OS Therapies Schedules United Kingdom’s Medicines and Healthcare products Regulatory Agency's (MHRA) Scientific Advice Meeting in the Third Quarter of 2025 for Review of its OST-HER2 Immunotherapy Candidate for Osteosarcoma
OS Therapies (NYSE-A: OSTX) has scheduled a Scientific Advice Meeting with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in Q3 2025 to discuss the Innovative Licensing and Access Pathway for its OST-HER2 immunotherapy. This therapy aims to prevent metastases recurrence in osteosarcoma patients.
The company reported positive Phase 2b data in January 2025, showing statistically significant results in the primary endpoint of 12-month event-free survival. The meeting positions OS Therapies to potentially launch OST-HER2 in the UK market in 2025.
As a UK reference country approval could facilitate approvals in multiple nations including Australia, Canada, and several European countries. The treatment has already received Fast Track and Orphan Drug designations from the European Medicines Agency.
OS Therapies (NYSE-A: OSTX) ha programmato un incontro di consulenza scientifica con l'Agenzia Regolatoria dei Farmaci e dei Prodotti Sanitari del Regno Unito (MHRA) nel terzo trimestre del 2025 per discutere il percorso di licenza innovativa e accesso per la sua immunoterapia OST-HER2. Questa terapia mira a prevenire la recidiva delle metastasi nei pazienti affetti da osteosarcoma.
La società ha riportato dati positivi della Fase 2b a gennaio 2025, mostrando risultati statisticamente significativi nel principale obiettivo di sopravvivenza libera da eventi a 12 mesi. L'incontro posiziona OS Therapies per un potenziale lancio di OST-HER2 nel mercato del Regno Unito nel 2025.
Poiché il Regno Unito è un paese di riferimento, l'approvazione potrebbe facilitare le autorizzazioni in più nazioni, tra cui Australia, Canada e diversi paesi europei. Il trattamento ha già ricevuto designazioni di Fast Track e Orphan Drug dall'Agenzia Europea dei Medicinali.
OS Therapies (NYSE-A: OSTX) ha programado una reunión de asesoramiento científico con la Agencia Reguladora de Medicamentos y Productos de Salud del Reino Unido (MHRA) en el tercer trimestre de 2025 para discutir la Ruta de Licencia Innovadora y Acceso para su inmunoterapia OST-HER2. Esta terapia tiene como objetivo prevenir la recurrencia de metástasis en pacientes con osteosarcoma.
La compañía informó sobre datos positivos de la Fase 2b en enero de 2025, mostrando resultados estadísticamente significativos en el objetivo primario de supervivencia libre de eventos a 12 meses. La reunión posiciona a OS Therapies para un posible lanzamiento de OST-HER2 en el mercado del Reino Unido en 2025.
Dado que el Reino Unido es un país de referencia, la aprobación podría facilitar las autorizaciones en múltiples naciones, incluyendo Australia, Canadá y varios países europeos. El tratamiento ya ha recibido designaciones de Fast Track y Orphan Drug de la Agencia Europea de Medicamentos.
OS Therapies (NYSE-A: OSTX)는 2025년 3분기에 영국의 의약품 및 의료제품 규제청(MHRA)과 과학 자문 회의를 예정하여 OST-HER2 면역요법의 혁신적인 라이센스 및 접근 경로에 대해 논의할 예정입니다. 이 요법은 골육종 환자에서 전이 재발을 예방하는 것을 목표로 합니다.
회사는 2025년 1월에 긍정적인 2b상 데이터를 보고하였으며, 12개월 사건 없는 생존의 주요 목표에서 통계적으로 유의미한 결과를 보여주었습니다. 이 회의는 OS Therapies가 2025년 영국 시장에 OST-HER2를 출시할 수 있는 가능성을 높입니다.
영국이 기준 국가로서 승인을 받으면 호주, 캐나다 및 여러 유럽 국가를 포함한 여러 국가에서의 승인을 용이하게 할 수 있습니다. 이 치료법은 이미 유럽 의약품청으로부터 패스트 트랙 및 희귀약 지정을 받았습니다.
OS Therapies (NYSE-A: OSTX) a prévu une réunion de conseil scientifique avec l'Agence de réglementation des médicaments et des produits de santé du Royaume-Uni (MHRA) au troisième trimestre 2025 pour discuter du parcours de licence innovante et d'accès pour sa immunothérapie OST-HER2. Cette thérapie vise à prévenir la récurrence des métastases chez les patients atteints d'ostéosarcome.
L'entreprise a rapporté des données positives de la Phase 2b en janvier 2025, montrant des résultats statistiquement significatifs dans l'objectif principal de survie sans événement à 12 mois. La réunion positionne OS Therapies pour un lancement potentiel d'OST-HER2 sur le marché britannique en 2025.
Étant donné que le Royaume-Uni est un pays de référence, l'approbation pourrait faciliter les autorisations dans plusieurs pays, y compris l'Australie, le Canada et plusieurs pays européens. Le traitement a déjà reçu des décisions de Fast Track et de médicament orphelin de l'Agence européenne des médicaments.
OS Therapies (NYSE-A: OSTX) hat ein wissenschaftliches Beratungsgespräch mit der britischen Arzneimittel- und Gesundheitsbehörde (MHRA) für das dritte Quartal 2025 angesetzt, um den innovativen Lizenz- und Zugangsweg für ihre OST-HER2-Immuntherapie zu besprechen. Diese Therapie zielt darauf ab, das Wiederauftreten von Metastasen bei Patienten mit Osteosarkom zu verhindern.
Das Unternehmen berichtete im Januar 2025 über positive Phase-2b-Daten, die statistisch signifikante Ergebnisse beim primären Endpunkt der 12-monatigen ereignisfreien Überlebensrate zeigten. Das Treffen positioniert OS Therapies, um OST-HER2 möglicherweise 2025 auf dem britischen Markt einzuführen.
Da das Vereinigte Königreich ein Referenzland ist, könnte die Genehmigung die Zulassungen in mehreren Ländern, einschließlich Australien, Kanada und mehreren europäischen Ländern, erleichtern. Die Behandlung hat bereits Fast-Track- und Orphan-Drug-Designationen von der Europäischen Arzneimittel-Agentur erhalten.
- Positive Phase 2b results with statistically significant 12-month event-free survival
- Fast Track and Orphan Drug designations from European Medicines Agency
- UK approval could facilitate multi-country approvals due to reference country status
- Potential market launch in UK by 2025
- Still requires regulatory approvals before commercialization
- Timeline to market depends on successful regulatory meetings and reviews
“Today’s announcement marks the beginning of the regulatory process required to bring our OST-HER2 immunotherapy to market globally,” stated OS Therapies’ CEO Paul Romness. “As we prepare for regulatory interactions in the
The
About OS Therapies
OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company announced that its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma achieved the primary endpoint of the study of 12-month event free survival (EFS). The Company anticipates submitting a Biologics Licensing Application (BLA) to the US FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the
In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone linker technology, enabling the delivery of multiple payloads per linker. For more information, please visit www.ostherapies.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the US FDA and grant of a priority review voucher and other risks and uncertainties described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s registration statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024, as amended on November 27, 2024, and other subsequent documents we file with the SEC, including but not limited to our Quarterly Reports on Form 10-Q. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Source: OS Therapies, Inc.
FAQ
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