Preparing IND filing for novel lung cancer therapeutic

Project Summary Abstract Quench Medical's unique chemotherapeutic inhalation formulation is intended to significantly improve the control of tumors and the survival of patients while minimizing systemic toxicity. Five-year survival rates are 20%, two-thirds of patients do not qualify for “gold standard” surgery, and systemically administered chemotherapy drugs deliver a low drug concentration to the lungs due to blood volume dilution and metabolism. Local aerosol delivery to the lung can bypass the systemic drug delivery limitations and is a strategy that has been shown to significantly improve the control of pulmonary tumors. Therefore, we are developing an efficient and targeted inhaled dry powder aerosol formulation to better treat patients with lung cancer. This CRP project will complete the regulatory data required for investigational new drug (IND) filing of QM-269 to the Food and Drug Administration (FDA) Division of Oncology. The efforts in this proposal continue the commercial translation of a new type of targeted lung cancer treatment with a highly efficient and novel dry powder formulation that is optimized to maximize efficacy and minimize toxicity to significantly improve treatment for patients with non-small cell lung cancer. Together with the ongoing Phase II SBIR efforts, we have identified a clear path to clinical study, 505(b)(2) FDA approval, and marketing. The commercialization readiness milestones in this project will allow for immediate FDA regulatory IND filing to begin first-in-human clinical testing of QM-269.