NEWSLETTER VOLUME 7

2018 has been a great year for American Gene Technologies: it added four new patents to its $2.4 billion-valuated IP portfolio; earned an Orphan Drug Designation from the FDA for its PKU cure project; moved the HIV cure IND into the final stage of development; received an invitation to the Westin St Francis Hotel, core meeting of the JP Morgan Healthcare Conference; met with seven of the largest global pharmaceutical companies about its drug pipeline and over 22 investment banks and companies regarding the possibility of an initial public offering (IPO) in 2019; and celebrated its 10-year anniversary.

This past quarter, AGT added four new patents to its existing portfolio (full list of granted patents viewable here) to further protect AGT ownership of gamma delta T cell stimulation and secure its HIV asset for partnering and commercialization. Specifically, three of the new patents granted protect the methods and compositions for gene therapy and immunotherapy that activate gamma delta T-cells, which can be used in the treatment of various cancers and infectious diseases. The fourth patent is AGT’s first in its HIV Cure program and protects both a lentiviral vector and proprietary process for generating autologous cell products for treating HIV.

AGT’s new patents and their associated press releases are listed below:

This quarter AGT received orphan-drug designation #DRU-2018-6572 from the U.S. Food and Drug Administration (FDA) for the treatment of phenylketonuria (PKU) using its proprietary, lentiviral vector based technology. PKU is a debilitating inherited disease affecting 1 in 13,500 children born in the U.S. Mandatory screening identifies affected children who can be supported with a strict synthetic diet that does not cure disease. If successful, AGT's lentiviral vector approach will provide a permanent cure, improving quality of life for more than 16,000 people living with PKU in the U.S. alone. To read the press release, click here.

AGT is starting to branch out into other tumor types including breast cancer in collaboration with its advisor Robert Clarke, PhD, Professor of the Department of Oncology and Co-Director of the Breast Cancer Program at Georgetown University Medical Center. To read more about Dr. Clarke’s work at AGT, click here.

AGT’s expansion into breast cancer is a natural progression. AGT's patented methods and compositions for the activation of human immune system gamma delta (γδ) T cells, initially designed to kill liver cancer, not only kills primary tumors, it kills secondary tumors or metastases. AGT’s animal tests have shown that this approach works on a wide variety of epithelial cancers, including breast cancer, prostate cancer, and others. To learn more about AGT’s Gamma Delta T Cell Therapy for cancer, ImmunoTox™, click here. For more information on its Immuno-Oncology program, click here.