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+ [4]

Active Indication

MelanomaUnresectable MelanomaHemangiosarcoma+ [12]

Inactive Indication-

Originator Organization

Replimune Group, Inc.

Active Organization

Replimune, Inc.

Replimune Group, Inc.

The Institute of Cancer Research: Royal Cancer Hospital

+ [1]

Inactive Organization-

License Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationPriority Review (United States), Breakthrough Therapy (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: Norman, Derek D. ; Shin, Yoojin ; 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.

02 Nov 2025·Future Medicinal Chemistry

“Spiro-pyrrolizidine-benzyloxy hybrid as synergistic partner to doxorubicin cardio-safe breast cancer chemotherapy”

Article

Author: Sivakumar, K. ; Manikandan, H. ; Rajapandiyan, Uthirapathi ; Raj Kumar, M.

PURPOSE OF OBJECTIVE:

This study aims to develop novel spiro-pyrrolizidine-benzyloxy hybrids (RP₁, RP₂, and RP₃) to reduce the dosage and mitigate the side effects of doxorubicin (DOX) while harnessing potential synergistic effects for enhanced anticancer efficacy.

METHODS:

Spiro-pyrrolizidine-benzyloxy hybrids (RP₁, RP₂, and RP₃) were synthesized using isatin, L-proline, and sub-chalcone. The anticancer potential of these compounds was evaluated against MDA-MB-231 breast cancer cells. Based on superior efficacy, RP₁ was selected and compounded with doxorubicin in different ratios. The anticancer efficacy of these compounded formulations was assessed through cell viability assays and IC50 values.

RESULTS:

Among the synthesized hybrids, RP₁ exhibited the highest anticancer efficacy against MDA-MB-231 cells. When RP1 was combined with doxorubicin, the combination showed reduced cell viability, with the most effective ratio being 23.50 µM (20:80) (RP₁: dox), followed by 11.22 µM (50:50) and 8.82 µM (80:20). The compounded formulation resulted in a lower IC50 value compared to doxorubicin alone, indicating enhanced efficacy.

CONCLUSIONS:

Compounding RP₁ with doxorubicin effectively enhances anticancer activity while potentially reducing the side effects associated with doxorubicin's quinone-hydroquinone moiety. The optimized formulation (80:20) presents a promising approach for improving breast cancer treatment outcomes.

114

News (Medical) associated with Vusolimogene oderparepvec

13 May 2026

·www.biospace.com

UniQure, Replimune shares rise as FDA’s Makary exits, but path forward unchanged

iStock, bobmadbob After devastating regulatory setbacks last year, shares of uniQure and Replimune rose on the news that FDA Commissioner Marty Makary is leaving. But analysts don’t expect much relief, no matter who helms the agency. Shares of UniQure and Replimune, two companies that received painful and unexpected rebukes from the FDA over the past year, climbed on the news that Commissioner Marty Makary has resigned. But the departure may not mean much for these companies that have been struggling to move forward since the FDA flipped their regulatory worlds upside down. UniQure’s shares have risen 23% to $28.44 apiece over the past five days. Rumors emerged of Makary’s potential firing on Friday, May 8. Replimune, meanwhile, has climbed nearly 29% to $4.44, including an 8% rise as the markets opened this morning. On Friday, BMO Capital Markets warned that Replimune’s situation is unlikely to change—even without Makary. The FDA has rejected the company’s advanced melanoma drug RP1 twice. The first time was in July 2025, when the agency argued that the study used to underpin the application was not considered an “adequate and well-controlled clinical investigation,” Replimune said at the time. Then-Center for Biologics Evaluation and Research (CBER) head Vinay Prasad was thought to have intervened at the 11th hour . It was later revealed , however, that former oncology head—and short-term Center for Drug Evaluation and Research director—Richard Pazdur had a hand in the rejection. Then last month, a different team of FDA reviewers came to the same conclusion: a single-arm trial was not appropriate to support approval. Makary himself defended the decision and stood by the scientists at the agency in an interview with CNBC that aired on May 5. Huntington’s disease UniQure’s Path for Huntington’s Gene Therapy Clouded by Ethical Questions as Potential Phase 3 Looms While the FDA appears to be adamant that uniQure conduct a sham surgery–controlled Phase 3 trial before AMT-130 can be considered for approval, experts believe there is an alternate path forward for the therapy, perhaps even based on precedent from the recent drama surrounding Moderna’s mRNA flu vaccine. March 5, 2026 · 7 min read · Heather McKenzie Read more Replimune quickly announced that the biotech would have to cut jobs and scale back without timely accelerated approval of RP1. “If Makary is removed as commissioner, we do not expect this meaningfully changes RP1’s second denial,” BMO wrote on Friday prior to the official resignation. The agency raised many concerns with the trial that would require a completely new study, the analysts said. While Replimune’s shares are moving on the news of Makary’s departure, BMO said on Friday that RP1’s future is still in doubt. “While REPL shares are reacting positively to this news, we expect a reversal on prior FDA CRLs for Replimune to be unlikely, even if Makary is replaced,” BMO wrote. “We’re not saying a revisit isn’t impossible, but we would not expect a quick resolution following a potential departure.” UniQure, on the other hand, was preparing an application for the Huntington’s disease gene therapy AMT-130, which had recently recorded positive pivotal data that was heralded as a potential breakthrough for the intractable neurodegenerative disease. But during a pre-BLA meeting, the FDA informed the company that the Phase 1/2 data would not be enough to support an application . This went against previous guidance that uniQure had received under the prior administration. The FDA now wants uniQure to conduct a Phase 3 sham surgery-controlled trial—which would require patients to be anesthetized for 10 to 12 hours while a surgeon cuts through the skin and makes a burr hole in the skull. In an attempt to overcome the FDA roadblock, uniQure has scheduled a type B meeting with the FDA this quarter to discuss a potential Phase 3 trial. At the same time, the company is preparing a regulatory package in the U.K. for the third quarter. While both Replimune and uniQure may have a few good days at the market with Makary’s exit, analysts pointed to the larger ripple effects of the FDA chief’s departure. “While near-term there are select names—most notably QURE and REPL—that could immediately benefit from the removal of regulatory headwinds tied to this particular leadership, over the more medium-term, we see today’s news as likely renewing an overhang at a time when biopharma had been performing relatively well,” RBC Capital Markets wrote Tuesday afternoon. Complete response letters Second rejection for tumor destroyer puts Replimune on a ‘challenging path’ Replimune’s CEO Sushil Patel has already warned that the biotech will need to cut staff and substantially scale back its U.S. manufacturing operations. April 13, 2026 · 2 min read · Tristan Manalac Read more

Phase 3Gene Therapy

11 May 2026

·www.biopharmadive.com

Biotech layoffs are easing, but is the worst over?

There have been over 40 rounds of layoffs announced this year as of April 30, compared to more than 50 in the last four months of 2025, according to one industry tracker.At the beginning of the year at least one analyst predicted that industry reductions would trend downward in 2026. But similar optimism last year proved misplaced when job losses rose 16%year over year amid unanticipated market turbulence in the U.S., including tariff threats, most-favored-nation pricing proposals and continuing cost pressures from the Inflation Reduction Act.So far, many of this years cuts were driven by familiar industry pressures, such as investigational drug failures, strategic reprioritizations and efforts to improve operational efficiency.Planned and unplanned layoffsBioNTech said in early May it will undergo a major restructuring as it pivots to oncology and declining sales of its COVID-19 vaccine. The company plans to downsize its manufacturing operations in Germany and Singapore, a move that will eliminate an estimated 1,860 jobs.Earlier announcements also included cuts from Vistagen, which aims to reduce its workforce by about 20% to save money and focus on its lead candidate, a nasal spray for social anxiety disorder. The decision came after the drug failed a phase 3 trial last December. The candidate is now in the midst of another phase 3 trial.Replimune, an oncology-focused biotech, also had two rounds of layoffs 63 workers on April 13 and an additional 161 on April 17. The decision stemmed from a controversial FDA rejection of its melanoma drug, RP1. The agency declined to approve its drug in combination with nivolumab after a new review team took over the case and cited issues with its trial design. Replimune said that feedback from the new team contradicted earlier advice the company was given by the FDA. Despite the substantial downsizing, Replimune plans to forge ahead with an additional phase 2/3 drug candidate RP2,which is being tested in metastatic uveal melanoma and hepatocellular carcinoma.While some layoffs were related to investigational drug issues, other companies, including Takeda Pharmaceutical, carried out reductions in line with larger reorganization plans. Takeda is navigating a billion-dollar-plus restructuring effort and announced a 600-plus person workforce reduction that will affect staff in Massachusetts and other states. The goal of the changes, which wont go into effect until July, is to increase efficiency and to redirect savings into R&D investments and upcoming drug launches.Merck & Co. has also been streamlining and said it will reduce its global workforce by 8%. The large pharma is tightening its belt as it prepares for its mega-blockbuster Keytruda to move off patent. But its most recent round of job cuts in February came in response to slowing market demand for its human papillomavirus vaccineGardasil. As a result, Merck is scaling back manufacturing and cutting nearly 150 workers at its Durham, North Carolina, plant.While many layoff drivers this year have been typical for the industry, eyes are still on other potential factors, including AI. So far, its too soon to say how big of an impact AI will have and some contend that it wont encroach on jobs in pharma the same way it has in other industries like tech. '

VaccinePhase 3

27 Apr 2026

·www.biospace.com

Replimune to Present at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

WOBURN, Mass., April 27, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from May 29-June 2, 2026. The Company has two abstracts selected for oral presentation, including a 3-year landmark overall survival analysis from the IGNYTE clinical trial of RP1 (vusolimogene oderparepvec) plus nivolumab in anti-PD-1 failed melanoma, and an oral presentation on the final safety, efficacy, and biomarker results from the Phase 1 first-in-human study of RP2 alone and combined with nivolumab in advanced solid tumors. Four additional posters for RP1 and RP2 will be presented. Details for the presentations are as follows: Oral data presentations Abstract Title: A 3-year landmark overall survival analysis of RP1 plus nivolumab in patients with anti-PD-1-failed melanoma from the IGNYTE clinical trial. Session Title: Rapid Oral Abstract Session - Melanoma/Skin Cancers Presenter: Michael Wong, MD, PhD Date: May 30, 2026, 5:30-5:36 pm CDT Location: E451 Abstract #: 9518 Abstract Title: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study. Session Title: Oral Abstract Session - Developmental Therapeutics-Immunotherapy Presenter: Joseph Sacco, PhD, MBChB Date: May 31, 2026, 9:12-9:24 AM CDT Location: Arie Crown Theater Abstract #: 2504 Poster presentations Abstract Title: Safety and feasibility of intratumoral injection of RP1 or RP2 oncolytic immunotherapies in visceral metastases. Poster Session Title: Developmental Therapeutics-Immunotherapy Presenter: Caroline Robert, MD, PhD Date: May 30, 2026, 1:30-4:30 PM CDT Location: Hall A, Poster 387 Abstract # : 2597 Abstract Title: A randomized, phase 2/3 clinical trial investigating RP2 plus nivolumab vs ipilimumab plus nivolumab in immune checkpoint inhibitor-naïve patients with metastatic uveal melanoma. Poster Session Title: Melanoma/Skin Cancers Presenter: Marlana Orloff, MD Date: May 31, 2025, 9:00 AM-12:00 PM CDT Location: Hall A, Poster 481a Abstract #: TPS9598 Abstract Title: A randomized, controlled, multicenter, phase 3 study of RP1 (vusolimogene oderparepvec) combined with nivolumab vs physician's choice of therapy 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 Presenter: Yana Najjar, MD Date: May 31, 2026, 9:00 AM-12:00 PM CDT Location: Hall A, Poster 480b Abstract #: TPS9597 Abstract Title: A multicenter, open-label study of RP2 oncolytic immunotherapy expressing anti-CTLA-4 combined with second-line atezolizumab plus bevacizumab in advanced hepatocellular carcinoma (HCC) or with first-line durvalumab in advanced biliary tract cancer (BTC). Poster Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary Presenter: Richard Kim, MD Date: May 30, 2026, 9:00 AM-12:00 PM CDT Location: Hall A, Poster 230a Abstract #: TPS4255 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

ImmunotherapyPhase 3ASCOPhase 1Clinical Result

100 Deals associated with Vusolimogene oderparepvec

R&D Status

10 top R&D records.

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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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03767348 (IGNYTE, Pubmed \| J Clin Oncol) Manual	Phase 2	Melanoma	140	Vusolimogene oderparepvec + Nivolumab	zydmjjrbdv(zsobgfrhpc) = iraakarmzg cjgptvffqi (tynqxymwae, 25.2% - 41.3) View more	Positive	20 Nov 2025
NCT03767348 (IGNYTE, ESMO2025)	Phase 2	Acral Lentiginous Malignant Melanoma	18	RP1 + nivolumab (acral melanoma)	sylzjewdmb(lfbdthizvs) = the most common TRAEs (any grade) were chills, pyrexia, fatigue, injection-site pain, and nausea cgdmflkmeb (mrsqzehtfh ) View more	Positive	17 Oct 2025
NCT03767348 (IGNYTE, ESMO2025)	Phase 1/2	Skin Neoplasms	99	RP1 + nivo (MCC)	uduqqdmipy(bsbswuzrai) = cqoejwdprb lvnktrwpnk (guroceaywp ) View more	Positive	17 Oct 2025
NCT03767348 (IGNYTE, ESMO2025)	Phase 1/2	Skin Neoplasms	99	RP1 + nivo (LA/Met + CSCC)	uduqqdmipy(bsbswuzrai) = wlrdmxkgxg lvnktrwpnk (guroceaywp ) View more	Positive	17 Oct 2025
NCT03767348 (IGNYTE, ASCO2025)	Phase 2	Skin Neoplasms	-	RP1 + nivolumab	jkguiuwyua(nvdhltakbf) = hqctkdgeye glmqrkrhlg (zpefdfecjg ) View more	-	30 May 2025
NCT06264180 (IGNYTE-3, ASCO2025)	Phase 3	Melanoma BRAF V600-mutant	-	Vusolimogene oderparepvec + Nivolumab	pcwlejiqdz(gycwrkbuht) = hxzgqczedb ewrtbwfgld (slffdiyzrq )	Positive	30 May 2025
NCT03767348 (IGNYTE, HOPA2025)	Phase 1/2	Skin Neoplasms	278	RP1 plus nivolumab	oxzhplywka(skdjqzmggf) = vfklubtipz yxwvfrxvab (zbjpjbswcg ) View more	Positive	09 Apr 2025
NCT03767348 (IGNYTE, SITC2024 \| NEWS) Manual	Phase 2	Melanoma Second line	140	Vusolimogene oderparepvec + Nivolumab	qcmiavrhvm(pminxnhulf) = cvghhmdvmy ypuovxwwnf (lriftikhlf ) View more	Positive	05 Nov 2024
NCT03767348 (IGNYTE, ESMO2024) Manual	Phase 2	Melanoma Second line	140	RP1+nivolumab	ddqshalmyl(zgywnmgmmo) = pcnogepqxb recnaafdck (embrpwbjuq ) 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)	ddqshalmyl(zgywnmgmmo) = oucoyxirlb recnaafdck (embrpwbjuq )	Positive	15 Sep 2024
NCT03767348 (IGNYTE, Company_Website) Manual	Phase 1/2	Refractory Melanoma Second line	140	RP1 plus nivolumab	geiznkfwsj(ofzxwzovad) = ltjvjpnabd mkreduuuro (oneiffgphh )	Positive	06 Jun 2024
NCT03767348 (IGNYTE, ASCO2024) Manual	Phase 1/2	Melanoma	156	RP1 + nivolumab	drvhhjpdqj(jijbgcjwxb) = zogykkayux juqvrhpddz (jgaaxjlasg ) View more	Positive	24 May 2024

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