Oncolytics Biotech (ONCY) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Mechanism of action and clinical evidence

• Pelareorep is an IV immunotherapeutic targeting both primary and metastatic tumors, stimulating anti-tumor immune responses and modifying the tumor microenvironment.

• The AWARE-1 study in breast cancer showed increased tumor-infiltrating lymphocytes (TILs) and upregulation of chemokines and cytokines, supporting the drug's mechanism.

• Positive phase II data were observed in combination with paclitaxel in the BRACELET-1 and IND.213 studies, with overall survival data expected in the second half of the year.

• A 3-4 month improvement in overall survival is considered meaningful by the oncology community, with final progression-free survival data also forthcoming.

Registration strategy and study design

• The path to registration for breast cancer involves a large, randomized, controlled phase II study (~200 patients) targeting patients who failed hormonal and antibody-drug conjugate therapies.

• The primary endpoint will be progression-free survival, aiming for accelerated approval if statistical significance is achieved.

• Success in this study would either support accelerated approval or de-risk a subsequent phase III trial.

• The company plans to offer pelareorep as an option for patients who fail or cannot take antibody-drug conjugate therapy, not as a competitor to those therapies.

Pancreatic and other cancer indications

• Positive data in first-line advanced/metastatic pancreatic cancer from the GOBLET trial (62% response rate) led to a collaboration with GCAR for an adaptive registrational trial, expected to start enrollment in the first half of next year.

• Cohort 5 of GOBLET, using pelareorep with FOLFIRINOX, began enrollment recently, with initial safety data expected later this year or early next year.

• In second-line anal cancer, a 37.5% response rate was observed, with further efficacy updates expected in 2025.

• No immediate plans for new studies in colorectal cancer, focusing resources on breast and pancreatic cancer.