Preclinical and IND enabling studies for treatment of advanced lung cancer and other cancers metastatic to lung by pulmonary delivery of engineered Influenza A Virus (eIAV)

PROJECT SUMMARY / ABSTRACT There are more than 230,000 new cases of lung cancer and over 130,000 deaths due to lung cancer each year in the U.S. Approximately 120,000 people each year will present with metastatic Non-Small Cell Lung Cancer (mNSCLC) for the first time, and only 7% of these patients will survive five years or more. accurius is developing the first of a kind inhalable agent that will be a safe and highly effective treatment for mNSCLC and other cancers metastatic to the lung. The agent is an engineered oncolytic virus based on the Influenza A virus (eIAV) which will selectively infect and destroy cancer cells while sparing healthy cells and induce the body’s own anti-tumor immune response. This treatment will dramatically improve overall survival rates for the metastatic NSCLC patient population as well for the 50,000 patients each year with different tumor types that have their cancer metastasize to the lung. Phase I of the accurius project will determine the top two eIAV candidates in the accurius pipeline, each of which must improve median survival time by more than 50% versus the control arm in animal models while showing significant ability to elicit the natural immune response to the presence of the tumors. Follow-up testing will determine if either or both of the candidates can improve median survival time by an additional 25% in combination with an immune checkpoint blocker. Phase II will finalize the cell culture-based manufacturing process for the candidate(s) which passed both tests in phase I and also optimize their inhalable form. The inhalable forms will then have to pass the same efficacy and natural immune response stimulation tests as in Phase I as well as demonstrating safety in animal models without tumors in order to proceed to further clinical testing in humans. The potential realizable market for accurius’s safe, inhalable, effective eIAV is over 100,000 metastatic lung cancer patients annually in the US alone, the vast majority of whom will not respond to currently available treatments and face dismal survival prospects.