Date: 2012-10-08
Type of information: Licensing agreement
Compound: StabyExpress™ system
Company: Delphi Genetics (Belgium) Merck&Co (USA)
Therapeutic area:
Type agreement: licensing
Action mechanism: Plasmid instability is a significant concern in protein production. Typically, protein-production processes require the use of bacterial plasmids as vectors carrying the gene to be over-expressed. It has been demonstrated that the growth rate of plasmid-bearing cells is significantly reduced relative to that of a plasmid-free host, simply because protein production (corresponding to the gene-of-interest over-expression) represents a significant burden on cellular metabolism. Antibiotic-resistance genes are the most common selectable markers used in fermentation procedures to avoid plasmid-free cells to survive and dominate the culture. However, contamination of the product or biomass by antibiotics (or genes encoding an antibiotic resistance) is unacceptable from a medical or regulatory perspective. The StabyExpress system is a stabilization system based on the use of antidote/poison genes naturally found in plasmids, chromosomes, and bacteriophages. The ccdB selection gene codes for a small stable protein (about 100 amino acids) whereas the ccdA antidote gene codes for a small unstable protein (about 90 aa) that neutralizes the selection protein. The kit combines two technologies (T7 expression and Staby plasmid stabilization) that allow high-yield protein expression and standardization of the production-protocol. In this plasmid-stability system, the antidote gene is introduced in the plasmid DNA under the control of a constitutive promoter. On the other hand, the selection gene is introduced in the chromosome of the bacteria. Expression of this selection gene is under the control of a promoter strongly repressed by the antidote protein. Hence, when the plasmid is present in the bacteria, the poison is not produced. On the other hand, when the plasmid is lost, the antidote is degraded and the production of the toxin is induced, causing cell death.
Disease:
Details: Delphi Genetics has announced a broad licensing agreement with a subsidiary of Merck & Co, for the use of the StabyExpress™ technology, which allows high yield, cost effective protein expression without the use of antibiotics. Cedric Szpirer, PhD, co-founder of Delphi Genetics and CEO explained: \"This is Delphi\'s first broad-based licensing agreement that covers potential use of the StabyExpress™ technology for protein based product in the areas of human and animal health.
Under the agreement, Merck&Co receives a non-exclusive license to use the StabyExpress™ technology for protein expression in research and product development. In exchange, Delphi is eligible to receive milestone payments associated with the development of Merck product candidates that utilize the StabyExpress™ technology, as well as royalties on sales of such products. Delphi also has licensing agreements with Sanofi-Pasteur, announced in June 2009, and with GSK, announced in September 2010.
Financial terms: The financial details of the agreement were not disclosed.
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