Pelareorep

Cancer rates among those under 50 are surging globally, with a 79% rise in new cases. The UN predicts a 77% increase by 2050. The FDA has approved 16 oncology treatments between July and September 2024. Oncolytics Biotech Inc. is progressing with its immunotherapeutic agent, pelareorep, in breast and pancreatic cancer trials, aiming for an accelerated FDA approval. The global oncology drug market is expected to grow at a CAGR of 11.5% to $564.50 billion by 2033, with AI in oncology growing at a 35% CAGR to $13.6 billion by 2032.

Oncolytics Biotech® Inc. plans to submit a pelareorep + paclitaxel combination therapy breast cancer trial to the FDA in 2025, aiming for an accelerated approval based on BRACELET-1 trial results. The study targets HR+/HER2- advanced/metastatic breast cancer patients who have progressed on antibody-drug conjugates. Oncolytics also anticipates key milestones in gastrointestinal cancer clinical trials in 2025, with a focus on pancreatic cancer.

Oncolytics Biotech Inc. advances pelareorep therapy, showing significant survival benefits in breast cancer patients. Other biotech companies like Nurix, Incyte, Regeneron, and Foghorn also report promising developments in cancer treatments.

Recent cancer research breakthroughs include Oncolytics Biotech's BRACELET-1 study showing promising results for pelareorep in HR+/HER2- breast cancer, Novartis AG's FDA approval of Kisqali for early-stage breast cancer, Lantheus Holdings' positive Phase 3 SPLASH trial results for 177Lu-PNT2002 in prostate cancer, Sutro Biopharma's encouraging Phase 1b study data for Luvelta in ovarian cancer, and Zymeworks' upcoming presentation of preclinical data on its antibody-drug conjugate programs.

The BRACELET-1 study showed pelareorep plus paclitaxel did not reach median overall survival (OS) in HR-positive/HER2-negative breast cancer patients, with 64% survival at 2 years vs 33% with paclitaxel alone. Median progression-free survival (PFS) was 12.1 months vs 6.4 months, and overall response rate (ORR) was 37.5% vs 13.3%. These results support further development of pelareorep-based combination therapy.

BRACELET-1 study results show improved overall survival (OS) and progression-free survival (PFS) when combining pelareorep with paclitaxel for HR-positive, HER2-negative advanced or metastatic breast cancer patients. The median OS was not reached with pelareorep/paclitaxel vs 18.2 months with paclitaxel alone, and the median PFS was 12.1 months vs 6.4 months. The overall response rate (ORR) was 37.5% with pelareorep/paclitaxel vs 13.3% with paclitaxel alone. These findings support further development of pelareorep in clinical settings.

The global oncolytic virus immunotherapy market, projected to exceed USD 1.50 billion by 2030, is advancing with over 180 therapies in clinical trials. Key therapies like IMLYGIC, Oncorine, and Delytact are approved, with more expected due to FDA and EMA designations. Innovations and partnerships, such as RenovoRx and Imugene's collaboration, are driving growth, aiming for safer, targeted cancer treatments.

Oncolytic viruses (OVs) selectively infect and kill cancer cells, showing significant anti-tumor effects with mild adverse events. As of October 2021, 408 clinical trials on 31 OV products have been conducted, with phase I and II studies making up 80%. OVs like H101, T-VEC, and G47Δ have been approved, demonstrating safety and efficacy in tumor treatment. Challenges include targeting, vector cell selection, and viral diffusion. OVs combined with other therapies enhance anti-tumor effects, indicating a promising future in cancer immunotherapy.