Oncolytics Biotech® Begins Pelareorep/FOLFIRINOX Therapy Study in Pancreatic Cancer Patients

Oncolytics Biotech Inc. has initiated the dosing of patients in a new cohort of its GOBLET study, evaluating a combination therapy of pelareorep and modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab, for newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). The study is funded by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN) and aims to assess the treatment's objective response rate (ORR) and safety.

The GOBLET study, managed by AIO-Studien-gGmbH in Germany, is a Phase 1/2 trial exploring pelareorep-based combinations in gastrointestinal cancers. Oncolytics Biotech, a clinical-stage company focusing on immunotherapeutics, is optimistic about this trial's potential to provide new treatment options for pancreatic cancer patients. Dr. Thomas Heineman, Chief Medical Officer at Oncolytics, emphasized the importance of this milestone, noting that previous studies showed promising results with pelareorep combinations, leading to Fast Track Designation from the FDA.

The new cohort will evaluate the efficacy and safety of pelareorep combined with mFOLFIRINOX, both with and without atezolizumab. The study will initially involve a three-patient safety run-in phase followed by a larger trial group if initial criteria are met. The objective is to determine whether this combination can improve outcomes for PDAC patients, potentially leading to its registration as a new treatment regimen.

Anna Berkenblit, Chief Scientific and Medical Officer at PanCAN, highlighted the Therapeutic Accelerator Award's role in expediting the drug development process. Dosing the first patient in this new cohort marks a significant step toward evaluating this innovative immunotherapeutic approach.

Dr. Dirk Arnold, primary investigator of the GOBLET trial, expressed his satisfaction with the clinical response data observed in previous cohorts, particularly in pancreatic and anal cancer. He noted that mFOLFIRINOX is regarded as an effective treatment option for many pancreatic cancer patients, and the combination with pelareorep could expand the number of patients who may benefit from this therapy.

Oncolytics Biotech is strategically positioned to advance multiple pelareorep programs towards registration studies. The company is collaborating with the Global Coalition for Adaptive Research (GCAR) on a registration-enabling study for pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel. Additionally, Oncolytics is in discussions with the FDA regarding their breast cancer program and has expanded enrollment in the GOBLET anal cancer cohort.

Dr. Matt Coffey, President and CEO of Oncolytics, emphasized the company's commitment to improving the lives of cancer patients. He noted that the initiation of dosing in the mFOLFIRINOX cohort of GOBLET represents another step towards achieving this goal.

The GOBLET study involves five treatment groups, including pelareorep in combination with various drugs for different types of advanced or metastatic gastrointestinal tumors. Any cohort meeting the pre-specified efficacy criteria in Stage 1 may advance to Stage 2, enrolling additional patients to further evaluate the treatment's effectiveness.

Oncolytics Biotech, known for its development of pelareorep, continues to make strides in cancer immunotherapy. Pelareorep has shown synergy with multiple approved oncology treatments and is currently undergoing various combination clinical trials. The company's efforts are geared towards achieving registration for pelareorep in treating metastatic breast cancer and pancreatic cancer, both of which have received FDA Fast Track designation.