Pro Bono Bio Group (PBB) exercised an option to take out an exclusive, global license to PolyTherics’ TheraPEG™ platform for use in the development and commercialization of a TheraPEG-FVIII product designed to have a longer half-life than existing FVIII products. The firms inked an agreement in May evaluate the feasibility of using PolyTherics’ TheraPEG technology for developing a long-acting PEGylated formulation of Factor VIII.
PBB already has exclusive global licenses to the technology for use in the development of long-acting forms of Factor IV for the treatment of hemophilia B, and Factor VIIa for the treatment of hemophilia A or B in patients who demonstrate immune responses to FVIII or FIX respectively, and also for use in trauma applications.
Exercising of the latest option for the Factor VIII product has triggered a milestone payment to PolyTherics. The firm will also receive development and regulatory milestones, plus sales royalties. “We are pleased to have been able to confirm that the significant increases in half-life we have seen with TheraPEG Factors VIIa and IX can also be shown with TheraPEG Factor VIII, remarks Michael Earl, PBB’s COO. “The benefits of prophylaxis for patients with more severe forms of hemophilia are well-established, and the development of this further product will make patients’ lives simpler and enhance compliance, whilst providing a significant opportunity for our alliance with PolyTherics.”
PolyTherics has developed a range of technologies and polymers for the site-specific conjugation and PEGylation of proteins, peptides, and antibodies. These include the low-viscosity polymer PolyPEG, a glycopolymer technology GlycoPol™ for targeting specific cells and tissue, and three PEGylation platforms: TheraPEG (PEGylation across a native disulfide bond), CyPEG™ (PEGylation at a thiol on a free cysteine); and HiPEG™ (PEGylation at a histidine residue).
PBB is an Anglo-Russian pharmaceutical firm formed a year ago as a result of a three-year project by Celtic Pharma in the U.K., which combines global financial and pharmaceutical expertise from the U.K. with international capital and matched funding from RUSNANO in Russia. Its first marketed product, Flexiseq™, is a nonpharmaceutical, topically applied sequessome nanoparticle-containing gel for the treatment of joint pain associated with osteoarthritis. Formulations are also in development for the topical treatment of conditions including psoriasis, eczema, and seborrheic dermatitis. In addition to its blood products pipeline, PBB is in addition developing anti-infectives against key organisms including including MRSA, Clostridium difficile, and tuberculosis, based on the re-engineering of existing drug families. The firm has also invested in Dialog Devices, which is developing a five-minute point-of-care diagnostic for peripheral artery disease.
PBB has been established with a humanitarian ethos that aims to donate medicines to the East African Community (EAC), and spearhead research into the development of treatments for some of the most prevalent and devastating diseases on the continent. The firm says it aims to establish a charity to support this work.