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Strengths of the LEX System

The Strengths of the LEX System include:

  • Production of Complex Proteins. We have not encountered a class of proteins that cannot be expressed by the LEX System. To date, as part of our research and development activities, we have produced more than 35 different proteins using the LEX System, including complex proteins that are challenging to produce in traditional production systems. For instance, the protein plasmin has been studied for several decades as a drug candidate for resolving blood clots, but production of full-length human plasmin at commercially viable levels has not been reported with any traditional recombinant production system. Our product candidate BLX-155, a recombinant full-length plasmin, can be produced at commercially viable levels using the LEX System.
  • Complex Protein Folding . Lemna is able to correctly produce proteins requiring folding or other complex processing, which is key to the efficient production of many proteins, including interferon alfa. Traditional production systems are unable to express interferon alfa that is correctly folded, therefore requiring a series of unfolding and refolding steps during purification that results in substantial yield loss and contributes to the high cost of production in these systems.
  • Optimization of Monoclonal Antibodies. The LEX System has demonstrated the capability to express monoclonal antibodies in which the glycosylation structure has been optimized to enhance the efficacy and potency of the antibodies.
  • Access to Product Candidates. The Lemna-based protein production system is a novel technology that we believe will provide us with multiple opportunities to produce proteins without conflicting with patent claims relating to the production of certain proteins in traditional production systems. For example, the LEX System allows us to produce the interferon alfa used in Locteron without conflicting with the patent claims covering the production of interferon alfa in a bacteria-based system.
  • Reduced Safety Risk. The LEX System contains no human or animal components, which can carry a risk of viral or other infectious agent contamination.
  • Reduced Capital Cost and Facility Timelines. We believe that the simplicity and other characteristics of the LEX System will result in capital investment requirements and timelines for implementation of manufacturing facilities that are substantially less than those associated with traditional systems.

We believe that the LEX System represents a novel technology platform because of the potential breadth of its production capabilities compared to other systems. The results of our research to date suggest that the LEX System has the ability to produce cytokines and other regulatory proteins, traditionally produced only in microbial systems, and monoclonal antibodies, produced today only in mammalian systems. In addition, we believe that our intellectual property position precludes others from using Lemna in the production of therapeutic proteins.

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