Recoly

Technologies

NecLip Technology

NecLip (non-encapsulating liposomes) technology is based on the phenomenon whereby certain proteins and peptides that contain a specific sequence of amino acids spontaneously bind to the surface of our PEGylated liposome. We have shown that the combination of a NecLip liposome and a bound protein enhance the therapeutic efficacy of certain proteins.

PEGylated liposomes are microscopic fluid-filled spheres with synthetic non-toxic polyethylene glycol molecules attached to their surface. Traditional technologies either encapsulate a drug within a PEGylated liposome or directly PEGylate the drug itself. NecLip differs from these traditional approaches in that the protein or peptide attaches to the surface of our PEGylated liposome, thus enhancing the therapeutic efficacy of the protein without requiring any change in the manufacturing or extracting methods of the protein or its mode of administration to patients.

NecLip technology offers the following key benefits:

• Enhances the efficacy of delivered proteins including FVIII, FVIIa and G-CSF. Preclinical and clinical results indicate that Neclip enhances the efficacy of FVIII, FVIIa and G-CSF. Current treatments with FVIII and FVIIa can be modified to use lower and less frequent doses, thereby decreasing the cost and inconvenience of treatments and increasing patient compliance. In the case of G-CSF, the use of our NecLip technology is expected to induce stronger mobilization of stem cells, leading to shorter and fewer cycles required to reach adequate stem cell levels and increasing the number of patients from whom stem cells can be harvested.
• NecLip technology does not require any changes in manufacturing methods or modes of administration. The formulation of proteins such as FVIII, FVIIa and G-CSF with PEGylated liposomes is an easy process that involves adding a solution of PEGylated liposomes to the proteins just prior to their administration to the patient. The proteins attach spontaneously to the surface of the PEGylated liposomes. This is a key benefit since the technology does not require any change in the manufacturing process of the proteins or in the method of administration used by patients.
• NecLip application does not affect the activity or increase the immunogenicity risk of the targeted protein. Due to the non-covalent binding between NecLip liposomes and targeted proteins or peptides, NecLip can be applied to large and sensitive proteins without negatively affecting their activity or increasing the risk of their immunogenicity.

The application and use of NecLip includes:

• Manufacturing/extracting the targeted protein in the exact same (non-NecLip) approved process
• Reconstituting the lyophilized protein with NecLip liposomes (the same as with water-for-injection)
• The protein binds non-covalently to the surface of the NecLip liposome.
• The NecLip-protein is administrated to the patient using the same mode of administration as for standard proteins.

REC-200 – Liposomal Glucocorticoid Technology

The use of glucocorticoids (GCs) in rheumatoid arthritis and other autoimmune diseases, though proven to be clinically effective, is limited due to the systemic distribution of GCs resulting in a wide range of side effects. These side effects are the result of the relatively high dosage of GCs that are usually used due to the inability to target the drug to the site of inflammation. REC-200 technology uses small (80-100 nm), long-circulating, PEGylated nano-liposomes, which are remote-loaded with an amphipathic weak acid GC (such as methyl prednisolone hemisuccinate). This unique loading method actually traps the GC within the liposomal aqueous phase as a calcium-GC precipitate with an encapsulation efficacy of over 90%. Following injection, the PEGylated nano-liposomes (loaded with GC) accumulate at the inflammation sites as a result of their size and composition, and the amount of GC that is released from the liposomes and found in the blood is significantly smaller than following the injection of standard GC. This results in increased therapeutic efficacy and reduced side effects of GC. We believe that REC-200 technology has the potential to significantly improve GC therapy in rheumatoid arthritis and other autoimmune diseases.

Recoly licensed this technology, which was developed by Prof. Yechezkel Barenholz and Prof. Yaakov Naparstek from the Hebrew University and Hadassah University Hospital, Jerusalem, Israel.