OS Therapies Initiates Commercial-ready Manufacturing of OST-HER2 to Support Anticipated Biologics Licensing Authorization (BLA) Filing
OS Therapies (NYSE-A: OSTX) has announced steps toward commercial manufacturing of OST-HER2, marking progress in its development of cancer immunotherapies. The company has secured agreements for commercial manufacturing as it prepares for a potential Biologics Licensing Authorization (BLA) submission to the FDA.
The announcement follows the completion of a Phase 2b trial testing OST-HER2 for preventing lung metastatic osteosarcoma recurrence. The company is currently organizing trial data for an upcoming Type B or Type C meeting with the FDA, after which it plans to submit a BLA application for accelerated or conditional approval consideration.
OS Therapies (NYSE-A: OSTX) ha annunciato i passi verso la produzione commerciale di OST-HER2, segnando un progresso nello sviluppo delle immunoterapie contro il cancro. L'azienda ha ottenuto accordi per la produzione commerciale mentre si prepara per una potenziale Autorizzazione alla Licenza Biologica (BLA) da presentare alla FDA.
L'annuncio segue il completamento di uno studio di Fase 2b che ha testato OST-HER2 per prevenire la recidiva dell'osteosarcoma metastatico polmonare. L'azienda sta attualmente organizzando i dati dello studio per un prossimo incontro di Tipo B o Tipo C con la FDA, dopo il quale prevede di presentare una domanda di BLA per la considerazione di approvazione accelerata o condizionata.
OS Therapies (NYSE-A: OSTX) ha anunciado pasos hacia la fabricación comercial de OST-HER2, marcando un progreso en su desarrollo de inmunoterapias contra el cáncer. La empresa ha asegurado acuerdos para la fabricación comercial mientras se prepara para una posible Autorización de Licencia Biológica (BLA) que presentará a la FDA.
El anuncio sigue a la finalización de un ensayo de Fase 2b que prueba OST-HER2 para prevenir la recurrencia del osteosarcoma metastásico pulmonar. La empresa está organizando actualmente los datos del ensayo para una próxima reunión de Tipo B o Tipo C con la FDA, tras la cual planea presentar una solicitud de BLA para la consideración de aprobación acelerada o condicional.
OS Therapies (NYSE-A: OSTX)는 OST-HER2의 상업적 제조를 위한 단계들을 발표하며 암 면역 요법 개발에서 진전을 이루었다고 밝혔습니다. 이 회사는 FDA에 생물학적 제품 라이센스 승인(BLA) 제출을 준비하면서 상업적 제조를 위한 계약을 확보했습니다.
이번 발표는 폐 전이성 골육종 재발 방지를 위한 OST-HER2의 2b상 임상 시험 완료에 따른 것입니다. 이 회사는 현재 FDA와의 예정된 B형 또는 C형 회의를 위해 임상 시험 데이터를 정리하고 있으며, 이후 BLA 신청을 제출할 계획입니다.
OS Therapies (NYSE-A: OSTX) a annoncé des étapes vers la fabrication commerciale d'OST-HER2, marquant des progrès dans le développement de ses immunothérapies contre le cancer. L'entreprise a sécurisé des accords pour la fabrication commerciale alors qu'elle se prépare à une éventuelle Autorisation de Licence Biologique (BLA) à soumettre à la FDA.
L'annonce fait suite à l'achèvement d'un essai de Phase 2b testant OST-HER2 pour prévenir la récidive de l'ostéosarcome métastatique pulmonaire. L'entreprise organise actuellement les données de l'essai pour une prochaine réunion de Type B ou Type C avec la FDA, après quoi elle prévoit de soumettre une demande de BLA pour une considération d'approbation accélérée ou conditionnelle.
OS Therapies (NYSE-A: OSTX) hat Schritte zur kommerziellen Herstellung von OST-HER2 angekündigt, was einen Fortschritt in der Entwicklung von Krebsimmuntherapien markiert. Das Unternehmen hat Vereinbarungen zur kommerziellen Herstellung gesichert, während es sich auf eine mögliche Biologics Licensing Authorization (BLA) Einreichung bei der FDA vorbereitet.
Die Ankündigung folgt dem Abschluss einer Phase-2b-Studie, die OST-HER2 zur Prävention von Lungenmetastasen des Osteosarkoms testete. Das Unternehmen organisiert derzeit die Studiendaten für ein bevorstehendes Typ-B- oder Typ-C-Meeting mit der FDA, nach dem es plant, einen BLA-Antrag auf beschleunigte oder bedingte Genehmigung einzureichen.
- Advancement toward commercial manufacturing indicates progress in product development pipeline
- Completion of Phase 2b trial for OST-HER2
- Potential accelerated/conditional FDA approval pathway
- Commercial manufacturing agreements may increase operational costs
- FDA approval remains uncertain pending review meeting and BLA submission
Insights
The initiation of commercial-ready manufacturing for OST-HER2 represents a strategically timed milestone that carries several important implications for OS Therapies' advancement toward market entry. Establishing manufacturing capabilities ahead of BLA submission is a calculated move that typically signals strong confidence in clinical outcomes and regulatory prospects.
The company's preparation for Type B/C FDA meetings following their Phase 2b trial completion in lung metastatic osteosarcoma prevention suggests they're positioning for an accelerated approval pathway. This regulatory strategy is particularly noteworthy as accelerated approvals can potentially reduce time-to-market by 1-2 years compared to traditional approval routes.
The manufacturing investment at this stage carries significant strategic weight:
- It demonstrates financial commitment and operational readiness for commercialization
- It addresses a critical FDA requirement for BLA submissions regarding manufacturing process validation
- It potentially reduces time between potential approval and market launch
For a company with a market capitalization of
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, fast-track and orphan drug designations from the US FDA. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, with positive results released in the first quarter of 2025. 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) platform, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250214059335/en/
OS Therapies Contact Information:
Jack Doll
571.243.9455
Irpr@ostherapies.com
https://x.com/OSTherapies
https://www.instagram.com/ostherapies/
https://www.facebook.com/OSTherapies/
https://www.linkedin.com/company/os-therapies/
Source: OS Therapies, Inc.
FAQ
What is the current status of OST-HER2's Phase 2b trial for OSTX?
When will OSTX submit the BLA application for OST-HER2?
What type of FDA approval is OSTX seeking for OST-HER2?
What manufacturing developments has OSTX announced for OST-HER2?
