Pelareorep

Oncolytics Biotech reports promising BRACELET-1 results in HR+/HER2- metastatic breast cancer, setting stage for potential registration-enabling study and accelerated approval. The company also highlights advancements in its gastrointestinal cancer pipeline, with collaborations for pancreatic cancer studies. Anticipated milestones include finalizing protocols and safety data in 2025.

The global pancreatic cancer market is projected to grow from USD 3.1 billion in 2023 to USD 11.5 billion by 2033, driven by advancements in precision medicine, novel chemotherapy combinations, and emerging immunotherapies. Key trends include targeting KRAS mutations, reevaluating growth factors like G-CSF, and innovations in diagnostic technologies and gene-editing. Despite challenges, ongoing research and drug approvals offer hope for improved patient outcomes.

DSMB recommends continuing GOBLET study cohort 5 after safety review. Cohort 5 investigates pelareorep with mFOLFIRINOX, with/without atezolizumab, in newly diagnosed PDAC. Full trial updates expected in 2025.

Oncolytics Biotech reports DSMB recommendation for continued enrollment in GOBLET study Cohort 5, assessing pelareorep with modified FOLFIRINOX and atezolizumab for pancreatic ductal adenocarcinoma, pending PEI approval. Safety data expected in H1 2025, with initial efficacy results in H2.

Oncolytics Biotech Inc. announces key progress and upcoming studies for breast and pancreatic cancer treatments, preparing for FDA accelerated approval. The company's lead intravenously administered immunotherapy, pelareorep, shows promising efficacy in ongoing trials, with plans to initiate a clinical trial to support accelerated FDA approval in 2025.

Oncolytics Biotech reports Q3 2024 financials and operational highlights, including positive BRACELET-1 data in HR+/HER2- metastatic breast cancer, affirming the potential of pelareorep + paclitaxel combination for a registrational study. The company also highlights upcoming milestones like updated efficacy data from the anal cancer cohort and safety data from the modified FOLFIRINOX pancreatic cancer cohort. Cash position as of September 30, 2024, was $19.6 million. Management hosted a conference call and webcast on November 12, 2024.

The global pancreatic cancer market is expected to grow to USD 11.5 billion by 2033, driven by advancements in precision medicine and innovative treatments targeting KRAS mutations. Recent FDA approvals and clinical trials, such as Pelareorep and LGK-974, highlight progress. Key trends include targeted immunotherapies, novel chemotherapy combinations, and advancements in diagnostic techniques. Personalized treatment approaches and gene-editing therapies are also emerging, promising improved patient outcomes.

Oncolytics Biotech seeks accelerated approval for pelareorep, its lead cancer therapy, based on positive Phase II BRACELET-1 trial data. A registrational Phase II trial is planned for 2025, evaluating pelareorep combined with paclitaxel in breast cancer patients. Oncolytics' stock rose 18.22% on the news, reflecting investor optimism. Oncolytic virus therapies are projected to see significant growth, from $114m in 2023 to $2.4bn by 2029.