OS Therapies Announces Last Patient Enrolled in OST-504 (previously ADXS-504) Phase 1b Prostate Cancer Clinical Trial Completes Last Visit
OS Therapies (NYSE American: OSTX) announced the completion of the last patient visit in its OST-504 Phase 1b clinical trial for biochemically recurrent prostate cancer. The trial enrolled 7 patients, with data expected in Q4 2025.
Additionally, the company will release updated 2-year overall survival data from its Phase 2b trial of OST-HER2 in osteosarcoma on October 10, 2025. OS Therapies is preparing to initiate a rolling submission for a Biologics Licensing Application (BLA) for OST-HER2 in the coming weeks.
The company sees significant potential for OST-504 in prostate cancer treatment, noting that 1 in 8 men are diagnosed with prostate cancer, making it the second leading cause of male cancer deaths after lung cancer.
OS Therapies (NYSE American: OSTX) ha annunciato il completamento dell’ultima visita del paziente nel suo OST-504 Phase 1b clinical trial per il cancro alla prostata biochemicamente recidivo. Lo studio ha arruolato 7 pazienti, con i dati previsti nel Q4 2025.
Inoltre, l’azienda rilascerà dati aggiornati sulla sopravvivenza globale a 2 anni dal suo trial di fase 2b di OST-HER2 nell’osteosarcoma il 10 ottobre 2025. OS Therapies si sta preparando ad avviare una presentazione continua per una Biologics Licensing Application (BLA) per OST-HER2 nelle prossime settimane.
L’azienda vede un potenziale significativo per OST-504 nel trattamento del cancro alla prostata, osservando che 1 su 8 uomini è diagnosticato con cancro alla prostata, rendendolo la seconda principale causa di morte per cancro tra gli uomini dopo il cancro ai polmoni.
OS Therapies (NYSE American: OSTX) anunció la finalización de la última visita de los pacientes en su ensayo clínico OST-504 Phase 1b para el cáncer de próstata bioquímicamente recurrente. El ensayo inscribió a 7 pacientes, con datos esperados en Q4 2025.
Además, la empresa difundirá datos actualizados de supervivencia global a 2 años de su ensayo de fase 2b de OST-HER2 en osteosarcoma el 10 de octubre de 2025. OS Therapies se prepara para iniciar una presentación continua para una Biologics Licensing Application (BLA) para OST-HER2 en las próximas semanas.
La compañía ve un potencial significativo para OST-504 en el tratamiento del cáncer de próstata, señalando que 1 de cada 8 hombres es diagnosticado con cáncer de próstata, lo que lo convierte en la segunda causa principal de muertes por cáncer en hombres después del cáncer de pulmón.
OS Therapies (NYSE American: OSTX)는 생화학적으로 재발하는 전립선암에 대한 OST-504 Phase 1b 임상시험의 마지막 환자 방문 완료를 발표했습니다. 이 연구에는 7명의 환자가 등록되었으며 데이터는 2025년 4분기에 기대됩니다.
또한 회사는 2025년 10월 10일에 OST-HER2의 골육종 2상 연구에서의 2년 overall survival 데이터를 공개할 예정입니다. OS Therapies는 향후 수주 이내에 OST-HER2에 대한 Biologics Licensing Application(BLA)의 롤링 제출을 시작할 준비를 하고 있습니다.
회사는 전립선암 치료에서 OST-504의 상당한 잠재력을 보고 있으며, 8명 중 1명의 남성이 전립선암으로 진단된다고 언급하여 이것이 폐암에 이은 남성 암 사망의 두 번째 주요 원인이라고 지적합니다.
OS Therapies (NYSE American: OSTX) a annoncé l’achèvement de la dernière visite du patient dans son essai clinique OST-504 Phase 1b pour le cancer de la prostate biochemically récurrent. L’essai a recruté 7 patients, les données étant attendues au Q4 2025.
De plus, l’entreprise publiera des données actualisées sur la survie globale sur 2 ans de son essai de phase 2b OST-HER2 dans l’ostéosarcome le 10 octobre 2025. OS Therapies se prépare à lancer une présentation continue pour une Biologics Licensing Application (BLA) pour OST-HER2 dans les prochaines semaines.
L’entreprise voit un potentiel significatif pour OST-504 dans le traitement du cancer de la prostate, notant que 1 homme sur 8 est diagnostiqué avec un cancer de la prostate, ce qui en fait la deuxième cause majeure de décès par cancer chez les hommes après le cancer du poumon.
OS Therapies (NYSE American: OSTX) kündigte den Abschluss des letzten Besuchs eines Patienten in der OST-504 Phase 1b klinischen Studie für biochemisch rezidivierenden Prostatakrebs an. Die Studie rekrutierte 7 Patienten, die Daten werden voraussichtlich im Q4 2025 vorliegen.
Darüber hinaus wird das Unternehmen aktualisierte 2-Jahres-Überlebensdaten aus seiner Phase-2b-Studie OST-HER2 im Osteosarkom am 10. Oktober 2025 veröffentlichen. OS Therapies bereitet den Beginn einer Rolling Submission für eine Biologics Licensing Application (BLA) für OST-HER2 in den kommenden Wochen vor.
Das Unternehmen sieht erhebliches Potenzial für OST-504 in der Behandlung von Prostatakrebs und weist darauf hin, dass 1 von 8 Männern mit Prostatakrebs diagnostiziert wird, was es zur zweitgrößten Todesursache durch Krebs bei Männern nach Lungenkrebs macht.
OS Therapies (NYSE American: OSTX) أعلنت عن اكتمال زيارة المريض الأخيرة في تجربتها السريرية OST-504 Phase 1b لعلاج سرطان البروستاتا المعاود كيميائياً. شمل التجربة 7 مرضى، والبيانات متوقعة في الربع الرابع من 2025.
بالإضافة إلى ذلك، ستصدر الشركة بيانات محدثة لبقاء على قيد الحياة لمدة سنتين من تجربتها في المرحلة 2b لـ OST-HER2 في سرطان العظم الأوستيود إلى التو 10 أكتوبر 2025. كما تخطط OS Therapies لبدء تقديم متدرج لـ Biologics Licensing Application (BLA) لـ OST-HER2 في الأسابيع المقبلة.
وترى الشركة إمكانات كبيرة لـ OST-504 في علاج سرطان البروستاتا، مع الإشارة إلى أن واحد من كل 8 رجال يصاب بسرطان البروستاتا، مما يجعله ثاني أبرز سبب للوفاة المرتبطة بسرطان الرجال بعد سرطان الرئة.
OS Therapies (NYSE American: OSTX) 宣布完成其 OST-504 Phase 1b 期临床试验中生化性复发性前列腺癌的最后一位患者访视。试验共招募7名患者，数据预计在2025年第四季度公布。
此外，公司将于 2025年10月10日 公布其 OST-HER2 2期在骨肉瘤中的2年总体生存数据更新。OS Therapies 正准备在未来数周内启动针对 OST-HER2 的生物制品许可申请（BLA）的滚动提交。
公司认为 OST-504 在前列腺癌治疗方面具有显著潜力，并指出 8名男性中就有1名 被诊断患有前列腺癌，这使其成为仅次于肺癌的男性癌症死亡的第二大原因。
- Completion of OST-504 Phase 1b trial patient enrollment and final visit
- Strong investigator enthusiasm and demand for expanded access for OST-504
- Upcoming BLA submission for OST-HER2 in osteosarcoma
- Potential FDA Platform Designation eligibility for OST-504
- Large market opportunity in prostate cancer treatment
- None.
Insights
OS Therapies progresses with dual clinical programs: completed prostate cancer trial enrollment and advancing osteosarcoma BLA submission.
This announcement represents meaningful progress across OS Therapies' clinical pipeline. The completion of the last patient visit in the Phase 1b trial of OST-504 for biochemically recurrent prostate cancer sets up an important data readout in Q4 2025. While the trial enrolled only 7 patients, management noted significant investigator enthusiasm and demand for expanded access, suggesting possible early signs of efficacy or safety that warrant attention.
More strategically significant is the company's preparation to initiate a rolling BLA submission for OST-HER2 in osteosarcoma "in the next several weeks." This regulatory advancement indicates management's confidence in their Phase 2b data involving 40 patients with fully resected, pulmonary metastatic osteosarcoma. The upcoming 2-year overall survival data release on October 10, 2025 will be critical for validating this confidence.
The company's mention of potential FDA Platform Designation for OST-504 represents a sophisticated regulatory strategy that could accelerate development if OST-HER2 gains approval. This approach could significantly reduce time-to-market for their prostate cancer program while addressing a substantial market opportunity in a disease that affects 1 in 8 men and represents the second leading cause of male cancer deaths.
- Clinical data from Phase 1b prostate cancer trial to be released in Q4/25
- Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025
New York, New York--(Newsfile Corp. - September 12, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that the last patient enrolled in its OST-504 (previously ADXS-504) Phase 1b clinical trial in subjects with biochemically recurrent prostate cancer previously treated with radical prostatectomy (RP) or radiation therapy (external beam or brachytherapy) who are not currently receiving androgen ablation therapy has completed their last patient visit (NCT05077098). A total of 7 patients enrolled in the study.
"We were pleasantly surprised by the level of enthusiasm around the OST-504 program from the clinical investigators at Columbia University after we took over the program as part of the acquisition of assets from Ayala," said Robert Petit, PhD, Chief Medical & Scientific Officer at OS Therapies. "We were especially excited that there was significant demand for expanded access following treatment. We believe the OST-504 construct has significant potential to be used in various prostate cancer settings and look forward to reporting on the study results in the fourth quarter of 2025."
"While we remain extremely focused on the regulatory pathway for OST-HER2 in osteosarcoma where we are preparing to initiate a rolling submission for a Biologics Licensing Application (BLA) in the next several weeks, we are in the fortunate position of being able to read out on an important initial proof of concept study in a major clinical indication without having to spend any money treating patients," said Paul Romness, MHP, Chairman & CEO of OS Therapies. "Prostate cancer represents a huge market opportunity with significant unmet medical need. 1 in 8 men are diagnosed at some point in their lives, with 1 in 44 men dying of prostate cancer, second among male cancer deaths only to lung cancer. If we are successful in our regulatory efforts with OST-HER2, we believe that OST-504 would become eligible for the FDA's new Platform Designation that could significantly accelerate OST-504's path to market."
Concurrent with this announcement, the Company announced that updated 2-year overall survival data from all 40 patients in the Company's Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (NCT04974008) to be released on October 10, 2025.
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. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and Fast-Track and Orphan Drug designations from the U.S. FDA and European Medicines Agency. The Company reported positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a Biologics Licensing Application (BLA) to the U.S. FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma.
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. 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 press 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 U.S. FDA and other risks and uncertainties described in "Risk Factors" in the Company's most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other subsequent documents the Company files with the Securities and Exchange Commission. 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.
OS Therapies Contact Information:
Investor Relations
Harrison Seidner, PhD
WaterSeid Partners
OSTX@waterseid.com
Public Relations
Stephanie Chen
Elev8 New Media
stephanie@elev8newmedia.com
https://x.com/OSTherapies
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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/266139
FAQ
When will OS Therapies (OSTX) release the clinical data for OST-504 Phase 1b prostate cancer trial?
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When will OS Therapies release the 2-year survival data for OST-HER2 in osteosarcoma?
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