OS Therapies Announces Last Patient Enrolled in OST-HER2 Osteosarcoma Phase 2b Clinical Trial Receives Last Treatment Dose
OS Therapies (NYSE American: OSTX) announced the completion of treatment for the final patient in its Phase 2b clinical trial of OST-HER2 for recurred, resected Osteosarcoma. The trial, AOST-2121 (NCT04974008), enrolled 41 patients across 21 U.S. sites. The primary endpoint is 12-month Event Free Survival, with final evaluation expected in early Q4 2024. OST-HER2 is a Listeria-based immunotherapeutic vaccine designed to prevent metastasis and increase survival in Osteosarcoma patients.
The study aims to demonstrate efficacy in patients with high recurrence risk. Topline data, including 12-month Event Free Survival and interim 2-year Overall Survival, is anticipated in Q4 2024. This trial is significant as no new FDA-approved treatments have improved Osteosarcoma outcomes in over 40 years.
OS Therapies (NYSE American: OSTX) ha annunciato il completamento del trattamento per l'ultimo paziente nel suo studio clinico di fase 2b su OST-HER2 per osteosarcoma recidivato e resecato. Lo studio, AOST-2121 (NCT04974008), ha coinvolto 41 pazienti in 21 siti negli Stati Uniti. L'endpoint primario è la Sopravvivenza Libera da Eventi a 12 mesi, con la valutazione finale prevista all'inizio del quarto trimestre del 2024. OST-HER2 è un vaccino immunoterapeutico basato su Listeria progettato per prevenire la metastasi e aumentare la sopravvivenza nei pazienti affetti da Osteosarcoma.
Lo studio mira a dimostrare l'efficacia nei pazienti con alto rischio di recidiva. I dati preliminari, inclusa la Sopravvivenza Libera da Eventi a 12 mesi e la Sopravvivenza Complessiva a 2 anni, sono previsti nel quarto trimestre del 2024. Questo studio è significativo poiché non ci sono stati nuovi trattamenti approvati dalla FDA che abbiano migliorato gli esiti dell'Osteosarcoma negli ultimi 40 anni.
OS Therapies (NYSE American: OSTX) anunció la finalización del tratamiento para el último paciente en su ensayo clínico de fase 2b de OST-HER2 para osteosarcoma recurrente y resecado. El ensayo, AOST-2121 (NCT04974008), inscribió a 41 pacientes en 21 sitios de EE. UU. El objetivo principal es la Supervivencia Libre de Eventos a 12 meses, con la evaluación final esperada a principios del cuarto trimestre de 2024. OST-HER2 es una vacuna inmunoterapéutica basada en Listeria diseñada para prevenir la metástasis y aumentar la supervivencia en pacientes con Osteosarcoma.
El estudio tiene como objetivo demostrar la eficacia en pacientes con alto riesgo de recaída. Se anticipan datos preliminares, incluida la Supervivencia Libre de Eventos a 12 meses y la Supervivencia General a 2 años, en el cuarto trimestre de 2024. Este ensayo es significativo ya que no ha habido tratamientos nuevos aprobados por la FDA que hayan mejorado los resultados del Osteosarcoma en más de 40 años.
OS Therapies(NYSE American: OSTX)는 재발된 절제성 골육종 치료를 위한 임상 시험 2b의 마지막 환자에 대한 치료 완료를 발표했습니다. 이 시험, AOST-2121(NCT04974008)은 미국 21개 사이트에서 41명의 환자를 모집했습니다. 주요 목표는 12개월 사건 무사고 생존율이며 최종 평가는 2024년 4분기 초로 예상됩니다. OST-HER2는 전이 예방과 골육종 환자의 생존율을 증가시키기 위해 설계된 리스테리아 기반 면역 치료 백신입니다.
이 연구는 재발 위험이 높은 환자에서의 효능을 입증하는 것을 목표로 합니다. 12개월 사건 무사고 생존율과 중간 2년 전체 생존율을 포함한 주요 데이터는 2024년 4분기에 발표될 예정입니다. 이 시험은 새로운 FDA 승인 치료법이 40년 이상 골육종 결과를 개선하지 못한 만큼 중요합니다.
OS Therapies (NYSE American: OSTX) a annoncé l'achèvement du traitement du dernier patient dans son essai clinique de phase 2b de OST-HER2 pour l'ostéosarcome récidivant et réséqué. L'essai, AOST-2121 (NCT04974008), a inscrit 41 patients dans 21 sites aux États-Unis. L'objectif principal est la Survie Sans Événement à 12 mois, avec une évaluation finale attendue au début du quatrième trimestre 2024. OST-HER2 est un vaccin immunothérapeutique basé sur la Listeria conçu pour prévenir la métastase et augmenter la survie des patients atteints d'ostéosarcome.
L'étude vise à démontrer l'efficacité chez les patients à haut risque de récidive. Les données préliminaires, incluant la Survie Sans Événement à 12 mois et la Survie Globale intermédiaire à 2 ans, sont anticipées pour le quatrième trimestre 2024. Cet essai est important car aucun nouveau traitement approuvé par la FDA n'a amélioré les résultats de l'ostéosarcome depuis plus de 40 ans.
OS Therapies (NYSE American: OSTX) hat den Abschluss der Behandlung für den letzten Patienten in seiner klinischen Phase-2b-Studie zu OST-HER2 bei rekurriertem, reseziertem Osteosarkom bekannt gegeben. Die Studie, AOST-2121 (NCT04974008), umfasste 41 Patienten an 21 Standorten in den USA. Der primäre Endpunkt ist das 12-monatige ereignisfreie Überleben, wobei die endgültige Auswertung Anfang des vierten Quartals 2024 erwartet wird. OST-HER2 ist ein auf Listeria basierender immuntherapeutischer Impfstoff, der entwickelt wurde, um Metastasen zu verhindern und das Überleben von Osteosarkom-Patienten zu erhöhen.
Die Studie zielt darauf ab, die Wirksamkeit bei Patienten mit hohem Rückfallrisiko zu demonstrieren. Die wichtigsten Daten, einschließlich des 12-monatigen ereignisfreien Überlebens und des vorläufigen 2-Jahres-Gesamtüberlebens, werden im vierten Quartal 2024 erwartet. Diese Studie ist bedeutend, da in den letzten 40 Jahren keine neuen von der FDA zugelassenen Behandlungen die Ergebnisse von Osteosarkomen verbessert haben.
- Completion of treatment for the final patient in Phase 2b trial of OST-HER2
- Full enrollment achieved with 41 patients across 21 U.S. clinical sites
- Potential to be the first FDA-approved treatment improving Osteosarcoma outcomes in over 40 years
- Topline data expected in Q4 2024, including 12-month Event Free Survival and interim 2-year Overall Survival
- Final results and FDA approval still pending, with no guarantee of success
- Long timeline for full data analysis, with final patient evaluation not expected until early Q4 2024
Insights
The completion of OST-HER2's Phase 2b trial marks a significant milestone in Osteosarcoma treatment research. With 41 patients treated across 21 U.S. sites, this study's scope is substantial for a rare cancer. The 12-month Event Free Survival primary endpoint, alongside Overall Survival data, could provide important insights into OST-HER2's efficacy.
The immunotherapeutic approach of OST-HER2, targeting HER2 expression in tumors, represents an innovative strategy in a field that hasn't seen major advancements in over 40 years. If successful, this could potentially fill a critical treatment gap for recurrent Osteosarcoma patients, who currently lack approved adjuvant therapies in the U.S.
Investors should closely monitor the Q4 2024 data readout, as positive results could significantly impact OS Therapies' market position and potentially lead to accelerated FDA approval discussions.
The completion of OST-HER2's Phase 2b trial in recurrent Osteosarcoma is a beacon of hope in a challenging therapeutic landscape. The trial's design, focusing on patients with a high likelihood of recurrence, addresses a critical unmet need in Osteosarcoma treatment.
The Listeria-based vector approach is particularly intriguing, as it harnesses both innate and adaptive immune responses. This dual-action mechanism could potentially offer a more robust and durable anti-tumor effect compared to traditional therapies.
However, it's important to temper enthusiasm with caution. While the 16-dose regimen over 52 weeks is comprehensive, it may pose adherence challenges. Additionally, the true test will be in the long-term Overall Survival data, which won't be fully mature until the 36-month mark. The interim data expected in Q4 2024 will provide valuable insights, but won't tell the complete story.
The completion of OS Therapies' Phase 2b trial for OST-HER2 is a significant milestone for the company. With no new FDA-approved treatments for Osteosarcoma in over four decades, a successful outcome could position OS Therapies as a pioneer in this underserved market.
Investors should note that the topline data expected in Q4 2024 could be a major catalyst for the stock. Positive results may lead to accelerated FDA discussions and potential partnerships, significantly enhancing the company's value proposition.
However, it's important to consider the financial implications of bringing a novel therapy to market, especially for a rare disease. While the unmet need presents a significant opportunity, the patient population may impact revenue potential. Additionally, the company's pipeline beyond Osteosarcoma, including plans for breast cancer trials, will be critical for long-term growth prospects.
OST-HER2, a biologic therapeutic candidate, is a Lm (Listeria monocytogenes) vector-based off-the-shelf immunotherapeutic vaccine designed to prevent metastasis, delay recurrence, and increase overall survival in patients with Osteosarcoma. The AOST-2121 study is designed to demonstrate efficacy in patients who have already had recurrent disease and are highly likely to recur. A total of 16 OST-HER2 doses are administered once every three weeks, with a follow-up approximately four weeks after the final dose is administered, for a total of 52 weeks study. Radiographic evaluation of recurrence is evaluated throughout treatment. The proposed OST-HER2 mechanism of action is based on innate and adaptive immune stimulating responses activated by the Lm vector. This treatment generates T-cells that can eliminate or slow potential micro-metastases that can grow into recurrent Osteosarcoma. T-cell responses target HER2 expressed by the tumor and then kill the cell, releasing additional tumor targets. There are currently no approved adjuvant treatments for recurrent Osteosarcoma in
AOST-2121 has achieved full enrollment of 41 patients treated with OST-HER2 at 21 clinical trial sites across
The addition of the data from this final patient, along with Patient #40, will enhance interim data announced in conjunction with ASCO 2024. This is in addition to previously reported Phase I clinical data in Breast cancer, which the Company plans to target after Osteosarcoma. We thank the patients, families, clinicians, researchers, assistants and the entire Osteosarcoma community for supporting this important and ground-breaking trial.
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 initially filed with the Securities and Exchange Commission (the “SEC”) on May 30, 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.
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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 is the current status of OS Therapies' (OSTX) OST-HER2 clinical trial for Osteosarcoma?
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