Oncolytic Virus Therapy: Global Clinical Trial Landscape (2024)

Oncolytic virus (OV) therapy represents a promising frontier in cancer treatment, utilizing genetically engineered or naturally occurring viruses to selectively infect and destroy cancer cells while sparing healthy tissue. These viruses not only induce direct tumor cell lysis but also stimulate systemic anti-tumor immune responses by releasing tumor-associated antigens. As of 2024, the United States leads in funding, contributing $405.2 million towards early-phase research and development. Regulatory agencies are adapting frameworks to address the unique challenges posed by OVs, including considerations for viral shedding, genetic stability, and long-term safety. Close collaboration between developers and regulators is essential to navigate these complexities and bring effective OV therapies to patients.

Despite significant advancements, OV therapy faces several challenges. These include the body's innate and adaptive immune responses, and delivery challenges. To overcome these obstacles, strategies such as genetic modifications to enhance tumor selectivity, arming viruses with immune-stimulatory genes, and combining OVs with other treatments like immune checkpoint inhibitors are under investigation. While OV therapy holds significant promise, addressing these immunological challenges and navigating the evolving regulatory environment are critical for its successful integration into clinical practice.