2023 Grantee: Thomas Heineman, MD, PhD
Oncolytics Biotech, Inc.
Research Project: Pelareorep + mFOLFIRINOX +/- atezolizumab for the treatment of 1L mPDAC
Award: 2023 Pancreatic Cancer Action Network Therapeutic Accelerator Award
Award Period: July 1, 2023 – June 30, 2025
Dr. Heineman holds MD and PhD (Virology) degrees from the University of Chicago and has extensive experience in vaccine and drug development. Prior to joining Oncolytics as Chief Medical Officer, he held senior positions in biopharmaceutical companies dedicated to developing cancer therapeutics. These included Senior Vice President and Head of Clinical Development at Denovo Biopharma, Vice President and Head of Clinical Development/Translational Medicine at Halozyme Therapeutics and Vice President and Head of Clinical Development at Genocea Biosciences. At Halozyme, Dr. Heineman oversaw their pivotal Phase 3 study of PEGPH20 and gemcitabine/nab-paclitaxel in metastatic pancreatic cancer. He has also conducted oncology/immuno-oncology studies in colorectal cancer, anal carcinoma, cholangiocarcinoma, breast cancer, glioblastoma and other indications. Dr. Heineman previously served as Executive Director at GSK Vaccines, where he led the clinical development of the herpes zoster vaccine, Shingrix. Before entering the industry, he was a tenured Associate Professor at the Saint Louis University of Medicine and has co-authored over 60 peer-reviewed publications.
Immunotherapies, which have dramatically improved outcomes for many cancers, have failed to benefit the majority of people with metastatic pancreatic cancer. Oncolytics Biotech is developing pelareorep as an immunologic treatment for metastatic pancreatic cancer. Pelareorep is a virus-based immunotherapy designed to help the patient’s own immune system attack and kill the cancer cells.
Pelareorep is an oncolytic reovirus that selectively infects and replicates (reproduces itself) in cancer cells, including pancreatic cancer cells. In addition to causing the death of cancer cells, the virus induces an immune response targeted to both the viral genetic material (double-stranded RNA) and the proteins that are present in the cancer cells but not the healthy cells. The company’s clinical data show that treatment with the virus results in the recruitment and activation of cancer-fighting immune cells, including natural killer cells, dendritic cells and T-cells, leading to an immune response that is both innate (the cells’ immediate reaction to any foreign threat) and adaptive (a response that is specific to these viral and cellular components).
Through their PanCAN Therapeutic Accelerator Award, Dr. Heineman and his team will conduct a clinical trial evaluating pelareorep in patients with metastatic pancreatic cancer who have not received prior treatment, in combination with modified FOLFIRINOX chemotherapy and a checkpoint inhibitor called atezolizumab, and compare those results to pelareorep and chemotherapy without atezolizumab. Immune checkpoint inhibitors like atezolizumab block the activity of proteins that signal to avoid immune recognition and attack cancer cells. Dr. Heineman and his team’s primary objectives are to evaluate the safety of the proposed combination as well as objective response rate (the percentage of tumors that shrink or disappear following the treatment). They will also analyze other endpoints, such as progression-free and overall survival and measure the immune response to the therapeutic approach.
If either pelareorep combination therapy shows a promising result, the next step will be to confirm its therapeutic effect in a larger study with the goal of making better treatment options available to all people with metastatic pancreatic cancer. PanCAN’s Therapeutic Accelerator Award was designed with the intent of supporting companies like Oncolytics to conduct clinical trials of promising investigational treatment combinations and then, if results are encouraging, incorporate the investigational treatment regimen into the PanCAN Precision PromiseSM adaptive clinical trial platform for later-stage evaluation.