BioNTech boasts a diverse pipeline, featuring multiple drugs in various phases of clinical trials (Phase I, II, and III). These therapies primarily target solid tumors, including melanoma, prostate cancer, cervical cancer, non-small cell lung cancer, and pancreatic cancer. Notably, at the recent annual meeting of the American Society of Clinical Oncology (ASCO), BioNTech unveiled promising Phase I results for its pancreatic cancer drug, BNT122.
This trial, conducted in collaboration with Memorial Sloan Kettering Cancer Center and in partnership with Genentech, combines BNT122 with the immune checkpoint inhibitor (ICI) atezolizumab. Preliminary findings suggest a favorable safety profile and encouraging clinical activity, further solidifying BioNTech’s position as a frontrunner in the mRNA oncology market.
Melanoma remains a focal point for advanced mRNA-based therapies, with noteworthy progress seen in Phase II trials. This trial involves a combination with the renowned immune checkpoint inhibitor (ICI) pembrolizumab. Success in this trial could mark a groundbreaking achievement, showcasing improved recurrence-free survival rates through the synergy of an mRNA cancer vaccine and an immune checkpoint inhibitor.
Dr. Biswajit Podder, an Oncology and Hematology Analyst at GlobalData, emphasizes, “mRNA-based therapies hold the promise to revolutionize cancer treatment, especially for challenging-to-treat solid tumors.” Notably, Omega Therapeutics’ OTX-2002, an mRNA therapy, is projected to generate $658 million in global sales by 2029, accounting for 33.2% of the total mRNA therapy market. This highlights growing competition and diversification in this groundbreaking field.
GlobalData’s research highlights a dynamic landscape of clinical trials, with 36 mRNA-based products participating in 65 distinct Phase I-III trials across various cancer indications. Additionally, 178 mRNA-based therapies are in various stages of discovery, preclinical, and clinical development for oncology. This extensive research activity underscores the versatile potential of mRNA therapies in addressing various cancer types.
However, despite significant clinical progress, the healthcare industry awaits the first regulatory approval of mRNA-based therapy for oncology indications.
Dr. Podder concludes by emphasizing, “The path to market approval for mRNA-based therapies presents challenges, including issues related to mRNA stability and delivery specificity. Therefore, advancements in foundational mRNA biology and delivery platforms remain crucial for companies specializing in mRNA-based therapeutics. Moderna/Merck’s focus should be on expeditiously generating Phase III data for mRNA-4157 to accelerate the Biologics License Application (BLA) process and secure a first-to-market advantage.”
- BioNTech to lead $2 billion mRNA-based oncology therapy – (https://www.globaldata.com/media/pharma/biontech-lead-2-billion-mrna-based-oncology-therapy-market-despite-challenges-says-globaldata/)