Oncolytics Biotech® to Present New Clinical Trial Data at ASCO Showing Pelareorep's Unique Immune Activation Capabilities
Oncolytics Biotech (NASDAQ: ONCY) presented new data from its Phase I/II GOBLET clinical trial at the 2025 ASCO Annual Meeting, demonstrating the effectiveness of its immunotherapy drug pelareorep in treating pancreatic ductal adenocarcinoma (PDAC). The study revealed pelareorep's mechanism of action, showing how it stimulates multiple immune responses and converts immunologically cold tumors into active ones.
Key findings include pelareorep's ability to expand reovirus-specific T cells and increase cytokines and chemokines that enable anti-tumor immune responses. The GOBLET Cohort 1 trial, which evaluated pelareorep in combination with nab-paclitaxel, gemcitabine, and atezolizumab, demonstrated impressive results with a 62% overall response rate, 85% disease control rate, and 45% 12-month survival rate in first-line metastatic PDAC patients.
Oncolytics Biotech (NASDAQ: ONCY) ha presentato nuovi dati dal suo trial clinico di Fase I/II GOBLET durante l'ASCO Annual Meeting 2025, dimostrando l'efficacia del suo farmaco immunoterapico pelareorep nel trattamento dell'adenocarcinoma duttale pancreatico (PDAC). Lo studio ha rivelato il meccanismo d'azione di pelareorep, mostrando come stimoli molteplici risposte immunitarie e trasformi tumori immunologicamente freddi in tumori attivi.
I risultati chiave includono la capacità di pelareorep di espandere le cellule T specifiche per il reovirus e aumentare citochine e chemochine che favoriscono risposte immunitarie antitumorali. Il trial GOBLET Cohort 1, che ha valutato pelareorep in combinazione con nab-paclitaxel, gemcitabina e atezolizumab, ha mostrato risultati impressionanti con un tasso di risposta globale del 62%, un tasso di controllo della malattia dell'85% e un tasso di sopravvivenza a 12 mesi del 45% nei pazienti con PDAC metastatico in prima linea.
Oncolytics Biotech (NASDAQ: ONCY) presentó nuevos datos de su ensayo clínico de Fase I/II GOBLET en la Reunión Anual ASCO 2025, demostrando la eficacia de su fármaco de inmunoterapia pelareorep para tratar el adenocarcinoma ductal pancreático (PDAC). El estudio reveló el mecanismo de acción de pelareorep, mostrando cómo estimula múltiples respuestas inmunitarias y convierte tumores inmunológicamente fríos en activos.
Los hallazgos clave incluyen la capacidad de pelareorep para expandir las células T específicas del reovirus y aumentar las citocinas y quimioquinas que permiten respuestas inmunitarias antitumorales. El ensayo GOBLET Cohorte 1, que evaluó pelareorep en combinación con nab-paclitaxel, gemcitabina y atezolizumab, mostró resultados impresionantes con una tasa de respuesta global del 62%, una tasa de control de la enfermedad del 85% y una tasa de supervivencia a 12 meses del 45% en pacientes con PDAC metastásico en primera línea.
Oncolytics Biotech (NASDAQ: ONCY)는 2025년 ASCO 연례회의에서 1/2상 GOBLET 임상시험의 새로운 데이터를 발표하며, 췌관선암(PDAC) 치료에 있어 면역치료제 pelareorep의 효과를 입증했습니다. 연구는 pelareorep의 작용 기전을 밝혀내어, 여러 면역 반응을 자극하고 면역학적으로 냉담한 종양을 활성 종양으로 전환시키는 과정을 보여주었습니다.
주요 결과로는 pelareorep가 리오바이러스 특이 T세포를 확장시키고, 항종양 면역 반응을 가능하게 하는 사이토카인과 케모카인을 증가시키는 능력이 포함됩니다. nab-paclitaxel, gemcitabine, atezolizumab과 병용한 GOBLET 1군 시험은 1차 전이성 PDAC 환자에서 전체 반응률 62%, 질병 조절률 85%, 12개월 생존율 45%라는 인상적인 결과를 보여주었습니다.
Oncolytics Biotech (NASDAQ : ONCY) a présenté de nouvelles données issues de son essai clinique de phase I/II GOBLET lors du congrès annuel ASCO 2025, démontrant l'efficacité de son médicament d'immunothérapie pelareorep dans le traitement de l'adénocarcinome canalaire pancréatique (PDAC). L'étude a révélé le mécanisme d'action de pelareorep, montrant comment il stimule plusieurs réponses immunitaires et transforme les tumeurs immunologiquement froides en tumeurs actives.
Les résultats clés incluent la capacité de pelareorep à augmenter les cellules T spécifiques au réovirus ainsi que les cytokines et chimiokines favorisant les réponses immunitaires antitumorales. L'essai GOBLET Cohorte 1, qui a évalué pelareorep en combinaison avec le nab-paclitaxel, la gemcitabine et l'atezolizumab, a démontré des résultats impressionnants avec un taux de réponse globale de 62 %, un taux de contrôle de la maladie de 85 % et un taux de survie à 12 mois de 45 % chez des patients atteints de PDAC métastatique en première ligne.
Oncolytics Biotech (NASDAQ: ONCY) präsentierte neue Daten aus der Phase-I/II-Studie GOBLET auf dem ASCO-Jahrestreffen 2025, die die Wirksamkeit seines Immuntherapie-Medikaments pelareorep bei der Behandlung des duktalen Adenokarzinoms der Bauchspeicheldrüse (PDAC) zeigen. Die Studie enthüllte den Wirkmechanismus von pelareorep und zeigte, wie es mehrere Immunantworten stimuliert und immunologisch kalte Tumoren in aktive umwandelt.
Wichtige Erkenntnisse umfassen die Fähigkeit von pelareorep, reovirus-spezifische T-Zellen zu erweitern und Zytokine sowie Chemokine zu erhöhen, die antitumorale Immunantworten ermöglichen. Die GOBLET Kohorte 1 Studie, die pelareorep in Kombination mit nab-Paclitaxel, Gemcitabin und Atezolizumab bewertete, zeigte beeindruckende Ergebnisse mit einer Gesamtansprechrate von 62%, einer Erkrankungskontrollrate von 85% und einer 12-Monats-Überlebensrate von 45% bei Patienten mit metastasiertem PDAC in der Erstlinie.
- Strong clinical results with 62% overall response rate and 85% disease control rate in PDAC patients
- Successful demonstration of pelareorep's mechanism of action in converting cold tumors to immunologically active ones
- 45% 12-month survival rate in first-line metastatic PDAC patients
- None.
Insights
Pelareorep shows promising immune activation in pancreatic cancer, with 62% response rate and novel mechanism converting "cold" tumors to immunologically active.
The new clinical data presented at ASCO for Oncolytics Biotech's pelareorep represents a potentially significant advancement in pancreatic cancer treatment, one of the most challenging and lethal cancer types. The reported 62% overall response rate in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients is particularly noteworthy when compared to historical response rates for standard treatments, which typically hover around 20-30%.
What's mechanistically innovative is pelareorep's demonstrated ability to transform immunologically "cold" tumors (which typically don't respond well to immunotherapy) into "hot" ones. The data reveals a multi-step immune activation process: first expanding anti-reovirus T cells, then upregulating chemokines that mediate expansion of tumor-infiltrating lymphocyte (TIL) clones, which subsequently attack the tumor. This represents a potential solution to one of immunotherapy's greatest challenges in solid tumors - getting immune cells to effectively penetrate and attack the cancer.
The 85% disease control rate and 45% 12-month survival rate from the GOBLET Cohort 1 provide encouraging efficacy signals. While these are early-phase results from a relatively small cohort, they suggest pelareorep's combination with standard chemotherapy (nab-paclitaxel, gemcitabine) plus atezolizumab could potentially improve outcomes in a disease with historically poor prognosis.
The identification of blood-based TIL clones as potential biomarkers for response is also clinically valuable, potentially allowing for patient selection and response monitoring through minimally invasive blood sampling rather than tumor biopsies.
Pelareorep initiates a pro-inflammatory tumor microenvironment (TME) and induces innate and adaptive immune responses
New analyses confirm that pelareorep primes the TME to allow circulating tumor-infiltrating lymphocytes (TILs) in the blood to attack tumors
Pre-existing TIL clones in plasma may correlate positively with tumor shrinkage in pancreatic cancer
"For the first time, we're able to map the cascade of immune responses stimulated by pelareorep," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL clones in the blood. These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size. Pelareorep-mediated upregulation of chemokines also makes the tumor microenvironment immunologically active and able to actively recruit cancer-specific T cells to the tumor. These findings deepen our understanding of pelareorep's ability to convert immunologically cold tumors into immunologically active ones that may benefit from pelareorep-based combination therapy."
Abstract Number: 2562
Title: Role of pelareorep in activating anti-tumor immunity in PDAC.
Presentation Type: Poster
Session Title: Developmental Therapeutics – Immunotherapy
Session Date and Time: June 2, 2025, 1:30 - 4:30 p.m. CT
A copy of the ASCO presentation will be available on the Media page of Oncolytics' website (LINK) following the conclusion of the meeting.
Highlights from the poster and abstract include:
- Pelareorep initiates the expansion of reovirus-specific T cells that are associated with favorable clinical responses at week 24
- Pelareorep increases cytokines and chemokines associated with altering the TME to allow anti-viral and anti-tumor T cells to attack the tumor
- The presence of TIL clones in the blood before treatment and the expansion of these clones in the blood post-treatment are associated with favorable clinical responses
- Previously reported efficacy results from GOBLET Cohort 1, which is evaluating the therapeutic regimen of pelareorep, nab-paclitaxel, gemcitabine, and atezolizumab (Tecentriq®) in first-line metastatic PDAC patients, showed a
62% overall response rate, an85% disease control rate, and a45% 12-month survival rate
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 pancreatic cancer 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 advanced and unresectable anal cancer patients; and
- Pelareorep in combination with modified FOLFIRINOX 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 more about Oncolytics, 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; 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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