Caisson Biotech announced the issuance of a new patent, US patent 9,370,583, by the US Patent and Trademark Office (USPTO) for long lasting recombinant heparosan Factor VIIa conjugate. The naturally occurring polysaccharide, heparosan, has proven to be as effective as polyethylene glycol (PEG) in prolonging the half-life of haemophilia FVIIa, but retains significantly higher activity (48 ± 4)%, as compared to (27 ± 1)% for a corresponding PEG conjugate. Results were presented at the recent World Federation of Hemophilia World Congress Conference.

While recombinant FVIIa is a safe and reliable option for treatment of bleeding episodes in haemophilia patients with inhibitors, a longer acting molecule is desirable for routine prophylaxis. PEG conjugation is effective in prolonging the in vivo half-life of FVIIa, however, at the expense of a significant reduction in activity. Caisson Biotech’s HEPtune is a new half-life extension principle based on the conjugation of a naturally occurring heparosan polysaccharide coupled to active pharmaceutical ingredients, providing enhancement of therapeutics. Heparosan can be produced chemoenzymatically, which allows for tailoring of size and incorporation of chemical handles for drug conjugation. The heparosan conjugation technology offers a novel approach to existing industry half-life extension technologies including PEGylation, Fc fusion to immunoglobulin, and Fc fusion to albumin.

Novo Nordisk entered into an exclusive license with Caisson in 2012 for haemophilia drug targets, which was later expanded in 2014. “Novo Nordisk, as a world leader in protein therapeutics, has been a strong foundational partner for Caisson. The partnership has helped identify strengths with our technology and has further validated performance and transferability of HEPtune for scale up and manufacturing. We look forward to continuing to support Novo Nordisk’s product innovation to improve the lives of patients, as well as to bring the benefits of HEPtune to the broader market,” said Dr. Breca Tracy, vice president of Caisson Biotech.

Caisson has engaged a New York-based investment bank to assist in the sale of the HEPtune platform in order to accelerate broad industry adoption and deliver heparosan’s clinical benefits to the maximum number of patients and indications. The proprietary platform has been proven in hemophilia, and additional opportunities are available in a wide range of other established billion dollar therapeutics/indications including insulin, diabetes, neutropenia, and for improved delivery of small molecules via nanocarriers, including liposomes and micelles.

Heparosan conjugation has been developed by Caisson and Presidential Professor Dr. Paul DeAngelis at the University of Oklahoma Health Sciences Center, and includes a robust US. and international patent portfolio enabling its clients to create new composition of matter patents by leveraging the patent protected drug delivery system.

Caisson is funded and managed by Emergent Technologies, Inc., an innovation solutions and technology commercialization leader headquartered in Austin, Texas.