OS Therapies Forms Osteosarcoma Patient Advocacy Advisory Board
OS Therapies (NYSE-A: OSTX) has formed a Patient Advocacy Advisory Board (PAAB) for its osteosarcoma program. The PAAB will represent the osteosarcoma community in discussions with the FDA regarding potential Biologics License Authorization for OST-HER2, the company's immunotherapeutic product candidate. The board includes representatives from various osteosarcoma organizations and patients.
OST-HER2 is an innovative immunotherapy using a HER2 bioengineered form of Listeria monocytogenes to trigger an immune response against HER2-expressing cancer cells. A Phase IIb clinical trial for recurred, resected osteosarcoma has been fully enrolled with 41 patients across 21 US sites. Positive interim data was reported in June 2024, with topline data expected in Q4 2024.
OST-HER2 has received Rare Pediatric Disease, Fast Track, and Orphan Drug Designations from the FDA and EMA. OS Therapies is seeking Breakthrough Therapy Designation based on Phase IIb trial data. The company plans to pursue therapeutic development in breast cancer following FDA approval for osteosarcoma.
OS Therapies (NYSE-A: OSTX) ha formato un Consiglio consultivo per la difesa dei pazienti (PAAB) per il suo programma sull'osteosarcoma. Il PAAB rappresenterà la comunità dell'osteosarcoma nelle discussioni con la FDA riguardo al potenziale Autorizzazione alla Licenza di Biologici per OST-HER2, il candidato prodotto immunoterapico dell'azienda. Il consiglio include rappresentanti di varie organizzazioni sull'osteosarcoma e pazienti.
OST-HER2 è un'immunoterapia innovativa che utilizza una forma bio-ingegnerizzata di Listeria monocytogenes per attivare una risposta immunitaria contro le cellule tumorali che esprimono HER2. Un studio clinico di Fase IIb per osteosarcoma recidivante e resecato è stato completamente arruolato con 41 pazienti in 21 siti negli Stati Uniti. Dati positivi intermedi sono stati riportati a giugno 2024, con i dati principali attesi nel quarto trimestre del 2024.
OST-HER2 ha ricevuto le Designazioni per malattia pediatrica rara, percorso accelerato e farmaco orfano da parte della FDA e dell'EMA. OS Therapies sta cercando la Designazione di Terapia Innovativa basata sui dati dello studio di Fase IIb. L'azienda prevede di perseguire lo sviluppo terapeutico nel carcinoma mammario dopo l'approvazione della FDA per l'osteosarcoma.
OS Therapies (NYSE-A: OSTX) ha formado un Consejo Asesor de Defensa del Paciente (PAAB) para su programa de osteosarcoma. El PAAB representará a la comunidad de osteosarcoma en las discusiones con la FDA sobre la posible Autorización de Licencia Biológica para OST-HER2, el candidato de producto inmunoterapéutico de la empresa. El consejo incluye representantes de varias organizaciones de osteosarcoma y pacientes.
OST-HER2 es una inmunoterapia innovadora que utiliza una forma bioingenierizada de Listeria monocytogenes para desencadenar una respuesta inmune contra las células cancerosas que expresan HER2. Se ha completado la inscripción en un ensayo clínico de Fase IIb para osteosarcoma recurrente y resecado, con 41 pacientes en 21 sitios en EE. UU. Se informaron datos interinos positivos en junio de 2024, con datos generales esperados en el cuarto trimestre de 2024.
OST-HER2 ha recibido Designaciones como Enfermedad Pediátrica Rara, Vía Rápida y Medicamento Huérfano de la FDA y la EMA. OS Therapies busca la Designación de Terapia Innovadora basada en los datos del ensayo de Fase IIb. La empresa planea continuar con el desarrollo terapéutico en cáncer de mama tras la aprobación de la FDA para el osteosarcoma.
OS Therapies (NYSE-A: OSTX)는 자신의 골육종 프로그램을 위해 환자 옹호 자문 위원회(PAAB)를 구성했습니다. PAAB는 FDA와의 논의에서 OST-HER2에 대한 잠재적 생물학적 허가 인증을 정세 대표합니다. 이 위원회는 다양한 골육종 조직 및 환자 대표들로 구성되어 있습니다.
OST-HER2는 HER2를 발현하는 암세포에 대한 면역 반응을 유도하기 위해 Listeria monocytogenes의 바이오 공학적 형태를 사용하는 혁신적인 면역 요법입니다. 재발된 절제된 골육종을 위한 2b상 임상 시험은 21개 미국 사이트에서 41명의 환자로 완전히 등록되었습니다. 2024년 6월에 긍정적인 중간 데이터가 보고되었으며, 2024년 4분기에 주요 데이터가 예상됩니다.
OST-HER2는 FDA와 EMA로부터 희귀 소아 질병, 신속하게 승인 받을 수 있는 의약품 및 고아 약물 지정을 받았습니다. OS Therapies는 2b상 시험 데이터를 기반으로 혁신 치료 지정 승인을 추구하고 있습니다. 이 회사는 골육종에 대한 FDA 승인이 나온 이후 유방암에서의 치료 개발을 계속할 계획입니다.
OS Therapies (NYSE-A: OSTX) a formé un Conseil consultatif de défense des patients (PAAB) pour son programme d'ostéosarcome. Le PAAB représentera la communauté de l'ostéosarcome lors des discussions avec la FDA concernant une éventuelle autorisation de licence biologique pour OST-HER2, le candidat produit immunothérapeutique de l'entreprise. Le conseil comprend des représentants de diverses organisations d'ostéosarcome et des patients.
OST-HER2 est une immunothérapie innovante utilisant une forme bio-ingénierie de Listeria monocytogenes pour déclencher une réponse immunitaire contre les cellules cancéreuses exprimant HER2. Un essai clinique de Phase IIb pour l'ostéosarcome récidivant et réséqué a été entièrement recruté avec 41 patients sur 21 sites aux États-Unis. Des données intermédiaires positives ont été rapportées en juin 2024, avec des données finales attendues au quatrième trimestre 2024.
OST-HER2 a reçu des désignations de maladie pédiatrique rare, d'accélération de procédure et de médicament orphelin de la part de la FDA et de l'EMA. OS Therapies cherche à obtenir la désignation de thérapie innovante basée sur les données de l'essai de Phase IIb. L'entreprise prévoit de poursuivre le développement thérapeutique dans le cancer du sein après l'approbation de la FDA pour l'ostéosarcome.
OS Therapies (NYSE-A: OSTX) hat einen Patient Advocacy Advisory Board (PAAB) für sein Osteosarkom-Programm gebildet. Das PAAB wird die Osteosarkom-Gemeinschaft in Gesprächen mit der FDA über eine potenzielle Biologics-Lizenzautorisierung für OST-HER2, das immuntherapeutische Produkt des Unternehmens, vertreten. Der Ausschuss umfasst Vertreter verschiedener Osteosarkom-Organisationen und Patienten.
OST-HER2 ist eine innovative Immuntherapie, die eine bioengineering Form von Listeria monocytogenes verwendet, um eine Immunantwort gegen HER2-exprimierende Krebszellen auszulösen. Eine Phase-IIb-Studie für rezidiviertes, reseziertes Osteosarkom wurde vollständig mit 41 Patienten an 21 Standorten in den USA rekrutiert. Positive Zwischenberichte wurden im Juni 2024 veröffentlicht, und die Gesamtdaten werden im vierten Quartal 2024 erwartet.
OST-HER2 hat Seltene pädiatrische Erkrankungen, Schnellverfahrens- und Waisenarzneimittel-Designationen von der FDA und EMA erhalten. OS Therapies strebt eine Durchbruch-Therapie-Designierung basierend auf den Daten der Phase-IIb-Studie an. Das Unternehmen plant, nach der FDA-Zulassung für Osteosarkom die therapeutische Entwicklung bei Brustkrebs voranzutreiben.
- Formation of Patient Advocacy Advisory Board to represent osteosarcoma community in FDA discussions
- Fully enrolled Phase IIb clinical trial for OST-HER2 with 41 patients across 21 US sites
- Positive interim data reported in June 2024 for OST-HER2 trial
- Multiple FDA and EMA designations received for OST-HER2 (Rare Pediatric Disease, Fast Track, Orphan Drug)
- Potential for Priority Review Voucher upon BLA approval for OST-HER2 in osteosarcoma
- Plans to expand OST-HER2 development into breast cancer market following FDA approval for osteosarcoma
- Topline data for Phase IIb trial not yet available, expected in Q4 2024
- Breakthrough Therapy Designation not yet received, still being sought
- No guarantee of FDA approval for OST-HER2 in osteosarcoma
Members of the PAAB include:
- Miriam Cohen – Chair of Osteosarcoma Collaborative
- Mac Tichenor – Chair of Osteosarcoma Institute
- Tony Trent – Chair of Tyler Trent Foundation
- Olivia Egge – Osteosarcoma Patient, OSTX Board
- Serena Subada – Osteosarcoma Patient, AOST-2121 OST-HER2 Trial Participant
Members of the PAAB will not receive financial compensation from OS Therapies. Members expect to meet on a quarterly basis to review information with regards to progress in the OS Therapies’ osteosarcoma clinical program, and the meetings will be chaired by the Company’s CEO.
OS Therapies’ lead product candidate, OST-HER2, is an innovative immunotherapy using a HER2 bioengineered form of the bacteria Listeria monocytogenes (Lm) to trigger a strong immune response against cancer cells expressing HER2. This off-the-shelf immunotherapy treatment is designed to prevent metastasis, delay recurrence, kill primary tumors expressing HER2 and increase overall survival. The Company has fully enrolled a potentially pivotal Phase IIb clinical trial in recurred, resected osteosarcoma, dosing 41 patients with OST-HER2 at 21 clinical trial sites across
OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the FDA and Fast Track and Orphan Drug Designations from the FDA and European Medicines Agency (EMA).
OS Therapies is seeking Breakthrough Therapy Designation for OST-HER2 for osteosarcoma from the FDA based on data from its Phase IIb clinical trial. Upon any BLA from the FDA for OST-HER2 in osteosarcoma, the Company will be granted a Priority Review Voucher based upon the RPDD. In 2023, the US FDA approved 28 drugs and 12 biologics for the treatment of orphan diseases. OST-HER2 has completed a Phase 1 clinical trial, primarily in breast cancer patients, in addition to strong preclinical data demonstrating efficacy on a standalone basis and in combination with HER2-targeting therapeutic antibodies such as Herceptin®. The Company intends to pursue therapeutic development of OST-HER2 in breast cancer following FDA approval for OST-HER2 in osteosarcoma.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities in the offering, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Osteosarcoma
Osteosarcoma is a solid tumor of the bone that predominantly occurs in children and young adults. It is an extremely challenging and often aggressive cancer that has particular treatment challenges due to its location, changing genotypes and high recurrence rates. Standard treatment includes surgery and chemotherapy. For patients with metastatic or recurrence after chemotherapy, there is a significantly poorer prognosis.
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 offer and sale of shares, the timing of the listing of OS Therapies’ common stock on the NYSE American, the timing of the closing of the offering, the use of the proceeds from the sale of shares of common stock in the offering, and 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 caption “Risk Factors” and elsewhere in the prospectus filed with the SEC relating to the offering 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240802033946/en/
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 Incorporated
FAQ
What is the purpose of OS Therapies' new Patient Advocacy Advisory Board (PAAB) for osteosarcoma?
What is the current status of OS Therapies' (OSTX) Phase IIb clinical trial for OST-HER2 in osteosarcoma?
What regulatory designations has OS Therapies (OSTX) received for OST-HER2?
What are OS Therapies' (OSTX) plans for OST-HER2 beyond osteosarcoma treatment?
