BLESSED: Expanded Access for DNG64-CAR-V for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast

DNG64-CAR-V is a replication incompetent chimeric tumor targeted amphtropic RNA vector that displays a Sig-binding decapeptide for binding to abnormally exposed Signature (Sig) proteins in the tumor microenvironment (TME) and encoding a CCNG1 inhibitor gene for killing cancer cells, neoangiogenic cells and pro-inflammatory, immune suppressive, stroma producing cancer associated fibroblasts (CAFs), thus reducing inflammation and converting an immune-cold to an immune-hot tumor, and reducing extracellular matrix production in the TME, hence augmenting drug entry and immune cell trafficking into the TME. Enhanced CCNG1 expression has been found in all cancer types tested at the Cancer Center of Southern California as of June 2023. Hence, in July 2023, the USFDA authorized the use of DNG64-CAR-V as platform therapy upon which one or more FDA approved cancer drugs immunotherapies and/or certain FDA authorized investigational agents may be added. This would allow a personalized approach in the treatment of all cancer patients. Forty patients with pancreatic cancer, sarcoma and carcinoma of breast will receive DNG64-CAR-V intravenously or intratumorally at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 1.0-6.0 x 10e10 VC per dose one-three times a week. DNG64-CAR-V may be given alone or with an FDA approved cancer therapy/immunotherapy and/or certain FDA authorized investigational agents on physician discretion.