Shares of biotech company Xenetic (XBIO) has soared 302% since market open at the time of writing. The company is focused on advancing XCART, a personal CAR T platform technology targeted at tumor specific neoantigens.
Xenetic’s partner, PJSC Pharmsynthez has reported in a press release positive data from Phase 3 clinical trial leveraging PolyXen. The leverage provided development of a treatment for anemia in patients with chronic kidney disease (CKD).
PolyXen is Xenetic’s patent-protected platform technology designed for protein or peptide therapeutics. It enables next gen biological drugs by the prolonging of a drugs circulating half-life and potential to improve other pharmacological properties.
The technology was used to develop Epolong (also known as ErepoXen or PSA-EPO), a polysialylated form of recombinant human erythropoietin, a hormone produced by the kidneys to promote blood cell production. Pharmsynthez reported in its press release that Epolong is under investigation with the goal of reducing the required dosing frequency and reducing potential side effects, as compared to existing EPO products.
The data study
As reported in the press release issued by Pharmsynthez, the pivotal Phase 3 multi-center randomized study was conducted in Russia by Pharmsynthez and was designed to study the efficacy, safety and tolerability of Epolong in comparison with Aranesp® (darbepoetin alfa), the current leader in the long-acting erythropoietin segment.
The study enrolled approximately 150 patients with CKD across 36 medical institutions. The results of the study indicated that Epolong was non-inferior to Aranesp with respect to primary and secondary endpoints. Furthermore, the proportion of patients who achieved the target hemoglobin range (10.0-12.0 g/dL inclusive) during the evaluation period was 74% in the Epolong group versus 52% in the Aranesp group.
Pharmsynthez also reported that the study revealed that the proportion of patients who exceeded the target threshold level of hemoglobin (12.0 g/dL) was 3.5 times greater in the Aranesp group than in the Epolong group (34.7% versus 10.0%, respectively).
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.
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