Immuno-oncology (IO) has transformed cancer treatment, shifting the paradigm from cytotoxic and targeted therapies to immune-driven disease control (harnessing the body’s own immune system). Immune checkpoint inhibitors (ICIs), CAR-T cell therapies and cancer vaccines have produced durable responses in defined patient populations; however, the first wave of IO is approaching clinical and commercial saturation. ICI response rates remain limited to c 20–40% in solid tumours, while CAR-T therapies, despite curative potential in haematological malignancies, are restricted by high cost, complex manufacturing, immune-related toxicities and lower efficacy in solid tumours. Earlier cancer vaccines also failed to show consistent benefit. These constraints are driving next-generation approaches, focused on platforms that actively programme immune responses, rather than simply releasing inhibitory checkpoints. This report examines key innovation vectors shaping the next phase for this sector.

In this interview, CEO James Graham discusses Recce Pharmaceuticals’ recent commencement of a registrational Phase III study in Indonesia for its topical gel formulation of lead compound RECCE 327 (R327G) in the treatment of diabetic foot infections (DFIs). He also describes the commercial opportunity for treating DFIs and other bacterial skin infections in Indonesian and other Association of Southeast Asian Nation countries, where R327G commercialisation could start in 2026 upon positive data from this Phase III study. Mr Graham also discusses the most recent positive human clinical trial data for R327G in the treatment of skin infections, and Recce Pharmaceuticals’ upcoming plans to start a separate Australian Phase III study of R327G for the treatment of acute bacterial skin and skin structure infections, a broader indication than DFIs. He also elaborates on the company’s strategy for advancing R327 to US clinical development, including recent successes through its collaborations with the US Department of Defense.

Recce Pharmaceuticals is an innovative, clinical-stage Australian company developing novel, broad-spectrum synthetic polymer anti-infective drugs to treat several infectious diseases, including DFIs and other bacterial skin and skin structure infections, as well as sepsis and complex urinary tract infections.

Central nervous system (CNS) conditions are among the most significant unmet medical needs globally, with neurological conditions now one of the leading causes of disabilities, and having an impact on over 3.4 billion people worldwide. After decades of limited progress, the CNS field is experiencing a renaissance marked by novel technological advances that are overcoming barriers to effective drug development. Sophisticated blood-brain barrier crossing technologies are finally solving the fundamental delivery challenge, while AI-powered platforms are making unprecedented advances in drug discovery and biomarker identification. Most critically, the development of blood-based biomarkers is enabling early diagnosis and precision patient monitoring, addressing key issues that have historically limited CNS therapeutic success rates.