Is a Fungus Among Us the Key to Tomorrow’s Biologic Drugs?

(DGIwire) – If the word “fungus” stirs up nothing but unpleasant thoughts, it might be time to reconsider. Recall that a fungal organism was instrumental to the serendipitous discovery of the first true antibiotic, penicillin. In 1928, as Healio.com notes, Sir Alexander Fleming returned from a two-week vacation to find that a mold had developed on an accidentally contaminated staphylococcus culture plate. Upon examination of the mold, he noticed that the culture prevented the growth of staphylococci.

Ninety years later, some believe that many of the biologic drugs on pharmacists’ shelves might be developed with the help of a specific type of this class of organism. This scenario is the vision of a group of researchers who have been paying close attention to the potential of the fungus Myceliophthora thermophila, named C1.

According to Biocompare.com, Chinese hamster ovary (CHO) cells has been described as the “workhorse” method for creating certain complex molecules such as monoclonal antibodies. But although it is well-established today, a look at history shows that its dominance may have been largely the result of trial and error. One theory suggests that while CHO was never perfect, it became the leading method of biologic production because it struck a good balance between manufacturing considerations and safety considerations 30 years ago.

A spur to innovation, either in tandem with CHO or away from it, has come from industry regulators. In a July 2018 speech at the Brookings Institution, for example, U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D., commented on biopharma. According to Biocompare.com, the commissioner noted that while less than two percent of Americans use biologics, the medicines account for 40 percent of total spending on prescription drugs. Meanwhile, an industry survey conducted in 2017 by BioPharma-Reporter.com found that nearly half of biomanufacturing experts believe the industry is too reliant on CHO.

Dyadic International is involved in several collaborations to bring C1 to mainstream biopharmaceutical production, notes the article. One project, with the European Union, has demonstrated a high level of production of an antigen protein. Another collaboration is aiming to overcome gene expression challenges for two important therapeutic compounds. Dyadic is also working with the Israel Institute for Biological Research to advance C1 for producing certain vaccines, and investigating the potential of C1 for mainstream therapeutic enzymes and proteins.

“C1 is robust, versatile and easily manipulated for protein expression,” says Mark Emalfarb, President and CEO of Dyadic, who is among the industry observers showcased in the Biocompare.com article. “We believe this fungus holds great promise for changing the way biologics are made, which could have an impact on the industry as a whole by introducing new medicines and resulting in an improved state of care in the biologics market.”

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