Regulatory Approval Clears Path for Oncolytics Biotech® to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data

Rhea-AI Summary

Oncolytics Biotech (NASDAQ: ONCY) has received approval from Germany's Paul-Ehrlich-Institute to continue enrollment in Cohort 5 of the GOBLET study, which evaluates pelareorep combined with mFOLFIRINOX, with or without atezolizumab, for newly diagnosed pancreatic ductal adenocarcinoma patients.

The approval follows a positive safety review by the independent Data Safety Monitoring Board and allows for full enrollment of 30 patients in Stage 1. Early safety data will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium, with initial efficacy results expected in H2 2025.

The company reports encouraging tumor response rates from an earlier GOBLET cohort, suggesting pelareorep's potential to improve outcomes for metastatic pancreatic cancer patients. The current cohort explores a different chemotherapy combination to potentially benefit a broader patient population.

Positive

• Regulatory approval received to continue patient enrollment in GOBLET study Cohort 5
• Positive safety review from independent Data Safety Monitoring Board
• Early encouraging tumor response rates from previous GOBLET cohort

Negative

• None.

Insights

Medical Research Analyst

The PEI's approval for GOBLET study's Cohort 5 continuation represents a important milestone in pelareorep's development pathway. The combination of pelareorep with mFOLFIRINOX, with or without atezolizumab, targets first-line PDAC treatment - a significant market opportunity given pancreatic cancer's poor prognosis and treatment options.

The DSMB's positive safety review is particularly noteworthy as mFOLFIRINOX is already known for its challenging side effect profile. The ability to combine pelareorep safely with this regimen suggests a manageable therapeutic window. The 30-patient enrollment target for Stage 1 is appropriately sized for an early efficacy signal while managing development costs.

In simpler terms: Think of this like testing if a new ingredient (pelareorep) can be safely added to an existing recipe (chemotherapy) to make it work better. The safety reviewers gave a thumbs up and now they can test it in more patients.

Oncology Expert

The strategic selection of mFOLFIRINOX as the combination partner is particularly astute. mFOLFIRINOX is already considered the most effective first-line chemotherapy for PDAC patients with good performance status. By demonstrating compatibility with this backbone therapy, Oncolytics positions pelareorep to potentially enhance outcomes in the optimal treatment setting.

Building on previous GOBLET cohort data showing encouraging response rates, this expansion provides a critical opportunity to validate pelareorep's efficacy with a different chemotherapy combination. The inclusion of an atezolizumab arm also allows exploration of potential synergy between viral and checkpoint immunotherapies - a mechanism of particular interest in typically "cold" tumors like PDAC.

For non-experts: Pancreatic cancer is one of the hardest cancers to treat. This study combines a new immunotherapy approach with the current best chemotherapy to try to improve patient survival. The early safety results are promising enough to expand the trial.

New pancreatic cancer cohort moves forward with full enrollment of 30 patients in Stage 1

SAN DIEGO and CALGARY, AB, Jan. 15, 2025 /PRNewswire/ -- Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq^®) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients.

Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI's approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year.

"Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep's promise in this disease.  GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed."

About GOBLET Cohort 5 
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic PDAC 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 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 Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1. Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1^st line advanced/metastatic PDAC patients;
2. Pelareorep in combination with atezolizumab in 1^st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
3. Pelareorep in combination with atezolizumab and TAS-102 in 3^rd line metastatic colorectal cancer patients;
4. Pelareorep in combination with atezolizumab in 2^nd line or later advanced and unresectable anal cancer patients; and
5. Pelareorep in combination with mFOLFIRINOX 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 further information, 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; continued enrollment in the GOBLET study and the expansion thereof to additional participants; 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 U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

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

 

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SOURCE Oncolytics Biotech® Inc.

FAQ

What is the latest regulatory approval received by Oncolytics Biotech (ONCY) for their pancreatic cancer treatment?

Germany's Paul-Ehrlich-Institute (PEI) has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study, evaluating pelareorep with mFOLFIRINOX.

How many patients will be enrolled in Stage 1 of ONCY's GOBLET study Cohort 5?

The study will enroll 30 patients in Stage 1 of Cohort 5.

When will ONCY release the initial efficacy results for the GOBLET study Cohort 5?

Initial efficacy results are expected in the second half of 2025.

What combination therapy is being tested in ONCY's GOBLET study Cohort 5?

The study is testing pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®).

When will ONCY present the early safety data from the GOBLET study Cohort 5?

Early safety data will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium in January 2025.