OS Therapies Announces Positive Safety Data from Phase 1 Clinical Trial of OST-HER2 in HER2-Expressing Breast Cancer and in Preclinical Efficacy in Models of Breast Cancer
OS Therapies (NYSE-A: OSTX) has announced positive safety data from a Phase 1 clinical trial of OST-HER2 in HER2-expressing solid tumors, primarily breast cancer. The trial involved 12 patients, with 10 having breast cancer. The dose selected for the ongoing Phase 2b trial in Osteosarcoma was well-tolerated in breast cancer patients.
Additionally, preclinical efficacy data showed promising results in breast cancer models, including:
- 78% reduction in tumor size
- 33% prevention of breast cancer
- 20% reduction in tumor size when combined with HER2-targeted antibodies
- 65% reduction in metastatic cells in brain metastasis models
OST-HER2 has received Rare Pediatric Disease, Orphan Drug, and Fast Track Designations from the FDA for Osteosarcoma. The company is currently in discussions with the FDA regarding a Breakthrough Therapy designation application based on interim results from their Phase 2b trial.
OS Therapies (NYSE-A: OSTX) ha annunciato dati di sicurezza positivi da uno studio clinico di Fase 1 su OST-HER2 in tumori solidi esprimenti HER2, principalmente il cancro al seno. Lo studio ha coinvolto 12 pazienti, di cui 10 con cancro al seno. La dose selezionata per la fase 2b in osteosarcoma è stata ben tollerata nei pazienti con cancro al seno.
Inoltre, i dati di efficacia preclinica hanno mostrato risultati promettenti nei modelli di cancro al seno, tra cui:
- riduzione del 78% della dimensione del tumore
- prevenzione del 33% del cancro al seno
- riduzione del 20% della dimensione del tumore quando combinato con anticorpi mirati su HER2
- riduzione del 65% delle cellule metastatiche nei modelli di metastasi cerebrale
OST-HER2 ha ricevuto designazioni di Malattia Pediatrica Rara, Farmaco Orfano e Fast Track dalla FDA per l'osteosarcoma. La società è attualmente in discussione con la FDA riguardo a una richiesta di designazione di Terapia Innovativa basata sui risultati intermedi del loro studio di Fase 2b.
OS Therapies (NYSE-A: OSTX) ha anunciado datos de seguridad positivos de un ensayo clínico de Fase 1 para OST-HER2 en tumores sólidos que expresan HER2, principalmente cáncer de mama. El ensayo involucró a 12 pacientes, de los cuales 10 tenían cáncer de mama. La dosis seleccionada para el ensayo de fase 2b en osteosarcoma se toleró bien en pacientes con cáncer de mama.
Además, los dátiles de eficacia preclínica mostraron resultados prometedores en modelos de cáncer de mama, incluyendo:
- reducción del 78% en el tamaño del tumor
- prevención del 33% del cáncer de mama
- reducción del 20% en el tamaño del tumor cuando se combina con anticuerpos dirigidos a HER2
- reducción del 65% en células metastásicas en modelos de metástasis cerebral
OST-HER2 ha recibido designaciones de Enfermedad Pediátrica Rara, Medicamento Huérfano y Vía Rápida de la FDA para osteosarcoma. La empresa está actualmente en conversaciones con la FDA sobre una solicitud de designación de Terapia Innovadora basada en resultados interinos de su ensayo de Fase 2b.
OS Therapies (NYSE-A: OSTX)는 HER2 발현 고형 종양, 주로 유방암에 대한 OST-HER2의 1상 임상 시험에서 긍정적인 안전성 데이터를 발표했습니다. 이 시험에는 12명의 환자가 참여했으며, 그 중 10명이 유방암 환자였습니다. 유방암 환자에게서 진행 중인 2b 단계의 골육종 시험에 대해 선택된 용량은 잘 견뎌졌습니다.
또한, 전임상 효능 데이터는 유방암 모델에서 유망한 결과를 보여주었으며, 포함된 내용은 다음과 같습니다:
- 종양 크기 78% 감소
- 유방암 예방 33%
- HER2 표적 항체와 병용 시 종양 크기 20% 감소
- 뇌 전이 모델에서 전이 세포 65% 감소
OST-HER2는 골육종에 대해 FDA로부터 희귀 소아 질병, 고아약 및 패스트 트랙 지정을 받았습니다. 현재 이 회사는 2b 단계 시험의 중간 결과를 바탕으로 FDA와 혁신 치료 지정 신청에 대해 논의 중입니다.
OS Therapies (NYSE-A: OSTX) a annoncé des données de sécurité positives issues d’un essai clinique de phase 1 concernant OST-HER2 dans des tumeurs solides exprimant HER2, principalement le cancer du sein. L'essai a impliqué 12 patients, dont 10 atteints de cancer du sein. La dose choisie pour l'essai de phase 2b d'ostéosarcome a été bien tolérée par les patients ayant un cancer du sein.
De plus, les données d'efficacité préclinique ont montré des résultats prometteurs dans des modèles de cancer du sein, notamment :
- réduction de 78 % de la taille de la tumeur
- prévention de 33 % du cancer du sein
- réduction de 20 % de la taille de la tumeur lorsqu'elle est combinée avec des anticorps ciblant HER2
- réduction de 65 % des cellules métastatiques dans des modèles de métastases cérébrales
OST-HER2 a reçu des diligences de Maladie Pédiatrique Rare, de Médicament Orphelin et de Voie Accélérée de la FDA pour l’ostéosarcome. L’entreprise est actuellement en discussions avec la FDA concernant une demande de désignation de Thérapie Innovante basée sur des résultats préliminaires de leur essai de phase 2b.
OS Therapies (NYSE-A: OSTX) hat positive Sicherheitsdaten aus einer klinischen Studie der Phase 1 zu OST-HER2 bei HER2-expressierenden soliden Tumoren, hauptsächlich Brustkrebs, bekannt gegeben. Die Studie umfasste 12 Patienten, von denen 10 an Brustkrebs litten. Die für die laufende Phase 2b-Studie bei Osteosarkomen ausgewählte Dosis wurde bei Brustkrebspatienten gut vertragen.
Darüber hinaus zeigten die präklinischen Wirksamkeitsdaten vielversprechende Ergebnisse in Brustkrebsmodellen, darunter:
- 78%ige Reduktion der Tumorgröße
- 33% Reduktion der Brustkrebsfälle
- 20%ige Reduktion der Tumorgröße in Kombination mit HER2-gerichteten Antikörpern
- 65%ige Reduktion von metastatischen Zellen in Modellen für Gehirnmetastasen
OST-HER2 hat von der FDA die Bezeichnungen Seltene Pädiatrische Krankheit, Waisenarzneimittel und Fast-Track für Osteosarkome erhalten. Das Unternehmen führt derzeit Gespräche mit der FDA über einen Antrag auf Durchbruchtherapie, basierend auf den vorläufigen Ergebnissen ihrer Phase 2b-Studie.
- Phase 1 clinical trial showed OST-HER2 to be safe and well-tolerated in HER2-expressing solid tumors
- Preclinical breast cancer models showed 78% reduction in tumor size
- 33% prevention of breast cancer in preclinical models
- 65% reduction in metastatic cells in brain metastasis models
- FDA granted Rare Pediatric Disease, Orphan Drug, and Fast Track Designations for OST-HER2 in Osteosarcoma
- Ongoing discussions with FDA for potential Breakthrough Therapy designation
- None.
Insights
The Phase 1 clinical trial results for OST-HER2 in HER2-expressing solid tumors, particularly breast cancer, are encouraging. The safety profile demonstrated at the dose used in the ongoing Phase 2b osteosarcoma trial is a positive indicator for future development. However, it's important to note that safety data alone doesn't guarantee efficacy.
The preclinical efficacy data in breast cancer models is intriguing, especially the
While these preclinical results are promising, we must remember that animal models don't always translate directly to human outcomes. The combination therapy showing a
The multiple regulatory designations (RPDD, ODD, FTD) for osteosarcoma indicate the potential unmet medical need that OST-HER2 might address. The ongoing discussions with the FDA regarding Breakthrough Therapy Designation could accelerate development if granted.
Overall, these results warrant continued investigation, but investors should remain cautious until more robust clinical data in breast cancer patients becomes available.
The potential of OST-HER2 as an immunotherapeutic vaccine is intriguing from a clinical perspective. Its mechanism of action, targeting both innate and adaptive immune responses, aligns with current trends in cancer immunotherapy. The focus on preventing metastasis and delaying recurrence addresses critical needs in cancer treatment.
The safety data from the Phase 1b trial, particularly in breast cancer patients, is reassuring. However, it's important to emphasize that safety doesn't equate to efficacy. The real test will be in larger, randomized trials that can demonstrate meaningful clinical outcomes.
The preclinical data showing efficacy in preventing brain metastases is particularly exciting. Brain metastases are a significant challenge in HER2-positive breast cancer, often with poor prognosis. If this translates to human trials, it could represent a major advancement.
The
While the primary focus seems to be on osteosarcoma, the potential expansion into breast cancer and other HER2-expressing cancers could significantly broaden the therapeutic applications of OST-HER2. However, it's important to await results from well-designed clinical trials in these indications before drawing firm conclusions about its efficacy in breast cancer.
From a financial perspective, OS Therapies' development of OST-HER2 presents several interesting aspects for investors to consider:
- The multiple regulatory designations for osteosarcoma (RPDD, ODD, FTD) could potentially accelerate the path to market and provide market exclusivity benefits, enhancing the commercial potential in this indication.
- The ongoing discussions with the FDA regarding Breakthrough Therapy Designation (BTD) for osteosarcoma could be a significant catalyst if granted, potentially leading to a faster review process and earlier market entry.
- The potential expansion into breast cancer and other HER2-expressing cancers represents a substantial market opportunity. HER2-positive breast cancer alone accounts for about
20% of breast cancers, a significant patient population. - The preclinical data suggesting efficacy in preventing brain metastases could position OST-HER2 as a valuable addition to current treatment regimens, potentially commanding premium pricing if clinically validated.
- The combination therapy potential with existing HER2-targeted antibodies could facilitate market penetration and adoption among oncologists already familiar with these treatments.
However, investors should be cautious. The company is still in early clinical stages for breast cancer indications and significant R&D expenses are likely before any potential commercialization. The path from preclinical success to approved therapy is long and often fraught with setbacks.
While the data is promising, it's important to monitor upcoming clinical trial results, particularly in breast cancer, to better assess the long-term revenue potential and market positioning of OST-HER2. The company's ability to secure partnerships or additional funding for further development will be critical factors to watch.
- 10 of 12 patients treated in HER2 expressing solid tumor Phase 1b trial were breast cancer patients
- Dose selected for ongoing Phase 2b clinical trial in Osteosarcoma was shown to be well tolerated in breast cancer patients
-
Preclinical breast cancer efficacy models showed positive data to prevent breast cancer metastases to the brain, reduce tumor growth by over
90% in combination with HER2-targeted antibodies, and prevent the formation of breast cancer compared with controls
The FDA has granted Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for OST-HER2 in Osteosarcoma. 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 and other solid tumors. 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 micrometastases that can grow into recurrent osteosarcoma and other solid tumors, including breast cancer. T cell responses home in on 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
A total of twelve (12) patients with a history of HER2 positive cancer were enrolled in the Phase 1b clinical study, comprised of ten (10) patients with breast cancer, one (1) patient with esophageal cancer and one (1) patient with GE junction cancer. OST-HER2 was determined to be safe and well tolerated in patients with HER2-expressing solid tumors, including at the dose currently being used in the Company’s ongoing Phase 2b clinical trial in recurrent, resected osteosarcoma (AOST-2121, NCT04974008). The Company previously announced positive AOST-2121 interim data and is now in active discussions with the US FDA regarding a Breakthrough Therapy (BTD) designation application submitted for OST-HER2 based on the interim results. The Company is focused on approval for OST-HER2 in osteosarcoma, and thereafter plans to expand development into breast cancer and other HER2 expressing cancers such as esophageal cancer and colorectal cancer.
In addition, the Company announced positive data from multiple preclinical models of breast cancer. The key data for OST-HER2 include:
-
78% reduction in tumor size (3mm for OST-HER2 treated vs. 14mm for control arm) in FVB/N HER2 transgenic mouse model of breast cancer treatment at day 75 -
33% prevention of breast cancer in OST-HER2 treated mice vs.0% prevention of breast cancer in FVB/N HER2 transgenic model of breast cancer prevention at week 50 -
20% reduction of tumor size for OST-HER2 plus HER2-targeted antibody vs. HER2-targeted antibody alone Tg tumor regression model of breast cancer at day 42 -
65% reduction cellular concentration of metastatic cells for OST-HER2-treated mice compared with controls in brain metastasis model of primary breast cancer
About OS Therapies
OS Therapies, Inc. (NYSE-A: OSTX) is a clinical stage oncology company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2 is an immunotherapy leveraging the immune stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. The Company has fully-enrolled 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 also completed a Phase 1b clinical trial in other solid tumors and has demonstrated efficacy in multiple preclinical models of breast cancer. OS Therapies is also developing the next generations Antibody Drug Conjugate (ADC) platform tunable ADC (tADC) centered around tunable, tailored antibody-linker-payload candidates built around the Company’s unique silicone linker technology that allows for multiple payloads to be delivered per linker.
About OST-HER2
The OST-HER2 Lm vector platform technology has been administered to over 450 cancer patients in ongoing and completed clinical trials. AOST-2121 is a Phase IIB clinical trial intended to prevent or delay metastasis and improve Overall Survival (OS) in Osteosarcoma. OST-HER2 has already received Fast-Track, Orphan, and Rare Disease Designation (RDD). OST hopes to seek a Break-Through Designation (BTD) based on data from this Phase IIb clinical trial. OST31-164 has previously received USDA provisional approval for treatment of Osteosarcoma in canines. In a completed Phase III study in canines (n=180), early data demonstrated a clear separation of treated and untreated canine patients (p=.0007) in Overall Survival (OS) and Disease Progression.
For more information, please see the Company's website at www.ostherapies.com
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Source: OS Therapies, Inc.
FAQ
What were the results of OS Therapies' (OSTX) Phase 1 trial for OST-HER2 in breast cancer?
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Is OS Therapies (OSTX) seeking Breakthrough Therapy Designation for OST-HER2?
