Sirona Biochem believes there is a strong commercial demand for the development of superior biological ingredients.

Our chemistry technology platform can be used for the development of enhanced inducers for recombinant protein production and adjuvants for the preservation of stem/islet cells.  More specifically inducers could be valuable in the production of insulin, human growth hormone, vaccines, interferon (anti-viral/bacterial/parasitic/tumor) and interleukin-2 (immune), and other recombinant protein produced by E. Coli.

Sirona Biochem’s biological ingredients program includes the development of biological inducers and adjuvants  for biological preservation.

Inducers

Inducers are biological reagents that are used in laboratories for gene expression, an important process for the production of recombinant proteins.  Our product, IPGMim, is in development for the production of recombinant protein by E. Coli.  In the mid-eighties, biotechnology revolutionnized insulin production when it was discovered that inserting an appropriate gene into a host organism i.e. E. Coli could produce this “recombinant protein”.

We have applied our proprietary fluorination process with the aim of producing valuable inducers that initiate protein expression more efficiently.  It is our goal to develop enhanced inducers which are more stable and have less toxicity for the host organism and improved duration of gene expression.

• Status & Milestones

Using gold standard tests, we are currently testing our inducer compounds and comparing them with similar inducers.  Our aim is to demonstrate that our molecules can successfully induce the expression of recombinant proteins in E. Coli and to compare the molecules’ efficiency, stability and protein yield against commercial products.  An initial evaluation has been conducted successfully on β-Galactosidase expression. An experienced contract research organization has been selected for further evaluation of our program.  Several tests will be conducted over the next few months to validate the viability of our compounds on different types of recombinant protein.

• Market Opportunity

There are several recombinant proteins in clinical development for CNS disease, blood disorders, cardiovascular diseases, cancer and Type 1 & 2 diabetes.  Hematology, diabetes, endocrinology and oncology will be the most valuable therapeutic areas for the development of recombinant protein production.

The market for recombinant proteins is expected to significantly rise with sales forecasted to reach $75.8 billion in 2012, a 50% increase from 2007.

There are disadvantages of current inducers that are used in the production of proteins in E. Coli.  One is that it must be stored at -20°C.   This requires appropriate on-site storage at production facilities as well as appropriate transport.  A second disadvantage is that the product undergoes degradation under cell culture conditions of the bacteria.

There is a recognized need for more stable inducers for the production of proteins in E. Coli to improve protein expression and facilitate production.

Our inducer for protein production in E. Coli has been shown to be stable at ambient temperature and therefore can be stored and transported more economically than current inducers.

Adjuvants for Biological Preservation

Our scientists are developing glycopeptides as an adjuvant to be used for organ, tissue and cells preservation.

Research shows that freezing resistance in Antarctic fish is due to blood serum glycoproteins that lower the freezing temperature to below subzero.  This helps inhibit the growth of ice and protects cells from hypothermic damage.  These antifreeze glycoproteins have an unusual structure that can protect species from cold induced damage.

By mimicking these glycoproteins, modified glycopeptides can be developed to protect organs destined for transplant.  Currently, heart and lungs can be preserved for up to six hours, limiting its transport time for organ transplantation.  By developing these modified glycopeptides, we aim to preserve the integrity of organs for a longer period of time, leading to an expanded geographical reach for organ matching and transplantation.  Our goal is to develop a family of compounds with specific applications for soft tissue, stem cells, islet cells and other sensitive cells preservation.

• Status & Milestones

Sirona Biochem’s subsidiary, TFChem, has worked extensively on the development of new processes to prepare families of modified glycopeptides.  Our scientists are the first to have developed these types of compounds (Patent EP10306493). Studies are underway to evaluate their efficiency as adjuvants for cells/tissues preservation.