Replimune Receives Breakthrough Therapy Designation for RP1 and Submits RP1 Biologics License Application to the FDA under the Accelerated Approval Pathway
Replimune Group (NASDAQ: REPL) has submitted a biologics license application (BLA) to the FDA for RP1 in combination with nivolumab to treat advanced melanoma patients who previously received anti-PD1 treatment. The FDA has granted Breakthrough Therapy designation for this combination therapy, potentially expediting its development and review process. The submission was made under the Accelerated Approval pathway, based on safety and clinical activity data from the IGNYTE clinical trial. A confirmatory Phase 3 IGNYTE-3 trial is currently enrolling patients.
Replimune Group (NASDAQ: REPL) ha presentato una domanda di licenza biologica (BLA) alla FDA per RP1 in combinazione con nivolumab per trattare pazienti con melanoma avanzato che hanno precedentemente ricevuto trattamento anti-PD1. La FDA ha conferito la designazione di Terapia Innovativa per questa terapia combinata, accelerando potenzialmente il suo sviluppo e processo di revisione. La domanda è stata presentata nell'ambito del percorso di Approvazione Accelerata, basata sui dati di sicurezza e attività clinica provenienti dallo studio clinico IGNYTE. Un trial di conferma di Fase 3, IGNYTE-3, è attualmente in fase di arruolamento per pazienti.
Replimune Group (NASDAQ: REPL) ha presentado una solicitud de licencia de productos biológicos (BLA) a la FDA para RP1 en combinación con nivolumab para tratar a pacientes con melanoma avanzado que han recibido previamente tratamiento anti-PD1. La FDA ha otorgado la designación de Terapia Innovadora para esta terapia combinada, lo que puede acelerar su desarrollo y proceso de revisión. La presentación se realizó bajo la vía de Aprobación Acelerada, basada en datos de seguridad y actividad clínica del ensayo clínico IGNYTE. Actualmente, se está reclutando pacientes para un ensayo de confirmación de Fase 3, IGNYTE-3.
Replimune Group (NASDAQ: REPL)은 RP1과 nivolumab의 조합으로 PD-1 항체 치료를 이전에 받은 진행성 흑색종 환자를 치료하기 위해 FDA에 생물학적 제제 허가 신청(BLA)을 제출했습니다. FDA는 이 조합 요법에 대해 혁신 치료제 지정을 부여하였으며, 이는 개발 및 검토 과정을 신속하게 진행할 수 있도록 도와줍니다. 제출은 IGNYTE 임상 시험의 안전성 및 임상 활동 데이터에 근거하여 신속 승인 경로로 이루어졌습니다. 현재, 환자를 모집 중인 확인 Phase 3 IGNYTE-3 시험이 진행되고 있습니다.
Replimune Group (NASDAQ: REPL) a soumis une demande de licence biologique (BLA) à la FDA pour RP1 en combinaison avec le nivolumab afin de traiter des patients atteints de mélanome avancé ayant précédemment reçu un traitement anti-PD1. La FDA a accordé la désignation de Thérapie Avancée pour cette thérapie combinée, ce qui pourrait accélérer son développement et son processus de révision. La soumission a été effectuée dans le cadre du chemin d'Approvisionnement Accéléré, basé sur des données de sécurité et d'activité clinique provenant de l'essai clinique IGNYTE. Un essai de confirmation de Phase 3, IGNYTE-3, recrute actuellement des patients.
Replimune Group (NASDAQ: REPL) hat einen Biologics-Lizenzantrag (BLA) bei der FDA für RP1 in Kombination mit Nivolumab eingereicht, um Patienten mit fortgeschrittenem Melanom zu behandeln, die zuvor eine Anti-PD1-Behandlung erhalten haben. Die FDA hat für diese Kombinationstherapie die Breakthrough-Therapie-Designierung erteilt, was die Entwicklung und den Prüfprozess möglicherweise beschleunigt. Der Antrag wurde im Rahmen des beschleunigten Genehmigungsverfahrens auf der Grundlage von Sicherheits- und klinischen Aktivitätsdaten aus der klinischen IGNYTE-Studie eingereicht. Eine bestätigende Phase-3-Studie IGNYTE-3 rekrutiert derzeit Patienten.
- Received FDA Breakthrough Therapy designation for RP1
- Submitted BLA under Accelerated Approval pathway
- Potential new treatment option for advanced melanoma patients who failed prior therapy
- Phase 3 confirmatory trial still ongoing and required for full approval
- to patients who previously failed anti-PD1 treatment
Insights
The BLA submission and Breakthrough Therapy designation for RP1 represent significant regulatory milestones for Replimune. The FDA's Breakthrough designation, granted based on promising clinical data from the IGNYTE trial, could expedite RP1's path to market by up to several months. This is particularly noteworthy for advanced melanoma patients who have failed anti-PD1 therapy, where treatment options are
The accelerated approval pathway could enable faster market entry while the confirmatory Phase 3 IGNYTE-3 trial continues. If approved, RP1 would enter a multi-billion dollar melanoma market where it could capture significant share among second-line patients. The combination with nivolumab, an established immunotherapy, enhances the commercial potential.
The ongoing Phase 3 trial will be important for full approval and broader market adoption. Success could position Replimune as a key player in advanced melanoma treatment.
WOBURN, Mass., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the Accelerated Approval pathway. The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting.
Breakthrough Therapy designation is intended to expedite the development and review of therapies for serious diseases when preliminary clinical evidence indicates that the therapy may provide substantial improvement over existing available therapies on one or more clinically significant endpoints. This Breakthrough Therapy designation is based on the safety and clinical activity observed in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial.
“Today is an important milestone for Replimune and for the melanoma community as we are one step closer to having another potential treatment available for patients who have limited options after progressing on anti-PD1 containing regimens,” said Sushil Patel, Ph.D., CEO of Replimune.
The confirmatory Phase 3 IGNYTE-3 trial of RP1 in combination with nivolumab in advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are not candidates for anti-CTLA-4 treatment is currently enrolling patients. For more information, visit https://replimune.com/clinical-trials/ignyte-3/.
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 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 designed to have 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 our belief regarding the effect that the breakthrough designation will have on the timing and development of RP1 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, 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 the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military 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 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
ICR Healthcare
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
FAQ
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