Pro Bono Bio Group plc and PolyTherics Limited have announced progress on their haematology alliance to produce longer-acting versions of blood factor proteins.
The lead programme, for the development of TheraPEG™ Factor IX, has shown good technical and scientific progress and the parties have extended their agreement to actively pursue the development of a further blood factor product, TheraPEG™ Factor VIIa.
In addition, encouraged by the results achieved with these two programmes they have embarked on a feasibility study to assess the potential of a TheraPEG™ Factor VIII product.
PBB affiliates and PolyTherics have been working together to develop a longer-acting version of Factor IX using PolyTherics’ TheraPEG™ technology to conjugate poly(ethylene) glycol (“PEG”) to the protein.
PBB successfully completed a preclinical pharmacology study with TheraPEG™ Factor IX in 2011 and PolyTherics has now transferred its TheraPEG™ PEGylation process for this protein to PBB’s biomanufacturing affiliate to enable the production of larger quantities of this longer-acting blood factor for further development.
Completion of the technology transfer process triggered a milestone payment to PolyTherics in April 2012.
The Parties have also recently signed an exclusive global license agreement to develop and commercialize a PEGylated version of blood factor VIIa, which again uses the PolyTherics’ site-specific TheraPEG™ conjugation technology.
This product has successfully completed preclinical pharmacology studies and the TheraPEG™ PEGylation process is now being transferred to enable PBB’s biomanufacturing affiliate to produce material for further development.
PolyTherics is due to receive further development and regulatory milestones as well as royalties on future worldwide product sales under the terms of the TheraPEG™ license agreements for Factor IX and Factor VIIa. Clinical development of both products is expected to be initiated within the next 18-24 months.
In addition to the two license agreements, the Parties have signed an exclusive option agreement to develop a PEGylated form of blood factor VIII under a feasibility programme.
The option agreement includes a pre-agreed exclusive global license for TheraPEG™ Factor VIII.
John Mayo, CEO of PBB commented, “Pro Bono Bio has invested heavily in haematology and this partnership, together with our own internal development activity, is now bearing fruit. We are now confident of producing new products with life-changing benefits for haemophiliacs all over the world.”
John Burt, CEO of PolyTherics commented, “Progression of both TheraPEG™ Factor VIIa and TheraPEG™ Factor IX towards the clinic is an exciting development for PolyTherics and completion of the technology transfer reinforces our confidence in TheraPEG™ as an approach to enable the development of better biopharmaceuticals. We work flexibly with companies so that key stages of their programmes, such as technology transfer, can be built into agreements at the point which best suits our partners’ own resources and development strategy”.