Royalty Report: Drugs, Biotechnology, Cancer – Collection: 4504

License Grant

The agreement is to develop products with an extended half-life of certain proteins and molecules using the Licensor’s patent protected PolyXen® technology whereby polysialyic acid (“PSA” – a chain of polysialic acids) is chemically conjugated with the Licensee’s proprietary molecule(s) to create a new generation of drugs to treat the failure of blood to coagulate in the therapeutic treatment of blood and bleeding disorders, such as hemophilia. The lead candidate in this collaboration is a longer-acting form of a full length recombinant Factor VIII protein.  Under the terms of the Agreement, the Licensor is entitled to research and development funding and is responsible for providing Licensee with a transfer of the Licensor's proprietary technology and supplying its requirements for PSA.

License Grant

The original License Agreement with the Indian Licensee was a collaborative Development and Manufacturing Arrangement to develop agreed upon potential commercial product candidates using the Licensor's PolyXen® technology. Following the 2011 amendment, the Licensee retained an exclusive license to use the Licensor’s PolyXen® technology to research and develop one potential commercial product, Polysialylated Erythropoietin. The Licensee will be responsible for conducting all pre-clinical and clinical trials required to achieve regulatory approvals within the certain predetermined territories at Serum Licensee’s own expense.

License Property

PolyXen® is a platform technology based on the concept of polysialylation. PSA (polysialyic acid) is a polymer chain composed of sialic acids linked together. Sialic acid is found on the external membrane of a number of cell types in the body. In addition, it is a natural component expressed on the external membrane on a number of bacterial types. The chain of sialic acid molecules can be anywhere from 4 to over 200 individual sialic acid molecules in length. The Licensor uses the linear form of PSA called colominic acid. It is a natural, hydrophilic polymer isolated from a bacterial strain of E. coli K1. This natural glycan is negatively charged, non-toxic and is biodegradable. The PSA chain is extensively purified from large-scale bacterial cultures under Current Good Manufacturing Practices conditions, modified to specified sizes and then attached to defined sites on the therapeutic. Both the site of attachment and the length of the PSA chain can enhance the properties of the therapeutic.

The major effect of PSA addition to a therapeutic is to change the apparent hydrodynamic radius of the molecule. This physical alteration then changes a number of the biological characteristics of the therapeutic.

Field of Use

The most noticeable, and perhaps the most relevant use is an extension of the lifetime of the therapeutic in blood circulation. This is due to the increase in the size of the drug which results in a decrease in the clearance rate of the molecule in the kidney by glomerular filtration. In addition, studies have shown changes in other biological characteristics such as protease sensitivity and temperature sensitivity. An added benefit is that the conjugated molecules are less viscous in solution than comparable other technologies, providing the potential for easier injections and fewer injection site reactions. Furthermore, the Licensor believes that utilizing PSA in an existing marketed drug may allow for patent extension, thereby potentially creating a patent-protected next generation candidate.

License Grant

The agreement contains cross licensing.  The original License Agreement was a collaborative Development and Manufacturing Arrangement to develop agreed upon potential commercial product candidates using the Licensee's PolyXen® technology. Following the 2011 amendment, the Licensor retained an exclusive license to use the Licensee’s PolyXen® technology to research and develop one potential commercial product, Polysialylated Erythropoietin. The Licensor will be responsible for conducting all pre-clinical and clinical trials required to achieve regulatory approvals within the certain predetermined territories at Licensor’s own expense.

License Property

PolyXen® is a platform technology based on the concept of polysialylation. PSA (polysialyic acid) is a polymer chain composed of sialic acids linked together. Sialic acid is found on the external membrane of a number of cell types in the body. In addition, it is a natural component expressed on the external membrane on a number of bacterial types. The chain of sialic acid molecules can be anywhere from 4 to over 200 individual sialic acid molecules in length. The Licensee uses the linear form of PSA called colominic acid. It is a natural, hydrophilic polymer isolated from a bacterial strain of E. coli K1. This natural glycan is negatively charged, non-toxic and is biodegradable. The PSA chain is extensively purified from large-scale bacterial cultures under Current Good Manufacturing Practices conditions, modified to specified sizes and then attached to defined sites on the therapeutic. Both the site of attachment and the length of the PSA chain can enhance the properties of the therapeutic.

The major effect of PSA addition to a therapeutic is to change the apparent hydrodynamic radius of the molecule. This physical alteration then changes a number of the biological characteristics of the therapeutic.

Field of Use

The most noticeable, and perhaps the most relevant use is an extension of the lifetime of the therapeutic in blood circulation. This is due to the increase in the size of the drug which results in a decrease in the clearance rate of the molecule in the kidney by glomerular filtration. In addition, studies have shown changes in other biological characteristics such as protease sensitivity and temperature sensitivity. An added benefit is that the conjugated molecules are less viscous in solution than comparable other technologies, providing the potential for easier injections and fewer injection site reactions. Furthermore, the Licensee believes that utilizing PSA in an existing marketed drug may allow for patent extension, thereby potentially creating a patent-protected next generation candidate.

License Grant

The Licensor granted an exclusive license to develop pharmaceutical products using certain molecule(s) based on Licensee’s technology and the Licensor’s proprietary technology (PolyXen®, OncoHist™ and ImuXen®) that prolongs the active life and/or improves the pharmacokinetics of certain therapeutic proteins and peptides (as well as conventional drugs).

License Property

PolyXen® is an enabling technology that utilizes Polysialic Acid (“PSA”), a biopolymer, a chain of sialic acids which is a natural constituent of the human body. PSA is designed to extend the half-life in circulation in the human body for a variety of existing drug molecules and, thereby, to create potentially superior next generation drug candidates. OncoHist™ is a novel therapeutic platform that utilizes the properties of the human histone H1.3 (“H1.3”) for the development of drug candidates for the treatment of a broad range of cancer indications. OncoHist™, unlike many competing oncology therapies, is based on a molecule occurring naturally in the human body, in the cell nucleus, and is therefore expected to be less toxic and immunogenetic than other oncology therapies. ImuXen® is a novel liposomal co-entrapment encapsulation technology designed to create new vaccines and improve the use and efficacy of certain existing vaccines for use in the human body. The technology is based on the co-entrapment of the nominated antigen(s) in a liposomal vesicle, a design that is intended to maximize both cell and immune system mediated responses.

License Grant

The agreement contains cross licensing.  First, the Licensee granted an exclusive license to Licensor to develop pharmaceutical products using certain molecule(s) based on Licensor’s technology and the Licensee’s proprietary technology (PolyXen®, OncoHistâ„¢ and ImuXen®) that prolongs the active life and/or improves the pharmacokinetics of certain therapeutic proteins and peptides (as well as conventional drugs). In return, Licensor granted an exclusive license to the Licensee to use the pre-clinical and clinical data generated by Licensor in certain agreed products and engage in the development of commercial candidates.

License Property

PolyXen® is an enabling technology that utilizes Polysialic Acid (“PSA”), a biopolymer, a chain of sialic acids which is a natural constituent of the human body. PSA is designed to extend the half-life in circulation in the human body for a variety of existing drug molecules and, thereby, to create potentially superior next generation drug candidates.

OncoHist™ is a novel therapeutic platform that utilizes the properties of the human histone H1.3 (“H1.3”) for the development of drug candidates for the treatment of a broad range of cancer indications. OncoHist™, unlike many competing oncology therapies, is based on a molecule occurring naturally in the human body, in the cell nucleus, and is therefore expected to be less toxic and immunogenetic than other oncology therapies. ImuXen® is a novel liposomal co-entrapment encapsulation technology designed to create new vaccines and improve the use and efficacy of certain existing vaccines for use in the human body. The technology is based on the co-entrapment of the nominated antigen(s) in a liposomal vesicle, a design that is intended to maximize both cell and immune system mediated responses.

License Grant

The development and commercialization agreement is to develop and commercialize ELOCTATE and ALPROLIX globally.  Each party have specific territories.

License Property

ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] and ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], are extended half-life clotting-factor therapies for the treatment of hemophilia A and hemophilia B, respectively. ELOCTATE and ALPROLIX use a process known as Fc fusion to link recombinant factor VIII and factor IX, respectively, to a protein fragment in the body known as Fc. The fusion of the factor with the Fc protein fragment uses a naturally occurring pathway and is designed to extend the half-life of the factor, thereby making the product last longer in a persons blood than traditional factor therapies.

Field of Use

The agreement is for the drug industry, specifically for clotting-factor therapies.

Elocta is a medication for the treatment and prophylaxis of bleeding in people with hemophilia A. Efmoroctocog alfa is a recombinant human coagulation factor VIII, Fc fusion protein.

License Grant

The development and commercialization agreement is to develop and commercialize ELOCTATE and ALPROLIX globally.  Each party has specific territories.

License Property

ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] and ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], are extended half-life clotting-factor therapies for the treatment of hemophilia A and hemophilia B, respectively. ELOCTATE and ALPROLIX use a process known as Fc fusion to link recombinant factor VIII and factor IX, respectively, to a protein fragment in the body known as Fc. The fusion of the factor with the Fc protein fragment uses a naturally occurring pathway and is designed to extend the half-life of the factor, thereby making the product last longer in a persons blood than traditional factor therapies.

Field of Use

The agreement is for the drug industry, specifically for clotting-factor therapies.