- Oncolytics Biotech (TSX:ONC), a clinical-stage cancer immunotherapy stock, has received ethics and German regulatory approvals for a new GOBLET study pancreatic cancer cohort
- The cohort will evaluate pelareorep, Oncolytics’ flagship immunotherapeutic agent, in combination with modified Folfirinox, which is part of the current standard of care for pancreatic cancer
- Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent with promising results against breast cancer and pancreatic cancer
- Oncolytics Biotech stock has given back 25.11 per cent year-over-year and 32.23 per cent over the past five years
Oncolytics Biotech (TSX:ONC), a clinical-stage cancer immunotherapy stock, has received ethics and German regulatory approvals for a new GOBLET study pancreatic cancer cohort.
This latest instantiation of GOBLET – which stands for Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1 – will evaluate pelareorep, Oncolytics’ flagship intravenously delivered immunotherapeutic agent, in combination with modified Folfirinox, with or without the PD-L1 immune checkpoint inhibitor atezolizumab (Tecentriq), in newly diagnosed patients with pancreatic ductal adenocarcinoma (PDAC). The cohort will begin patient enrolment in Q2 2024 supported by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN).
The chemotherapy regimens of Folfirinox or gemcitabine and nab-paclitaxel are the two most common standards of care for pancreatic cancer. Building on previous Oncolytics data supporting pelareorep in combination with gemcitabine and nab-paclitaxel, the company stated it believes that positive results with Folfirinox would represent a significant step forward in pelareorep’s ability to fight pancreatic cancer.
Pelareorep
Pelareorep prompts and teaches the immune system to attack tumors and treat a variety of cancers. The agent has demonstrated synergies with multiple oncology treatments, including promising results in two randomized phase 2 studies in metastatic breast cancer and phase 1 and 2 studies in pancreatic cancer, with both treatments having received the Fast Track Designation from the U.S. Food and Drug Administration.
GOBLET
GOBLET is an ongoing phase 1/2 study in advanced or metastatic gastrointestinal tumors. The study is managed by AIO-Studien-gGmbH and is being conducted across 12 sites in Germany.
GOBLET’s primary endpoints are safety and objective response rate and/or disease control rate at week 16. Key secondary endpoints include other efficacy assessments and evaluation of potential biomarkers, such as T cell clonality and CEACAM6.
Leadership insights
“Oncolytics is pleased to announce receipt of regulatory clearance to initiate the Folfirinox cohort in patients with newly diagnosed metastatic PDAC. We appreciate the opportunity to collaborate with PanCAN, Roche, and AIO on this cohort, which is expected to initiate enrollment in the second quarter,” Matt Coffey, president and chief executive officer of Oncolytics Biotech, said in a statement. “We believe that working with PanCAN will help to further enrich Oncolytics’ clinical relationships with the pancreatic cancer community. We are also grateful for PanCAN’s Therapeutic Accelerator Award, which is enabling the evaluation of this combination therapy.”
“Oncolytics has taken a very strategic approach to the development of pelareorep in pancreatic cancer by focusing its clinical studies on combinations with the most widely used treatment regimens,” said Dirk Arnold, director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial. “My experience to date with the GOBLET study, including the positive metastatic PDAC and encouraging anal cancer data reported last year, makes me enthusiastic to initiate enrollment in the Folfirinox cohort.”
“We previously reported very encouraging results in pancreatic cancer patients for the combination of pelareorep, gemcitabine/nab-paclitaxel, and atezolizumab, and we plan to begin a registration-enabling study of this regimen later this year. The new pelareorep/Folfirinox cohort offers the opportunity to expand pelareorep’s role in pancreatic cancer. If the Folfirinox combination shows a compelling efficacy signal, this therapeutic approach could also be advanced to a registration-enabling study, providing two opportunities for pelareorep-based treatment to benefit pancreatic cancer patients,” added Thomas Heineman, Oncolytics’ chief medical officer. “In addition, translational research studies planned for this cohort will help to further elucidate pelareorep’s mechanism of action, including its ability to shape the tumor microenvironment. Notably, we will evaluate the correlation between tumor responses and the expansion of tumor-infiltrating lymphocytes in the blood, an effect that was observed in earlier pancreatic cancer studies.”
About Oncolytics Biotech
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent with promising results against breast cancer and pancreatic cancer.
Oncolytics Biotech Inc. stock (TSX:ONC) is up by 1.23 per cent, trading at C$1.64 per share as of 11:27 am ET. The stock has given back 25.11 per cent year-over-year and 32.23 per cent over the past five years.
Join the discussion: Find out what everybody’s saying about this cancer-fighting stock on the Oncolytics Biotech Inc. Bullboard, and check out the rest of Stockhouse’s stock forums and message boards.
The material provided in this article is for information only and should not be treated as investment advice. For full disclaimer information, please click here.
