Anticipated evaluation to include combination therapy featuring treatment regimen of checkpoint inhibition and chemotherapy utilized in cohort 1 of the GOBLET study

GCAR is launching a new master protocol for pancreatic cancer with the intent to create a registration-enabling pathway for investigational therapies

Innovative adaptive design could accelerate registrational study timeline and provide substantial cost savings compared to traditional trial designs

Oncolytics Biotech^® Inc. , a leading clinical-stage company specializing in immunotherapy for oncology,  announced that it has entered into a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR). The purpose of the preliminary collaboration is to commence planning activities for the evaluation of pelareorep in the treatment of first-line metastatic pancreatic ductal adenocarcinoma (PDAC) as part of GCAR's anticipated master protocol for metastatic pancreatic cancer. Activities are currently underway to finalize the seamless Phase 2/3 master protocol design that will evaluate multiple investigational therapies for the treatment of pancreatic cancer. An intent of the study is to produce registration-enabling data.

"We are thrilled to collaborate with GCAR and are honored that pelareorep has been selected as the first therapeutic for evaluation in GCAR's planned adaptive trial in pancreatic cancer patients. We believe this opportunity presents a strategic and efficient pathway forward for the development of pelareorep to address an urgent need for pancreatic cancer patients," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "GCAR's anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner. Through our interactions with GCAR, we have seen the strength of their capabilities and strong engagement with disease experts in pancreatic cancer. These attributes give us great enthusiasm to begin working together right away."

Meredith Buxton, PhD, MPH, Chief Executive Officer and President of GCAR, commented, "Our unwavering mission at GCAR is to accelerate the development of treatments for patients with deadly diseases such as pancreatic cancer. We believe that adaptive platform trials have the potential to achieve that mission and to be game-changing for patients. We are enthusiastic about collaborating with Oncolytics on our planned pancreatic cancer initiative, which was announced earlier this year, and we look forward to working with Oncolytics to advance our program."

Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics shared, "The combination of pelareorep's impressive results to date and GCAR's innovative trial design creates a powerful path forward. This strategy, which includes leveraging GCAR's extensive investigator network, enhances our ability to quickly and effectively advance the development of this pelareorep-based combination therapy for PDAC. Updated data from cohort 1 of the GOBLET study, presented at the European Society for Medical Oncology (ESMO) Congress 2023, showed that patients treated with pelareorep combined with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel experienced a 62% objective response rate, nearly triple what has been seen in historical control trials.^1-4 We hope to build on these results in GCAR's forthcoming study that will employ GCAR's broad and established network of clinical leaders in pancreatic cancer. I am very optimistic about our program and our collaboration with GCAR and look forward to advancing the evaluation of pelareorep as soon as possible."