Oncolytics Biotech® Advances Key Pancreatic and Anal Cancer Trials, Strengthening Pipeline in 2025
Oncolytics Biotech (NASDAQ: ONCY) has achieved significant progress in its cancer immunotherapy development program in 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 clinical data for pelareorep in both anal and pancreatic cancers. Anal cancer patients showed stronger responses to pelareorep plus atezolizumab compared to historical checkpoint inhibitor data. In pancreatic cancer, pelareorep demonstrated favorable safety when combined with modified FOLFIRINOX.
The company anticipates additional data readouts from ongoing gastrointestinal cancer trials and regulatory interactions that could accelerate future trials, particularly in breast cancer and gastrointestinal cancers.
Oncolytics Biotech (NASDAQ: ONCY) ha fatto progressi significativi nel suo programma di sviluppo dell'immunoterapia contro il cancro nel 2025. L'azienda ha ricevuto l'approvazione regolatoria dall'Istituto Paul-Ehrlich della Germania per avanzare l'arruolamento nel suo studio sul cancro pancreatico (Cohorte GOBLET 5), che includerà 30 pazienti in trattamento con pelareorep e FOLFIRINOX modificato, con e senza atezolizumab.
Durante il 2025 ASCO Gastrointestinal Cancers Symposium, l'azienda ha presentato dati clinici promettenti per pelareorep sia nel cancro anale che in quello pancreatico. I pazienti con cancro anale hanno mostrato risposte più forti a pelareorep più atezolizumab rispetto ai dati storici degli inibitori del checkpoint. Nel cancro pancreatico, pelareorep ha dimostrato un buon profilo di sicurezza quando combinato con FOLFIRINOX modificato.
L'azienda prevede ulteriori letture di dati da trial in corso sui tumori gastrointestinali e interazioni regolatorie che potrebbero accelerare i futuri trial, in particolare per il cancro al seno e i tumori gastrointestinali.
Oncolytics Biotech (NASDAQ: ONCY) ha logrado avances significativos en su programa de desarrollo de inmunoterapia contra el cáncer en 2025. La empresa recibió la aprobación regulatoria del Instituto Paul-Ehrlich de Alemania para avanzar en la inscripción de su estudio sobre el cáncer de páncreas (Cohorte GOBLET 5), que incluirá a 30 pacientes que recibirán pelareorep con FOLFIRINOX modificado con y sin atezolizumab.
En el Simposio de Cáncer Gastrointestinal ASCO 2025, la empresa presentó datos clínicos prometedores para pelareorep tanto en cáncer anal como pancreático. Los pacientes con cáncer anal mostraron respuestas más fuertes al pelareorep más atezolizumab en comparación con los datos históricos de los inhibidores de puntos de control. En el cáncer de páncreas, pelareorep demostró una seguridad favorable cuando se combinó con FOLFIRINOX modificado.
La empresa anticipa lecturas adicionales de datos de ensayos en curso sobre cáncer gastrointestinal e interacciones regulatorias que podrían acelerar futuros ensayos, particularmente en cáncer de mama y cánceres gastrointestinales.
온콜리틱스 바이오텍 (NASDAQ: ONCY)는 2025년 암 면역 요법 개발 프로그램에서 상당한 진전을 이루었습니다. 이 회사는 독일의 파울 에를리히 연구소로부터 췌장암 연구(GOBLET 코호트 5)에서 환자 등록을 진행할 수 있는 규제 승인을 받았습니다. 이 연구에는 pelareorep와 수정된 FOLFIRINOX를 사용하여 치료받는 30명의 환자가 포함됩니다.
2025 ASCO 위장관암 심포지엄에서 이 회사는 항문암과 췌장암 모두에 대한 pelareorep의 유망한 임상 데이터를 발표했습니다. 항문암 환자들은 역사적인 체크포인트 억제제 데이터에 비해 pelareorep와 atezolizumab의 병용 치료에 더 강한 반응을 보였습니다. 췌장암에서는 pelareorep가 수정된 FOLFIRINOX와 병용했을 때 우수한 안전성을 보였습니다.
회사는 진행 중인 위장관암 임상 시험과 향후 임상 시험을 가속화할 수 있는 규제 상호작용에 대한 추가 데이터 발표를 기대하고 있습니다. 특히 유방암 및 위장관암에 대한 것입니다.
Oncolytics Biotech (NASDAQ: ONCY) a réalisé des progrès significatifs dans son programme de développement d'immunothérapie contre le cancer en 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 le pelareorep avec FOLFIRINOX modifié avec et sans atezolizumab.
Lors du Symposium ASCO 2025 sur les cancers gastro-intestinaux, l'entreprise a présenté des données cliniques prometteuses pour le pelareorep dans les cancers anal et pancréatique. Les patients atteints de cancer anal ont montré des réponses plus fortes au pelareorep associé à l'atezolizumab par rapport aux données historiques des inhibiteurs de points de contrôle. Dans le cancer du pancréas, le pelareorep a démontré une sécurité favorable lorsqu'il est combiné avec le FOLFIRINOX modifié.
L'entreprise prévoit des lectures de données supplémentaires provenant d'essais en cours sur les cancers gastro-intestinaux et des interactions réglementaires qui pourraient accélérer les futurs essais, en particulier dans le cancer du sein et les cancers gastro-intestinaux.
Oncolytics Biotech (NASDAQ: ONCY) hat im Jahr 2025 bedeutende Fortschritte in seinem Entwicklungsprogramm für Krebsimmuntherapien erzielt. Das Unternehmen erhielt die regulatorische Genehmigung des Paul-Ehrlich-Instituts in Deutschland, um die Rekrutierung in seiner Studie über Bauchspeicheldrüsenkrebs (GOBLET Kohorte 5) voranzutreiben, die 30 Patienten umfasst, die pelareorep in Kombination mit modifiziertem FOLFIRINOX mit und ohne Atezolizumab testen werden.
Auf dem 2025 ASCO Gastrointestinal Cancers Symposium präsentierte das Unternehmen vielversprechende klinische Daten zu pelareorep bei sowohl Analkrebs als auch Bauchspeicheldrüsenkrebs. Patienten mit Analkrebs zeigten stärkere Reaktionen auf pelareorep plus Atezolizumab im Vergleich zu historischen Daten von Checkpoint-Inhibitoren. Bei Bauchspeicheldrüsenkrebs zeigte pelareorep eine günstige Sicherheit in Kombination mit modifiziertem FOLFIRINOX.
Das Unternehmen erwartet zusätzliche Daten aus laufenden klinischen Studien zu gastrointestinalen Krebserkrankungen und regulatorischen Interaktionen, die zukünftige Studien, insbesondere bei Brustkrebs und gastrointestinalen Krebserkrankungen, beschleunigen könnten.
- Received regulatory approval to advance pancreatic cancer trial enrollment
- Demonstrated stronger response rates in anal cancer compared to historical checkpoint inhibitor data
- Showed favorable safety profile in pancreatic cancer with new chemotherapy combination
- None.
Insights
The recent regulatory and clinical developments for Oncolytics Biotech represent significant progress in de-risking pelareorep's development program across multiple high-value indications. The German regulatory agency's approval to continue the pancreatic cancer trial is particularly noteworthy, as it validates the safety profile in combination with standard-of-care chemotherapy and checkpoint inhibitors. This regulatory milestone could accelerate the path to potential registration-enabling studies.
The clinical data presented at ASCO GI 2025 demonstrates pelareorep's versatility and potential efficacy across different gastrointestinal cancers. In pancreatic cancer, where the 5-year survival rate remains below
The multi-indication strategy across breast cancer and gastrointestinal cancers represents a sophisticated approach to value creation. By pursuing multiple indications with high unmet need, Oncolytics is building a robust pipeline that could support multiple approval opportunities. The favorable safety profile across different combination regimens suggests potential for broad clinical application, which could significantly expand the commercial opportunity.
The company's progression toward registration-enabling studies in breast cancer, coupled with the advancing gastrointestinal cancer programs, positions 2025 as a potentially transformative year. The upcoming efficacy readouts and regulatory interactions could provide multiple catalysts for value creation, particularly if they support advancement into pivotal trials.
Regulatory progress in pancreatic cancer and recent clinical data presentations in two hard-to-treat GI cancers, coupled with strong efficacy signals in breast cancer, highlight pelareorep's potential impact across a range of tumors
//Republication of press release issued February 18th 2025 due to news transmission coverage//
"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
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FAQ
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