Technology

Smart Animal's primary focus is on its flagship device.  The format of this proprietary technology will enable a physician to isolate a patient’s own antibodies, which can then be labeled with an imaging tag.  The labeled antibodies can be returned to the patient as a diagnostic, or can be recovered for use in a variety of rapid and enhanced analytical assays. 

The same device can be used to target a therapeutic compound to the imaged sites resulting in a quantitative drug delivery method with improved pharmacological properties.  Pharmaceutical companies who would like to discuss a synergistic opportunity are encouraged to contact us.

Personalized Medicine

The Immune System

Resistant Infections

Cancer

Autoimmune Diseases

Other Advantages of the Device

Personalized Medicine

The current model for personalized medicine (or individualized medicine) in the pharmaceutical industry involves selecting the right therapy/drug to suit the individual patient, based on their genetic framework or on the detection of proteins/biological markers expressed by the disease state.  The intention is to increase the propensity for a successful therapeutic outcome while avoiding any potentially detrimental side effects or even misdiagnosis.  The choice of therapeutic approach is restricted to those commercially available for the specific indication that is being treated.  As a rule, commercially available therapies are designed for effectiveness on a broad selection of the population requiring treatment.  As such, the action of the therapeutic is not specific to the individual.  Smart Animal will incorporate the patient’s own immune system as a drug delivery device, creating a true personalized approach to diagnosis and treatment.  (TOP)

The Immune System

An example of a patient specific approach can be found in the adaptive immune response of the patient to an infection or abnormal tissue growth, which we will refer to as a “pathogen”.  This inherent biological approach adapts to the nuances of a particular foreign or abnormal pathogen to provide a highly specialized defense.  The initial phase of the defense (Primary Immune Response) centers on the structural recognition of the pathogen by immunoglobulin molecules such as polyclonal IgG.  During the subsequent Secondary Immune Response, the pathogen is eliminated through the responses of a specific population of cells called lymphocytes, which are activated and have the ability to recognize the molecular structures associated with the specific pathogen, with the assistance of the unregulated expression of IgG.  Once a pathogen is eliminated, memory cells allow the body to more rapidly re-initiate the adaptive immune response to any re-introduction of the same pathogen.  It is on this principle that the concept of vaccination against future pathogens is based.  (TOP)

Resistant Infections

This adaptive immune system can sometimes be ineffective in eliminating a pathogen, such as in the case of a chronic infection.  This may be due to several mechanisms. 

• The adaptive immune response may be weakened by external factors (such as HIV infection, stress, or chemotherapy).  In these cases, the Smart Animal device can enhance the inadequate response by employing the immunoglobulins to deliver a cell destroying drug, such as colicheamicin.
• In some cases the adaptive immune system is triggered, however the lymphocyte response is unable to overcome and eliminate the pathogen.  Some pathogens, such as the Herpes virus, have the ability to mutate the structure of their surface proteins which render them less detectable to the Secondary Immune Response, which is targeted to the initially presented surface protein.  However, the Primary Immune Response is initiated in days, and can create immunoglobulins at microgram per milliliter levels in the blood.  These titers can be utilized by the Smart Animal device to mount an enhanced attack against the invading pathogen before it gets a chance to mutate.  Enhancing the Primary Immune Response also gives an advantage when combating very aggressive infections such as anthrax or smallpox.
• Sometimes the pathogen may be in possession of an innate mechanism that defeats the actions of the immune system.  By delivering an alternative mode of treatment, the device will give the immunoglobulins an orthogonal approach of attach designed to circumvent the defense mechanism.  (TOP)

Cancer

Cancer cells originate from tissues that the immune system normally recognizes as “self”.  As such, the structural surface of these cells may not be properly recognized as pathogenic (foreign) by the immune system and an effective adaptive immunoglobulin-based response may not be triggered.  However, evidence suggests that many tumors do stimulate a B-cell response and create a polyclonal antibody titer in circulation.  These can still be employed by the Smart Animal device as a means of delivering cancer therapeutics to the site of interest.

• Targeted Immunotherapy by utilizing monoclonal antibodies has been successful in the past.  Monoclonal antibodies are a single homogenous immunoglobulin type that are developed through mammalian cell culture to recognize cultured cancer cells or purified tumor proteins in vitro.  These optimal targets may not have the same effectiveness on a human patient’s specific tumor in vivo.  Also, these monoclonal immunoglobulins are selected for effectiveness against a broad selection of patients and do not meet the definition of personalized medicine.  The Smart Animal device employs polyclonal antibodies that recognize several features of the patient’s own specific tumor population, to deliver these same successful targeted therapies.
• Targeted Immunotherapy approaches by vaccinating patients with their own tumor proteins do meet the definition of personalized medicine.  The antigenic proteins from a patient’s own excised tumor tissue can be purified and re-introduced to the patient in the form of a vaccine.  The approach is available for the treatment of kidney cancer and metastatic melanoma.  An alternative means of presenting a patient’s own tumor protein as a vaccine is being pursued for the treatment of B-cell non-Hodgkin's lymphoma.  Unique idiotype genes are identified from tumor biopsy tissue. These tumor-specific genes are then used to manufacture a recombinant, patient-specific protein in a non-mammalian cell system, which is purified and presented back to the patient.  Although these methods aim to produce the appropriate immunoglobulin and lymphocyte responses, they offer no specific enhancement if the patient’s immune system is already recognizing the tumor, nor are they compatible with drug delivery to the site.  Furthermore, the preparation of the vaccine can take weeks or months.  (TOP)

Autoimmune Diseases

The adaptive immune system can also malfunction, resulting in any of a number of chronic conditions such as autoimmune diseases.  The defective genetic expression/translation of key components of the immune response can result in an inadequate immune response to a pathogen, or a hypersensitive response to a pathogen or even a self protein.  Compounds that can both enhance an inadequate immune response or inhibit an overactive immune response have been employed to address these situations.  These therapies are designed for effectiveness against a broad selection of patients and do not meet the definition of personalized medicine.  The Smart Animal device acts directly on the immunoglobulins to target the drug to the site of interest.  This focuses the therapeutic action on the relevant components of the misdirected immune response.  (TOP)

Other Advantages of the Device

Using the Smart Animal device, one can realize a number of other important advantages of targeted drug delivery including:

• Reduced dosing requirements as compared to systemic dosing.
• Reduced side-effects of the drug as compared to systemic dosing.
• Reduced immunogenicity of the delivered drug.
• Improved pharmacokinetics of the drug imposed by the IgG.

Improved solubility of the delivered drug.  (TOP)