Oncolytics Biotech

The BRACELET-1 trial demonstrated that pelareorep combined with paclitaxel achieved a 31% objective response rate and 12.1-month median progression-free survival in HR+ HER2- metastatic breast cancer patients.

Oncolytics Biotech has appointed Jared Kelly as CEO, leveraging his expertise from orchestrating the $2 billion sale of Ambrx Biopharma to Johnson & Johnson.

Oncolytics Biotech will present new data from Cohort 1 of the GOBLET study at the 2025 ASCO Annual Meeting in Chicago.

The Paul-Ehrlich-Institute (PEI) in Germany has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study.

Oncolytics Biotech presented data at the ASCO GI Symposium, highlighting pelareorep's potential in treating relapsed anal and metastatic pancreatic cancers.

BRACELET-1 trial data reveals a significant overall survival benefit with pelareorep plus paclitaxel in HR+/HER2- metastatic breast cancer, supporting further registrational study.

• Oncolytics Biotech plans to submit a pelareorep and paclitaxel combination therapy trial to the FDA in early 2025 for HR+/HER2- metastatic breast cancer, seeking accelerated approval. • The planned Phase 2 study will enroll approximately 180 patients who have progressed on or are ineligible for antibody-drug conjugates (ADCs), addressing a significant unmet need. • Oncolytics is collaborating with GCAR and PanCAN to advance pelareorep in gastrointestinal cancers, with key milestones expected in 2025, including updates from the GOBLET study in pancreatic cancer. • BRACELET-1 study results showed a 5.7-month PFS benefit for the pelareorep + paclitaxel arm compared to chemotherapy alone, supporting the accelerated approval pathway.

• The FDA issued 16 oncology approvals between July and September 2024, addressing the global surge in cancer cases, particularly among individuals under 50. • Oncolytics Biotech is advancing pelareorep, with plans to submit a clinical trial for HR+/HER2- breast cancer to the FDA in early 2025, following positive BRACELET-1 trial results. • AbbVie has submitted a BLA for telisotuzumab vedotin for previously treated non-small cell lung cancer (NSCLC) with c-Met protein overexpression. • HUTCHMED's partner, Takeda, received approval in Japan for FRUZAQLA (fruquintinib) for previously treated metastatic colorectal cancer (CRC).

Oncolytics Biotech's BRACELET-1 trial showed pelareorep, combined with paclitaxel, significantly improved survival rates in HR+/HER2- advanced or metastatic breast cancer patients.