Xenetic Biosciences and Catalent sign agreement for cGMP manufacturing


Xenetic Biosciences and Catalent Pharma Solutions have signed an agreement for the cGMP manufacturing of Xenetic’s recombinant protein, Human DNase I.

As part of the agreement, Catalent will use its biomanufacturing capabilities in Madison, Wisconsin to advance Xenetic’s DNase clinical development program into first-in-human studies.

Xenetic’s DNase-based interventional oncology platform aims to improve the outcomes of current therapies, including immunotherapies.

Xenetic has obtained an exclusive intellectual property license for the use of DNases in oncology, including the systemic co-administration of DNases with standard treatments, such as chemotherapy, radiation therapy and checkpoint inhibitors, or in combination with standard chimeric antigen receptor (CAR) T therapies.

The DNase platform can potentially act on neutrophil extracellular traps (NETs), which are web-like structures made of extracellular chromatin coated with histones and other proteins.

In response to microbial or pro-inflammatory challenges, activated neutrophils expel NETs. Overproduction or decreased clearance of NETs can cause serious inflammatory and autoimmune pathologies and create pro-tumorigenic niches for cancer growth and metastasis.

Currently, Catalent plans to conduct the first-in-human study to evaluate DNase in combination with immune checkpoint inhibitors or chemotherapy.

Jeffrey Eisenberg, CEO of Xenetic Biosciences, said, “We are delighted to be working with a preeminent contract development and manufacturing organization such as Catalent, and to have the opportunity to leverage their extensive expertise and track record. successful with early development through commercial manufacturing.

“We are excited to take this step forward in the clinic and look forward to studying systemic DNase as an adjunct therapy for locally advanced or metastatic cancers.”

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