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Novel Injectable Biomaterials and Drugs for Localised Therapy – Kuros Biosurgery has appointed Euro Japan to secure licensees and partners in Japan and Asia-Pacific.
The versatility of the Kuros technology makes it ideal for addressing a number of therapeutic areas, including spinal surgery, dermatology, drug delivery, and infection/pain control.


Full Platform of Enabling Technologies for Highly Effective Localised Therapy

Kuros focuses on three different aspects of localized therapy in which the product goal is to regenerate or restore the function of diseased and damaged tissue or to delivery a therapeutic locally.

Regenerative medicine : Ideally, one would like to regenerate the original injured tissue. Kuros uses proprietary combinations of matrices and bioactives to promote tissue re-growth.

Restorative medicine : In some cases it may not be possible to regenerate tissue at the injury site. In this case, Kuros' products aim to restore the functional activity of the lost tissue through the use of implanted synthetic polymeric tissue.

Local therapeutic delivery : Kuros is additionally evaluating localized therapeutics (proteins, peptides and small molecules) for localized drug delivery outside the fields of regenerative or restorative medicine.

1. Regenerative Medicine

In regenerative medicine the goal is to regenerate the original injured tissue. Kuros uses proprietary combinations of matrices and bioactives to promote tissue re-growth. The base matrix in regenerative medicine is either a natural – fibrin – or a synthetic polymer-based material (see below for more details).

Kuros technology enables bioactives to be linked into the matrix. Additional cell binding or cell signaling molecules may also be incorporated into the matrix to promote cell infiltration. The bound bioactives are released on cellular demand as the cells infiltrate the matrix, and act locally to direct the infiltrating cells to form specific types of new tissue. All of the matrix components used by Kuros have been extensively tested and have proven biocompatibility.

Kuros Fibrin Matrix Products (click here for more detailed scientific information)

Fibrin is an ideal biomaterial in that it is a naturally hemostatic, contains adhesion sites and proteolytic sites, and is widely used in many surgical specialities. However, natural fibrin does not contain bioactives that are necessary for directing cellular differentiation into specific tissue types.

In the body, the initial step in fibrin formation is the cleavage of fibrinogen by thrombin to form fibrin monomers. A self-assembly step then occurs in which the fibrin monomers form a non-covalently cross-linked gel. When a sufficient molecular size is reached, these precipitate to give a solid fibrin clot. However, such a clot lacks tensile strength. Kuros' Factor XIII is activated by thrombine to form the active enzyme Factor XIIIa, which covalently cross-links the fibrin clot network to form a cross-linked fibrin gel.

Kuros new tissue regeneration products have two key advantages –

  • Proprietary incorporation of bioactives into fibrin sealant matrix to present growth factors in a manner consistent with the normal biological mode of action (click here for more details).

  • A highly localized response which requires only very low doses of growth factor (click here for more details).

Kuros exploits the enzymology of fibrin sealant cross-linking chemistry to incorporate bioactives into the fibrin gel. A modified bioactive fusion protein or peptide is made recombinantly to contain both a bioactive and a Factor XIIIa substrate site. Mixing of this fusion protein with fibrinogen during the process of clot formation covalently incorporates the bioactive. The fusion protein or peptide can be engineered to contain a release switch by placing a protease-sensitive linker between the bioactive and the crosslinking substrate site. The bioactive is then released during cellular infiltration and remodelling of the material. This concept has been successfully demonstrated with several bioactives.

Kuros Synthetic Matrix Products (click here for more detailed scientific information)

Kuros synthetic regenerative products have two key advantages –

  • the proprietary incorporation of bioactives with a synthetic hydrogel matrix to present growth factors in a manner consistent with the normal biological mode of action. (click here for more details)

  • the use of the Kuros novel family of materials which, whilst synthetic, behave from a biological perspective as though formed from natural fibrin. Key advantages include control of mechanical properties including degradation kinetics, avoidance of the use of animal derived products, incorporation and presentation of bioactive factors, in situ formation for delivery via minimally invasive surgery, easy delivery and biocompatibility. (click here for more details)

Therapeutic bioactives are incorporated via free cysteine residues that are chemically or recombinantly incorporated into the bioactive. The bioactives are covalently bound into the hydrogel through the reaction of the cysteine residue with the acrylate residues of a hydrogel. Proteolytic degradation sites can be additionally incorporated between the cysteine linkage site and the bioactive, allowing enzymatically mediated release of the bioactive.

Kuros has taken this technology successfully into animal trials that have demonstrated good efficacy and validation of the technology.

2. Restorative Medicine

Kuros' products aim to restore the functional activity of the lost tissue through the use of implanted synthetic polymeric tissue. In restorative medicine the materials are based on polymeric precursors that are liquids prior to application and then cross-link in-situ to form polymer gels. Kuros proprietory technology involves cross-linked solids (details below) and allows the materials that are formed to be as hard as bone or as soft as facial tissue. The starting monomers react via gentle chemistries that react preferentially with each other, minimizing unwanted tissue or protein reactions.

Cross-linked Solids

Kuros uses a technology with synthetic materials that are formed as three dimensionally cross-linked solids in situ after mixing two fluid precursors. The chemical reaction has been designed specifically for biocompatibility, surgical speed and ease and suitability of the final implant. The liquid-to-solid transition permits full integration with minimally invasive surgical technique. The materials can be made with various combinations of strength, elasticity, mechanical properties, stability or degradability, and bio-functionality. The control of the material properties is controlled through the choice of the two components in the system.

3. Local Therapeutic Delivery

Kuros' two novel fibrin and synthetic technology platforms are broadly applicable to injectable-controlled-release of proteins, peptides and small molecules. In both platforms, the drug is encapsulated in biodegradable and biocompatible materials. Each platform offers customizable release profiles. A single injection can last from days to months, with the potential for even longer release. Injections are patient-friendly as they utilise small gauge needles.

Both platforms have the potential for:

  • Optional covalent, degradable linkage between matrix and bioactive

  • Injectable in-situ formation for use in minimally invasive surgery

  • Gentle crosslinking chemistry that does not react with most bioactives

  • Use of incorporation technology can lead to NCE, thus extending product life cycles and patent protection

  • Improved patient convenience and compliance by reducing dosing frequency

  • Improved safety and tolerability

  • Reduced adverse effects associated with peak/trough levels of other dosage forms

Partnering Opportunities

Kuros has already established partnerships and relationships with leading healthcare companies, protein development and manufacturing companies and chemical synthesis companies, including Baxter Healthcare; Straumann AG, Strathmann Biotec AG, Eugenex Biotechnologies and Cambrex. It is now looking to develop partnerships and relationships with companies in Japan and Asia-Pacific.

Kuros is working to develop products both in-house and with partners through several methods:

  • Partnerships for further development and marketing of products currently under development..

  • Partnerships with companies for development of Kuros materials for new indications.

  • Partnerships to test a partnering company's bioactives in combination with Kuros technology.

1. Partnerships for further development and marketing of products currently under development  

The Company has focused its own proprietary product development activities to date within the fields of bone and skin repair and on indications within these two fields where there is a clear unmet medical need. These products have demonstrated promising pre-clinical and clinical results.

Indication Patient Population Market Size Growth Potential Competition Kuros Product
Bone
Spinal Verteboplasty 200,000+ $100 million+ High Fragmented Phase I / II
Long Bone Fractues 100,000+ $100 million+ High Fragmented Phase I
Spinal Fusion 700,000 $650 million+ High Fragmented Pre-clinic
Skin
Venous Ulcers 1,000,000 $1 billion High Fragmented Phase I / II a
Diabetic Ulcers 500,000 $1 billion High Fragmented Phase I / II a

Kuros current in-house pipeline consists of:

  • Fibrin and synthetic based materials for dermatology applications, including chronic wounds and psoriasis (click here for further details)

  • Fibrin and synthetic based materials for orthopaedic applications, including bone graft substitutes and cartilage (click here for further details)

  • Fibrin and synthetic based materials for urological applications

  • Fibrin and synthetic based materials for soft tissue repair (incl. urology, reconstruction)

  • Fibrin and synthetic based materials for drug delivery (anti-inflammatory, anti-cancer materials ready for testing)

Kuros is looking for partners with strong development and marketing capabilities.

Terms for partnering with Kuros on these indications is flexible and is likely to be determined by the partner's needs,. It can, for example, include continued development by Kuros in-house or a simple out-licensing arrangement.

2. Partnerships with companies for development of Kuros materials for new indications.

Kuros has the ability to leverage its internal know-how in materials and associated bioactive incorporation to meet the product design criteria for new indications. Examples of new product opportunities that could be developed working with Kuros include:  

  • Fibrin based engineered matrices which use a bioactive for healing of cartilage, nerve, eye, cardiovascular, etc.

  • Synthetic based tissue engineering products which use a bioactive for repair or accelerated healing of cartilage, nerves, the eye, cardiovascular, etc.

  • Synthetic based materials for internal or external tissue sealants, for tissue augmentation in reconstructive surgery or for other applications in which no biological response is required.

3. Partnerships to test a partnering company's bioactives in combination with Kuros technology

Kuros is actively diversifying and expanding its bioactive pipeline by seeking funded feasibility studies which use a partner's proprietary bioactives or materials. Under such studies, Kuros would conduct feasibility studies with the partner materials. Such studies would be jointly designed by Kuros and the partner company. The primary objective of the study would be proof-of-concept of use of the bioactive with Kuros' technology. After demonstrated proof-of-principle, further animal or clinical studies could be pursued either in conjunction with Kuros or independently by the partner.

These feasibility studies will typically be agreed upon under a simple research contract. Thus these short term studies give our partners a rapid, inexpensive, low commitment path for evaluation of the capabilities of Kuros and its technologies. When a client decides to move forward into further animal or clinical studies with a Kuros based product, the parties will enter negotiations for licensing, royalty, and other standard terms.

Kuros' Capabilities

Kuros technology can incorporate a broad range of bioactives of any molecular weight either with or without cleavable linkage sites. Materials can be applied minimally invasively and are designed to solidify in-situ. This technology is also capable of using small molecule bioactives.

Kuros has the capability and experience to run/contract small and large animal studies. Kuros has appropriate in-house quality assurance and regulatory personnel to meet our partner's regulatory requirements. Additionally, Kuros has access to manufacturing facilities for clinical grade bioactives as well as clinical grade fibrin and synthetic matrix materials. Kuros thus has the capability to take materials into Phase I/II studies, and beyond, if necessary.

Materials formulated using Kuros' proprietary technologies can benefit from:

  • Improved or enabled efficacy

  • Increased safety

  • Extending product life cycles and patent lifetimes

  • In-situ gelation potential for minimally invasive surgery

Additional Information

More comprehensive details, including corporate information, can be found on the Kuros web-site. Alternatively, please contact us.


 


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