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.
Public Health Relevance Statement: PROJECT NARRATIVE accurius is developing a novel inhalable, safe, and highly effective treatment for the more than 100,000 patients that develop metastatic Non-Small Cell Lung Cancer every year in the U.S. Currently, only approximately 7% of these patients are expected to live five years or longer. The successful development and launch of this new technology could significantly improve the survival prospects for this large patient population.
Project Terms: Animals; Breathing; Respiratory Aspiration; Respiratory Inspiration; inspiration; Non-Small-Cell Lung Carcinoma; NSCLC; NSCLC - Non-Small Cell Lung Cancer; Non-Small Cell Lung Cancer; Nonsmall Cell Lung Carcinoma; Cell Culture Techniques; cell culture; cell cultures; Cells; Cell Body; Clinical Research; Clinical Study; Cessation of life; Death; Combination Drug Therapy; Polychemotherapy; combination chemotherapy; combination pharmacotherapy; combined drug therapy; Engineering; Face; faces; facial; Goals; Human; Modern Man; Immunity; Immunotherapy; Immune mediated therapy; Immunologically Directed Therapy; immune therapeutic approach; immune therapeutic interventions; immune therapeutic regimens; immune therapeutic strategy; immune therapy; immune-based therapies; immune-based treatments; immuno therapy; Joints; Lead; Pb element; heavy metal Pb; heavy metal lead; Lung; Lung Respiratory System; pulmonary; Lung Neoplasms; Lung Tumor; Pulmonary Neoplasms; Marketing; Mus; Mice; Mice Mammals; Murine; Persons; Nebulizer; nebulization; nebulize; Neoplasm Metastasis; Metastasis; Metastasize; Metastatic Lesion; Metastatic Mass; Metastatic Neoplasm; Metastatic Tumor; Secondary Neoplasm; Secondary Tumor; cancer metastasis; tumor cell metastasis; Oncolytic viruses; Overdose; Patients; Production; Safety; medical schools; medical college; school of medicine; Metastatic to; Survival Rate; Testing; Time; United States; Up-Regulation; Upregulation; Body Weight decreased; Weight Loss; Weight Reduction; body weight loss; wt-loss; Mediating; Metastasis to the Lung; Metastatic Tumor to the Lung; lung metastasis; metastasize to the lung; pulmonary metastasis; Metastatic Neoplasm to the Lung; Immune Markers; immune-based biomarkers; immunological biomarkers; immunological markers; Immunologic Markers; injuries; Injury; improved; Phase; Licensing; Malignant Tumor of the Lung; Pulmonary Cancer; Pulmonary malignant Neoplasm; lung cancer; Malignant neoplasm of lung; Oncology Cancer; Oncology; Collaborations; Intellectual Property; Immunological response; host response; immune system response; immunoresponse; Immune response; Therapeutic; cancer cell; Malignant Cell; Disseminated Malignant Neoplasm; Metastatic Cancer; Metastatic Malignant Neoplasm; Intravenous; Diagnostic; Immune; Immunes; Clinic; Distant; Infusion procedures; Infusion; infusions; success; Animal Model; Animal Models and Related Studies; model of animal; Toxic effect; Toxicities; Primary Neoplasm; Primary Tumor; novel; Agreement; new technology; novel technologies; response; Influenza A virus; Influenza A; Influenza Viruses Type A; Influenzavirus A; Orthomyxovirus Type A; Type A Influenza; Address; Dose; Data; Cancer Model; CancerModel; Cancer Patient; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Process; follow-up; Active Follow-up; active followup; follow up; followed up; followup; Therapeutic Effect; Development; developmental; pre-clinical; preclinical; intervention efficacy; therapeutic efficacy; therapy efficacy; Treatment Efficacy; manufacturing process; chemotherapy; new drug treatments; new drugs; new pharmacological therapeutic; new therapeutics; new therapy; next generation therapeutics; novel drug treatments; novel drugs; novel pharmaco-therapeutic; novel pharmacological therapeutic; novel therapy; novel therapeutics; murine model; mouse model; commercial application; commercialization; tumor; patient population; effective treatment; effective therapy; pre-clinical efficacy; preclinical efficacy; Immune Cell Activation; immune activation; arm; Drug Targeting; Formulation; experiment; experimental research; experiments; experimental study; check point blocker; checkpoint blockers; immune check point blocker; immune checkpoint blockers; immune-mediated adverse events; immune-related adverse events; antitumor immune response; anti-tumor immune response; Injections; manufacture; T cell infiltration
