Regulatory Approval Clears Path for Oncolytics Biotech® to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data
Oncolytics Biotech (NASDAQ: ONCY) has received approval from Germany's Paul-Ehrlich-Institute to continue enrollment in Cohort 5 of the GOBLET study, which evaluates pelareorep combined with mFOLFIRINOX, with or without atezolizumab, for newly diagnosed pancreatic ductal adenocarcinoma patients.
The approval follows a positive safety review by the independent Data Safety Monitoring Board and allows for full enrollment of 30 patients in Stage 1. Early safety data will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium, with initial efficacy results expected in H2 2025.
The company reports encouraging tumor response rates from an earlier GOBLET cohort, suggesting pelareorep's potential to improve outcomes for metastatic pancreatic cancer patients. The current cohort explores a different chemotherapy combination to potentially benefit a broader patient population.
Oncolytics Biotech (NASDAQ: ONCY) ha ricevuto l'approvazione dall'Istituto Paul-Ehrlich della Germania per continuare l'arruolamento nel Coorte 5 dello studio GOBLET, che valuta pelareorep combinato con mFOLFIRINOX, con o senza atezolizumab, per pazienti con adenocarcinoma duttale pancreatico appena diagnosticato.
L'approvazione segue una revisione positiva della sicurezza da parte del Data Safety Monitoring Board indipendente e consente l'arruolamento completo di 30 pazienti nella Fase 1. I dati preliminari di sicurezza saranno presentati al Simposio ASCO sui Tumori Gastrointestinali del 2025, con i risultati iniziali di efficacia previsti nella seconda metà del 2025.
La società riporta tassi di risposta tumorale incoraggianti da una precedente coorte GOBLET, suggerendo il potenziale di pelareorep per migliorare i risultati per i pazienti con cancro pancreatico metastatico. La coorte attuale esplora una diversa combinazione di chemioterapia per potenzialmente avvantaggiare una popolazione di pazienti più ampia.
Oncolytics Biotech (NASDAQ: ONCY) ha recibido la aprobación del Instituto Paul-Ehrlich de Alemania para continuar con la inscripción en el Cohorte 5 del estudio GOBLET, que evalúa pelareorep combinado con mFOLFIRINOX, con o sin atezolizumab, para pacientes recién diagnosticados con adenocarcinoma ductal pancreático.
La aprobación sigue a una revisión positiva de seguridad por parte de la Junta de Monitoreo de Seguridad de Datos independiente y permite la inscripción completa de 30 pacientes en la Etapa 1. Los datos iniciales de seguridad se presentarán en el Simposio de Cánceres Gastrointestinales ASCO 2025, con resultados iniciales de eficacia esperados para la segunda mitad de 2025.
La empresa informa tasas de respuesta tumoral alentadoras de una cohorte anterior de GOBLET, sugiriendo el potencial de pelareorep para mejorar los resultados para los pacientes con cáncer de páncreas metastásico. La cohorte actual explora una combinación diferente de quimioterapia para potencialmente beneficiar a una población de pacientes más amplia.
온코리틱스 바이오텍 (NASDAQ: ONCY)는 독일 파울 에를리히 연구소로부터 펠라레오렙을 mFOLFIRINOX와 함께 또는 독립적으로 아테졸리주맙과 조합하여 새로 진단된 췌장 관 duct 선암 환자를 위한 GOBLET 연구의 5차 코호트에 대한 등록을 계속 허가받았습니다.
이번 승인은 독립적인 데이터 안전성 모니터링 위원회의 긍정적인 안전성 검토에 따른 것이며, 1단계에서 30명의 환자를 완전히 등록할 수 있도록 허용합니다. 초기 안전성 데이터는 2025년 ASCO 위장관암 심포지엄에서 발표될 예정이며, 초기 효능 결과는 2025년 하반기에 예상됩니다.
회사는 이전 GOBLET 코호트에서 고무적인 종양 반응률을 보고하고 있으며, 이는 펠라레오렙이 전이성 췌장암 환자의 결과를 개선할 가능성이 있음을 제안합니다. 현재 코호트는 더 넓은 환자 집단에 혜택을 줄 수 있는 다른 화학요법 조합을 탐색합니다.
Oncolytics Biotech (NASDAQ: ONCY) a reçu l'approbation de l'Institut Paul-Ehrlich d'Allemagne pour poursuivre l'enrôlement dans la Cohorte 5 de l'étude GOBLET, qui évalue pelareorep combiné avec mFOLFIRINOX, avec ou sans atezolizumab, pour des patients nouvellement diagnostiqués avec un adénocarcinome canalaire pancréatique.
L'approbation fait suite à une évaluation positive de sécurité par le Conseil de surveillance de la sécurité des données indépendant et permet l'enrôlement complet de 30 patients à l'Étape 1. Les données préliminaires de sécurité seront présentées au Symposium ASCO sur les cancers gastro-intestinaux 2025, avec les premiers résultats d'efficacité attendus au second semestre 2025.
La société rapporte des taux de réponse tumorale encourageants d'une cohorte GOBLET antérieure, suggérant le potentiel de pelareorep d'améliorer les résultats pour les patients atteints de cancer du pancréas métastatique. La cohorte actuelle explore une combinaison de chimiothérapie différente pour bénéficier potentiellement à une population de patients plus large.
Oncolytics Biotech (NASDAQ: ONCY) hat die Genehmigung vom Paul-Ehrlich-Institut in Deutschland erhalten, um die Rekrutierung in Kohorte 5 der GOBLET-Studie fortzusetzen, die pelareorep in Kombination mit mFOLFIRINOX, mit oder ohne Atezolizumab, für neu diagnostizierte Patienten mit duktalem Adenokarzinom des Pankreas bewertet.
Die Genehmigung folgt einer positiven Sicherheitsbewertung durch das unabhängige Daten-Sicherheitsüberwachungsgremium und ermöglicht die vollständige Rekrutierung von 30 Patienten in Phase 1. Erste Sicherheitsdaten werden auf dem ASCO Symposium für gastrointestinalen Krebs 2025 präsentiert, während erste Wirksamkeitsergebnisse in der zweiten Hälfte 2025 erwartet werden.
Das Unternehmen berichtet von ermutigenden Tumoransprechraten aus einer früheren GOBLET-Kohorte, was auf das Potenzial von pelareorep hinweist, die Ergebnisse bei Patienten mit metastasiertem Bauchspeicheldrüsenkrebs zu verbessern. Die aktuelle Kohorte untersucht eine andere Chemotherapie-Kombination, um möglicherweise einer breiteren Patientengruppe zugutekommen zu können.
- Regulatory approval received to continue patient enrollment in GOBLET study Cohort 5
- Positive safety review from independent Data Safety Monitoring Board
- Early encouraging tumor response rates from previous GOBLET cohort
- None.
Insights
The PEI's approval for GOBLET study's Cohort 5 continuation represents a important milestone in pelareorep's development pathway. The combination of pelareorep with mFOLFIRINOX, with or without atezolizumab, targets first-line PDAC treatment - a significant market opportunity given pancreatic cancer's poor prognosis and treatment options.
The DSMB's positive safety review is particularly noteworthy as mFOLFIRINOX is already known for its challenging side effect profile. The ability to combine pelareorep safely with this regimen suggests a manageable therapeutic window. The 30-patient enrollment target for Stage 1 is appropriately sized for an early efficacy signal while managing development costs.
In simpler terms: Think of this like testing if a new ingredient (pelareorep) can be safely added to an existing recipe (chemotherapy) to make it work better. The safety reviewers gave a thumbs up and now they can test it in more patients.
The strategic selection of mFOLFIRINOX as the combination partner is particularly astute. mFOLFIRINOX is already considered the most effective first-line chemotherapy for PDAC patients with good performance status. By demonstrating compatibility with this backbone therapy, Oncolytics positions pelareorep to potentially enhance outcomes in the optimal treatment setting.
Building on previous GOBLET cohort data showing encouraging response rates, this expansion provides a critical opportunity to validate pelareorep's efficacy with a different chemotherapy combination. The inclusion of an atezolizumab arm also allows exploration of potential synergy between viral and checkpoint immunotherapies - a mechanism of particular interest in typically "cold" tumors like PDAC.
For non-experts: Pancreatic cancer is one of the hardest cancers to treat. This study combines a new immunotherapy approach with the current best chemotherapy to try to improve patient survival. The early safety results are promising enough to expand the trial.
New pancreatic cancer cohort moves forward with full enrollment of 30 patients in Stage 1
Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI's approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year.
"Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep's promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed."
About GOBLET Cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in
- Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic PDAC patients;
- Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
- Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients;
- Pelareorep in combination with atezolizumab in 2nd line or later advanced and unresectable anal cancer patients; and
- Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; continued enrollment in the GOBLET study and the expansion thereof to additional participants; our belief that pelareorep is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and
Company Contact
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Director of IR & Communication
jpatton@oncolytics.ca
Investor Relations for Oncolytics
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SOURCE Oncolytics Biotech® Inc.
FAQ
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