Oncolytics Biotech® Presents Aggregated Translational Data Providing Evidence of Pelareorep's Effectiveness Across Multiple Tumor Types
Oncolytics Biotech (NASDAQ: ONCY) presented comprehensive translational data demonstrating the effectiveness of its immunotherapy candidate pelareorep across multiple tumor types. The data, derived from the GOBLET and AWARE-1 studies, showed consistent immune activation signatures in pancreatic, gastrointestinal, and breast cancers.
Key findings revealed that pelareorep successfully converts 'cold' tumors to 'hot' by upregulating interferons and PD-L1, expanding tumor-infiltrating lymphocytes, and modifying the tumor microenvironment. The company expects additional translational data readouts next year and plans to provide an updated clinical timeline by the end of Q3 2025.
Oncolytics Biotech (NASDAQ: ONCY) ha presentato dati traslazionali completi che dimostrano l'efficacia del suo candidato immunoterapico pelareorep in diversi tipi di tumore. I dati, provenienti dagli studi GOBLET e AWARE-1, hanno evidenziato firme di attivazione immunitaria costanti nei tumori pancreatici, gastrointestinali e mammari.
I risultati principali hanno mostrato che pelareorep riesce a trasformare i tumori 'freddi' in 'caldi' aumentando l'espressione di interferoni e PD-L1, espandendo i linfociti infiltranti il tumore e modificando il microambiente tumorale. L'azienda prevede ulteriori dati traslazionali il prossimo anno e intende fornire un aggiornamento sul calendario clinico entro la fine del terzo trimestre 2025.
Oncolytics Biotech (NASDAQ: ONCY) presentó datos traslacionales completos que demuestran la eficacia de su candidato inmunoterapéutico pelareorep en varios tipos de tumores. Los datos, obtenidos de los estudios GOBLET y AWARE-1, mostraron firmas consistentes de activación inmune en cánceres de páncreas, gastrointestinales y de mama.
Los hallazgos clave revelaron que pelareorep logra convertir tumores 'fríos' en 'calientes' mediante la regulación al alza de interferones y PD-L1, la expansión de linfocitos infiltrantes tumorales y la modificación del microambiente tumoral. La compañía espera obtener más datos traslacionales el próximo año y planea ofrecer una actualización del cronograma clínico para finales del tercer trimestre de 2025.
Oncolytics Biotech (NASDAQ: ONCY)는 다양한 종양 유형에서 면역치료 후보물질 pelareorep의 효능을 입증하는 포괄적인 전이학 데이터를 발표했습니다. GOBLET 및 AWARE-1 연구에서 도출된 데이터는 췌장암, 위장관암, 유방암에서 일관된 면역 활성화 신호를 보여주었습니다.
주요 결과는 pelareorep가 인터페론과 PD-L1을 상향 조절하고, 종양 침윤 림프구를 확장하며, 종양 미세환경을 변화시켜 '차가운' 종양을 '뜨거운' 종양으로 전환하는 데 성공했음을 나타냅니다. 회사는 내년에 추가 전이학 데이터 결과를 기대하며 2025년 3분기 말까지 임상 일정 업데이트를 제공할 계획입니다.
Oncolytics Biotech (NASDAQ : ONCY) a présenté des données translationnelles complètes démontrant l'efficacité de son candidat immunothérapeutique pelareorep sur plusieurs types de tumeurs. Les données, issues des études GOBLET et AWARE-1, ont montré des signatures d'activation immunitaire cohérentes dans les cancers du pancréas, gastro-intestinaux et du sein.
Les résultats clés ont révélé que pelareorep réussit à convertir les tumeurs « froides » en « chaudes » en augmentant l'expression des interférons et du PD-L1, en élargissant les lymphocytes infiltrant la tumeur et en modifiant le microenvironnement tumoral. La société prévoit des résultats supplémentaires de données translationnelles l'année prochaine et envisage de fournir une mise à jour du calendrier clinique d'ici la fin du troisième trimestre 2025.
Oncolytics Biotech (NASDAQ: ONCY) präsentierte umfassende translationale Daten, die die Wirksamkeit ihres Immuntherapie-Kandidaten pelareorep bei verschiedenen Tumorarten belegen. Die Daten, gewonnen aus den GOBLET- und AWARE-1-Studien, zeigten konsistente Immunaktivierungssignaturen bei Pankreas-, gastrointestinalen und Brustkrebsarten.
Wesentliche Erkenntnisse zeigten, dass pelareorep erfolgreich 'kalte' Tumoren in 'heiße' Tumoren umwandelt, indem Interferone und PD-L1 hochreguliert, tumorinfiltrierende Lymphozyten erweitert und das Tumormikromilieu verändert werden. Das Unternehmen erwartet im nächsten Jahr weitere translationale Daten und plant, bis Ende Q3 2025 einen aktualisierten klinischen Zeitplan bereitzustellen.
- Confirmed viral replication and immune activation across multiple tumor types
- Successfully converts immunologically 'cold' tumors to 'hot' phenotypes
- Shows effectiveness in historically immunotherapy-resistant cancers
- Demonstrates strong platform potential for multiple cancer indications
- Additional clinical data readouts still pending
- Registration-enabling studies yet to commence
- Regulatory pathway still under discussion
Insights
Pelareorep shows robust immune activation across tumor types, validating its mechanism of action and advancing toward registration-enabling trials.
The translational data presented by Oncolytics Biotech provides compelling evidence of pelareorep's immunotherapeutic mechanism across multiple challenging cancer types. Analyses from the GOBLET and AWARE-1 studies show the oncolytic virus consistently triggers critical immune responses: viral replication in cancer cells, interferon signaling activation, and increased tumor-infiltrating lymphocytes.
What's particularly significant is pelareorep's demonstrated ability to convert immunologically 'cold' tumors (which typically resist immunotherapy) into 'hot' tumors with robust immune cell infiltration. The upregulation of PD-L1 expression is especially valuable as it creates a rational basis for combination with checkpoint inhibitors, potentially overcoming resistance mechanisms that limit current immunotherapies.
The cross-study consistency of these immune signatures across difficult-to-treat cancers like pancreatic ductal adenocarcinoma and HR+/HER2- breast cancer provides strong validation of pelareorep's platform potential. The correlation between TIL clone expansion and tumor size reduction represents a critical translational link between mechanism and clinical benefit.
With enrollment continuing in the GOBLET study and additional translational data expected next year, Oncolytics is positioning pelareorep for registration-enabling trials. The upcoming clinical timeline update in Q3 will be crucial for understanding the regulatory pathway and potential time to market for this promising immunotherapeutic.
Integrated biomarker analyses confirm viral replication, interferon signaling, and a surge in tumor-infiltrating lymphocytes after pelareorep treatment
Cross-study data show pelareorep increases PD-L1 expression and boosts cytotoxic T-cell activity, priming resistant tumors for checkpoint inhibitors
Results reinforce pelareorep's ability to turn cold tumors hot, paving the way for registration-enabling trials
The translational research included the analysis of blood and tumor samples from patients in the GOBLET (pancreatic ductal adenocarcinoma (PDAC) and other gastrointestinal cancers) and AWARE-1 (breast cancer) studies. Analyses revealed consistent immune activation signatures, including:
- Upregulation of interferons, CXCL9/10/11, and PD-L1
- Conversion of immunologically 'cold' tumors into 'hot' phenotypes
- Expansion and mobilization of tumor-infiltrating lymphocyte (TIL) clones in the blood, which correlates with a reduction in tumor size
- Modulation of the tumor microenvironment (TME) to enhance responsiveness to immune therapies
"This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep."
"The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, Chief Executive Officer of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs."
The GOBLET study continues to enroll PDAC and anal carcinoma patients, and additional translational data readouts are expected next year. The Company expects these and its other clinical data to support its focused and aggressive regulatory path and serve as the biological foundation for registration-enabled studies in immunotherapy-resistant solid tumors. As regulatory conversations progress throughout the summer, the Company expects to provide an updated clinical timeline before the end of the third quarter.
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 more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
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, objectives and strategies; our expectation that our data supports our focused and aggressive regulatory path and serves as the biological foundation for registration-enabled studies in immunotherapy-resistant solid tumors; our plans to advance pelareorep into registration enabling studies in metastatic breast cancer and pancreatic cancer; 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
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