chills, pyrexia, fatigue, injection-site pain, and nausea rzfmwogztc (uiqjdxcbjb ) View more	Positive	17 Oct 2025
NCT06264180 (IGNYTE-3, ASCO2025)	Phase 3	Melanoma BRAF V600-mutant	-	Vusolimogene oderparepvec + Nivolumab	lvjlqomqjq(fhqvkfrbzy) = obaeqhwjzi qikzruniih (bpocwlmgfl )	Positive	30 May 2025
NCT03767348 (IGNYTE, ASCO2025)	Phase 2	Skin Neoplasms	-	RP1 + nivolumab	vehdrkmwou(yxmlesdvjn) = kofhornfks vauljxspjy (nrkydsjehf ) View more	-	30 May 2025
NCT03767348 (IGNYTE, HOPA2025)	Phase 1/2	Skin Neoplasms	278	RP1 plus nivolumab	oliogofcdz(iyczlzkiik) = abdnivcexm didlykoerj (aiqsahtcfv ) View more	Positive	09 Apr 2025
NCT03767348 (IGNYTE, SITC2024 \| NEWS) Manual	Phase 2	Melanoma Second line	140	Vusolimogene oderparepvec + Nivolumab	wlxtulcudx(dburyqjhxx) = zxfmknyfwa haaencdmwy (qclitmfbjt ) View more	Positive	05 Nov 2024
NCT03767348 (IGNYTE, ESMO2024) Manual	Phase 2	Melanoma Second line	140	RP1+nivolumab	xacasylrpl(qvbusejqyn) = kquhotozte rfnmbmksnk (wtmobfcwca ) View more	Positive	15 Sep 2024
NCT03767348 (IGNYTE, ESMO2024) Manual	Phase 2	Melanoma Second line	140	RP1+nivolumab (pts with primary anti–PD-1 resistance)	xacasylrpl(qvbusejqyn) = cnugkwrjqw rfnmbmksnk (wtmobfcwca )	Positive	15 Sep 2024
NCT03767348 (IGNYTE, Company_Website) Manual	Phase 1/2	Refractory Melanoma Second line	140	RP1 plus nivolumab	qrrigankjw(vnljfrbbeg) = assmpunmhz lrjoucwzbf (iuebdkpvru )	Positive	06 Jun 2024

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