Earlier this year, Massachusetts-based firm Xenetic BioScience received a $3m (€2.8m) milestone payment from Shire relating to advancement of its long-acting form Factor VIII candidate SHP656 in a Phase I/IIa clinical study.
Discussing its end of year 2016 figures Tuesday, Xenetic BioScience said its partnership on the haemophilia A treatment could net the firm as much as $100m in payments and royalties if the candidate reaches market.
“Our agreement with Shire covers a series of novel polysialylated blood coagulation factors, including SHP656 that utilise our PolyXen delivery system,” COO Jeff Eisenberg told stakeholders.
Xenetic’ proprietary technology attaches polysialic acid (PSA), a biodegradable polymer found in living systems, to Shire’s therapeutic blood-clotting factor, in efforts to improve its pharmacological property.
The PSA increases the molecule’s apparent size, which reduces systemic clearance rates while shielding the protein from other degradation pathways, the company claims, permitting optimisation of a target therapeutic's pharmacological properties.
Shire – itself a significant stakeholder in Xenetic having invested $13m to date – is looking to complete the Phase I/II trial for the candidate in the next few months.
“If the trial is successful, we expect Shire to move into a Phase 3 trial this calendar year, at which point we believe there will be much more visibility into this projects and its potential impact on Xenetic from our existing shareholders as well as prospective investors. And this is one of the main reasons that this year could be transformational for Xenetic.”
Commercial success will also help validate the drug delivery system and drive industry interest, Eisenberg added.
“The PolyXen platform has significant potential across a wide range of biologics and the potential to create products that can make a real impact in their markets. In that sense, we expect PolyXen to be a significant growth driver for us for years to come, and our plans include aggressive business development efforts to expand our collaboration pipeline,” he said.
“We believe that success of SHP656 would further validate our technology and help to accelerate our partnering efforts. Our goal is to enter into more early stage collaborations leading to demonstration of feasibility and ultimately to additional Shire like license deals.”
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