Application/How it can be used
Cancer Vaccine and Disease Vaccine Design Technology
For vaccine solutions, Pure provides a series of assays to assist vaccine developers in epitope identification and validation and Pure provides HLA proteins for competitive binding assays. Pure also provides non-radioactive competitive peptide binding assays for cancer and viral peptide epitopes. Pure also help vaccine companies validate whether or not the particular peptide epitopes that their vaccine is generated against are actually found on infected, vaccinated, or cancerous cells.
SHARC™ - Selective Antibody Removal
Pure Protein has developed a proprietary immunotherapeutic protein suitable for integration into a combination medical device for use in a novel selective antibody removal therapy. This immunotherapeutic device is called the SHARC™ or Selective HLA Antibody Removal Column™. A SHARC™ therapy is similar to a dialysis therapy but instead of filtering the blood of byproducts as the kidney does, the anti-HLA antibodies would be specifically filtered and removed. The therapy would allow unacceptably matched organs to be transplanted.
Roughly one-third of all patients waiting for a transplant are considered "highly sensitized." This means that due to a previous surgery, blood transfusion, pregnancy or other factors they have already developed anti-HLA antibodies. As such, many patients that are “highly sensitized” may never receive a donor organ no matter how long they are on the waiting list. In fact, according to the study, only 6.5 percent of "highly sensitized" patients undergo a transplant each year. Without the transplant these individuals’ chances of survival decrease substantially and many die before a donor organ ever becomes available.
All current methods to remove HLA Abs are non-specific, leading to the removal of all serum immunoglobulins or clotting factors, or a combination of both. This lack of specificity leads to the myriad adverse effects of current methods including increased risk of infection, cancer, diabetes, hypertension, and systemic atherosclerosis.
The SHARC™ , a Sepharose based, reusable, HLA-protein column, offers a number of important clinical advantages for solid organ transplantation with exciting commercial application potential.
Specificity: SHARC™ will target and remove only the problematic HLA Abs. Beneficial Abs, such as virus-specific and anti-idiotype Abs are not removed. Also antibody based immunosuppresent therapise such as IVIG are not removed.
Tolerability: SHARC™ will not remove proteins required for normal coagulation and cardiovascular stability.
Effectiveness: SHARC™ will remove a large proportion (preliminary data suggest up to 80%) of plasma HLA Abs in one session. With good tolerability, prolonged and repeat treatment sessions are possible.
Safety: SHARC™ will leave the humoral immune system intact while removing problematic HLA Abs. The risk of infection will not increase because antibacterial, antifungal and antiviral Abs will not be removed.
What does this mean for the transplant patient and provider?
- Better patient care
- More transplant possibilities by making living donor, HLA antibody incompatible, transplants easier and safer.
- Antibody removal after the transplant will result in longer graft survival.
- Lower medical insurance impact from long-term dialysis care of wait-listed patients.
- Improved quality of life post-transplant by enhancing the effectiveness of traditional long-term anti-rejection therapy without creating secondary health conditions.
T-cell Receptor Mimics (TCRms)
A vaccine generates active immunity. It stimulates the immune system to begin making its own antibodies. Passive immunity is another way to protect the body against unwanted invaders. It is achieved by providing the body with an artificial supply of antibody that circulates in the blood stream. A TCRm is a monoclonal antibody that can target infected or cancerous cells, it confers passive immunotherapy. Herceptin, Rituxin, Xolair, and Remicade are all drugs that supply monoclonal antibodies to generate passive immune responses to cancer and autoimmune diseases.
This technology uses natural elemental-based chemistry that amplifies killing of cells targeted by antibodies. The lethal "arming" agent is metabolically safe and non-toxic to bystander cells. Pure provides the TCRm antibodies generated against the specific pathogenic epitope Pure has discovered. The TCRms are then “armed” to produce a significantly more effective immunotherapeutic.