Oncolytics Biotech® to Engage FDA for Potential Registration-Enabled Study in First-Line Pancreatic Cancer with Goal to Launch Trial Activities by Year-End
Oncolytics Biotech (NASDAQ: ONCY) has initiated FDA discussions for a potential registration-enabled pivotal study of pelareorep in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). The company plans to commence study activities by the end of 2025, focusing on a trial design that combines pelareorep with chemotherapy and potentially checkpoint inhibition.
The company aims to leverage its Fast Track and Orphan Drug designations in mPDAC, with overall survival as the primary endpoint. The strategy includes exploring an adaptive study design in collaboration with a third party, positioning Oncolytics for potential partnerships in GI oncology. Recent Key Opinion Leader feedback has validated pelareorep's ability to transform "cold" tumors into immunologically active ones, particularly in KRAS-mutated colorectal cancer.
Oncolytics Biotech (NASDAQ: ONCY) ha avviato discussioni con la FDA per uno studio pivotale potenzialmente abilitante alla registrazione di pelareorep nel carcinoma duttale pancreatico metastatico in prima linea (mPDAC). L'azienda prevede di iniziare le attività dello studio entro la fine del 2025, concentrandosi su un disegno sperimentale che combina pelareorep con chemioterapia e possibilmente con inibitori del checkpoint.
La società intende sfruttare le sue designazioni Fast Track e Orphan Drug nel mPDAC, con la sopravvivenza globale come endpoint primario. La strategia include l'esplorazione di un disegno adattativo dello studio in collaborazione con una terza parte, posizionando Oncolytics per potenziali partnership nell'oncologia gastrointestinale. Il recente feedback di Key Opinion Leader ha confermato la capacità di pelareorep di trasformare tumori “freddi” in tumori immunologicamente attivi, in particolare nel carcinoma colorettale con mutazione KRAS.
Oncolytics Biotech (NASDAQ: ONCY) ha iniciado conversaciones con la FDA para un posible estudio pivotal habilitante para registro de pelareorep en adenocarcinoma ductal pancreático metastásico de primera línea (mPDAC). La compañía planea comenzar las actividades del estudio para finales de 2025, enfocándose en un diseño de ensayo que combine pelareorep con quimioterapia y potencialmente inhibición de puntos de control.
La empresa busca aprovechar sus designaciones Fast Track y Orphan Drug en mPDAC, con la supervivencia global como punto final primario. La estrategia incluye explorar un diseño adaptativo del estudio en colaboración con un tercero, posicionando a Oncolytics para posibles asociaciones en oncología gastrointestinal. La retroalimentación reciente de líderes de opinión clave ha validado la capacidad de pelareorep para transformar tumores “fríos” en inmunológicamente activos, especialmente en cáncer colorrectal mutado en KRAS.
Oncolytics Biotech (NASDAQ: ONCY)는 1차 전이성 췌관선암(mPDAC)에서 펠라레오렙의 등록 가능성 있는 중추 연구를 위해 FDA와 논의를 시작했습니다. 회사는 2025년 말까지 연구 활동을 시작할 계획이며, 펠라레오렙과 화학요법, 그리고 잠재적으로 체크포인트 억제제를 결합한 임상시험 설계에 집중하고 있습니다.
회사는 mPDAC에서의 패스트 트랙 및 희귀 의약품 지정을 활용하여 전체 생존율을 주요 평가 지표로 삼고자 합니다. 이 전략에는 제3자와 협력하여 적응형 연구 설계를 탐색하는 내용도 포함되어 있으며, Oncolytics를 위장관 종양학 분야의 잠재적 파트너십에 유리한 위치에 놓고자 합니다. 최근 주요 의견 리더들의 피드백은 펠라레오렙이 KRAS 변이 대장암에서 특히 “냉담한” 종양을 면역학적으로 활성화된 종양으로 전환시키는 능력을 입증했습니다.
Oncolytics Biotech (NASDAQ : ONCY) a entamé des discussions avec la FDA pour une étude pivot potentiellement habilitante à l'enregistrement de pelareorep dans l'adénocarcinome canalaire pancréatique métastatique de première ligne (mPDAC). La société prévoit de commencer les activités de l'étude d'ici la fin 2025, en se concentrant sur un design d'essai combinant pelareorep avec la chimiothérapie et potentiellement une inhibition des points de contrôle.
La société vise à tirer parti de ses désignations Fast Track et Orphan Drug dans le mPDAC, avec la survie globale comme critère principal. La stratégie inclut l'exploration d'un design d'étude adaptatif en collaboration avec un tiers, positionnant Oncolytics pour d'éventuels partenariats en oncologie gastro-intestinale. Les retours récents des leaders d'opinion clés ont validé la capacité de pelareorep à transformer les tumeurs "froides" en tumeurs immunologiquement actives, notamment dans le cancer colorectal muté KRAS.
Oncolytics Biotech (NASDAQ: ONCY) hat Gespräche mit der FDA für eine potenzielle zulassungsrelevante Phase-Studie von Pelareorep bei metastasiertem Pankreasduktaladenokarzinom (mPDAC) in der Erstlinie aufgenommen. Das Unternehmen plant, bis Ende 2025 mit den Studienaktivitäten zu beginnen und konzentriert sich auf ein Studiendesign, das Pelareorep mit Chemotherapie und möglicherweise Checkpoint-Inhibition kombiniert.
Das Unternehmen beabsichtigt, seine Fast Track- und Orphan-Drug-Status bei mPDAC zu nutzen, wobei das Gesamtüberleben als primärer Endpunkt definiert ist. Die Strategie umfasst die Erkundung eines adaptiven Studiendesigns in Zusammenarbeit mit einem Drittpartner, um Oncolytics für potenzielle Partnerschaften in der gastrointestinalen Onkologie zu positionieren. Das jüngste Feedback von Key Opinion Leaders bestätigte die Fähigkeit von Pelareorep, "kalte" Tumoren in immunologisch aktive Tumoren zu verwandeln, insbesondere bei KRAS-mutiertem kolorektalem Krebs.
- Fast Track and Orphan Drug designations already secured for mPDAC indication
- Demonstrated synergy between pelareorep and chemotherapy with/without checkpoint inhibition
- Potential for strategic partnerships in GI oncology pipeline
- Clear regulatory pathway with FDA discussions initiated
- Final study design and timeline dependent on FDA feedback
- Additional partnership or funding may be required for trial execution
- Competitive landscape in pancreatic cancer treatment development
Insights
Oncolytics' move toward a registration-enabled pancreatic cancer trial represents significant advancement in a therapy-resistant cancer with few effective options.
Oncolytics Biotech is making a strategic shift toward a registration-enabled pivotal study for pelareorep in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), which represents a significant advancement in their clinical program. This is particularly noteworthy as pancreatic cancer remains one of the most lethal and treatment-resistant malignancies, with dismal five-year survival rates below
The company's decision to engage the FDA with overall survival as the primary endpoint is clinically sound and ambitious. In pancreatic cancer, meaningful survival improvements are exceedingly difficult to achieve, making this a high-risk but potentially high-reward strategy. The mention of an adaptive study design is particularly intriguing, as it could allow for more efficient evaluation of pelareorep's efficacy, potentially saving time and resources while maximizing the chance of detecting a survival benefit.
Pelareorep's mechanism as an immunotherapy that can transform "cold" tumors into immunologically active ones addresses a critical challenge in pancreatic cancer treatment. Pancreatic tumors are notoriously immunosuppressive and resistant to checkpoint inhibitors alone. The combination approach with chemotherapy, with or without checkpoint inhibition, aligns with emerging evidence that combination strategies are necessary to overcome the complex tumor microenvironment in PDAC.
The Fast Track and Orphan Drug designations already secured provide regulatory advantages that could accelerate approval if the data proves compelling. However, investors should recognize that despite these encouraging signals, pancreatic cancer has been a graveyard for promising therapies, with numerous late-stage clinical trial failures over the past decade due to its biological complexity and heterogeneity.
Clear regulatory path and strong survival data in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) support accelerated strategy to drive shareholder value and partnership opportunities
This milestone reflects Oncolytics' conviction in pelareorep's differentiated mechanism of action and its encouraging survival signal in one of the most lethal and underserved solid tumors. The FDA interaction will focus on finalizing a clinical trial design that leverages pelareorep's demonstrated synergy with chemotherapy with or without checkpoint inhibition, and overall survival as the primary endpoint. Among the potential options, Oncolytics will consider proposing an adaptive study in collaboration with a third party.
"We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, Chief Executive Officer of Oncolytics. "This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors."
Oncolytics' recent Key Opinion Leader event reinforced the clinical promise of pelareorep in mPDAC and other gastrointestinal (GI) cancers, including KRAS-mutated colorectal cancer, and validated its ability to transform "cold" tumors into immunologically active ones. Experts emphasized the scarcity of innovation in pancreatic cancer and the urgent demand for new immunotherapies that can deliver a survival benefit in this setting.
With Fast Track and Orphan Drug designations in mPDAC and translational data supporting pelareorep's immunologic activity, the Company believes it is well-positioned to engage potential partners seeking to bolster their GI oncology pipelines. The upcoming regulatory discussions and planned trial initiation represent major catalysts for strategic collaboration and long-term value creation.
Additional information on the study design, timelines, and next steps will be provided following regulatory feedback.
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 early-phase studies in pancreatic and colorectal cancer. It induces anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses.
The Company is advancing pelareorep in combination with chemotherapy and checkpoint inhibitors in metastatic breast and pancreatic cancers, both of which have received Fast Track designation from the FDA. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics.
Forward-looking statements
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; our plans for a potential registration-enabled pivotal study in first-line mPDAC and the anticipated potential timing of commencement of start-up activities and enrollment in a study, the focus of our discussions with the FDA in respect of the study; the anticipated trial design; our plans to move quickly and decisively down a clear regulatory path; our goals, strategies and objectives; our belief in the clinical promise of pelareorep in mPDAC and other gastrointestinal cancers; our belief that we are well-positioned to engage potential partners seeking to bolster their GI oncology pipelines; and our active pursuit of strategic partnerships. 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. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, and market dynamics. Please refer to Oncolytics' public filings with securities regulators in the
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Company Contact
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca
Investor Relations for Oncolytics
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
Media Contact for Oncolytics
Owen Blaschak
LifeSci Communications
oblaschak@lifescicomms.com
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SOURCE Oncolytics Biotech® Inc.
FAQ
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