Cytonics Has Expressed and Purified an Enzymatically Active Recombinant Alpha-2-Macroglobulin Variant (Cyt-108)

JULY 10, 2018
Jupiter, FL:
Cytonics Corporation has developed a methodology for expressing and purifying recombinant A2M variants. Their lead recombinant variant, Cyt-108, has demonstrated enzymatic activity in in vitro protease inhibition studies. The company commissioned Goodwin
Biotechnology, a South Florida-based CRO, to develop the expression and purification procedures in accordance with the FDA’s guidelines for good manufacturing and laboratory practices. Goodwin conducted a series of experiments to optimize the growth conditions for the mammalian cell line expressing Cyt-108 and purify the large protein (720 kD) without sacrificing enzymatic activity. The laboratory was able to achieve a purity of 70% and overall yield of 10%. Goodwin has been commissioned to achieve a purity of ~99% and an overall yield of > 50%, which they expect to achieve by the end of 2018.

Cytonics’ recombinant A2M variants were developed as an improvement to their existing APICPRP technology, which concentrates naturally occurring A2M in a patients’ own blood for intraarticular injection into the afflicted joint. This procedure has demonstrated outstanding clinical efficacy, providing proof of concept for recombinant A2M technologies. The company’s lead drug candidate, Cyt-108, was determined to be almost twice as potent as the wild-type A2M. Cytonics anticipates initiating pre-clinical studies as soon as purity of 99% is reached.

“Expression and purification of our recombinant A2M variant, Cyt-108, is an impressive feat due to the enormous size of the protein. The fact that we were able to purify an enzymatically active protein was a huge relief, as our concerns that the protein would misfold once purified were alleviated. We are extremely confident that Goodwin Biotechnology will be able to achieve our final purity and yield goals.”

Joey Bose
President of Cytonics

About Cytonics:

Cytonics, founded in 2006, is a private research and development company focusing on molecular diagnostic and therapeutic products for chronic musculoskeletal diseases. The company developed the FACT diagnostic test which helps identify the source of back and joint pain and assists physicians in determining the most appropriate treatment. Cleared in January of 2014, Cytonics developed the Autologous Platelet-Integrated Concentrate (APIC) System as a platelet-rich-plasma (PRP) device. In addition, the company also developed autologous cell-free A2M
concentrate and other forms of A2M therapeutics, including optimized recombinant forms. The company is currently pursuing pre-clinical studies for their lead recombinant A2M candidate, Cyt-108.

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