Royalty Report: Drugs, Biotechnology, Disease – Collection: 7546

License Grant

The Licensee acquired world-wide rights to use an array of Licensor technology and technology licensed by the Licensor from affiliates of Licensor.

License Property

The technology licensed covers methods to transform cells of the human body, such as skin cells, into an embryonic state in which the cells will be pluripotent.

Field of Use

The License and Licensee Sublicense permit the commercialization of products in human therapeutic and diagnostic product markets.

License Grant

The Licensee entered into a License Agreement and a Sublicense Agreement with the Licensor.

The Licensee acquired world-wide rights to use an array of Licensor technology and technology licensed by the Licensor from affiliates of Kirin Pharma Company, Limited.

Field of Use

The License and Kirin Sublicense permit the commercialization of products in human therapeutic and diagnostic product markets.

The technology licensed covers methods to transform cells of the human body, such as skin cells, into an embryonic state in which the cells will be pluripotent.

License Grant

The Licensee acquired exclusive worldwide rights to use the Licensor's “ACTCellerate” technology for methods to accelerate the isolation of novel cell strains from pluripotent stem cells.

License Property

ACTCellerate” is technology for methods to accelerate the isolation of novel cell strains from pluripotent stem cells.

The licensed technology is designed to provide a large-scale and reproducible method of isolating clonally purified human embryonic progenitor cells or hEPCs, many of which may be capable of extended propagation in vitro

The licensed technology is designed to provide a large-scale and reproducible method of isolating clonally purified human embryonic progenitor cells or hEPCs, many of which may be capable of extended propagation in vitro. Initial testing suggests that the technology may be used to isolate at least 200 distinct clones that contain many previously uncharacterized cell types derived from all germ layers that display diverse embryo- and site-specific homeobox gene expression. Despite the expression of many oncofetal genes, none of the hEPC tested led to tumor formation when transplanted into immunocompromised mice. The cells studied appear to have a finite replicative lifespan but have longer telomeres than most fetal- or adult-derived cells, which may facilitate their use in the manufacture of purified lineages for research and human therapy.

Field of Use

The use of the licensed technology and cell lines is for research purposes and for the development of therapeutic and diagnostic products for human and veterinary use.

License Grant

Licensor hereby grants a royalty-bearing, worldwide, exclusive license, with the right to sublicense, to use the Patent Rights and Know-How to (a) research, develop, make, have made, use, sell, have sold, offer for sale, have offered for sale, import, have imported, export and have exported Licensed Products, (b) research, develop, use, practice, sell, have sold, offer for sale, have offered for sale, import, have imported, export and have exported Licensed Processes, and (c) develop, use, perform, sell, have sold, offer for sale, have offered for sale, import, have imported, export and have exported Licensed Services.

Company granted an exclusive license to use its “ACTCellerate” embryonic stem cell technology and a bank of over 140 diverse progenitor cell lines derived using that technology.

License Property

ACTCellerateâ„¢ is a recently discovered technology that allows the rapid isolation of novel highly purified embryonic progenitor cells. Embryonic progenitors are cells intermediate between embryonic stem cells and fully differentiated cells.  The progenitor cells are relatively easy to manufacture on a large scale and in a purified state, which may make it advantageous to work with these cells compared to the direct use of embryonic stem cells. Using the ACTCellerate platform technology over 140 distinguishable novel progenitor cell lines have already been created, scaled-up, and banked. These unique cell lines may possess the ability to become a wide array of products never before available to the medical community, with potential applications in research, drug discovery, and human regenerative stem cell therapy.  

The licensed rights include pending patent applications, knowledge and the existing bank of cell lines. The licence is exclusive and worldwide for all commercial purposes, including the development of research products, and therapeutic and diagnostic products for human and veterinary use.  Licensor has an option to reacquire rights to use the technology for the development of certain types of SCs for human therapeutic use in fields re-lated to its core business.

The technology allows the rapid isolation of novel, highly-purified embryonic progenitor cells. The progenitor cells are relatively easy to manufacture on a large scale and in a purified state, which may make it advantageous to work with these cells compared to the direct use of ESCs. These unique cell lines may have potential applications in research, drug discovery and human regenerative SC therapy.

Patent Rights
103080-069-WO1 (PCT/US06/13519, filed on 4-11-06) Novel uses of cells with Prenatal Patterns of prenatal gene expression, published as WO2007/058671
103080-071-P61 (USSN 60/791,400, filed on Apr. 11, 2006) Methods to accelerate the isolation of novel cell strains from pluripotent ST
103080-071-P66 (USSN 60/850,294, filed on Oct. 6, 2006), Methods to accelerate the isolation ov novel cell strains from pluripotent stem cells
103080-071-P01 (USSN 11/604,047, filed on Nov. 21, 2006), Methods to accelerate the isolation  of novel cell strains from pluripotent STE…
PCT is 103080-071-WO2 (PCT/US2006/45352, filed on Nov. 21, 2006), published as WO 2007/062198.

License Grant

The Licensee obtained a non-exclusive License to distribute human embryonic stem cell lines made by the Licensor through stem cell banks.

License Property

The term “stem cells” describe all of the cells that can give rise to the different cells found in tissues.  Cells from the same pluripotent stem cells can be used in any patient. This type of cell therapy is referred to as “allogeneic”. This permits the use of a single master stem cell bank in the manufacturing of the therapeutic doses to be used such that one uniform source of starting cells can be readily controlled for consistency, lack of infectious agents and cleared by regulatory agencies.

License Grant

The Licensee entered into a royalty Agreement with the Licensor and received the following assets from the Licensor

License Property

Certain patents and patent applications and all related active prosecution cases, trade secrets, know-how and certain other intellectual property rights, and all of the Licensor's goodwill with respect to the technology directly related to the research, development and commercialization of certain products and know-how related to hES cells;

Certain biological materials and reagents (including master and working cell banks, original and seed banks, and research, pilot and GMP grade lots and finished product);

Certain regulatory filings for clinical trials for GRNOPC-I for spinal cord injury, including the investigational new drug applications filed with the United States Food and Drug Administration for Licensor’s Phase I safety study of oligodendrocyte progenitor (GRNOPC-1) cells in patients with neurologically complete, subacute spinal cord injury (Protocol No. CP35A007), and long term follow up of subjects who received GRNOPC1 (Protocol No. CP35A008), and the clinical trial for VAC1 for acute myelogenous leukemia, including a Phase I/II study of active immunotherapy with GRNVAC1, autologous mature dendritic cells transfected with mRNA encoding human telomerase reverse transcriptase (hTERT), in patients with acute myelogenous leukemia (AML) in complete remission (Protocol No. CP06-151).

US Patent 6,800,480 – Methods and Materials for the Growth of Primate-Derived Primordial Stem Cells in Feeder-Free Culture
US Patent 7,413,902 – Feeder-Free Culture Method for Embryonic Stem Cells
US Patent 6,440,735 – Dendritic Cell Vaccine Containing Telomerase Reverse Transcriptase for the Treatment of Cancer
US Patent 7,402,307 – Method for Identifying and Killing Cancer Cells
US Patent 7,824,849 – Cellular Telomerase Vaccine and Its Use for Treating Cancer
US Patent 7,560,281 – Use of TGF Beta Superfamily Antagonists to Make Dopaminergic Neurons from Embryonic Stem Cells
US Patent 8,252,586 – Neural Cell Populations from Primate Pluripotent Stem Cells
US Patent 8,153,428 – Use of TGF Beta Superfamily Antagonists and Neurotrophins to Make Neurons from Embryonic Stem Cells
US Patent 6,667,176 – cDNA Libraries Reflecting Gene Expression During Growth and Differentiation of Human Pluripotent Stem Cells
US Patent 7,041,438 – Use of Human Embryonic Stem Cells for Drug Screening and Toxicity Testing
US Patent 7,413,904 – Embryonic Stem Cells Having Genetic Modifications
US Patent 7,410,798 – Culture System for Rapid Expansion of Human Embryonic Stem Cells
US Patent 7,297,539 – Medium for Growing Human Embryonic Stem Cells
US Patent 7,455,983 – Medium for Growing Human Embryonic Stem Cells
US Patent 8,097,458 – Culture System for Rapid Expansion of Human Embryonic Stem Cells
US Patent 6,642,048 – Conditioned Media for Propagating Human Pluripotent Stem Cells
US Patent 6,458,589 – Hepatocyte Lineage Cells Derived from Pluripotent Stem Cells
US Patent 6,506,574 – Hepatocyte Lineage Cells Derived from Pluripotent Stem Cells
US Patent 7,256,042 – Process for Making Hepatocytes from Pluripotent Stem Cells
US Patent 7,282,366 – Hepatocytes for Therapy and Drug Screening Made From Embryonic Stem Cells
US Patent 7,473,555 – Protocols for Making Hepatocytes from Embryonic Stem Cells
US Patent 8,148,151 – Differentiation of Primate Pluripotent Cells to Hepatocyte-Lineage Cells
US Patent 6,833,269 – Making Neural Cells for Human Therapy or Drug Screening from Human Embryonic Stem Cells
US Patent 8,148,148 – Neural Progenitor Cell Populations
US Patent 8,252,585 – Neural Progenitor Cell Populations
US Patent 7,250,294 – Screening Small Molecule Drugs Using Neural Cells Differentiated from Human Embryonic Stem Cells
US Patent 7,763,463 – Use of Cyclic AMP and Ascorbic Acid to Produce Dopaminergic Neurons from Embryonic Stem Cells
US Patent 6,576,464 – Differentiated Cells Suitable For Human Therapy
US Patent 6,921,665 – Selective Antibody Targeting of Undifferentiated Stem Cells
US Patent 7,732,199 – Process for Making Transplantable Cardiomyocytes from Human Embryonic Stem Cells
US Patent 7,763,464 – Differentiation Protocol for Making Human Cardiomyocytes
US Patent 7,452,718 – Direct Differentiation Method for Making Cardiomyocytes from Human Embryonic Stem Cells
US Patent 7,897,389 – Direct Differentiation Method for Making Cardiomyocytes from Human Embryonic Stem Cells
US Patent 7,851,167 – Differentiation Protocol for Making Human Cardiomyocytes

US Patent Application 13/561,296 – Neural Cell Populations from Primate Pluripotent Stem Cells
US Patent Application 12/170,219 – Culture System for Rapid Expansion of Human Embryonic Stem Cells
US Patent Application 12/710,078 – Culture System for Rapid Expansion of Human Embryonic Stem Cells
US Patent Application 13/323,567 – Culture System for Rapid Expansion of Human Embryonic Stem Cells
US Patent Application 11/917,993 – Suspension Culture of Human Embryonic Stem Cells
US Patent Application 12/277,136 – Protocols for Making Hepatocytes from Embryonic Stem Cells
US Patent Application 13/558,078 – Neural Progenitor Cell Populations
US Patent Application 11/359,341 – Differentiated Cells Suitable For Human Therapy
US Patent Application 11/471,916 – Differentiation of Primate Pluripotent Stem Cells to Cardiomyocyte-Lineage Cells

Field of Use

The Licensee is a biotechnology company focused on the emerging field of regenerative medicine, with core technologies centered on stem cells capable of becoming all of the cell types in the human body, a property called pluripotency.