Xenetic Biosciences, a biopharmaceutical company focused on advancing immune-oncology technologies addressing hard-to-treat cancers, has entered into a manufacturing agreement with Catalent Pharma Solutions, which will include cGMP manufacturing for the company’s recombinant protein, Human DNase I.

“We are pleased to be working with a preeminent contract development and manufacturing organization (CDMO) such as Catalent, and to have the opportunity to leverage their broad expertise and successful track record with early-stage development through commercial manufacturing,” said Jeffrey Eisenberg, CEO, Xenetic. “We are excited to take this step forward on the path to the clinic and look forward to investigating systemic DNase as an adjunctive therapy for locally advanced or metastatic cancers.”

Vikalp Mohan, global vice president, head of drug substance, Catalent Biologics, said, “This agreement is an important step towards long-term collaboration between Catalent and Xenetic. We look forward to leveraging Catalent’s proven biomanufacturing expertise at our site in Madison, WI to support the advancement of Xenetic’s DNase clinical development program and accelerating their path to first-in-human studies.”

Xenetic’s interventional DNase based oncology platform is aimed at improving outcomes of existing treatments, including immunotherapies. The company exclusively licensed intellectual property for uses of DNases in cancer include systemic co-administration of DNases along with standard therapies, including chemotherapy, radiation and checkpoint inhibitors, or along with conventional chimeric antigen receptor (CAR) T therapies.

The DNase platform is designed to target neutrophil extracellular traps (NETs), which are weblike structures composed of extracellular chromatin coated with histones and other proteins. NETs are expelled by activated neutrophils, in response to microbial or pro-inflammatory challenges. However, excessive production or reduced clearance of NETs can lead to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and metastasis.

The company is working toward its planned first-in-human study to evaluate DNase combined with immune checkpoint inhibitors or chemotherapy.