OS Therapies Receives Patent Notice of Allowance from U.S. Patent & Trademark Office Covering Commercial Manufacturing of OST-HER2
OS Therapies (NYSE-A: OSTX) received a USPTO Notice of Allowance for a patent covering OST-HER2 commercial manufacturing methods, with market exclusivity extended into 2040. The company is preparing for FDA discussions following its Phase 2b clinical trial in osteosarcoma, aiming for BLA submission and potential FDA approval in 2025.
The company completed a $7.1 million financing in January 2025, providing capital into mid-2026. OST-HER2 holds rare pediatric disease, fast-track, and orphan drug designations. Phase 1 trials in HER2-expressing cancers showed promising results, including a 78% reduction in tumor size in breast cancer models and 65% reduction in metastatic cells.
The company targets the osteosarcoma market, estimated at $1.2 billion in 2022, with an expected $500 million opportunity for OST-HER2. The breast cancer market, valued at $29.2 billion in 2023, presents an additional $1 billion opportunity.
OS Therapies (NYSE-A: OSTX) ha ricevuto un Avviso di Concessione dall'USPTO per un brevetto che copre i metodi di produzione commerciale di OST-HER2, con esclusività di mercato estesa fino al 2040. L'azienda si sta preparando per i colloqui con la FDA dopo il suo trial clinico di Fase 2b in osteosarcoma, con l'obiettivo di presentare la BLA e ottenere un'approvazione potenziale dalla FDA nel 2025.
L'azienda ha completato un finanziamento di 7,1 milioni di dollari a gennaio 2025, fornendo capitale fino a metà 2026. OST-HER2 possiede designazioni per malattie pediatriche rare, fast-track e farmaco orfano. I trial di Fase 1 nei tumori che esprimono HER2 hanno mostrato risultati promettenti, inclusa una riduzione del 78% delle dimensioni del tumore nei modelli di cancro al seno e una riduzione del 65% delle cellule metastatiche.
L'azienda mira al mercato dell'osteosarcoma, stimato in 1,2 miliardi di dollari nel 2022, con un'opportunità prevista di 500 milioni di dollari per OST-HER2. Il mercato del cancro al seno, valutato a 29,2 miliardi di dollari nel 2023, presenta un'opportunità aggiuntiva di 1 miliardo di dollari.
OS Therapies (NYSE-A: OSTX) recibió un Aviso de Concesión de la USPTO para una patente que cubre los métodos de fabricación comercial de OST-HER2, con exclusividad en el mercado extendida hasta 2040. La compañía se está preparando para las discusiones con la FDA después de su ensayo clínico de Fase 2b en osteosarcoma, con el objetivo de presentar la BLA y obtener una posible aprobación de la FDA en 2025.
La empresa completó una financiación de 7,1 millones de dólares en enero de 2025, proporcionando capital hasta mediados de 2026. OST-HER2 tiene designaciones de enfermedad pediátrica rara, vía rápida y medicamento huérfano. Los ensayos de Fase 1 en cánceres que expresan HER2 mostraron resultados prometedores, incluida una reducción del 78% en el tamaño del tumor en modelos de cáncer de mama y una reducción del 65% en células metastásicas.
La compañía se enfoca en el mercado de osteosarcoma, estimado en 1,2 mil millones de dólares en 2022, con una oportunidad esperada de 500 millones de dólares para OST-HER2. El mercado del cáncer de mama, valorado en 29,2 mil millones de dólares en 2023, presenta una oportunidad adicional de 1 mil millones de dólares.
OS Therapies (NYSE-A: OSTX)는 OST-HER2 상업 생산 방법을 다루는 특허에 대해 USPTO의 허가 통지를 받았으며, 시장 독점권은 2040년까지 연장되었습니다. 이 회사는 골육종에 대한 2b상 임상 시험 후 FDA와의 논의를 준비하고 있으며, 2025년 BLA 제출 및 FDA 승인을 목표로 하고 있습니다.
회사는 2025년 1월에 710만 달러의 자금을 조달하여 2026년 중반까지 자본을 확보했습니다. OST-HER2는 희귀 소아 질환, 신속 승인 및 고아 약물 지정을 보유하고 있습니다. HER2를 발현하는 암에 대한 1상 시험에서 유망한 결과를 보여주었으며, 유방암 모델에서 종양 크기가 78% 감소하고 전이 세포가 65% 감소했습니다.
회사는 2022년 12억 달러로 추정되는 골육종 시장을 목표로 하고 있으며, OST-HER2에 대한 5억 달러의 기회를 기대하고 있습니다. 2023년 292억 달러로 평가된 유방암 시장은 추가로 10억 달러의 기회를 제공합니다.
OS Therapies (NYSE-A: OSTX) a reçu un Avis de Concession de l'USPTO pour un brevet couvrant les méthodes de fabrication commerciale d'OST-HER2, avec une exclusivité sur le marché prolongée jusqu'en 2040. L'entreprise se prépare à des discussions avec la FDA suite à son essai clinique de Phase 2b en ostéosarcome, visant une soumission de BLA et une éventuelle approbation de la FDA en 2025.
L'entreprise a complété un financement de 7,1 millions de dollars en janvier 2025, fournissant des capitaux jusqu'à mi-2026. OST-HER2 détient des désignations pour maladie pédiatrique rare, procédure accélérée et médicament orphelin. Les essais de Phase 1 dans les cancers exprimant HER2 ont montré des résultats prometteurs, y compris une réduction de 78 % de la taille des tumeurs dans des modèles de cancer du sein et une réduction de 65 % des cellules métastatiques.
L'entreprise cible le marché de l'ostéosarcome, estimé à 1,2 milliard de dollars en 2022, avec une opportunité attendue de 500 millions de dollars pour OST-HER2. Le marché du cancer du sein, évalué à 29,2 milliards de dollars en 2023, présente une opportunité supplémentaire d'un milliard de dollars.
OS Therapies (NYSE-A: OSTX) erhielt eine Mitteilung über die Genehmigung vom USPTO für ein Patent, das die kommerziellen Herstellungsverfahren von OST-HER2 abdeckt, mit einer Marktexklusivität bis 2040. Das Unternehmen bereitet sich auf Gespräche mit der FDA nach seiner klinischen Studie der Phase 2b bei Osteosarkom vor, mit dem Ziel, 2025 einen BLA-Antrag zu stellen und möglicherweise eine FDA-Zulassung zu erhalten.
Das Unternehmen hat im Januar 2025 eine Finanzierung in Höhe von 7,1 Millionen US-Dollar abgeschlossen, die Kapital bis Mitte 2026 bereitstellt. OST-HER2 hat Auszeichnungen für seltene pädiatrische Erkrankungen, beschleunigte Zulassung und Arzneimittel für Waisen. Die Phase-1-Studien bei HER2-exprimierenden Krebserkrankungen zeigten vielversprechende Ergebnisse, darunter eine 78%ige Reduktion der Tumorgröße bei Brustkrebsmodellen und eine 65%ige Reduktion der metastatischen Zellen.
Das Unternehmen zielt auf den Osteosarkom-Markt ab, der 2022 auf 1,2 Milliarden US-Dollar geschätzt wird, mit einer erwarteten Gelegenheit von 500 Millionen US-Dollar für OST-HER2. Der Markt für Brustkrebs, der 2023 auf 29,2 Milliarden US-Dollar geschätzt wird, bietet eine zusätzliche Gelegenheit von 1 Milliarde US-Dollar.
- Patent protection secured until 2040 for OST-HER2 manufacturing methods
- Successful $7.1M financing securing operations into mid-2026
- Multiple FDA designations (RPDD, FTD, ODD) potentially accelerating approval process
- Promising Phase 1 trial results showing 78% tumor size reduction
- Large market opportunities: $500M in osteosarcoma and $1B in breast cancer
- BLA approval still pending and subject to FDA review
- Commercial success dependent on future clinical trial outcomes
- Current reliance on external financing for operations
Insights
The USPTO's Notice of Allowance for OST-HER2's manufacturing patent represents a transformative development for OS Therapies, establishing a critical competitive moat through 2040. The 572-day Patent Term Adjustment significantly enhances the asset's value proposition, providing nearly 15 years of market exclusivity post-potential approval.
The manufacturing patent is particularly important for complex biologics, where process patents often provide stronger protection than composition patents. This protection becomes especially valuable considering the $7.1 million financing secured in January 2025, which provides operational runway through mid-2026 - a critical period encompassing the anticipated BLA submission.
The company's multi-phase strategy presents several near-term value catalysts:
- The potential Priority Review Voucher, historically valued at
$150 million , could provide substantial non-dilutive funding by Q3 2026 - The triple regulatory designations (RPDD, FTD, ODD) significantly de-risk the approval pathway and potential market launch
- The preclinical breast cancer data, particularly the
78% tumor size reduction and65% reduction in metastatic cell concentration, suggests potential expansion beyond the initial osteosarcoma indication
The market opportunity is substantial, with osteosarcoma representing a
The comprehensive preclinical data package across multiple breast cancer models demonstrates robust efficacy, particularly in combination with existing HER2-targeted therapies. This positions OST-HER2 as a potential complementary treatment rather than just a competitive alternative, potentially expanding its market opportunity.
-
Patent Term Adjustment will provide market exclusivity in
the United States into 2040 for all therapeutic indications
OST-HER2 has already received rare pediatric disease (RPDD), fast-track (FTD) and orphan drug (ODD) designations from the US FDA for osteosarcoma. The Company intends to (1) focus on gaining FDA BLA approval for OST-HER2 in osteosarcoma in late 2025, (2) sell the Priority Review Voucher (PRV) it would receive from the FDA BLA approval prior to the September 30, 2026 PRV deadline to a larger pharmaceutical company at prevailing market prices (most recent PRV sale transaction was
OST-HER2 has successfully completed a Phase 1 trial in adult patients with HER2 overexpressing cancers, primarily breast cancer patients. Preclinical breast cancer results with OST-HER2 showed:
-
78% reduction in tumor size (3mm for OST-HER2 treated vs. 14mm for control arm) in FVB/N HER2 transgenic mouse model of breast cancer treatment at day 75 -
33% prevention of breast cancer in OST-HER2 treated mice vs.0% prevention of breast cancer in FVB/N HER2 transgenic model of breast cancer prevention at week 50 -
20% reduction of tumor size for OST-HER2 plus HER2-targeted antibody vs. HER2-targeted antibody alone Tg tumor regression model of breast cancer at day 42 -
65% reduction cellular concentration of metastatic cells for OST-HER2-treated mice compared with controls in brain metastasis model of primary breast cancer
The osteosarcoma treatment market was estimated at
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.
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OS Therapies Contact Information:
Jack Doll
571.243.9455
Irpr@ostherapies.com
https://x.com/OSTherapies
https://www.instagram.com/ostherapies/
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https://www.linkedin.com/company/os-therapies/
Source: OS Therapies, Inc.
FAQ
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