Under the lease, the landlord will provide Asterias with a $4.4 million tenant improvement allowance that Asterias plans to use to construct a production facility in the leased premises designed to satisfy requirements for both US and European current good manufacturing practices (cGMP) for the production of cell banks and Asterias drug product candidates. Construction of the manufacturing facility is expected to begin by the second quarter of 2014.
Asterias began formal product development activities in its current location in Menlo Park, California during October of 2013 after the closing of an Asset Contribution Agreement with Geron Corporation and BioTime, Inc., pursuant to which Asterias acquired Geron's human embryonic stem cell assets, as well as rights to use certain human embryonic stem cell lines, minority stakes in two of BioTime's subsidiaries and stock from BioTime. The Asterias product development portfolio includes two clinical programs - neural progenitors cells, currently under clinical development for spinal cord injury, and dendritic cells targeting telomerase, currently under clinical development for cancer. The Company's preclinical portfolio includes chondrocytes for osteoarthritis and degenerative disc disease, and cardiomyocytes for heart failure.
Asterias Biotherapeutics is a subsidiary of BioTime, Inc., whose mission is to acquire and develop best in class cell therapy product candidates. Our first acquisition was the stem cell assets of Geron Corporation, which was completed on October 1, 2013. That acquisition includes Geron's entire cell therapy intellectual property portfolio, existing contracts and license agreements related to their stem cell programs, INDs for OPC1 and VAC1 cell therapies, master cell banks of hESCs and therapeutic cells manufactured under cGMP, research cell banks, customized reagents and equipment, and banks of cGMP-manufactured OPC1 drug product used in Geron's Phase 1 trial in spinal cord injury, the world's first human clinical trial of hESC-derived cells.
Asterias has acquired four cell lines, each with animal proof of concept, from which multiple therapeutic product candidates may be selected for development indications in the fields of neurology (including OPC1 for spinal cord injury), oncology (including VAC1 autologous dendritric cells), orthopedics, and cardiovascular therapy.
Asterias Biotherapeutics will be part of the BioTime family of companies that now own a large and diverse stem cell patent portfolio, as well as a unique collection of cGMP-manufactured therapeutic cells and validated cell banks, placing it among today's leaders in regenerative medicine.
BioTime is a biotechnology company engaged in research and product development in the field of regenerative medicine. Regenerative medicine refers to therapies based on stem cell technology that are designed to rebuild cell and tissue function lost due to degenerative disease or injury. BioTime's focus is on pluripotent stem cell technology based on human embryonic stem ("hES") cells and induced pluripotent stem ("iPS") cells. hES and iPS cells provide a means of manufacturing every cell type in the human body and therefore show considerable promise for the development of a number of new therapeutic products. BioTime's therapeutic and research products include a wide array of proprietary PureStem™ progenitors, HyStem® hydrogels, culture media, and differentiation kits. BioTime is developing Renevia™ (a HyStem® product) as a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. In addition, BioTime has developed Hextend®, a blood plasma volume expander for use in surgery, emergency trauma treatment and other applications. Hextend® is manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research, therapeutic, and diagnostic use through its subsidiaries:
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