Companies create ‘road atlas’ of human biology

ALAMEDA, Calif.—A method by which to manufacture purifiedand identified stem cells and the need for a "road atlas" for the complexbranching tree of stem cells' progeny are goals highlighted by BioTime's recentacquisition of XenneX Inc.

BioTime will acquire XenneX through a merger of XenneX intoBioTime's subsidiary LifeMap Sciences. Through the merger, XenneX stockholderswill receive approximately 1,362,589 shares of LifeMap common stock, which willrepresent approximately 13 percent of LifeMap's common stock outstanding uponthe closing of the transaction. XenneX shareholders will also receiveapproximately 448,430 BioTime common shares as part of the transaction. Theacquisition is expected to close this month.

LifeMap is in the process of developing a web-based databasethat will aid scientists in their research and product development efforts inthe stem cells field, using embryonic stem cells, progenitor cells, inducedpluripotent stem cells and other relevant cells. The database will permit usersto follow the cellular ontology of embryonic development, from the zygote tothe progenitor cells and cell lineages, leading to developed organs. It willprovide access to available cell-related information and resources necessary toimprove stem cell research and development of therapeutics based onregenerative medicine.

XenneX will contribute its GeneCards and PanDaTox databasesfor which it holds the exclusive, worldwide marketing licenses. GeneCards is asearchable, integrated database of human genes that provides concise genomic,transcriptomic, genetic, proteomic, functional and disease-related informationon all known and predicted human genes. PanDaTox is a recently developed,searchable database that can be used to identify genes and intergenic regionsthat are unclonable in E. coli, toaid in the discovery of new antibiotics and biotechnologically beneficial functionalgenes and to improve the efficiency of metabolic engineering. GeneCards andPanDaTox are marketed by XenneX under a license from Yeda Research andDevelopment Company Ltd., the technology transfer company of the WeizmannInstitute.

LifeMap's team of scientists is building an integrated mapof the thousands of cell types in human development, beginning with thefertilized egg and ending in the developed human. Combined with genomicsinformation, the database is expected to become a "road atlas" of human biologybenefiting medicine and research.

"We believe that centralized online databases of biologicalknowledge will become indispensable tools for research in the field ofregenerative medicine," says Dr. Michael D. West, BioTime's CEO. "The risingstandards for identity and purity in the development of stem cell therapeuticsnecessitate an international consensus on cell markers, and building thedatabase is one component of BioTime's strategy to lead in this emerging fieldof medicine while capturing near-term revenue."

Dr. David Warshawsky, LifeMap Sciences' CEO—who also foundedXenneX in 2003 and serves as its chairman—adds, "LifeMap has made greatprogress with the LifeMap database and discovery platform, and we seeGeneCards, MalaCards and PanDaTox as a perfect fit for making LifeMap theleading source of online database research tools for genetic, biological andstem cell research and development."

In recent testimonybefore the California Institute for Regenerative Medicine (CIRM), West notedthat, "Human embryonic stem cells and related induced pluripotentstem cells are promising because of their ability to differentiate into all ofthe complex cell types in the human body. However, this is also their greatestchallenge. They make all of the celltypes in the human body. This logically leads to the manufacturing conundrum ofhow do we manufacture purified and identified cell types when thousands ofdiverse cell types emerge from these cultures."

BioTime has benefited from a $4.7 million grant from theCIRM to further the development of ACTCellerate, a novel manufacturingtechnology allowing the scalable manufacture of more than 200 diverse highlypurified cell types. This advance has highlighted the urgent need for a "roadatlas" for this complex branching tree from pluripotent stem cells.

Currently, for all the thousands of cell types that emergefrom pluripotent stem cells, little to no information is available in anorganized form for the scientific community to help identify the cells (i.e., where the scientist is on the roadfrom pluripotent stem cells to the final desired cell type). As a result, tomeet the rigorous standards of the U.S. Food and Drug Administration in regardto purity and identity, companies have found themselves paddling upstreamagainst the very difficult challenge of identifying the cells contaminatingtheir potential products.

"Similar to the foundational impact that the mapping of thegenome had on science and medicine, the mapping of the 'embryome' would lay abroad and effective foundation for subsequent product development worldwide fordecades to come," says West.