Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer
Oncolytics Biotech (NASDAQ: ONCY) has reported significant progress in its clinical programs for pelareorep in early 2025. The company received regulatory clearance from Germany's Paul-Ehrlich-Institute to advance enrollment in its pancreatic cancer study (GOBLET Cohort 5), which will include 30 patients testing pelareorep with modified FOLFIRINOX with and without atezolizumab.
At the 2025 ASCO Gastrointestinal Cancers Symposium, the company presented promising data in both anal and pancreatic cancers. Anal cancer patients receiving pelareorep with atezolizumab showed enhanced responses compared to historical checkpoint inhibitor data. In pancreatic cancer, pelareorep demonstrated favorable safety when combined with modified FOLFIRINOX.
The company expects additional data readouts from ongoing gastrointestinal cancer trials and regulatory interactions that could accelerate future trials in breast cancer and gastrointestinal cancers.
Oncolytics Biotech (NASDAQ: ONCY) ha riportato progressi significativi nei suoi programmi clinici per pelareorep all'inizio del 2025. L'azienda ha ricevuto l'autorizzazione normativa dall'Istituto Paul-Ehrlich della Germania per avanzare nell'arruolamento del suo studio sul cancro pancreatico (GOBLET Cohort 5), che includerà 30 pazienti in trattamento con pelareorep in combinazione con FOLFIRINOX modificato, con e senza atezolizumab.
Al Simposio ASCO 2025 sui Tumori Gastrointestinali, l'azienda ha presentato dati promettenti sia per i tumori anali che per quelli pancreatici. I pazienti con cancro anale trattati con pelareorep e atezolizumab hanno mostrato risposte potenziate rispetto ai dati storici degli inibitori dei checkpoint. Nel cancro pancreatico, pelareorep ha dimostrato un profilo di sicurezza favorevole quando combinato con FOLFIRINOX modificato.
L'azienda si aspetta ulteriori risultati dai trial in corso sui tumori gastrointestinali e interazioni normative che potrebbero accelerare futuri trial sul cancro al seno e sui tumori gastrointestinali.
Oncolytics Biotech (NASDAQ: ONCY) ha reportado avances significativos en sus programas clínicos para pelareorep a principios de 2025. La compañía recibió la autorización regulatoria del Instituto Paul-Ehrlich de Alemania para avanzar en la inscripción de su estudio sobre cáncer de páncreas (Cohorte GOBLET 5), que incluirá a 30 pacientes que probarán pelareorep con FOLFIRINOX modificado, con y sin atezolizumab.
En el Simposio de Cáncer Gastrointestinal ASCO 2025, la compañía presentó datos prometedores tanto en cáncer anal como pancreático. Los pacientes con cáncer anal que recibieron pelareorep con atezolizumab mostraron respuestas mejoradas en comparación con los datos históricos de inhibidores de puntos de control. En el cáncer de páncreas, pelareorep demostró una seguridad favorable cuando se combinó con FOLFIRINOX modificado.
La compañía espera resultados adicionales de los ensayos en curso sobre cáncer gastrointestinal e interacciones regulatorias que podrían acelerar futuros ensayos en cáncer de mama y cáncer gastrointestinal.
온콜리틱스 바이오텍 (NASDAQ: ONCY)은 2025년 초에 pelareorep의 임상 프로그램에서 중요한 진전을 보고했습니다. 이 회사는 독일의 파울 에를리히 연구소로부터 췌장암 연구(GOBLET Cohort 5)에 대한 환자 등록을 진행할 수 있는 규제 승인을 받았습니다. 이 연구에는 pelareorep와 수정된 FOLFIRINOX를 사용하여 총 30명의 환자가 포함될 예정입니다. atezolizumab 사용 여부에 따라 다릅니다.
2025 ASCO 위장관 암 심포지엄에서 이 회사는 항문암과 췌장암 모두에서 유망한 데이터를 발표했습니다. atezolizumab와 함께 pelareorep를 받은 항문암 환자는 역사적인 체크포인트 억제제 데이터에 비해 향상된 반응을 보였습니다. 췌장암의 경우, pelareorep는 수정된 FOLFIRINOX와 병용했을 때 우수한 안전성을 보여주었습니다.
회사는 진행 중인 위장관 암 임상 시험과 규제 상호작용에서 추가적인 데이터 결과를 기대하고 있으며, 이는 유방암 및 위장관 암에 대한 향후 임상 시험을 가속화할 수 있습니다.
Oncolytics Biotech (NASDAQ: ONCY) a rapporté des progrès significatifs dans ses programmes cliniques pour pelareorep début 2025. L'entreprise a reçu l'autorisation réglementaire de l'Institut Paul-Ehrlich d'Allemagne pour avancer dans l'inscription de son étude sur le cancer du pancréas (Cohorte GOBLET 5), qui comprendra 30 patients testant pelareorep avec FOLFIRINOX modifié, avec et sans atezolizumab.
Lors du Symposium ASCO 2025 sur les cancers gastro-intestinaux, l'entreprise a présenté des données prometteuses tant pour le cancer anal que pour le cancer du pancréas. Les patients atteints de cancer anal recevant pelareorep avec atezolizumab ont montré des réponses améliorées par rapport aux données historiques des inhibiteurs de points de contrôle. Dans le cancer du pancréas, pelareorep a démontré une sécurité favorable lorsqu'il est combiné avec FOLFIRINOX modifié.
L'entreprise s'attend à des résultats supplémentaires des essais cliniques en cours sur les cancers gastro-intestinaux et à des interactions réglementaires qui pourraient accélérer de futurs essais sur le cancer du sein et les cancers gastro-intestinaux.
Oncolytics Biotech (NASDAQ: ONCY) hat bedeutende Fortschritte in seinen klinischen Programmen für pelareorep zu Beginn des Jahres 2025 berichtet. Das Unternehmen erhielt die regulatorische Genehmigung vom Paul-Ehrlich-Institut in Deutschland, um die Einschreibung in seine Studie über Bauchspeicheldrüsenkrebs (GOBLET Kohorte 5) voranzutreiben, die 30 Patienten umfassen wird, die pelareorep in Kombination mit modifiziertem FOLFIRINOX mit und ohne Atezolizumab testen.
Auf dem ASCO 2025 Symposium für gastrointestinalen Krebs präsentierte das Unternehmen vielversprechende Daten sowohl zu analem als auch zu Bauchspeicheldrüsenkrebs. Patienten mit Analkrebs, die pelareorep zusammen mit Atezolizumab erhielten, zeigten verbesserte Reaktionen im Vergleich zu historischen Daten zu Checkpoint-Inhibitoren. Bei Bauchspeicheldrüsenkrebs zeigte pelareorep eine günstige Sicherheit in Kombination mit modifiziertem FOLFIRINOX.
Das Unternehmen erwartet weitere Datenausgaben aus laufenden klinischen Studien zu gastrointestinalem Krebs sowie regulatorische Interaktionen, die zukünftige Studien zu Brustkrebs und gastrointestinalem Krebs beschleunigen könnten.
- Received regulatory approval to advance pancreatic cancer trial enrollment
- Demonstrated enhanced response rates in anal cancer patients compared to historical data
- Showed favorable safety profile in pancreatic cancer with new chemotherapy combination
- Multiple data readouts expected throughout 2025
- None.
Insights
The latest developments for Oncolytics Biotech represent significant progress in expanding pelareorep's therapeutic potential across multiple high-value oncology indications. The regulatory clearance from Germany's Paul-Ehrlich-Institute is particularly noteworthy as it validates the safety profile of pelareorep in combination with modified FOLFIRINOX, a standard-of-care chemotherapy regimen in pancreatic cancer.
The multi-indication strategy being pursued is strategically sound. Pancreatic cancer represents a $4.2 billion market with treatment options and poor survival rates, while anal cancer, though rare, has shown promising responses to pelareorep combined with checkpoint inhibitors. This dual-track approach in gastrointestinal cancers, alongside the ongoing breast cancer program, significantly reduces development risk through indication diversification.
The safety profile demonstrated across multiple combination regimens is crucial, as it:
- Enables potential combination with various standard-of-care treatments
- Reduces development risk in future trials
- Increases the likelihood of regulatory approval
- Expands potential market opportunities
The upcoming efficacy readout for the pancreatic cancer trial later this year could serve as a significant catalyst. Historical data shows that positive early-stage results in pancreatic cancer often lead to accelerated development pathways due to the high unmet medical need. The potential for registration-enabling studies in both breast and gastrointestinal cancers suggests a well-planned clinical development strategy that could lead to multiple market opportunities.
Recent clinical data presentations in these two hard-to-treat GI cancers, coupled with strong efficacy signals in breast cancer, demonstrate the potential of pelareorep across very different tumor types
"We're hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "With positive feedback from regulators in place, we're advancing our pancreatic cancer study toward full enrollment, and our ASCO GI presentations highlighted pelareorep's strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025."
German Regulatory Agency Gives Green Light for Pancreatic Cancer Study to Continue as Planned
- Approval to Fully Enroll the Cohort Secured:
Germany's Paul-Ehrlich-Institute (PEI) has given Oncolytics the go-ahead to continue enrolling patients in its pancreatic cancer trial (GOBLET Cohort 5) after a positive safety review. - What This Means: Pelareorep, in combination with modified FOLFIRINOX with and without atezolizumab, is now progressing toward full enrollment, with 30 patients set to participate in Stage 1 across the two treatment arms.
- Next Steps: Oncolytics will continue to collect safety data, and an initial efficacy readout is expected later this year.
ASCO GI 2025 Data Confirms Pelareorep's Potential in Pancreatic and Anal Cancers
At ASCO GI 2025, Oncolytics presented new clinical results demonstrating pelareorep's potential in two challenging cancer types:
- Anal Cancer: Patients receiving pelareorep + atezolizumab continue to show stronger responses than expected based on published studies with checkpoint inhibitors alone.
- Pancreatic Cancer: Pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel, and atezolizumab. The most recent data supports a favorable safety profile when combining pelareorep with a different chemotherapy regimen (modified FOLFIRINOX) with and without the checkpoint inhibitor atezolizumab, potentially expanding its treatment applications.
Why This Matters: These findings further de-risk pelareorep's development and could pave the way for larger registration-enabling clinical trials in these indications.
Looking Ahead: More Catalysts in 2025
Oncolytics is entering a pivotal year with multiple upcoming milestones, including:
- Additional data readouts from ongoing trials in gastrointestinal cancers, including translational results that further characterize pelareorep's mechanism of action.
- Interactions with Regulatory Agencies that could accelerate future trials and move pelareorep closer to potential registration-enabling studies in breast cancer and gastrointestinal cancers.
"We're seeing clinical validation across multiple studies," added Pisano. "With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in GOBLET, BRACELET-1, and numerous previous studies, pelareorep has a favorable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers."
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
About GOBLET Cohort 5
The modified FOLFIRINOX (mFOLFIRINOX) cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic pancreatic ductal adenocarcinoma 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 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 prepares for 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.
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 to advance our pancreatic cancer study toward full enrollment; our focus on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025; our plans to continue to collect safety data; the anticipated timing of an initial efficacy readout; our belief that our new clinical results in anal and pancreatic cancer further de-risk pelareorep's development and could pave the way for larger registration-enabling clinical trials in these indications; our upcoming milestones, including additional data readouts and interactions with regulatory agencies; 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
Jon Patton
Director of IR & Communication
jpatton@oncolytics.ca
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
tim@lifesciadvisors.com
Media Contact for Oncolytics
Michael Rubenstein
LifeSci Communications
mrubenstein@lifescicomms.com
Logo - https://mma.prnewswire.com/media/2408622/5171389/Oncolytics_Biotech_Inc_Logo.jpg
SOURCE Oncolytics Biotech® Inc.
FAQ
What was the key regulatory approval ONCY received for its pancreatic cancer trial in 2025?
How many patients will be enrolled in ONCY's GOBLET Cohort 5 pancreatic cancer trial?
What were the key findings for ONCY's pelareorep in anal cancer at ASCO GI 2025?
What new combination therapy showed favorable safety results for ONCY's pelareorep in pancreatic cancer?
What major catalysts does ONCY expect for pelareorep in 2025?
