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Our precision therapeutics cancer vaccine platform supports our research and development activities for our PolyPEPI™ Immunotherapy Cancer Vaccine Family and our diagnostic tests.

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PolyPEPI™ Immunotherapy Cancer Vaccine Family

Using our cancer vaccine platform we completed the preclinical development of PolyPEPI™ immunotherapy vaccines for colorectal cancer, breast cancer, lung cancer, ovarian cancer, glioma, melanoma, and leukemia. We expect to advance the colorectal cancer vaccine to the first-in-man trial in 2017.

 

Our in silico clinical trials predict our vaccines to be effective in significant proportion of cancer patients, with reliable predictions of individual responses to treatment and minimal safety concern. We plan to conduct clinical trials that will enroll only those cancer patients identified by our companion diagnostic test to be likely responders.

 

Each PolyPEPI™ vaccine has four essential immunological design features:

 

  • Safety – attacking only cancer cells and not healthy cells
  • Potency – killing multiple varieties of cancer cells
  • Efficacy – producing an immune response in a significant proportion of cancer patients
  • Personalization – identifying likely responders before treatment
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PolyPEPI™ Companion Diagnostics (PolyPEPI CDx)

Each of our PolyPEPI™ cancer vaccines in development is accompanied by a companion diagnostic – a test to predict whether a treatment will be effective in a particular patient. Each PolyPEPI™ CDx enables us to tailor our vaccines to the genetics of cancer patients.

 

Our PolyPEPI™ CDx has four essential immunological design features:

 

  • Personalization – matching patients with PolyPEPI™ vaccines using HLA sequence data
  • Specificity – each PolyPEPI™ vaccine is accompanied by a specific PolyPEPI™ CDx
  • Potency – selecting responders with immune responses to kill multiple cancer cells
  • No tumor biopsy – DNA sequencing is performed from saliva samples

 

To support our PolyPEPI CDx development, we have completed clinical validation of the PEPI Test and Melanoma Screening Test, and received EU market approval.

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PEPI™ Test

Our PEPI™ Test uses genetic data obtained from a saliva or blood sample to predict an individual’s antigen specific immune response. PEPI™ Test data provide our basis for developing cancer vaccines and companion diagnostic tests.

 

In 2015, the PEPI™ Test obtained European Union market approval as a tool for identifying likely responders to cancer vaccines. It is validated as an in vitro diagnostic device indicated to predict the antigen specific cytotoxic T cell responses of HLA genotyped subjects.

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Melanoma Screening Test

While developing our PolyPEPI™ melanoma vaccine, our immune-genetic data analysis revealed a higher incidence of melanoma in people with certain genetic profiles. This led us to develop our Melanoma PEPI™ Test (MPT), which has completed clinical validation as a test for identifying individuals at high risk of developing melanoma, based on genetic information obtained from a blood or saliva sample.

Precision cancer vaccines

In Vitro Diagnostics