Replimune Announces Positive Pre-BLA Meeting with FDA and Confirms BLA Submission On Track for 2H 2024
Replimune Group, Inc. (NASDAQ: REPL) has successfully completed a pre-Biologics License Application (pre-BLA) meeting with the FDA, supporting their plans to submit a BLA for RP1 (vusolimogene oderparepvec) in the treatment of anti-PD1 failed melanoma via the accelerated approval pathway in 2H 2024. The company's CEO, Sushil Patel, confirmed that the accelerated approval path is available for RP1 in this indication. Topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab showed an overall response rate of 33%. Independently reviewed data from this trial, including key secondary endpoints and subgroup analyses, will be presented at the ESMO Annual Congress 2024 in Barcelona on September 15, 2024.
Replimune Group, Inc. (NASDAQ: REPL) ha completato con successo un incontro pre-Biologics License Application (pre-BLA) con la FDA, a supporto dei loro piani per presentare una BLA per RP1 (vusolimogene oderparepvec) nel trattamento del melanoma resistente ad anti-PD1 attraverso il percorso di approvazione accelerata nel 2H 2024. Il CEO dell'azienda, Sushil Patel, ha confermato che il percorso di approvazione accelerata è disponibile per RP1 in questa indicazione. I risultati principali dall'analisi primaria del trial clinico IGNYTE di RP1 più nivolumab hanno mostrato un tasso di risposta globale del 33%. I dati revisionati in modo indipendente di questo trial, inclusi i principali endpoint secondari e le analisi di sottogruppo, saranno presentati al Congresso Annuale ESMO 2024 a Barcellona il 15 settembre 2024.
Replimune Group, Inc. (NASDAQ: REPL) ha completado con éxito una reunión previa a la Solicitud de Licencia Biológica (pre-BLA) con la FDA, apoyando sus planes de presentar una BLA para RP1 (vusolimogene oderparepvec) en el tratamiento de melanoma fallido con anti-PD1 a través de la vía de aprobación acelerada en 2H 2024. El CEO de la compañía, Sushil Patel, confirmó que la vía de aprobación acelerada está disponible para RP1 en esta indicación. Los resultados generales del análisis principal del ensayo clínico IGNYTE de RP1 más nivolumab mostraron una tasa de respuesta general del 33%. Los datos revisados de manera independiente de este ensayo, incluyendo los principales objetivos secundarios y los análisis de subgrupos, se presentarán en el Congreso Anual ESMO 2024 en Barcelona el 15 de septiembre de 2024.
Replimune Group, Inc. (NASDAQ: REPL)는 FDA와의 생물학적 라이센스 신청(pre-BLA) 회의를 성공적으로 완료하여 RP1 (vusolimogene oderparepvec)에 대한 BLA 제출 계획을 지원하며, 반응하지 않는 멜라노마 치료를 위한 가속 승인 경로를 통해 2024년 하반기에 진행할 예정입니다. 회사의 CEO인 Sushil Patel은 이 적응증에 대해 RP1의 가속 승인 경로가 가능하다고 확인했습니다. RP1과 니볼루맙의 IGNYTE 임상 시험의 주요 분석에서의 주요 결과는 33%의 전체 반응률을 나타냈습니다. 이 시험에서 독립적으로 검토된 데이터, 주요 2차 목표 및 하위 집단 분석을 포함한 내용은 ESMO 연례 회의 2024에서 바르셀로나에서 2024년 9월 15일에 발표될 예정입니다.
Replimune Group, Inc. (NASDAQ: REPL) a réussi à organiser une réunion pré-Biologics License Application (pré-BLA) avec la FDA, soutenant leurs projets de soumettre une BLA pour RP1 (vusolimogene oderparepvec) dans le traitement du mélanome échappant à l'anti-PD1 via le chemin d'approbation accélérée au 2H 2024. Le directeur général de l'entreprise, Sushil Patel, a confirmé que le chemin d'approbation accélérée est disponible pour RP1 dans cette indication. Les résultats globaux de l'analyse primaire de l'essai clinique IGNYTE de RP1 et nivolumab ont montré un taux de réponse global de 33%. Les données révisées de manière indépendante de cet essai, y compris les principaux critères secondaires et les analyses de sous-groupes, seront présentées lors du Congrès Annuel ESMO 2024 à Barcelone le 15 septembre 2024.
Die Replimune Group, Inc. (NASDAQ: REPL) hat erfolgreich ein Pre-Biologics License Application (pre-BLA) Meeting mit der FDA abgeschlossen, um ihre Pläne zur Einreichung eines BLA für RP1 (vusolimogene oderparepvec) zur Behandlung von anti-PD1-resistentem Melanom über den beschleunigten Genehmigungsweg im 2. Halbjahr 2024 zu unterstützen. Der CEO des Unternehmens, Sushil Patel, bestätigte, dass der beschleunigte Genehmigungsweg für RP1 in dieser Indikation verfügbar ist. Die wichtigsten Ergebnisse der primären Analyse der IGNYTE-Phase-3-Studie von RP1 plus Nivolumab zeigten eine Gesamtansprechrate von 33%. Unabhängig überprüfte Daten aus dieser Studie, einschließlich wichtiger sekundärer Endpunkte und Subgruppenanalysen, werden beim ESMO-Jahreskongress 2024 am 15. September 2024 in Barcelona präsentiert.
- Successful pre-BLA meeting with FDA supporting accelerated approval pathway
- BLA submission for RP1 in anti-PD1 failed melanoma on track for 2H 2024
- IGNYTE clinical trial showed 33% overall response rate for RP1 plus nivolumab
- Confirmatory IGNYTE-3 trial already underway
- None.
Insights
This pre-BLA meeting outcome is a significant milestone for Replimune and potentially for melanoma patients. The 33% overall response rate in anti-PD1 failed melanoma is noteworthy, as these patients typically have treatment options. The accelerated approval pathway could bring RP1 to market faster, addressing an unmet medical need.
However, it's important to note that accelerated approvals are conditional on confirmatory trials. The ongoing IGNYTE-3 trial will be pivotal for full approval. Investors should watch for the detailed ESMO presentation, which may provide insights into durability of response and safety profile - key factors for both regulatory and commercial success.
Replimune's successful pre-BLA meeting is a positive development, potentially accelerating RP1's path to market. The FDA's alignment on the accelerated approval pathway suggests confidence in the drug's potential benefit-risk profile. This could significantly reduce time-to-market and development costs.
Investors should note that the BLA submission timeline of 2H 2024 provides a clear catalyst. However, it's important to consider that accelerated approvals come with the obligation to complete confirmatory trials. The IGNYTE-3 trial results will be important for maintaining approval and expanding market acceptance. The upcoming ESMO presentation may offer insights into RP1's competitive positioning in the evolving melanoma treatment landscape.
The FDA's agreement on the accelerated approval pathway for RP1 is a significant regulatory win for Replimune. This pathway is typically reserved for drugs that address serious conditions with unmet medical needs, suggesting the FDA sees potential in RP1 for anti-PD1 failed melanoma patients.
However, it's important to understand that accelerated approvals come with conditions. Replimune must complete the confirmatory IGNYTE-3 trial to verify clinical benefit. If this trial fails to confirm benefit, the FDA could withdraw approval. Investors should be aware that while this news reduces regulatory uncertainty in the short term, long-term success still hinges on robust confirmatory data and ongoing FDA scrutiny.
Aligned with FDA on accelerated approval pathway for RP1 in anti-PD1 failed melanoma
WOBURN, Mass., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced it has completed a successful pre-Biologics License Application (pre-BLA) meeting with the U.S. Food and Drug Administration (FDA) that supports the Company’s plans to submit a BLA for RP1 (vusolimogene oderparepvec) for the treatment of anti-PD1 failed melanoma via the accelerated approval pathway in 2H 2024.
“This successful pre-BLA meeting confirmed that the accelerated approval path is available for RP1 in anti-PD1 failed melanoma,” said Sushil Patel, Ph.D., Chief Executive Officer at Replimune. “With the confirmatory IGNYTE-3 trial underway, we remain on track to submit the BLA in 2H 2024 and continue our preparations to bring RP1 to patients with advanced melanoma.”
Topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab shared earlier this year showed an overall response rate of
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 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, 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 Westwicke
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
FAQ
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