CaPtivate
Pharmaceuticals
 





















































































Anne working

Technology

Company's CaP technology has been in development as a novel vaccines adjuvant (CaPtiVantTM) for injection or needle-free administration, for drug delivery via mucosal routes (e.g. oral/buccal, pulmonary), and in aesthetic medicine as a facial "line-filler" which was licensed to Medical Aesthetics Technology Corporation (MATC). CaP has also been used to develop an industrial process to selectively fractionate soluble milk proteins from milk caseins. The method was applied to isolate recombinant proteins (e.g. rhFIX, rhα1-AT) form milk of transgenic animals in a casein-free, clear supernatant fraction that can directly be fed into chromatography columns for further purification. CaPtivate owns the IP rights for the US Patent that was issued for this novel process. Recent preclinical studies indicated that CaP can also be utilized as a dietary supplement (CaPliMentTM) for calcium and phosphorus; it has properties that are superior to those of commercially available supplements.

CaP nanoparticles have shown to have excellent absorption capacity for bioactive molecules, are stable for years in aqueous suspension, as gel, or as spray-dried powder. In acute toxicity studies in Guinea pigs, CaP has been proven safe for administration orally, into muscles, under the skin, and via inhalation into the lungs. CAP technology has also been proven safe in human in a Phase I "safety and toxicity" study conducted under an approved IND in the U.S. It is stable for many years when stored as spray-dried powder or in aqueous suspension.

CaP Novel Vaccine Adjuvant

What is Vaccine Adjuvant?
The goal of vaccination is to stimulate the immune system of an individual to develop long term protection against an infection caused by a pathogen (bacteria or viruses).  In order to achieve this objective, either the live but attenuated form of the pathogen, the whole inactivated pathogen, or a purified component of the pathogen is administered in the body.  Many of the modern day vaccines are based on pure recombinant or synthetic antigens which are inherently poorly immunogenic, thus require the use of adjuvants to boost the immune response to vaccine.  Adjuvants, in the most traditionally sense, are the agents that are mixed in vaccine formulations to enhance the antigen-specific immune response in vivo. Currently in the USA and in the majority of countries, aluminum hydroxide (alum) remains as the only compound that is approved in human vaccines.

Demand for New Adjuvants
The vaccine industry has experienced significant growth over the past decade. U.S. demand for vaccines is estimated to grow from approximately $4.9 billion in the U.S. to approximately $20 billion by 2010. The two main driving forces in the market's growth will be entry into emerging third world countries, where alternative delivery is particularly desirable and the development of vaccines targeting new diseases that have not previously been covered by immunizations such as biodefense toxins and pandemic flu. Other examples of vaccines include pediatric, hepatitis, influenza, encephalitis, rabies, meningococcal, and veterinary vaccines.

In spite of the critical role of adjuvants for vaccine development, only a few new adjuvants have been successfully incorporated into human vaccines due to the high toxicity associated with many experimental adjuvants.  Despite being the only FDA-approved adjuvant in the US, alum has immunological limitations that hinder our ability to produce novel or improved vaccines. Alum mainly induces antibody (Th2) response but has little capacity to stimulate cellular (Th1) immune responses which are critical for protection against many pathogens. Since alum is neither suitable nor approved for mucosal administration, alum-adjuvanted vaccines also lack ability to induce mucosal protection thus are ineffective at providing first line of defense to infected cells.  Furthermore, being an inflammatory chemical, it can also cause serious systemic and local allergic reactions including eosinophilia, tissue irritation, granumolas, abscesses, or subcutaneous nodules at the site of administration.

Consequently, the lack of choice for safer, non-toxic, and effective adjuvants able to stimulate cellular immune responses and suitable for mucosal administration still remains as a major obstacle in improving current vaccines or developing new vaccines against many life-threatening diseases.  Availability of an efficacious mucosal adjuvant to produce both systemic and mucosal immunity would enable administration of variety of vaccine antigens using non-invasive routes.

Our CaPtiVantTM Vaccine Adjuvant TechnologyBottles ofCaP

Despite the presence of many adjuvants in development that are clearly more potent than alum, toxicity has been the single most important impediment in introducing them in human vaccines. This need and opportunity have been the driving forces in the development of our CaP nanoparticle vaccine adjuvant technology (CaPtiVantTM) and we believe that CaP has the potential to play a major role in this growing market.

Over the years, extensive preclinical data have been generated which show CaP's ability to enhance immunogenicity of existing vaccines and novel vaccine antigens after administered by injection or by mucosal routes. The safety and efficacy of CaP in vaccines has been demonstrated using various viral and bacterial antigens, such as seasonal flu (H3N2, H1N1), H5N1 avian flu, H1N1 swine flu, genital herpes (HSV-2), HIV, Epstein Barr, anthrax, malaria, hepatitis B, tetanus, tuberculosis. We demonstrated that CaP-adjuvanted vaccines can induce higher IgG and IgG2a (Th1-like) responses than alum, can induce mucosal IgA response. CaP produces insignificant IgE and only minimal local irritation when administered by injection or mucosal routes. We have also shown that CaP does not interfere with the native structure of the protein/peptide drugs and can enhance storage stability of the active component in the formulation. We also conducted preclinical vaccine studies as a subcontractor for the U.S. Department of Defense and presented promising results which further validates CaP's potential as a safer and needle-free alternative to injectable alum-adjuvanted vaccines. CaP vaccine adjuvant has also demonstrated dose sparing potential often leading to the use of lower vaccine dosage while maintaining or improving effectiveness and offering an improved safety profile.

Advantages of CaP Adjuvant (CaPtiVantTM)