Technology & Benefits.
Protein Pharmaceuticals
Half life extension is a critical aspect of developing a successful protein pharmaceutical, as not all efficacious payloads have natural half lives that are amenable to reasonable dosing intervals or regimens.
Current approaches to half life extension have met with modest success. Significant limitations of these approaches include complex conjugation or other similarly challenging manufacturing steps, heterogeneous product mixtures, increased cost of goods, renal tubular vacuolation, and injection site complications amongst others. Therefore, novel solutions are needed to address this important issue.
21st Century Half-Life Extension Technology
In the frame of a Therapeutics Development and Collaboration Agreement with its technology partner, XL-protein GmbH, DNX has licensed the highly innovative PASylation? technology as half-life extension/drug delivery platform to creating the selected DNX drugs. PASylation is a biological alternative to PEGylation, which is unique in its flexibility: it can be deployed either as a molecular biology-based, recombinant peptide technology mode, or in a chemical conjugation mode, to achieving dramatic increases in half-lives when compared with the unmodified biopharmaceutical drug. Together with the proven biodegradability of the PAS biopolymers, both modes are promising and provide for potentially disruptive advances relative to the current PEGylation methods in use.
Integration: DNX will deploy its own proprietary technologies and its core strength, with 250+ person-years of experience with proteins, to seamlessly integrate the novel PASylation platform for the efficient design, clinical development and GMP production of the select drugs, using high-yield industrially-robust processes.
Validation: The PASylation platform has been licensed by XL-protein for defined products to a number of international biopharma companies. XL-protein has generated in vivo efficacy and Proof-of-Concept data on more than 15 therapeutically-important drugs, of which more than 5 have progressed through preclinical validation and two are scheduled for IND application filing in 2017.
TECHNOLOGY BENEFITS
The PASylation drug delivery system is highly tunable and is designed to offer improved half-life, pharmacokinetics, pharmacodynamics, bioavailability, solubility and overall enhanced patient compliance and safety.
TECHNOLOGY BENEFITS INCLUDES:
"Tunable"
The ability to precisely control the sequence and length of the PAS polymer allows for the creation
of exceptionally long half-lives to precisely meet medical needs.
"Inert/No Toxic Metabolites"
The human body produces no extracellular enzymes that degrade PAS polymers, and there are no known
receptors or binding proteins.
"Biocompatible/Biodegradable"
The PAS polymer is made of natural amino acids, thus allowing physiological metabolization and causing
no harm upon degradation inside cells.
"Flexible"
A variety of customizable PAS polymers are available with extraordinarily "monodisperse" structure, demonstrating single-peak
uniformity. PAS polymers can be attached to therapeutic molecules either through genetic fusion or chemical conjugation.
"Superior"
The PAS polymers have the potential to generate novel drug conjugates with significantly enhanced therapeutic
value over unmodified forms of current drugs.
Patient Benefits
The half-life extension technologies deployed by DNX offers a paradigm shift in patient care and better compliance in multiple therapeutic areas to improve the quality of life for millions of patients.
The drug delivery platforms are natural and biocompatible unlike other delivery systems that are synthetic and merely tolerated by the body. Such platform(s) benefits patients with its non-toxic potential and its ability to increase the half-life of a drug, requiring less frequent administration. These attributes lead to increased compliance and safety, and thus is a transformative advancement for those with life-long diseases.
Potential For New IP
The half-life extension technology(s) utilized by DNX presents a new way to enhance pharmaceutical pipelines by lengthening the patent life of proprietary drugs. This allows for either regaining or increasing market share.
The delivery platform(s) is unique, bio-superior, safer and more effective than many delivery platforms being developed. It is customizable and adaptable, making it easier to improve existing drugs and extend patent life. These additionally offer greater quality and control of manufacturing, ensuring a secure supply chain.