AVENI FOUNDATION

THE AVENI FOUNDATION REPORTED THE PERFORMANCE OF TWO CLINICAL STUDIES:1. Compassionate Use of Intravenous DeltaRex-G Tumor-Targeted Retrovector Bearing a Cytocidal Dominant Negative Cyclin G1 Inhibitor for Advanced Sarcoma, Pancreatic Cancer, Non-small Cell Lung Cancer, Breast Cancer, Cholangiocarcinoma, Basal Cell Carcinoma (Single Use INDs)2. Blessed: Expanded Access for DeltaRex-G for Advanced Pancreatic Cancer, Sarcoma and Carcinoma of Breast for an Intermediate Size Population (NCT04091295)Twenty-six patients were enrolled, 15 sarcoma, 4 pancreatic adenocarcinoma, 1 non-small cell lung cancer, 3 breast carcinoma, 1 prostate cancer, 1 cholangiocarcinoma and 1 basal cell carcinoma. Fifteen patients were enrolled in Study 1 single patient IND, 11 patients were enrolled in Study 2. Three patients were initially enrolled in Study 2 and later enrolled in Study 1. Twenty-one of 26 enrolled patients were treated with DeltaRex-G monotherapy or in combination with FDA approved cancer therapies. Three of the 21 patients treated with DeltaRex-G and FDA approved drugs were also treated with SNK01 autologous enhanced natural killer cell therapy.Eight of 11 (73%) patients treated with DeltaRex-G + FDA approved drugs are alive 7-59 months from treatment initiation, 2 with breast cancer are alive in complete remission, 1 with breast cancer with partial response, 4 with sarcoma are alive with partial response or stable disease, 1 with basal cell carcinoma is alive with partial response. Two patients with Stage 4 pancreatic adenocarcinoma who initially failed standard chemotherapy and who were treated with DeltaRex-G and low dose chemo lived 8.5-9.5 months, which is similar to the median survival duration of pancreatic cancer patients receiving first line therapy. One patient with liposarcoma who was treated with DeltaRex-G and low dose chemo lived 12 months, which is similar to the median survival duration of sarcoma patients receiving first line therapy. None of the Stage 4 patients treated with DeltaRex-G alone are alive.