NanOlogy

Approach: Clinical interest in intratumoral therapy is increasing because of advancements in interventional oncology and growing recognition of the importance of treating the primary tumor across the disease spectrum. Clinical trials are underway by NanOlogy in multiple therapeutic areas to evaluate local delivery of concentrated, sustained chemotherapies to increase solid tumor response, eliminate toxicities associated with systemic agents, and promote favorable immunomodulation. Technology: The NanOlogy commercial scale GMP production platform precipitates dissolved drug substances with sonication and compressed supercritical carbon dioxide to form stable large surface area microparticles (LSAMs) of pure drug containing no excipients or coating agents. LSAMs have a disproportionately large surface area to particle size ratio that enables retention of particles at the disease site and continuous local drug release over time with gradual systemic clearance at subtoxic levels. Initial investigational drugs are LSAM-PTX and LSAM-DTX, which have completed clinical trials in multiple solid tumors with excellent tolerability and promising signs of tumor response and immunomodulation. NanOlogy has established feasibility of forming LSAMs in multiple drug classes including taxanes, cisplatin, TKIs, and PARPIs. Therapeutic Potential: Therapeutic potential exists across the cancer disease spectrum with NanOlogy intratumoral investigational drugs. In local disease, the potential to delay or prevention of solid tumor progression as an alternative to organ removal or other invasive procedures as the only curative options. In metastatic disease, the potential for immunomodulation by sustained primary tumor cell death to boost the local and systemic response to immunoncology therapies without adding systemic toxicity.