Oncolytics Biotech庐 Provides Updated Clinical Safety Data for Pelareorep, Including Across Multiple Gastrointestinal Tumors
Oncolytics Biotech (NASDAQ: ONCY) has released updated safety data for its immunotherapy drug pelareorep, showcasing favorable results across multiple gastrointestinal cancers. The analysis encompasses over 1,200 total patients, including more than 300 gastrointestinal cancer patients across 8 clinical studies.
The data confirms pelareorep's consistent safety profile, with most adverse events being Grade 1 and 2, including fever, chills, fatigue, and gastrointestinal symptoms. The therapy has been tested in combination with various treatments, including modified FOLFIRINOX for metastatic pancreatic cancer, and in multiple tumor types such as colorectal and anal cancer.
Oncolytics Biotech (NASDAQ: ONCY) ha pubblicato dati di sicurezza aggiornati sul suo immunoterapico pelareorep, mostrando risultati favorevoli in diversi tumori gastrointestinali. L'analisi riguarda oltre 1.200 pazienti in totale, di cui pi霉 di 300 con tumori gastrointestinali coinvolti in 8 studi clinici.
I dati confermano un profilo di sicurezza costante per pelareorep: la maggior parte degli eventi avversi sono di Grado 1 e 2, come febbre, brividi, affaticamento e sintomi gastrointestinali. Il trattamento 猫 stato valutato in combinazione con varie terapie, incluso il FOLFIRINOX modificato per il carcinoma pancreatico metastatico, e in pi霉 tipi tumorali come il carcinoma colorettale e anale.
Oncolytics Biotech (NASDAQ: ONCY) ha publicado datos de seguridad actualizados sobre su inmunoter谩pico pelareorep, mostrando resultados favorables en varios c谩nceres gastrointestinales. El an谩lisis incluye a m谩s de 1.200 pacientes en total, entre ellos m谩s de 300 con c谩ncer gastrointestinal en 8 estudios cl铆nicos.
Los datos confirman un perfil de seguridad consistente para pelareorep, con la mayor铆a de los eventos adversos siendo de Grado 1 y 2, como fiebre, escalofr铆os, fatiga y s铆ntomas gastrointestinales. La terapia se ha probado en combinaci贸n con distintos tratamientos, incluido el FOLFIRINOX modificado para c谩ncer de p谩ncreas metast谩sico, y en varios tipos tumorales como c谩ncer colorrectal y anal.
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Oncolytics Biotech (NASDAQ: ONCY) a publi茅 des donn茅es de s茅curit茅 mises 脿 jour concernant son immunoth茅rapeutique pelareorep, montrant des r茅sultats favorables dans plusieurs cancers gastro-intestinaux. L'analyse porte sur plus de 1 200 patients au total, dont plus de 300 patients atteints de cancers gastro-intestinaux r茅partis sur 8 茅tudes cliniques.
Les donn茅es confirment un profil de s茅curit茅 stable pour pelareorep, la majorit茅 des 茅v茅nements ind茅sirables 茅tant de grade 1 et 2, tels que fi猫vre, frissons, fatigue et sympt么mes gastro-intestinaux. Le traitement a 茅t茅 test茅 en combinaison avec diverses th茅rapies, y compris un FOLFIRINOX modifi茅 pour le cancer du pancr茅as m茅tastatique, et dans plusieurs types tumoraux comme les cancers colorectal et anal.
Oncolytics Biotech (NASDAQ: ONCY) hat aktualisierte Sicherheitsdaten zu seinem Immuntherapeutikum Pelareorep ver枚ffentlicht, die in mehreren gastrointestinalen Krebserkrankungen g眉nstige Ergebnisse zeigen. Die Analyse umfasst 眉ber 1.200 Patienten insgesamt, darunter mehr als 300 Patienten mit gastrointestinalen Tumoren in 8 klinischen Studien.
Die Daten best盲tigen ein konsistentes Sicherheitsprofil f眉r Pelareorep, wobei die meisten Nebenwirkungen Grad 1 und 2 sind, darunter Fieber, Sch眉ttelfrost, M眉digkeit und gastrointestinale Symptome. Die Therapie wurde in Kombination mit verschiedenen Behandlungen getestet, darunter modifiziertes FOLFIRINOX bei metastasiertem Pankreaskarzinom, sowie in mehreren Tumorentit盲ten wie Darm- und Analcarcinom.
- Safety profile remains favorable across 1,200+ patients and multiple treatment combinations
- Most adverse events are only Grade 1 and 2, indicating good tolerability
- Pelareorep does not appear to worsen chemotherapy-related adverse events
- Extensive clinical testing across 300+ gastrointestinal cancer patients demonstrates platform potential
- Common adverse events include flu-like symptoms and neutropenia
- Still in clinical-stage, pending regulatory approval
Insights
Pelareorep shows favorable safety profile across 1,200+ patients; positions company well for registration studies in GI cancers.
Oncolytics Biotech's updated safety analysis for pelareorep represents a meaningful development in their clinical program. The data now encompasses over 1,200 patients, including 300+ with gastrointestinal tumors across 8 clinical studies - a substantial patient population that strengthens the statistical reliability of their safety findings.
The safety profile remains consistent with previous analyses, with most adverse events being Grade 1-2 fever, chills, fatigue, nausea, vomiting, and diarrhea. Critically, pelareorep doesn't appear to exacerbate Grade 3-4 chemotherapy-related adverse events when used in combination treatments - a significant advantage for an oncology agent. For GI cancer patients specifically, the most common adverse events were flu-like symptoms and neutropenia.
This expanded safety database positions pelareorep as one of the more de-risked immunotherapies in the GI cancer space from a tolerability perspective. The consistent safety profile across multiple tumor types and in combination with various treatment regimens (including modified FOLFIRINOX for pancreatic cancer) suggests pelareorep has versatility as a potential platform therapy.
The announcement of progression toward registration-enabled studies signals confidence in both the safety and efficacy profiles, though specific efficacy data wasn't detailed in this release. For an intravenously administered immunotherapy, maintaining a favorable safety profile across such a diverse patient population represents a meaningful achievement in development and reduces a key risk factor as the company advances toward regulatory submissions.
Data continue to demonstrate a favorable safety profile for pelareorep across multiple indications and in combination with multiple treatments
Updated clinical data now account for over 300 gastrointestinal cancer patients, including patients from the GOBLET study, demonstrating pelareorep's potential as a platform therapy
Intravenously administered pelareorep continues to show clinical benefit
A previous analysis of safety data from studies involving pelareorep () in combination with multiple therapies in over 500 patients concluded that the most frequent adverse events were Grade 1 and 2 fever, chills, fatigue, nausea, vomiting, and diarrhea. Additionally, Grade 3 or 4 adverse events associated with chemotherapy do not appear to be modified by adding pelareorep to the treatment regimen. An updated analysis involving patients who received at least one intravenous dose of pelareorep demonstrates the existing favorable safety profile of pelareorep in combination with numerous treatment regimens across multiple tumor types.
"With over 1,200 patients dosed and a consistent safety profile, pelareorep represents one of the most de-risked immunotherapies that is not already approved as a treatment option in gastrointestinal tumors," said Jared Kelly, Chief Executive Officer of Oncolytics. "As we move forward to registration-enabled studies, we are confident the safety data will be a positive characteristic for regulators and potential partners."
To date, over 300 gastrointestinal cancer patients across 8 clinical studies have received pelareorep. It has been evaluated in combination with new treatment regimens like modified FOLFIRINOX in metastatic pancreatic cancer and in other tumor types, including colorectal cancer and anal cancer. The most common adverse events associated with pelareorep in patients with gastrointestinal tumors are flu-like symptoms and neutropenia.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated promising results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It induces anti-cancer immune responses by converting immunologically "cold"听tumors "hot"听through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit:听听or follow the Company on social media on 听and on X @.
Forward-looking statements
This press release contains forward-looking statements, within the meaning of Section 21E of the
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FAQ
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