From Jeans to Genes – A Story of Dyadic International, Inc.

Introduction:

July, 2003 -- What is the relationship between jeans and genes, or volcanic lava and pharmaceuticals? As highlighted by one biotechnology company's entrepreneurial path, two seemingly unrelated things are in fact closer than you may think.

Dyadic, a private biotechnology company based in the tropical coastal Florida town of Jupiter, has literally evolved from "jeans to genes". Here, in an unlikely place thousands of miles away from the biotechnology hotbeds of Silicon Valley or Boston, next to the turquoise waters of the Atlantic visited by millions of tourists seeking rest and relaxation, Dyadic's researchers are working tirelessly to find a solution to the pharmaceutical industry's biggest challenge – how to manufacture drugs more quickly and cost effectively.

The genomics revolution that took place at the end of the 20th century has helped discover thousands of new gene targets, which many thought would enable and speed up the development of genomics-based medicines. This, in turn, would produce less expensive drugs for many incurable diseases. Paradoxically, these efforts have not yet improved the speed, or decreased the cost, of drug discovery and development.

The pharmaceutical industry wishing to convert genes into drugs still faces several bottlenecks. One of the major bottlenecks is the industry's lack of ability to produce sufficient quantities of proteins from newly discovered genes for use in laboratory and clinical trials.

A Historical Perspective:
As we remember from high school biology lessons, every living organism contains a hereditary blueprint - a collection of genes - each of which contains the information necessary for the organism to make a particular protein. Proteins come in a variety of shapes and sizes, and virtually all life processes are mediated by proteins. Many of the genes found among the variety of different organisms in nature lead to the production of proteins that are useful products.

One of the largest classes of useful proteins consists of enzymes, which are catalysts (or moderators) for specific chemical reactions. These enzymes are useful in a number of industries including pharmaceutical, diagnostic, textile, and others. An increasingly important class of proteins consists of those used as therapeutic agents. These biopharmaceuticals are used to treat a variety of diseases and afflictions.

So, how did Dyadic evolve from jeans to genes? In the late 1970's, Mark Emalfarb, Dyadic's Founder and CEO, was importing garden stones, which included volcanic lava rock (pumice stone) when he learned about the emerging utilization of pumice in Europe to stone wash blue jeans. In the early 1980's, Dyadic began promoting and selling pumice stones to the large U.S. jeans manufacturers, such as Levi Strauss and Wrangler. In 1987, Dyadic began to sell specialty chemicals and enzymes, purchased from other manufacturers, to its existing customer base.

In the early 1990's Mr. Emalfarb made a major decision to enter the promising area of biotechnology to develop his own industrial enzymes. His search led him to the former Soviet Union and the formation of a business collaboration, which exists to this day, with premiere scientists at Moscow State University and The Russian Academy of Sciences. This collaboration has led to successful commercialization of several patented industrial enzymes for textile, animal feed, and other markets.

The most important discovery, however, was the discovery of a novel fungus used to produce many of those enzymes. After its discovery, work on this fungus, called C1 for Chrysosporium lucknowense, was moved to the United States. In 1996, Dyadic discovered during its ongoing C1 improvement program that it had created a novel mutant with several unique genetic properties that made it an excellent candidate for economical production of foreign genes and their protein products. With this discovery in hand, Dyadic began in 1997 to focus a significant portion of its research on exploring and improving the unique properties of its novel C1 strain.

The present:
The patented C1 integrated Gene Expression and Gene Discovery systems provide Dyadic and its business partners with the only integrated system to rapidly discover, optimize, develop, and manufacture complex genes and their protein products from the Earth's entire gene pool. Dyadic intends to be a global leader in functional genomics and protein expression through the discovery, development, and manufacturing of novel products derived from the DNA of complex living organisms (including humans).

Dyadic believes its systems overcome the limitations of the existing techniques of gene discovery and product development, which are limited in their ability to efficiently access the full spectrum of biodiversity, ability to produce sufficient quantities of proteins for use in laboratory and clinical testing and ability to bring biological drug leads to market.

Today, Dyadic's integrated platform not only addresses each of these obstacles individually, but also provides a total package for bringing products from discovery to commercialization quickly and significantly less expensively. Its Gene Discovery technology uses state-of-the-art robotic screening to identify therapeutically relevant genes. Dyadic's Gene Expression system converts those genes into their protein products.

Finally, utilizing its Product Development expertise and Large-scale Manufacturing know-how and alliances, Dyadic brings those products to market economically. All of the above technologies use a single biological host, Dyadic's proprietary C1 fungal host system. The company has exploited C1's natural ability to rapidly produce proteins in designing its paradigm-defining platform for gene discovery through product manufacturing. Using an integrated platform increases the odds of commercial success while shortening the R&D timeline.

Most importantly, Dyadic's systems also virtually ensure that any useful gene that is discovered can also be converted into a product, and the product can be produced in commercial quantities at economically viable levels.

The promise:
Using the Dyadic C1 technology, pharmaceutical companies can make drugs faster and cheaper. Moreover, thousands of promising drug leads that failed or were deemed unfeasible to produce because pharmaceutical companies could not manufacture sufficient amounts of protein, can be "rescued", put back into clinical trials and turned into safe and effective drugs.

The promise of Dyadic's technology does not stop with the pharmaceutical and biotechnology industries. The textile industry is already utilizing Dyadic's enzymes as a tool for supporting new fashions as well as improving the basic processing steps in the making of textiles. The pulp and paper industry, which already uses some of Dyadic's products, is facing a growing trend of the recycling of paper, where enzymes play a key role. Other examples of industries, where Dyadic's technology can be utilized include industries such as brewing, biofuels, agriculture & animal feed, chemical processing and others.

Conclusion:
So, in its unique way Dyadic has literally evolved from jeans to genes. As the company battles the ever-present scientific and financial challenges of developing and commercializing its promising technology, it relies on its long history of creativity, innovation, survival and focus on commercializing its discoveries for the benefit of human health, well-being and quality of life.

With its focus on unraveling the secrets of life to make the world a better place to live, one gene at a time, its pursuit is admirable and much needed.




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