OS Therapies Completes Acquisition of Advaxis Immunotherapies Clinical, Pre-clinical and IP Assets from Ayala Pharmaceuticals
OS Therapies (NYSE-A: OSTX) has completed the acquisition of Advaxis Immunotherapies' listeria-based cancer immunotherapy assets from Ayala Pharmaceuticals, positioning itself as the world leader in this field. The acquisition includes:
- Three clinical-stage cancer immunotherapy candidates:
- OST-AXAL for HPV-associated cancers
- OST-503 for Non-Small Cell Lung Cancer & Glioblastoma
- OST-PSA for Prostate Cancer
Additionally, 8 pre-clinical immunotherapy candidates were acquired, targeting 30+ cancers. The company's lead asset, OST-HER2, targets approval by year-end 2025 for preventing recurrence in fully-resected, lung metastatic osteosarcoma. New manufacturing-based IP protects the platform until 2040. The global cancer immunotherapy market is valued at $126 billion (2023) and projected to exceed $296 billion by 2033.
OS Therapies (NYSE-A: OSTX) ha completato l'acquisizione degli asset di immunoterapia contro il cancro basati su listeria di Advaxis Immunotherapies da Ayala Pharmaceuticals, posizionandosi come leader mondiale in questo campo. L'acquisizione include:
- Tre candidati per l'immunoterapia contro il cancro in fase clinica:
- OST-AXAL per i tumori associati all'HPV
- OST-503 per il cancro polmonare non a piccole cellule e il glioblastoma
- OST-PSA per il cancro alla prostata
Inoltre, sono stati acquisiti 8 candidati per l'immunoterapia in fase preclinica, mirati a oltre 30 tipi di cancro. L'asset principale dell'azienda, OST-HER2, punta all'approvazione entro la fine del 2025 per prevenire la recidiva nell'osteosarcoma polmonare metastatico completamente asportato. La nuova proprietà intellettuale basata sulla produzione protegge la piattaforma fino al 2040. Il mercato globale dell'immunoterapia contro il cancro è valutato a 126 miliardi di dollari (2023) e si prevede che supererà i 296 miliardi di dollari entro il 2033.
OS Therapies (NYSE-A: OSTX) ha completado la adquisición de los activos de inmunoterapia contra el cáncer basados en listeria de Advaxis Immunotherapies de Ayala Pharmaceuticals, posicionándose como líder mundial en este campo. La adquisición incluye:
- Tres candidatos de inmunoterapia contra el cáncer en fase clínica:
- OST-AXAL para cánceres asociados al VPH
- OST-503 para cáncer de pulmón no microcítico y glioblastoma
- OST-PSA para cáncer de próstata
Además, se adquirieron 8 candidatos de inmunoterapia en fase preclínica, dirigidos a más de 30 tipos de cáncer. El activo principal de la empresa, OST-HER2, busca la aprobación para finales de 2025 para prevenir la recurrencia en osteosarcoma metastásico pulmonar completamente resecado. La nueva propiedad intelectual basada en la fabricación protege la plataforma hasta 2040. El mercado global de inmunoterapia contra el cáncer está valorado en 126 mil millones de dólares (2023) y se proyecta que superará los 296 mil millones de dólares para 2033.
OS Therapies (NYSE-A: OSTX)는 Ayala Pharmaceuticals로부터 Advaxis Immunotherapies의 리스테리아 기반 암 면역 치료 자산을 인수 완료하며, 이 분야의 세계적 리더로 자리매김했습니다. 인수에는 다음이 포함됩니다:
- 임상 단계의 암 면역 치료 후보 3가지:
- OST-AXAL, HPV 관련 암 치료
- OST-503, 비소세포 폐암 및 교모세포종 치료
- OST-PSA, 전립선암 치료
또한, 30개 이상의 암을 겨냥한 8개의 전임상 면역 치료 후보도 인수되었습니다. 회사의 주요 자산인 OST-HER2는 완전히 절제된 폐 전이성 골육종의 재발을 예방하기 위해 2025년 말까지 승인을 목표로 하고 있습니다. 새로운 제조 기반의 지식 재산권은 2040년까지 플랫폼을 보호합니다. 전 세계 암 면역 치료 시장은 2023년 기준으로 1260억 달러로 평가되며, 2033년까지 2960억 달러를 초과할 것으로 예상됩니다.
OS Therapies (NYSE-A: OSTX) a achevé l'acquisition des actifs d'immunothérapie contre le cancer basés sur la listeria d'Advaxis Immunotherapies auprès d'Ayala Pharmaceuticals, se positionnant ainsi comme le leader mondial dans ce domaine. L'acquisition comprend :
- Trois candidats à l'immunothérapie contre le cancer en phase clinique :
- OST-AXAL pour les cancers associés au VPH
- OST-503 pour le cancer du poumon non à petites cellules et le glioblastome
- OST-PSA pour le cancer de la prostate
De plus, 8 candidats à l'immunothérapie préclinique ont été acquis, ciblant plus de 30 cancers. L'actif principal de l'entreprise, OST-HER2, vise une approbation d'ici fin 2025 pour prévenir la récidive de l'ostéosarcome pulmonaire métastatique complètement réséqué. Une nouvelle propriété intellectuelle basée sur la fabrication protège la plateforme jusqu'en 2040. Le marché mondial de l'immunothérapie contre le cancer est évalué à 126 milliards de dollars (2023) et devrait dépasser 296 milliards de dollars d'ici 2033.
OS Therapies (NYSE-A: OSTX) hat die Übernahme der auf Listeria basierenden Krebsimmuntherapie-Assets von Advaxis Immunotherapies von Ayala Pharmaceuticals abgeschlossen und sich damit als Weltmarktführer in diesem Bereich positioniert. Die Übernahme umfasst:
- Drei klinische Kandidaten für die Krebsimmuntherapie:
- OST-AXAL für HPV-assoziierte Krebserkrankungen
- OST-503 für nicht-kleinzelliges Lungenkarzinom und Glioblastom
- OST-PSA für Prostatakrebs
Zusätzlich wurden 8 präklinische Immuntherapie-Kandidaten erworben, die auf über 30 Krebsarten abzielen. Das Hauptasset des Unternehmens, OST-HER2, strebt bis Ende 2025 die Genehmigung zur Verhinderung von Rückfällen bei vollständig reseziertem, lungengemetastasiertem Osteosarkom an. Neues, auf der Herstellung basierendes geistiges Eigentum schützt die Plattform bis 2040. Der globale Markt für Krebsimmuntherapien wird 2023 auf 126 Milliarden Dollar geschätzt und soll bis 2033 296 Milliarden Dollar überschreiten.
- Acquisition positions OSTX as world leader in listeria-based cancer immunotherapy
- IP protection extended to 2040 for platform and candidates
- Expanded pipeline with 3 clinical-stage and 8 pre-clinical candidates
- OST-503 reported positive Phase 2 data in NSCLC
- Large market opportunity with $126B current market size
- Lead asset OST-HER2 approval not expected until end of 2025
- Financial terms of acquisition not disclosed
Insights
This acquisition represents a significant strategic expansion for OS Therapies, transforming its clinical pipeline and positioning it as the self-described leader in listeria-based cancer immunotherapies. With a current market cap of just
The deal's strategic value is enhanced by extended IP protection to 2040, creating a runway for commercialization. The company's targeting year-end 2025 approval for its lead asset OST-HER2 suggests a potential near-term catalyst. The acquired assets complement their existing focus on immunotherapy, creating portfolio synergy rather than diversification into unfamiliar territory.
What's notably missing is any disclosure of financial terms - how much was paid, how the acquisition was financed, and the impact on cash position. For a micro-cap company, these details are crucial for assessing the true value proposition. The global cancer immunotherapy market context (
The acquisition of assets with completed Phase 3 and positive Phase 2 data significantly derisks the development pathway compared to early-stage assets, potentially accelerating time to market. However, investors should recognize that regulatory approval remains the critical hurdle, especially for novel immunotherapy approaches.
The consolidation of Advaxis' listeria-based immunotherapy platform under OS Therapies creates a more focused development pathway for this unique approach to cancer treatment. The scientific rationale behind listeria-based immunotherapies is particularly compelling - they can deliver cancer antigens directly to the immune system to generate T-cell responses against tumors that might otherwise evade detection.
The most advanced acquired asset, OST-AXAL for HPV-associated cancers, has completed one Phase 3 trial (AIM2CERV), representing significant clinical validation. Similarly, OST-503's positive Phase 2 data in non-small cell lung cancer provides proof-of-concept in one of oncology's largest markets. These clinical-stage assets complement OST-HER2, which targets the prevention of recurrence in osteosarcoma - an area with high unmet need.
What makes this platform potentially valuable is its applicability where checkpoint inhibitors have limitations. As Dr. Petit notes, checkpoint inhibitors work by removing the brakes on existing immune responses, but they're ineffective when sufficient T-cell responses against tumor antigens haven't developed. The listeria platform potentially addresses this gap by generating new T-cell responses.
The addition of 8 preclinical constructs targeting hotspot mutations and cancer-testes antigens creates opportunities to address multiple cancer types. However, the scientific community should note that despite the platform's elegance, listeria-based approaches have faced challenges in translating preclinical success to clinical efficacy. The key technical hurdle remains optimizing the balance between immunogenicity and safety while achieving sufficient target delivery to generate robust anti-tumor responses.
- Company now listeria-based cancer immunotherapy world leader
- Expands clinical pipeline with 3 new cancer immunotherapy candidates
- 8 pre-clinical immunotherapy candidates targeting 30+ cancers added
“We are thrilled to have now consolidated all of the intellectual property for the listeria cancer immunotherapy platform into OS Therapies, positioning us to fully expand it in the years ahead and improve the standard of care across cancer treatment in the years ahead,” said Paul Romness, CEO of OS Therapies. “We now have late-stage, mid-stage and early-stage cancer immunotherapy candidates, a rich pipeline of preclinical cancer immunotherapy candidates and a long IP runway to in order to fully leverage this powerful cancer immunotherapy platform.”
A video explaining how the listeria platform works is available here.
Clinical-stage Cancer Immunotherapy Programs Acquired
- OST-AXAL (previously AXAL/ADXS/HPV) for Human Papilloma Virus (HPV) associated cancers completed 1st (AIM2CERV) of 2 Phase 3 trials;
- OST-503 (previously ADXS-503) for Non-Small Cell Lung Cancer (NSCLC) & Glioblastoma reported positive Phase 2 data in NSCLC;
- OST-PSA (previously ADXS-504/ADXS31142) for Prostate Cancer.
Pre-clinical Cancer Immunotherapy Programs Acquired
8 un-named OST-HOT Listeria constructs designed for off-the shelf treatment of common cancers with shared hotspot mutations and cancer-testes antigen targets.
“The listeria cancer immunotherapy platform holds tremendous potential to improve the outcomes for cancer patients worldwide” said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. “Immune-checkpoint inhibitors have revolutionized cancer treatment in settings where tumor antigens have generated a sufficient T cell response. However, in many cancers these treatments don’t help because T cell responses against key tumor antigens have not developed. The OST Listeria platform specifically delivers relevant cancer targets directly to the immune system and generates new T cell responses that can be used to fight these cancers and help eliminate metastases. With OST-HER2 and the rest of the listeria platform, we have the potential to generate novel, more potent immune and targeted immune responses against solid tumors, metastatic disease and micro metastases from early-stage to late-stage cancers. I am thrilled to be able to guide the OST-HER2 asset through approval in osteosarcoma, and then fully explore that listeria platform’s potential to improve treatment outcomes for cancer patients.”
The global cancer immunotherapy market size was valued at
About OS Therapies
OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of new class immunotherapy candidates for solid tumors, beginning with osteosarcoma. OST-HER2, the Company's lead asset, is the first in a new class of immunotherapy leveraging the immune-stimulatory effects of Listeria monocytogenes to initiate a strong immune response targeting to specific cancer antigens. The Company’s lead asset OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the US Food & Drug Administration. OST-HER2 demonstrated positive data in a Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma and intends to submit a BLA Accelerated Approval request to the US FDA in the third quarter of 2025. Upon approval, the Company will become eligible to receive a Priority Review Voucher, currently valued at
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 through its wholly-owned subsidiary OS Drug Candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) 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:
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Source: OS Therapies
FAQ
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