OS Therapies Announces Osteosarcoma Scientific and Medical Advisory Board
OS Therapies (NYSE American:OSTX) has announced its Scientific and Medical Advisory Board (SMAB) for osteosarcoma, consisting of experts from six US institutions. The SMAB will assist in FDA engagement regarding OST-HER2, the company's lead immunotherapy product candidate. OST-HER2, an innovative HER2-targeted Listeria-based immunotherapy, is designed to combat osteosarcoma by triggering immune responses against HER2-expressing cancer cells.
The company has fully enrolled a Phase IIb clinical trial with 41 patients across 21 US sites, reporting positive interim data in June 2024. Topline data is expected in Q4 2024. OST-HER2 has received multiple FDA designations, including Rare Pediatric Disease, Fast Track, and Orphan Drug. OS Therapies is pursuing Breakthrough Therapy Designation and plans to expand into breast cancer treatment post-FDA approval for osteosarcoma.
OS Therapies (NYSE American:OSTX) ha annunciato il suo Comitato Consultivo Scientifico e Medico (SMAB) per l'osteosarcoma, composto da esperti di sei istituzioni statunitensi. Lo SMAB assisterà nel coinvolgimento della FDA riguardo OST-HER2, il principale candidato immunoterapico dell'azienda. OST-HER2, un'innovativa immunoterapia basata su Listeria mirata a HER2, è progettata per combattere l'osteosarcoma scatenando risposte immune contro le cellule tumorali che esprimono HER2.
La società ha completato l'arruolamento per uno studio clinico di Fase IIb con 41 pazienti in 21 siti negli Stati Uniti, riportando dati provvisori positivi a giugno 2024. Sono attesi dati preliminari nel Q4 2024. OST-HER2 ha ricevuto numerose designazioni FDA, tra cui Malattia Pediatrica Rara, Fast Track e Farmaco Orfano. OS Therapies sta perseguendo la Designazione di Terapia Avanzata e prevede di espandersi nel trattamento del cancro al seno dopo l'approvazione della FDA per l'osteosarcoma.
OS Therapies (NYSE American:OSTX) ha anunciado su Consejo Asesor Científico y Médico (SMAB) para el osteosarcoma, compuesto por expertos de seis instituciones de EE. UU.. El SMAB ayudará en la interacción con la FDA sobre OST-HER2, el principal candidato a producto de inmunoterapia de la empresa. OST-HER2, una innovadora inmunoterapia basada en Listeria dirigida a HER2, está diseñada para combatir el osteosarcoma al desencadenar respuestas inmunitarias contra las células cancerosas que expresan HER2.
La compañía ha completado la inscripción de un ensayo clínico de Fase IIb con 41 pacientes en 21 sitios de EE. UU., reportando datos intermedios positivos en junio de 2024. Se esperan datos preliminares en el Q4 de 2024. OST-HER2 ha recibido múltiples designaciones de la FDA, incluyendo Enfermedad Pediátrica Rara, Fast Track y Medicamento Huérfano. OS Therapies está buscando la Designación de Terapia Innovadora y planea expandirse al tratamiento del cáncer de mama tras la aprobación de la FDA para el osteosarcoma.
OS Therapies (NYSE American:OSTX)는 미국의 여섯 개 기관의 전문가로 구성된 골육종 관련 과학 및 의학 자문 위원회(SMAB)를 발표했습니다. SMAB는 회사의 주요 면역 치료 후보 제품인 OST-HER2에 대한 FDA와의 협력을 도울 것입니다. OST-HER2는 HER2-표적 리스테리아 기반 면역 치료로 골육종과 싸우기 위해 HER2를 발현하는 암 세포에 대한 면역 반응을 유도하도록 설계되었습니다.
회사는 21개 미국 사이트에서 41명의 환자를 대상으로 2상 임상 시험에 완전히 등록했으며, 2024년 6월 긍정적인 중간 데이터를 보고했습니다. 요약 데이터는 2024년 4분기에 예상됩니다. OST-HER2는 희귀 소아 질환, 패스트트랙, 고아약 등 여러 FDA 지정을 받았습니다. OS Therapies는 혁신 치료법 지정을 추구하고 있으며, 골육종에 대한 FDA 승인 후 유방암 치료로의 확장을 계획하고 있습니다.
OS Therapies (NYSE American:OSTX) a annoncé son comité consultatif scientifique et médical (SMAB) pour l'ostéosarcome, composé d'experts de six institutions américaines. Le SMAB aidera dans l'engagement avec la FDA concernant OST-HER2, le principal candidat produit d'immunothérapie de l'entreprise. OST-HER2, une immunothérapie innovante ciblant HER2 basée sur Listeria, est conçue pour lutter contre l'ostéosarcome en déclenchant des réponses immunitaires contre les cellules cancéreuses exprimant HER2.
L'entreprise a complètement recruté dans un essai clinique de Phase IIb avec 41 patients à travers 21 sites aux États-Unis, rapportant des données intermédiaires positives en juin 2024. Les données principales sont attendues au quatrième trimestre 2024. OST-HER2 a reçu plusieurs désignations de la FDA, y compris Maladie pédiatrique rare, Fast Track et Médicament orphelin. OS Therapies poursuit la désignation de Thérapie révolutionnaire et prévoit de s'étendre au traitement du cancer du sein après l'approbation de la FDA pour l'ostéosarcome.
OS Therapies (NYSE American:OSTX) hat seinen Wissenschaftlichen und Medizinischen Beratungsausschuss (SMAB) für Osteosarkom angekündigt, der aus Experten von sechs US-Institutionen besteht. Der SMAB wird beim Engagement der FDA bezüglich OST-HER2 helfen, dem führenden immuntherapeutischen Produktkandidaten des Unternehmens. OST-HER2, eine innovative HER2-targeted Listeria-basierte Immuntherapie, ist darauf ausgelegt, Osteosarkom zu bekämpfen, indem sie Immunantworten gegen HER2-exprimierende Tumorzellen auslöst.
Das Unternehmen hat die Rekrutierung für eine klinische Phase-IIb-Studie vollständig abgeschlossen mit 41 Patienten an 21 US-Standorten und berichtete im Juni 2024 über positive Zwischenstatistiken. Die Topline-Daten werden im vierten Quartal 2024 erwartet. OST-HER2 hat mehrere FDA-Klassifizierungen erhalten, darunter Seltene Pädiatrische Erkrankung, Schnellverlauf und Waisenarzneimittel. OS Therapies strebt die Einstufung als Durchbruchstherapie an und plant, nach der FDA-Zulassung für Osteosarkom in die Brustkrebsbehandlung zu expandieren.
- 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 clinical trial
- Multiple FDA designations received for OST-HER2, including Rare Pediatric Disease, Fast Track, and Orphan Drug
- Potential for Priority Review Voucher upon BLA approval for OST-HER2 in osteosarcoma
- Established Scientific and Medical Advisory Board with experts from six US institutions
- None.
ROCKVILLE, MD / ACCESSWIRE / August 6, 2024 / OS Therapies (NYSE American:OSTX) ("OS Therapies" or "the Company"), an Antibody Drug Conjugate (ADC) and Immunotherapy research and clinical-stage biopharmaceutical company, highlights its Scientific and Medical Advisory Board (SMAB), comprised of experts in osteosarcoma from six institutions in the United States.
The following physicians have agreed to serve on the OS Therapies SMAB:
• Nabil M. Ahmed, MD - Texas Children's Hospital
• Peter M. Anderson, MD - Cleveland Clinic
• Doug S. Hawkins, MD - Seattle Children's Hospital
• Meenakshi Hedge, MD - Texas Children's Hospital
• Alejandro Sweet-Cordero, MD - University of California, San Francisco
• Brenda Weigel, MD - Masonic Cancer Center, University of Minnesota
• Felasfa M. Wodajo, MD - Inova Fairfax Hospital, Virginia
The SMAB will assist the Company in engaging with the US Food & Drug Administration (FDA) regarding the safety and efficacy of its lead immunotherapy product candidate, OST-HER2, for the treatment of osteosarcoma. This includes evaluating how OST-HER2 compares with the current standard of care in osteosarcoma, particularly in relation to a potential Biologics License Authorization (BLA) following the completion of the ongoing clinical trial for OST-HER2.
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 the United States. Positive interim data was reported in June 2024 with topline data expected in the fourth quarter of 2024.
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.
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. OS Therapies' drug development efforts, clinical trial results, patient enrollments, FDA regulatory approvals, designations, and intellectual property protections. 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.
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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FAQ
What is the primary focus of OS Therapies' OST-HER2 immunotherapy?
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What designations has OST-HER2 received from the FDA for osteosarcoma treatment?
How many patients and clinical trial sites are involved in OS Therapies' (OSTX) Phase IIb trial for OST-HER2?
