OS Therapies Announces Positive Efficacy and Safety Data for Ovarian Cancer Therapeutic Candidate Developed Based on Tunable Antibody Drug Conjugate (tADC) Platform Using Proprietary Silicone Linker Platform in Preclinical Models
OS Therapies (NYSE American:OSTX) has announced positive preclinical data for its ovarian cancer therapeutic candidate developed using its proprietary tunable Antibody Drug Conjugate (tADC) platform. The candidate, OST-tADC-FRA-H, combines a folate receptor alpha targeting small molecule with hexa-exatecan payloads linked by the company's SiLinker™ technology.
Key findings include:
- Strong antitumor activity in KB and IGROV-1 mouse models of ovarian cancer
- Excellent safety profile with no bodyweight loss compared to control animals
- Potential to improve safety and efficacy of existing ADC combinations
This proof-of-concept study paves the way for developing multiple tADC-based drug candidates for preclinical and clinical evaluation, potentially revolutionizing ADC construction.
OS Therapies (NYSE American:OSTX) ha annunciato dati preclinici positivi per il suo candidato terapeutico per il cancro ovarico sviluppato utilizzando la sua piattaforma proprietaria di Antibody Drug Conjugate (tADC) regolabile. Il candidato, OST-tADC-FRA-H, combina una piccola molecola mirata al recettore del folato alfa con carichi di hexa-exatecano legati dalla tecnologia SiLinker™ dell'azienda.
I risultati chiave includono:
- Forti attività antitumorali nei modelli murini di cancro ovarico KB e IGROV-1
- Eccellente profilo di sicurezza senza perdita di peso corporeo rispetto agli animali di controllo
- Potenziale per migliorare la sicurezza e l'efficacia delle combinazioni di ADC esistenti
Questo studio di proof-of-concept apre la strada allo sviluppo di numerosi candidati farmaceutici basati su tADC per la valutazione preclinica e clinica, potenzialmente rivoluzionando la costruzione di ADC.
OS Therapies (NYSE American:OSTX) ha anunciado datos preclínicos positivos para su candidato terapéutico para el cáncer de ovario desarrollado utilizando su plataforma propietaria de Antibody Drug Conjugate (tADC) ajustable. El candidato, OST-tADC-FRA-H, combina una pequeña molécula dirigida al receptor alfa del folato con cargas de hexa-exatecano unidas por la tecnología SiLinker™ de la compañía.
Los hallazgos clave incluyen:
- Fuerte actividad antitumoral en modelos murinos de cáncer de ovario KB e IGROV-1
- Excelente perfil de seguridad sin pérdida de peso en comparación con los animales de control
- Potencial para mejorar la seguridad y eficacia de las combinaciones de ADC existentes
Este estudio de prueba de concepto allana el camino para el desarrollo de múltiples candidatos a medicamentos basados en tADC para evaluación preclínica y clínica, potencialmente revolucionando la construcción de ADC.
OS Therapies (NYSE American:OSTX)는 자사의 독자적인 조정 가능한 항체 약물 접합체(tADC) 플랫폼을 사용하여 개발한 난소암 치료 후보의 긍정적인 전임상 데이터를 발표했습니다. 후보 물질인 OST-tADC-FRA-H는 회사의 SiLinker™ 기술로 연결된 헥사-엑세타컨(payload)과 엽산 수용체 알파를 목표로 하는 소분자로 구성되어 있습니다.
주요 결과는 다음과 같습니다:
- KB 및 IGROV-1 마우스 모델에서의 강력한 항종양 활동
- 대조군 동물에 비해 체중 감소가 없는 우수한 안전성 프로필
- 기존 ADC 조합의 안전성과 효능을 개선할 가능성
이 개념 증명 연구는 전임상 및 임상 평가를 위한 다수의 tADC 기반 약물 후보 개발을 위한 길을 열어주며, ADC 구성에 혁신을 가져올 가능성이 있습니다.
OS Therapies (NYSE American:OSTX) a annoncé des données précliniques positives pour son candidat thérapeutique contre le cancer de l'ovaire développé à l'aide de sa plateforme propriétaire de conjugat médicament anticorps (tADC) ajustable. Le candidat, OST-tADC-FRA-H, combine une petite molécule ciblant le récepteur alpha de l'acide folique avec des charges d'hexaméthylène liées par la technologie SiLinker™ de l'entreprise.
Les résultats clés comprennent :
- Une forte activité antitumorale dans des modèles murins de cancer de l'ovaire KB et IGROV-1
- Un excellent profil de sécurité sans perte de poids par rapport aux animaux témoins
- Un potentiel d'amélioration de la sécurité et de l'efficacité des combinaisons d'ADC existantes
Cette étude de preuve de concept ouvre la voie au développement de plusieurs candidats médicamenteux basés sur tADC pour l'évaluation préclinique et clinique, révolutionnant potentiellement la construction d'ADC.
OS Therapies (NYSE American:OSTX) hat positive präklinische Daten für seinen therapeutischen Kandidaten gegen Ovarialkarzinom veröffentlicht, der mit seiner proprietären einstellbaren Antikörper-Wirkstoff-Konjugat (tADC) Plattform entwickelt wurde. Der Kandidat, OST-tADC-FRA-H, kombiniert ein auf den Folsäure-Rezeptor Alpha zielendes kleines Molekül mit Hexa-Exatecan-Lasten, die durch die SiLinker™ Technologie des Unternehmens verbunden sind.
Wesentliche Ergebnisse umfassen:
- Starke antitumorale Aktivität in KB- und IGROV-1-Mausmodellen des Ovarialkarzinoms
- Exzellentes Sicherheitsprofil ohne Gewichtsverlust im Vergleich zu Kontrolltieren
- Potenzial zur Verbesserung der Sicherheit und Wirksamkeit bestehender ADC-Kombinationen
Diese Machbarkeitsstudie ebnet den Weg für die Entwicklung mehrerer auf tADC basierender Arzneimittelkandidaten für präklinische und klinische Bewertungen, was möglicherweise die Konstruktion von ADC revolutionieren könnte.
- Strong efficacy demonstrated in KB and IGROV-1 mouse models of ovarian cancer
- Excellent safety profile with no bodyweight loss in animal models
- Potential to improve safety and/or efficacy of existing ADC combinations
- Proof-of-concept study success opens doors for multiple therapeutic candidates
- Addresses growing global Antibody Drug Conjugate market, estimated at $11.29 billion in 2023
- None.
The preclinical data for OS Therapies' OST-tADC-FRA-H is highly promising. In the KB tumor model, the treatment showed complete tumor regression by Day 40, while control animals expired. The IGROV-1 model demonstrated significant tumor growth inhibition, with treated animals showing
The tADC platform's ability to deliver multiple payloads selectively to tumors could potentially revolutionize ADC therapy. This approach may enhance efficacy while reducing off-target toxicity, a common challenge in traditional ADCs. However, it's important to note that animal models don't always translate directly to human outcomes. The next critical step will be early-phase clinical trials to assess safety and efficacy in humans.
OS Therapies' tADC platform represents a significant potential market opportunity. With the global ADC market projected to reach
The company's proprietary SiLinker™ technology could provide a competitive edge in this growing market. If clinical trials prove successful, OS Therapies could potentially:
- Develop its own pipeline of improved ADCs
- License the technology to other pharma companies
- Become an attractive acquisition target
However, investors should be cautious as the path from preclinical success to market approval is long and risky. The company's ability to secure funding and partnerships for clinical development will be important to watch.
The intellectual property (IP) implications of OS Therapies' tADC platform are significant. The proprietary SiLinker™ technology appears to be a novel approach in ADC development, potentially offering strong patent protection. This could provide:
- A barrier to entry for competitors
- Opportunities for licensing revenues
- Extended market exclusivity for developed therapies
The platform's versatility in combining multiple payloads could lead to a broad patent portfolio, covering various combinations and applications. This may enhance the company's value proposition for potential partners or acquirers.
However, the strength of the IP will depend on the specificity and novelty of the claims in any granted patents. Investors should monitor the progress of patent applications and any potential challenges. The ability to defend and enforce these patents will be important for long-term value creation.
Folate receptor alpha targeting drug conjugate & hexa silanol exatecan (FRA-H) payloads tested in animal models of ovarian cancer
Strong efficacy for FRA-H in KB and IGROV-1 mouse models of ovarian cancer
Strong safety profile for FRA-H with no loss of bodyweight as compared with control in animal models
Success of tADC proof-of-concept study paves way for creating multiple potential therapeutic candidates for preclinical and clinical evaluation
NEW YORK, NY / ACCESSWIRE / September 11, 2024 / OS Therapies (NYSE American:OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announced positive data in animal models of ovarian cancer for its first therapeutic candidate developed based upon its proprietary tunable Antibody Drug Conjugate (tADC) platform. The first therapeutic candidate leverages a folate receptor alpha targeting small molecule combined with hexa-exatecan payloads (OST-tADC-FRA-H) linked together with the Company's proprietary silicone linker technology, SiLinker™. The data generated showed strong antitumor activity in the KB and IGROV-1 mouse models of ovarian cancer. Taken together, the data provide compelling preclinical proof of concept that the Company's SiLinker™ platform can be used to develop new therapeutic tADC-based drug candidates that can improve the safety and/or efficacy of ADC combinations currently on the market or in development, in addition to creating new intellectual property for competitive and life cycle management purposes.
OST-tADC technology is centered around the Company's proprietary next-generation tunable Antibody Drug Conjugate (tADC) platform. This advanced technology incorporates pH-sensitive silicon-based linkers, trademarked as SiLinkers™, which can release multiple therapeutic agents selectively within the tumor and tumor microenvironment, which experiences lower pH levels than the rest of the body. This approach aims to maximize the therapeutic effects while minimizing damage to healthy cells.
"We are very pleased with the results of this proof-of-concept data demonstrating that our tADC silicone linker SiLinker technology is able to safely deliver multiple payloads to the tumor without demonstrating side effects of payload loss in animal models of ovarian cancer," said Colin Goddard, PhD, tADC Founder and member of the OS Therapies ADC Advisory Board. "With the ability to link multiple payloads, including with different therapeutic agent combinations, we are potentially revolutionizing the way antibody drug conjugates will be constructed in the future."
KB tumor growth model: In this animal model, animals implanted with the KB tumor cell line were treated at Day 4, Day 8 and Day 12 with either OST-tADC-FRA-H or vehicle control. At Day 20, FRA-H treated animals demonstrated an average tumor volume of 10mm3 as compared with 1000 mm3 for the untreated animals. At Day 40 OST-tADC-FRA-H treated animals had no evidence of tumor growth, whereas control animals had expired.
IGROV-1 tumor growth model: In this animal model, animals implanted with the IGROV-1 tumor cell line were treated with either OST-tADC-FRA-H or vehicle control. At Day 50, the OST-tADC-FRA-H treated animals had an average tumor size of 40mm3 as compared animals treated placebo who had an average tumor size of 400 mm3
Bodyweight Comparison: Animals treated with OST-tADC-FRA-H at Day 1 and Day 7 demonstrated no loss in bodyweight as compared with control animals.
"This animal proof of concept experiment for tADC really opens the door in terms of creating multiple therapeutic candidates for preclinical and clinical evaluation," said Borys Shor, PhD, member of the OS Therapies ADC Advisory Board. "Now that we have this animal data and have begun the process of creating multiple other tADC constructs, we are able to meaningfully engage with potential collaborators and partners on helping them improve the way their ADC combinations are delivered, in addition to developing our own candidates in the future."
Grandview Research reports that the global Antibody Drug Conjugate market size was estimated at USD 11.29 billion in 2023 and is anticipated to grow at a compound annual growth rate (CAGR) 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. 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 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. 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
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