Application of Technologies
Recombinant Protein Production
Drug costs and profit margins can be significantly impacted by the choice of a production system. Neugenesis' technology utilizes the filamentous fungus Neurospora crassa as its host cell to produce recombinant proteins, including heteromeric proteins, such as human monoclonal antibodies, certain hormones, and cell surface receptors. The importance of this development is twofold:
- Economical production of complex proteins in sufficient quantities
remains a problem in the biopharmaceutical industry.
- Key patents exist on the manufacture of monoclonal antibodies, which
may prevent the development of many cost-effective monoclonal antibody-based
products.
Neugenesis' protein expression technology offers an alternative solution
to these problems. Neugenesis is targeting heteromeric proteins for its
expression systems, as well as proteins that are difficult to produce,
or cannot be produced in other systems.
Combinatorial Biology
This dilemma of long lead times and high cost to develop new drugs translates
to a clear opportunity for technology that can not only accelerate the
drug discovery process, thereby increasing the number of products entering
the pipeline, but that can also efficiently advance candidates through
the clinical development process. Neugenesis' approach to this problem
is to create better-quality candidates which are engineered to overcome
the hurdles of drug development, and increase the probability of success.
The better a protein candidate can be engineered to affect the intended
disease, the more likely it will achieve clinical success and FDA approval,
and the less likely its markets will be undermined or replaced by a competitor's
rival drug.
Neugenesis' combinatorial biology technology has applications for both
drug discovery and development:
- Creation of numerous new complex proteins from an already identified
hit -- Since the system is designed to fine-tune molecules, libraries
are likely to yield several optimal lead candidates once they are screened.
- Salvage failed candidates and increase the efficacy of development
candidates -- At least 60-80% of drug candidates fail in the clinical
development process. Neugenesis' technology has the potential to efficiently
reduce or eliminate functional problems with a protein drug candidate,
such as harmful side effects or low binding affinity. The technology
can also be used to optimize protein therapeutic candidates, improving
the odds of passing human clinical trials and achieving FDA approval.
- Incremental innovation of second and third generation drugs -- There is a clear danger of drugs being surpassed by a competitor's slightly more efficacious drug. In fact, non-novel drugs represent over 75% of the top 50 selling drugs worldwide. Neugenesis' system is designed to quickly create stronger biotherapeutic candidates, providing a competitive advantage over companies developing similar products.
