Company Overview of American International Biotechnology, LLC

AIBioTech announced receipt of a firm fixed price subcontract from DynPort Vaccine Company LLC valued at nearly $3 million for laboratory studies to support development of a biologic intended for use prior to an exposure to nerve agents. DVC issued this subcontract under its prime contract number W911QY-13-C-0056 with the U.S. Department of Defense. This medical countermeasure is intended to decrease incapacitation and death associated with nerve agent poisoning by binding and inactivating the nerve agent in the circulatory system before it can reach the nervous system. The program is intended to deliver a new capability to help soldiers in combat remain functional following nerve agent exposure and continue performing their mission. The U.S. Army has been evaluating a naturally occurring enzyme in humans called butyrylcholinesterase for its potential use as a chemical agent MCM. Under its previous subcontract to DVC, AIBioTech implemented and then validated a laboratory assay which measures the activity of BuChE and then used the assay to assess the enzyme levels in Phase I human clinical trial samples. The new contract builds on the initial body of work and includes development of new laboratory assays, new validation studies, qualification of the BuChE source materials, and assay of human clinical trial samples.

American International Biotechnology, LLC announced implementation of a new laboratory derived test to measure L-asparaginase levels in patients being treated with any of the current asparaginase drugs including: Oncaspar, Kidrolase, Erwinaze, and Elspar. In administering the L-asparaginase enzyme to patients, serum levels of asparagine are depleted, leaving the leukemia cells without asparagine, which results in leukemic cell death. The L-asparaginase activity assay developed at the company is intended to help physicians identify patients experiencing "silent inactivation" of asparaginase as well as to ensure that adequate asparaginase activity is present during treatment. The assay will measure asparaginase activity levels in the dosed patient, regardless of the form of the drug which is administered. This L-asparaginase activity assay has been fully validated in the company laboratories in accordance with Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) requirements and as defined in the U.S. Food and Drug Administration (FDA) Guidance for Industry on Bioanalytical Method Validation and according to the International Conference on Harmonization Guidelines on Validation of Analytical Procedures.

American International Biotechnology Services is quickly gaining ground in the niche market of custom synthesis of small molecules, including molecules which contain stable isotopes of particular atoms. The products of these syntheses are routinely used by its customers in their own drug development programs or as reference standards for sophisticated methods of sample analysis. In response to customer demand, AIBioTech has added staff and instrumentation necessary to produce gram quantities of dozens of compounds on a monthly basis, and has repeat orders from both domestic and international customers.