Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer
Oncolytics Biotech (NASDAQ: ONCY) reports significant progress in its clinical programs for pelareorep immunotherapy in 2025. The German Paul-Ehrlich-Institute has approved full enrollment for the pancreatic cancer trial (GOBLET Cohort 5) following positive safety review, allowing the study to proceed with 30 patients across two treatment arms.
At ASCO GI 2025, the company presented promising clinical results 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, with or without atezolizumab.
The company anticipates additional data readouts from ongoing gastrointestinal cancer trials and regulatory interactions that could accelerate future trials toward registration-enabling studies in breast cancer and gastrointestinal cancers.
Oncolytics Biotech (NASDAQ: ONCY) riporta progressi significativi nei suoi programmi clinici per l'immunoterapia con pelareorep nel 2025. L'Istituto Paul-Ehrlich tedesco ha approvato l'arruolamento completo per lo studio sul cancro pancreatico (Cohort 5 GOBLET) dopo una revisione positiva della sicurezza, consentendo allo studio di procedere con 30 pazienti suddivisi in due gruppi di trattamento.
Durante l'ASCO GI 2025, l'azienda ha presentato risultati clinici promettenti sia per i tumori anali che per quelli pancreatici. I pazienti con cancro anale che ricevevano pelareorep insieme ad atezolizumab hanno mostrato risposte migliorate rispetto ai dati storici degli inibitori del checkpoint. Nel cancro pancreatico, pelareorep ha dimostrato una sicurezza favorevole quando combinato con FOLFIRINOX modificato, con o senza atezolizumab.
L'azienda prevede ulteriori letture di dati da studi clinici in corso sui tumori gastrointestinali e interazioni regolatorie che potrebbero accelerare i futuri studi verso studi abilitanti alla registrazione per il cancro al seno e i tumori gastrointestinali.
Oncolytics Biotech (NASDAQ: ONCY) informa sobre un progreso significativo en sus programas clínicos para la inmunoterapia con pelareorep en 2025. El Instituto Paul-Ehrlich de Alemania ha aprobado el reclutamiento completo para el ensayo de cáncer de páncreas (Cohorte 5 GOBLET) tras una revisión positiva de seguridad, permitiendo que el estudio continúe con 30 pacientes en dos grupos de tratamiento.
En ASCO GI 2025, la compañía presentó resultados clínicos prometedores tanto en cáncer anal como pancreático. Los pacientes con cáncer anal que recibieron pelareorep junto con atezolizumab mostraron respuestas mejoradas en comparación con los datos históricos de inhibidores de checkpoint. En el cáncer de páncreas, pelareorep demostró una seguridad favorable cuando se combinó con FOLFIRINOX modificado, con o sin atezolizumab.
La compañía anticipa lecturas adicionales de datos de ensayos en curso sobre cáncer gastrointestinal e interacciones regulatorias que podrían acelerar futuros ensayos hacia estudios habilitantes para la inscripción en cáncer de mama y cánceres gastrointestinales.
온콜리틱스 바이오텍 (NASDAQ: ONCY)는 2025년 펠라레오렙 면역요법의 임상 프로그램에서 중요한 진전을 보고했습니다. 독일의 파울 에를리히 연구소는 안전성 검토 후 췌장암 시험(GOBLET 코호트 5)의 전체 등록을 승인하여 연구가 두 개의 치료 그룹에서 30명의 환자를 대상으로 진행될 수 있도록 했습니다.
ASCO GI 2025에서 회사는 항문암과 췌장암 모두에서 유망한 임상 결과를 발표했습니다. 펠라레오렙과 아테졸리주맙을 함께 받은 항문암 환자들은 역사적인 체크포인트 억제제 데이터에 비해 향상된 반응을 보였습니다. 췌장암에서 펠라레오렙은 수정된 FOLFIRINOX와 함께 사용했을 때(아테졸리주맙 포함 또는 제외) 유리한 안전성을 보였습니다.
회사는 진행 중인 위장관 암 연구와 향후 유방암 및 위장관 암에 대한 등록 지원 연구로의 임상 시험을 가속화할 수 있는 규제 상호작용에 대한 추가 데이터 발표를 예상하고 있습니다.
Oncolytics Biotech (NASDAQ: ONCY) fait état de progrès significatifs dans ses programmes cliniques pour l'immunothérapie à base de pelareorep en 2025. L'Institut Paul-Ehrlich en Allemagne a approuvé l'inscription complète pour l'essai sur le cancer du pancréas (Cohorte 5 GOBLET) suite à une évaluation positive de la sécurité, permettant à l'étude de se poursuivre avec 30 patients répartis sur deux groupes de traitement.
Lors de l'ASCO GI 2025, la société a présenté des résultats cliniques prometteurs tant pour les cancers anaux que pour les cancers 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 point de contrôle. Dans le cancer du pancréas, pelareorep a démontré une sécurité favorable lorsqu'il est combiné avec FOLFIRINOX modifié, avec ou sans atezolizumab.
La société anticipe d'autres résultats de données provenant d'essais en cours sur les cancers gastro-intestinaux et des interactions réglementaires qui pourraient accélérer les futurs essais vers des études permettant l'enregistrement dans le cancer du sein et les cancers gastro-intestinaux.
Oncolytics Biotech (NASDAQ: ONCY) berichtet über erhebliche Fortschritte in seinen klinischen Programmen zur Immuntherapie mit Pelareorep im Jahr 2025. Das Paul-Ehrlich-Institut in Deutschland hat die vollständige Rekrutierung für die Studie zu Bauchspeicheldrüsenkrebs (GOBLET Kohorte 5) nach einer positiven Sicherheitsbewertung genehmigt, sodass die Studie mit 30 Patienten in zwei Behandlungsarmen fortgesetzt werden kann.
Auf dem ASCO GI 2025 präsentierte das Unternehmen vielversprechende klinische Ergebnisse sowohl bei Anal- als auch bei Bauchspeicheldrüsenkrebs. Patienten mit Analkrebs, die Pelareorep zusammen mit Atezolizumab erhielten, zeigten im Vergleich zu historischen Daten von Checkpoint-Inhibitoren verbesserte Reaktionen. Bei Bauchspeicheldrüsenkrebs zeigte Pelareorep eine günstige Sicherheit in Kombination mit modifiziertem FOLFIRINOX, mit oder ohne Atezolizumab.
Das Unternehmen erwartet zusätzliche Datenfreigaben aus laufenden klinischen Studien zu gastrointestinalen Krebserkrankungen sowie regulatorische Interaktionen, die zukünftige Studien in Richtung registrierungsfähiger Studien zu Brustkrebs und gastrointestinalen Krebserkrankungen beschleunigen könnten.
- Regulatory approval to proceed with full enrollment in pancreatic cancer trial
- Strong efficacy signals in anal cancer patients with pelareorep + atezolizumab combination
- Favorable safety profile demonstrated in pancreatic cancer with modified FOLFIRINOX combination
- None.
Insights
The recent developments for Oncolytics Biotech represent significant progress in de-risking their lead candidate pelareorep across multiple cancer indications. The German regulatory clearance for the pancreatic cancer trial is particularly noteworthy as it validates the safety profile of pelareorep in combination with standard-of-care treatments. This is important for a small-cap biotech company, as safety concerns often derail promising candidates in late-stage development.
The data presented at ASCO GI 2025 carries substantial weight for two reasons: First, the improved responses in anal cancer compared to historical checkpoint inhibitor data suggest pelareorep could potentially become a valuable addition to the current treatment paradigm. Second, the favorable safety profile in combination with different chemotherapy regimens in pancreatic cancer significantly expands the potential market opportunity, as it provides flexibility in treatment combinations.
The pancreatic cancer market represents a significant commercial opportunity, with a global market size expected to exceed
Looking ahead, several value-driving catalysts are on the horizon, including:
- Initial efficacy readout from the pancreatic cancer trial later this year
- Additional translational data that could further validate pelareorep's mechanism of action
- Potential advancement toward registration-enabling studies in breast cancer
The company's progress in demonstrating efficacy across multiple tumor types strengthens the biological rationale for pelareorep and could attract partnership interest from larger pharmaceutical companies, particularly given the growing focus on immunotherapy combinations in oncology.
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
View original content to download multimedia:https://www.prnewswire.com/news-releases/oncolytics-biotech-strengthens-its-pipeline-in-2025-with-key-pancreatic-and-anal-cancer-advances-in-addition-to-metastatic-breast-cancer-302378414.html
SOURCE Oncolytics Biotech® Inc.
FAQ
What did the German regulatory agency approve for ONCY's pancreatic cancer trial in 2025?
What were the key findings for ONCY's pelareorep in anal cancer at ASCO GI 2025?
What treatment combinations is ONCY testing with pelareorep in pancreatic cancer?
What major milestones does ONCY expect for pelareorep in 2025?
