Benzinga | Feb 16, 2021 07:36AM EST

Xenetic Biosciences, Inc. Announces Partner's Filing Of Registration Dossier In Russia For Epolong Product Candidate That Utilizes Xenetic's PolyXen Platform Technology

* PJSC Pharmsynthez is leveraging Xenetic's PolyXen(r) technology to improve the pharmacological properties of its Epolong product candidate pursuant to a royalty-bearing collaboration agreement

* Russian registration filing of Epolong, a polysialylated form of recombinant human erythropoietin, follows previously reported positive Phase 3 data for the treatment of anemia in patients with chronic kidney disease

FRAMINGHAM, MA / ACCESSWIRE / February 16, 2021 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART(tm), a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, today announced its partner, PJSC Pharmsynthez ("Pharmsynthez"), has reported in a press release that it has started the registration phase of Epolong (erythropoietin and polysialic acid conjugate) by filing a registration dossier to obtain approval of Epolong in Russia for the treatment of anemia in patients with chronic kidney disease. The registration dossier is based on previously reported data from Pharmsynthez's Phase 3 clinical trials of Epolong in Russia, which reportedly demonstrated the efficacy of Epolong and its potential to reduce side effects. Pharmsynthez is leveraging Xenetic's PolyXen(r) technology to improve the pharmacological properties of its Epolong product candidate pursuant to a royalty-bearing collaboration agreement between the Company's wholly-owned subsidiary, Lipoxen Technologies Limited, and Pharmsynthez's wholly-owned subsidiary, SynBio LLC.

"The registration filing in Russia for Epolong represents an important advancement for Pharmsynthez and the Epolong program. If accepted and approved in Russia, Epolong would be the first approved product incorporating our propriety PolyXen delivery platform technology," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

Pharmsynthez reported in its press release that it expects that the Russian stage of registration activities will be completed in 2021 and that it will be able to start production of Epolong as early as Q1 2022.

In clinical and preclinical settings, therapeutic proteins polysialylated with the PolyXen platform have been shown to have extended circulating half-life, improved thermodynamic stability and resistance to proteases, while retaining pharmacological activity. PolyXen has been demonstrated in human clinical trials to confer prolonged half-life on biotherapeutics such as recombinant human erythropoietin and recombinant Factor VIII ("rFVIII"). PolyXen has potential utility in other molecule classes such as peptides and small molecules. The Company is leveraging its PolyXen technology through an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.

About Pharmsynthez

Pharmsynthez PJSC (LIFE) is a Russian pharmaceutical company that develops new medicines, drug technologies for organ-specific delivery, and innovative methods of manufacturing pharmaceutical ingredients. The company is engaged in production and sale of medicines for the treatment of respiratory diseases (original OM) as well as active pharmaceutical ingredients (API). The company has a research and production complex in Kapitolovo, commissioned in 2001. Pharmsynthez actively cooperates with North American, Canadian and European companies in the field of chemical compounds and API production.

About Xenetic Biosciences

Xenetic Biosciences, Inc. is a biopharmaceutical company focused on progressing XCART(tm), a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens. The Company is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient's malignant tumor cells for the treatment of B-cell lymphomas. XCART(tm) has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications.

Additionally, Xenetic is leveraging PolyXen(r), its proprietary drug delivery platform, by partnering with biotechnology and pharmaceutical companies. PolyXen(r) has demonstrated its ability to improve the half-life and other pharmacological properties of next-generation biologic drugs. The Company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.

For more information, please visit the Company's website at www.xeneticbio.com and connect on Twitter, LinkedIn, and Facebook.