This work is being done at Autoimmune's subsidiary company Stadius Biopharma LLC. For more information, please go to www.stadiusbio.com.

Common everyday pathogens can be lethal to people without robust immune systems, and the drugs currently available to treat these patients are not completely effective and also have significant side effects. The people whose lives are most at risk today from these widespread threats are the chronically ill, anyone living in a long term care facility, and immunosuppressed or immunocompromised patients, including those receiving bone marrow and organ transplants.

Autoimmune Technologies is developing protective human monoclonal antibodies to many of these pathogens. Monoclonal antibody drugs may prove to be superior to existing small molecule drugs in these cases, and the Company believes that its antibodies have the potential to become first-in-class therapeutics and prophylactics. The Company’s lead antibodies work against Candida and Cytomegalovirus, pathogens which have exhibited multi-drug resistance and can have a devastating impact on these groups of patients.

Anti-Candida Antibodies - Disseminated candidiasis is the third most prevalent hospital-acquired bloodstream infection in the United States. The infection is caused by several species of the fungal genus Candida, with C. albicans the most common and C. auris an emerging urgent threat. Crude mortality in the last decade has ranged from 36% to 90% despite the availability of various small molecule anti-fungal drugs, and the spread of drug resistant C. auris demonstrates the continuing danger of antimicrobial resistance to standard therapies. New treatment modalities are clearly needed, and the Company’s preclinical data suggests the possibility that a cocktail of two of its human monoclonal anti-Candida antibodies may help fill that need. In mouse models, this two-antibody combination has been found to protect mice from death from both C. albicans and C. auris, and an initial patent application covering both antibodies has been filed.

Anti-CMV Antibodies - Cytomegalovirus (CMV), a herpes virus, commonly causes mild or asymptomatic infections in otherwise healthy individuals. In immunocompromised patients such as transplant recipients, however, reactivation can result in serious and often fatal complications. Treatment and prophylaxis options for CMV are currently limited, and there is a need for new antiviral therapies. The Company isolated a panel comprising more than sixty unique human monoclonal antibodies that neutralize human CMV and the process of identifying several antibodies best suited for use in a combination drug cocktail is under way.

Stem Cell Based Antibody Delivery Platform - Autoimmune Technologies is also developing a patented immunotherapeutic delivery platform utilizing a nonintegrating episomal-based ex-vivo gene therapy method combined with adult adipose-derived mesenchymal stem cells (ADMSCs) to produce human monoclonal antibodies directly in patients. Episomes encoded with the DNA for the desired antibodies are transfected into the MSCs, and the MSCs are then injected into the patient, where they will deliver antibodies to the patient for the life of the stem cells or until the attending physician activates an encoded kill switch. The use of stem cells to generate monoclonal antibodies inside a patient represents a paradigm shift in how antibodies are delivered, and it enables the use of therapeutic antibodies in a prophylactic setting to prevent the development of infectious diseases in immunosuppressed or immunocompromised patients.