AgeX Therapeutics Acquires Technology To Regulate Immune Tolerance – Technology Supports Company’s Strategy For Off-The-Shelf (Allogeneic) Cell-Based Regenerative Medicine Products Through The Use Of The HLA-G Gene08/16/2018
ALAMEDA, Calif.–(BUSINESS WIRE)– AgeX Therapeutics, Inc., a subsidiary of BioTime, Inc. (NYSE American: BTX), focused on the development and commercialization of novel therapeutics targeting human aging, today announced that it has acquired certain patents and patent applications from Escape Therapeutics relating primarily to the use of the HLA-G gene to suppress rejection of transplanted cells and tissues. The Company plans to utilize the technology in conjunction with its pluripotent stem cell platform for applications in regenerative medicine.
“We believe that the implementation of a low immune observable profile in human pluripotent stem cells may facilitate an off-the-shelf product strategy by reducing the risk of transplant rejection of allogeneic cells,” said Michael West, Ph.D., CEO of AgeX. “We plan to use this patented technology, which we call ‘UniverCyteTM’,together with our proprietary PureStem® manufacturing method to develop cost-effective young living cell regenerative therapies primarily for indications related to aging. Our initial priority will be to utilize the technology in advancing our two lead programs AGEX-BAT1 and AGEX-VASC1 for age-related metabolic and vascular disease respectively.”
“The principals in the BioTime group of companies have a legacy of leading in what is a path to potential products,” said Basil M. Hantash, M.D., Ph.D., MBA, CEO of Escape Therapeutics. “We are confident that the technology developed at Escape together with that developed at BioTime and AgeX will facilitate the development of a potential portfolio of assets in the upcoming years.”
About UniverCyte Technology
The UniverCyte technology uses the tolerogenic molecule HLA-G, modified to be stably expressed on the cell extracellular membrane, to confer low immune observability to the resulting cells. AgeX plans to use this newly-acquired patented technology in producing genetically-modified master cell banks of pluripotent stem cells that can then be differentiated into many diverse young cell types using the Company’s PureStem manufacturing method. The PureStem manufacturing process has previously been shown to be capable of generating over 200 such diverse human cell types. Potential applications of the resulting cells may include the manufacture of a large number of off-the-shelf formulations potentially useful in repairing aged tissues in the body afflicted with chronic degenerative disease. The use of UniverCyte technology to reduce immune observability may eliminate or reduce the need for HLA matching or autologous sourcing for cell or tissue transplants.
About AgeX Therapeutics
AgeX Therapeutics, Inc., a subsidiary of BioTime, Inc. (NYSE American: BTX), is a biotechnology company focused on the development of novel therapeutics for age-related degenerative disease. The company’s mission is to apply the proprietary technology platform related to telomerase-mediated cell immortality and regenerative biology to address a broad range of diseases of aging. The current preclinical development efforts include two cell-based therapies derived from telomerase-positive pluripotent stem cells and two product candidates derived from the company’s proprietary induced Tissue Regeneration (iTR™) technology. AGEX-BAT1 and AGEX-VASC1 are cell-based approaches in the preclinical stage of development comprised of young regenerative cells modified using the Company’s UniverCyteTM technology facilitating immune tolerance, formulated in HyStem® matrix, designed to correct metabolic imbalances in aging and to restore vascular support in ischemic tissues respectively. AGEX-iTR1547 is a drug-based formulation in preclinical development intended to restore regenerative potential in a wide array of aged tissues afflicted with degenerative disease using the company’s proprietary iTR technology. Renelon™ is a first-generation iTR product designed to promote scarless tissue repair which the Company plans to initially develop as a topically-administered device for commercial development through a 510(k) application. In addition to the product candidates in early development, the company, through its LifeMap subsidiary, currently markets genomic interpretation algorithms. In addition, the company, through its ESI BIO division, markets Cytiva®, comprised of PSC-derived heart muscle cells used in screening drugs for efficacy and safety.
BioTime is a clinical-stage biotechnology company focused on degenerative diseases. Its clinical programs are based on two platform technologies: cell replacement and cell/drug delivery. With its cell replacement platform, BioTime is producing new cells and tissues with its proprietary pluripotent cell technologies. These cells and tissues are developed to replace those that are either rendered dysfunctional or lost due to degenerative diseases or injuries. BioTime’s cell/drug delivery programs are based upon its proprietary HyStem® cell and drug delivery hydrogel matrix technology. HyStem® was designed, in part, to provide for the transfer, retention and/or engraftment of cellular replacement therapies. HyStem® is a unique hydrogel that has been shown to support cellular attachment and proliferation in vivo. Current research at leading medical institutions has shown that HyStem® is compatible with a wide variety of cells and tissue types including brain, bone, skin, cartilage, vascular and heart tissues. Due to the unique cross-linking chemistry, HyStem® hydrogels have the ability to mix cells, biologics and small molecule drugs and can be injected or applied as a gel which allows the hydrogel to conform to a cavity or space. This property of HyStem® hydrogels offers several distinct advantages over other hydrogels, including the possibility of combining bioactive materials with the hydrogel at the point of use. BioTime is also developing HyStem® for the delivery of therapeutic drugs and cells to localized areas of the body, including for sustained drug release in the targeted anatomical sites. BioTime’s lead cell delivery clinical program is Renevia®, which consists of HyStem® combined with the patient’s own adipose (fat) derived tissue or cells. Renevia® met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients in 2017. BioTime has submitted Renevia® for CE Mark approval in the EU. There were no device related serious adverse events reported to date. BioTime’s lead cell replacement product candidate is OpRegen®, a retinal pigment epithelium transplant therapy, which is in a Phase I/IIa multicenter clinical trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in the developed world. There have been no unexpected serious adverse events reported to date. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE American: OCX), and a private company, AgeX Therapeutics, Inc.
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Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered forward-looking statements. Investors are cautioned that statements in this press release regarding: (a) any value to BioTime shareholders of the AgeX common stock; (b) BioTime’s plans or expectations for the distribution; and (c) potential listing of AgeX common stock on NYSE American, constitute forward-looking statements. Forward-looking statements involve risks and uncertainties. These risks and uncertainties, include, without limitation: (i) the possibility that BioTime shareholders may realize little or no value from the AgeX common stock; (ii) the potential inability of BioTime to complete distribution in a timely manner or at all, including as a result of the failure of BioTime and/or AgeX to obtain or maintain required federal and state registrations and qualifications necessary to enable the distribution, and related transactions; (iii) the possibility of litigation that could arise as a result of or in connection with the distribution and related transactions; and (iv) that there is no existing public market for AgeX common stock, nor may a public market for such securities ever develop. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of BioTime’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.