Oncolytics Biotech (NASDAQ: ONCY) (TSX: ONC) Fights Cancer With Pelareorep, Which Has Received FDA Fast Track Designation For Breast And Pancreatic Cancer

A clinical-stage immunotherapeutics company focused on oncology with the goal of helping cancer patients live longer and healthier lives may be close to bringing therapy targeting multiple cancers to licensure-enabling studies. 

Reporting positive clinical and translational data in 2023, Oncolytics Biotech ONCY continues to shepherd its novel immunotherapy pelareorep on the path to FDA approval. The company is looking forward to beginning registration-enabled studies in the near future, which could lead to regulatory approval. 

Through two of its clinical trials, Oncolytics Biotech is attempting to combat breast cancer, which caused 685,000 deaths globally in 2020 and remains a threat to hundreds of thousands today. 

In patients with HR+/HER2- breast cancer – comprising approximately 60% to 70% of all breast cancers – an oncolytic virus called pelareorep has the potential to work in synergy with chemotherapy, hormonal therapies and immune checkpoint inhibitors (ICIs) to improve treatment outcomes where current therapies fall short.

To combat breast and other cancers, Oncolytics is developing pelareorep, a unique immunotherapy that awakens the immune system and unlocks its antitumor potential. 

Oncolytics is investigating pelareorep in a randomized phase 2 clinical trial called BRACELET-1, a study with three arms: standard-of-care paclitaxel monotherapy, paclitaxel in combination with pelareorep, and paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor avelumab (Bavencio®).

The open-label, phase 2, randomized study – modeled after the IND-213 trial – showed a near tripling of overall response rate (37.5% vs. 13.3%), increased median progression-free survival (PFS) by 50% (9.5 months vs. 6.3 months), and recorded a hazard ratio of 0.29 (95% CI: 0.09, 0.98) for the pelareorep + paclitaxel cohort compared to paclitaxel monotherapy. 

Overall survival (OS) data from the study continues to mature as several patients in the pelareorep-paclitaxel cohort remain in the study.

Early-Stage Breast Cancer

Oncolytics has also investigated how pelareorep remodels the tumor microenvironment in early-stage breast cancer patients and the potential to improve treatment response. 

An open-label window-of-opportunity study in early-stage breast cancer patients, the AWARE-1 study combined pelareorep, with or without atezolizumab, and standard of care therapy according to breast cancer subtype. 

Here's how the study worked: Tumor tissue was collected from patients as part of their initial breast cancer diagnosis. It was collected again on day three following initial treatment and finally three weeks later on the day their tumor is surgically resected. 

The study's goal was to confirm that pelareorep is acting as a novel immunotherapy while evaluating the potential synergy between pelareorep and checkpoint blockade and collecting biomarker data.

“Translational data presented from the AWARE-1 study at SABCS (The San Antonio Breast Cancer Symposium) showed that pelareorep induced the expansion of tumor-infiltrating lymphocytes, or TILs, in matched tumor biopsy and peripheral blood samples of newly diagnosed breast cancer patients. In addition, sequencing of the T cell receptors (TCRs) showed a more prominent expansion of existing TIL clones in the blood. We consider these results to be positive and important because they build on additional translational results reported this fall at two other medical meetings, The Society for Immunotherapy of Cancer (SITC) and The European Society for Medical Oncology (ESMO), from the AWARE-1 and GOBLET studies respectively, and provide further support for pelareorep’s unique immunologic mechanism of action,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “Taken together, these translational data affirm pelareorep’s ability to enhance T cell infiltration into tumors and expand TILs in the peripheral blood, which have been correlated with tumor response. We intend to incorporate these learnings into the designs of our registrational studies in metastatic breast cancer and pancreatic cancer.”

The results build on additional translational results reported this fall at two other medical meetings: The Society for Immunotherapy of Cancer (SITC) and The European Society for Medical Oncology (ESMO). These results provided further support for pelareorep’s unique immunologic mechanism of action, Dr. Coffey said. 

Pelareorep is delivered intravenously and is systemically active, setting it apart from certain other immunotherapies that must be injected into the tumor. It has the potential to benefit patients with cancer across a variety of indications and can be used as a single agent or combined with other immunotherapies to enhance its tumor-fighting capabilities.

Pancreatic And Other Gastrointestinal Cancers

For the growing number of patients with gastrointestinal cancers, effective therapies that improve treatment outcomes and meaningfully extend survival are limited, with only about 12% of patients receiving the current standard of care for pancreatic cancer surviving five years beyond their diagnosis.

To address this profoundly unmet need, Oncolytics is conducting the GOBLET trial to examine the potential of pelareorep and the checkpoint inhibitor atezolizumab in addition to standard-of-care therapy, where appropriate, for gastrointestinal cancers, including advanced/metastatic pancreatic cancer. 

The combination of pelareorep, gemcitabine, nab-paclitaxel and atezolizumab received FDA Fast Track designation for the treatment of advanced/metastatic pancreatic cancer. As a result of the Fast Track designation and the promising data reported to date, Oncolytics reports it is planning an adaptive phase 3 program and intends to manage it directly within its Clinical Group and a contract research organization (CRO) with the goal of enrolling the first patient in mid-2024.

Positive interim data reported by Oncolytics in November from the anal cancer cohort of the phase 2 GOBLET study met the pre-specified success criteria for the cohort and exceeded results from historical controls in similar patient populations. This marked the third consecutive indication from the GOBLET study to meet its success criteria and the fourth indication combining pelareorep and atezolizumab to present positive data, further validating the potential clinical benefit of this combination and opening the door to another potential registrational pathway for pelareorep. 

Featured photo by National Cancer Institute on Unsplash.

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