Dyadic’s C1 gene expression technology has been heralded by the firm as a high-yielding, low-cost alternative to mammalian platforms, in particular the Chinese Hamster Ovary (CHO) cell line used in a number of commercial biologics including best-selling monoclonal antibodies Rituxan (rituximab), Humira (Abbvie) and Enbrel.
The C1 expression system is based on Myceliopthora thermophila fungus. Unlike tried-and-tested CHO cell lines, C1 is yet to have the regulatory validation of being used for commercial production, and despite demonstrating productivity of up to 80g/L – dozens of times more than with CHO platforms – the fungal expression system is far from an industry staple.
But this is changing, according to Dyadic’s MD of Business Development and Licensing, Matthew Jones.
Speaking on an investor call last week, he said Dyadic has been hearing discussions about switching from CHO to C1 “not just from Big Pharma, but also from the midsized pharma and large biotech who themselves are addressing the limitations that the CHO platform presents.”
He added Dyadic has signed an increasing number of deals with pharma firms but replacing mammalian cell culture with a fungal system “does take time.”
Confidentiality agreements restricted Jones from divulging the companies, but he said increased partnerships will validate the platform and help drive industry adoption.
“We need Big Pharma and we are getting Big Pharma,” he told investors. “And they would champion the regulatory and the opportunities going forward with us. And I think what we have announced and what we have been discussing today is how those collaboration are starting to take shape.”
After the call, Jones told this publication Dyadic has struck three deals this year alone, including with the Israel Institute for Biological Research and Mitsubishi Tanabe Pharma.
He also revealed data from a 2015 proof-of-concept study carried out by Sanofi Pasteur showing the safety and efficacy of C1 in producing preclinical influenza vaccines.
“This is further evidence Pharma is looking towards C1 as a true leading alternative to CHO,” he told Biopharma-Reporter.
Nearly half the respondents of a Biopharma-Reporter reader survey taken last year believed industry is too reliant on CHO expression systems.