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OS Therapies Announces Development of Two Novel Tunable Antibody Drug Conjugate (tADC)-Based Therapeutic Candidates

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OS Therapies (NYSE American: OSTX) has announced the development of two novel tunable Antibody Drug Conjugate (tADC) therapeutic candidates using its proprietary SiLinker™ technology. The first candidate targets Breast, Lung, and Gastric Cancer, while the second focuses on platinum-resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer. The company has completed target engagement tests for both candidates, confirming their therapeutic potential.

OS Therapies aims to advance its tADC platform through product development milestones and plans to out-license certain therapeutic candidates and components, particularly the ph-sensitive SiLinker™. The company's first tADC asset, OST-tADC-FRα-H, has achieved proof of concept in animal models of ovarian cancer. With these new additions to its pipeline, OS Therapies is positioning itself as a key provider of intellectual property for new therapeutic product development to partners.

OS Therapies (NYSE American: OSTX) ha annunciato lo sviluppo di due nuovi candidati terapeutici tunable Antibody Drug Conjugate (tADC) utilizzando la sua tecnologia proprietaria SiLinker™. Il primo candidato mira a trattare il cancro al seno, ai polmoni e allo stomaco, mentre il secondo si concentra sul cancro ovarico, della tuba di Falloppio e peritoneale primario resistenti al platino. L'azienda ha completato i test di ingaggio del bersaglio per entrambi i candidati, confermando il loro potenziale terapeutico.

OS Therapies punta ad avanzare la sua piattaforma tADC attraverso traguardi di sviluppo del prodotto e prevede di concedere in licenza alcuni candidati terapeutici e componenti, in particolare il SiLinker™ sensibile al pH. Il primo asset tADC dell'azienda, OST-tADC-FRα-H, ha raggiunto la prova di concetto in modelli animali di cancro ovarico. Con queste nuove aggiunte al suo pipeline, OS Therapies si sta posizionando come un fornitore chiave di proprietà intellettuale per lo sviluppo di nuovi prodotti terapeutici per i partner.

OS Therapies (NYSE American: OSTX) ha anunciado el desarrollo de dos nuevos candidatos terapéuticos de tunable Antibody Drug Conjugate (tADC) utilizando su tecnología patentada SiLinker™. El primer candidato se dirige al cáncer de mama, pulmonar y gástrico, mientras que el segundo se centra en el cáncer de ovario, trompas de Falopio y peritoneal primario resistente al platino. La empresa ha completado las pruebas de interacción con el objetivo para ambos candidatos, confirmando su potencial terapéutico.

OS Therapies tiene como objetivo avanzar en su plataforma tADC a través de hitos de desarrollo de productos y planea otorgar licencias a ciertos candidatos terapéuticos y componentes, en particular el SiLinker™ sensible al pH. El primer activo tADC de la empresa, OST-tADC-FRα-H, ha logrado prueba de concepto en modelos animales de cáncer de ovario. Con estas nuevas adiciones a su cartera, OS Therapies se está posicionando como un proveedor clave de propiedad intelectual para el desarrollo de nuevos productos terapéuticos para socios.

OS Therapies (NYSE American: OSTX)는 독자적인 SiLinker™ 기술를 사용하여 두 가지 새로운 조정 가능한 항체 약물 접합체(tADC) 치료 후보 물질의 개발을 발표했습니다. 첫 번째 후보는 유방암, 폐암 및 위암을 목표로 하고, 두 번째는 플라티넘 저항성 난소암, 나팔관암 및 원발성 복막암에 중점을 두고 있습니다. 이 회사는 두 후보 모두에 대한 타겟 상호작용 테스트를 완료하여 그들의 치료 잠재력을 확인했습니다.

OS Therapies는 제품 개발 이정표를 통해 tADC 플랫폼을 발전시킬 계획이며, 특히 pH 감응성 SiLinker™를 포함한 일부 치료 후보 및 구성 요소를 아웃라이센스할 계획입니다. 회사의 첫 번째 tADC 자산인 OST-tADC-FRα-H는 난소암의 동물 모델에서 개념 증명을 달성했습니다. 이러한 새로운 추가로 OS Therapies는 파트너를 위한 새로운 치료 제품 개발을 위한 지적 재산의 주요 제공업체로 자리 잡고 있습니다.

OS Therapies (NYSE American: OSTX) a annoncé le développement de deux nouveaux candidats thérapeutiques tunable Antibody Drug Conjugate (tADC) utilisant sa technologie propriétaire SiLinker™. Le premier candidat cible le cancer du sein, des poumons et de l'estomac, tandis que le second se concentre sur le cancer de l'ovaire, de la trompe de Fallope et péritonéal primitif résistant au platine. L'entreprise a complété les tests d'engagement de cible pour les deux candidats, confirmant leur potentiel thérapeutique.

OS Therapies vise à faire progresser sa plateforme tADC à travers des jalons de développement de produits et prévoit de concéder des licences pour certains candidats thérapeutiques et composants, en particulier le SiLinker™ sensible au pH. Le premier actif tADC de l'entreprise, OST-tADC-FRα-H, a atteint la preuve de concept dans des modèles animaux de cancer de l'ovaire. Avec ces nouvelles ajouts à son pipeline, OS Therapies se positionne comme un fournisseur clé de propriété intellectuelle pour le développement de nouveaux produits thérapeutiques pour ses partenaires.

OS Therapies (NYSE American: OSTX) hat die Entwicklung von zwei neuartigen tunable Antibody Drug Conjugate (tADC) therapeutischen Kandidaten bekannt gegeben, die mit der proprietären SiLinker™ Technologie entwickelt wurden. Der erste Kandidat zielt auf Brust-, Lungen- und Magenkrebs ab, während sich der zweite auf platinoresistente Eierstock-, Eileiter- und primäre Bauchfelldarmkrebs konzentriert. Das Unternehmen hat die Zielengagement-Tests für beide Kandidaten abgeschlossen und deren therapeutisches Potenzial bestätigt.

OS Therapies hat sich zum Ziel gesetzt, seine tADC-Plattform durch Produktentwicklungsmeilensteine voranzubringen und plant, bestimmte therapeutische Kandidaten und Komponenten, insbesondere den pH-sensitiven SiLinker™, auszulizenzieren. Das erste tADC-Asset des Unternehmens, OST-tADC-FRα-H, hat in Tiermodellen von Eierstockkrebs den Nachweis des Konzepts erbracht. Mit diesen neuen Ergänzungen zu seiner Pipeline positioniert sich OS Therapies als wichtiger Anbieter von geistigem Eigentum für die Entwicklung neuer therapeutischer Produkte für Partner.

Positive
  • Development of two novel tunable Antibody Drug Conjugate (tADC) therapeutic candidates
  • Successful completion of target engagement tests for both candidates
  • First tADC asset (OST-tADC-FRα-H) achieved proof of concept in animal models of ovarian cancer
  • Positioning as a key provider of intellectual property for new therapeutic product development
Negative
  • None.

Insights

OS Therapies' announcement of two novel tunable Antibody Drug Conjugate (tADC) candidates represents a significant advancement in targeted cancer therapies. The company's proprietary SiLinker™ technology enables the development of potentially more effective and safer ADCs. The first candidate targeting Breast, Lung and Gastric cancers addresses major unmet needs in oncology. The second candidate focusing on platinum-resistant Ovarian, Fallopian Tube and Primary Peritoneal cancers is particularly noteworthy, as platinum resistance remains a significant challenge in these hard-to-treat cancers.

The completion of target engagement tests and confirmation of therapeutic potential are important early milestones. However, it's important to note that these are still early-stage developments, with only in vitro data available. The path to clinical trials and potential approval is long and uncertain. The company's strategy to out-license certain candidates while focusing on its OST-HER2 immunotherapy platform demonstrates a balanced approach to pipeline development and resource allocation.

This announcement positions OS Therapies (NYSE: OSTX) as a potential key player in the lucrative ADC market, which is projected to reach $20 billion by 2028. The company's dual strategy of developing proprietary candidates and out-licensing its SiLinker™ technology could create multiple revenue streams. However, investors should be cautious as the financial impact is not immediate. The company will likely need substantial funding for further development and revenue from potential partnerships or out-licensing deals may take time to materialize. The focus on both human and canine markets with the OST-HER2 platform provides diversification but also increases development costs. While this news is positive for long-term growth potential, short-term financial pressures may persist as the company advances its pipeline.

The development of these tADC candidates by OS Therapies is promising from a clinical perspective. ADCs have shown significant potential in cancer treatment by delivering cytotoxic agents directly to cancer cells, potentially improving efficacy while reducing systemic toxicity. The company's focus on platinum-resistant ovarian cancer is particularly important, as these patients have treatment options and poor prognoses. The SiLinker™ technology, if proven effective, could address some of the limitations of current ADCs, such as premature drug release or inadequate tumor penetration. However, it's important to see how these candidates perform in animal studies and eventually in human trials. The transition from in vitro to in vivo efficacy is a critical hurdle in drug development. Additionally, the company's parallel development of the OST-HER2 immunotherapy for both humans and canines is an interesting approach that could yield valuable cross-species insights.

  • First therapeutic candidate targets Breast Cancer, Lung Cancer and Gastric Cancer
  • Second therapeutic candidate targets platinum-resistant Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer

NEW YORK--(BUSINESS WIRE)-- OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the development and in vitro concept data for two novel ADC therapeutic candidates leveraging the Company’s proprietary SiLinker™ technology. The Company has completed target engagement tests for both therapeutic candidates and confirmed their therapeutic potential. These new constructs will target Breast, Lung and Gastric Cancer; and Ovarian, Fallopian Tube and Primary Peritoneal Cancer, respectively.

The Company is advancing its tADC platform through successive product development de-risking milestones and intends to out-license certain therapeutic candidates and components that are strategic to potential partners’ pipelines – particularly the ph-sensitive SiLinker™. The Company’s first tADC asset OST-tADC-FRα-H has achieved proof of concept in animal models of ovarian cancer. With the additional two constructs now added to the pipeline, the Company is positioning itself to become a key provider of intellectual property for new therapeutic product development to partners. All while continuing to focus its internal resources on bringing to market the OST-HER2 off-the-shelf immunotherapy cancer vaccine platform for canines with osteosarcoma, and for humans with osteosarcoma and other HER2 positive cancers such as breast cancer and colorectal cancer.

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. The Company has completed enrollment for a 41-patient Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma, with results expected in the fourth quarter of 2024. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing strong preclinical efficacy data in various models of breast cancer. 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. 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. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those described under the section entitled “Risk Factors” of our Registration Statement on Form S-1 declared effective by the Securities and Exchange Commission (the “SEC”) on July 31, 2024, as well as any of our periodic reports filed with the SEC, and that actual results may differ materially from those indicated by such forward-looking statements. 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.

Corporate and Media Contact:

Jack Doll

410-297-7793

Irpr@ostherapies.com

Investor Relations:

Dave Gentry

RedChip Companies, Inc.

1-407-644-4256

OSTX@redchip.com

Source: OS Therapies

FAQ

What new therapeutic candidates has OS Therapies (OSTX) developed?

OS Therapies has developed two novel tunable Antibody Drug Conjugate (tADC) therapeutic candidates using its proprietary SiLinker™ technology. The first targets Breast, Lung, and Gastric Cancer, while the second focuses on platinum-resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer.

What is the current status of OS Therapies' (OSTX) tADC candidates?

OS Therapies has completed target engagement tests for both tADC candidates and confirmed their therapeutic potential. The company's first tADC asset, OST-tADC-FRα-H, has achieved proof of concept in animal models of ovarian cancer.

What is OS Therapies' (OSTX) strategy for its tADC platform?

OS Therapies aims to advance its tADC platform through product development milestones and plans to out-license certain therapeutic candidates and components, particularly the ph-sensitive SiLinker™. The company is positioning itself as a key provider of intellectual property for new therapeutic product development to partners.

What other products is OS Therapies (OSTX) focusing on besides tADCs?

OS Therapies is also focusing on bringing to market the OST-HER2 off-the-shelf immunotherapy cancer vaccine platform for canines with osteosarcoma, and for humans with osteosarcoma and other HER2 positive cancers such as breast cancer and colorectal cancer.

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