CARLSBAD, Calif.–(BUSINESS WIRE)–Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology firm creating allogeneic cell therapies for unmet medical wants, introduced right this moment the opening of a brand new analysis and growth (R&D) facility in Carlsbad, California, and the enlargement of its Good Manufacturing Observe (GMP) manufacturing facility primarily based in Jerusalem, Israel. Lineage’s new Carlsbad facility will broaden the Firm’s R&D capabilities within the U.S. and help the event of present and future allogeneic cell transplant packages. The enlargement of Lineage’s Israel-based facility will improve the Firm’s infrastructure, together with growth and optimization of larger-scale medical manufacturing processes, and continued execution below its ongoing collaboration with Roche and Genentech for RG6501 (OpRegen®), a retinal pigment epithelium cell substitute remedy which has accomplished enrollment in a Section 1/2a medical trial for the therapy of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
“Now we have elected to extend our R&D footprint at our present GMP manufacturing facility and set up a brand new R&D facility in Carlsbad, California,” said Brian M. Culley, Lineage CEO. “These steps will allow us to develop our course of growth and analytical testing capabilities and conduct exploratory work on future packages, whether or not owned by us or our present or future companions. This transfer additionally is predicted to scale back our reliance on sure distributors, which can cut back prices and dangers of timeline uncertainty or provide chain disruption. The extra capability additionally might help us turn out to be an much more succesful accomplice in potential alliances for brand new merchandise and permit us to discover extra makes use of for our present cell transplant packages.”
Mr. Culley added, “Challenges within the biotech sector are unlikely to persist indefinitely. We imagine you will need to take steps, even on this atmosphere, to be positioned for a future restoration. The modest investments we’re making right this moment, partially offset by the termination of the lease for our analysis facility in Alameda, California in January of subsequent 12 months, will assist centralize our operations and put us able of larger readiness for future success.”
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology firm creating novel cell therapies for unmet medical wants. Lineage’s packages are primarily based on its sturdy proprietary cell-based remedy platform and related in-house growth and manufacturing capabilities. With this platform Lineage develops and manufactures specialised, terminally differentiated human cells from its pluripotent and progenitor cell beginning supplies. These differentiated cells are developed to both change or help cells which are dysfunctional or absent resulting from degenerative illness or traumatic injury or administered as a method of serving to the physique mount an efficient immune response to most cancers. Lineage’s medical packages are in markets with billion greenback alternatives and embrace 5 allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell remedy in growth for the therapy of geographic atrophy secondary to age-related macular degeneration, is being developed below a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell remedy in Section 1/2a growth for the therapy of acute spinal cord accidents; (iii) VAC2, a dendritic cell remedy produced from Lineage’s VAC know-how platform for immuno-oncology and infectious illness, at the moment in Section 1 medical growth for the therapy of non-small cell lung most cancers; (iv) ANP1, an auditory neuronal progenitor cell remedy for the potential therapy of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell remedy for the therapy of imaginative and prescient loss resulting from photoreceptor dysfunction or injury. For extra info, please go to www.lineagecell.com or observe the corporate on Twitter @LineageCell.
Lineage cautions you that every one statements, apart from statements of historic details, contained on this press launch, are forward-looking statements. Ahead-looking statements, in some circumstances, might be recognized by phrases similar to “imagine,” “goal,” “might,” “will,” “estimate,” “proceed,” “anticipate,” “design,” “intend,” “count on,” “may,” “can,” “plan,” “potential,” “predict,” “search,” “ought to,” “would,” “ponder,” “challenge,” “goal,” “are likely to,” or the damaging model of those phrases and comparable expressions. Such statements embrace, however are usually not restricted to, statements referring to: the potential advantages of the brand new and expanded services to the Firm and its operations, together with the broadening of the Firm’s R&D capabilities, rising growth and optimization of larger-scale medical manufacturing processes, the enlargement of the Firm’s course of growth and analytical testing capabilities and skill to conduct exploratory work on future packages, the rise within the Firm’s manufacturing services, the decreased reliance on sure distributors, the discount in prices and dangers of timeline uncertainty and provide chain disruption, and the development within the Firm’s place of larger readiness for future success. Ahead-looking statements contain recognized and unknown dangers, uncertainties and different components that will trigger Lineage’s precise outcomes, efficiency or achievements to be materially completely different from future outcomes, efficiency or achievements expressed or implied by the forward-looking statements on this press launch, together with, however not restricted to, the next dangers: that potential advantages of the brand new and expanded services to the Firm and its operations will not be realized as rapidly as anticipated or in any respect; that we might must allocate our money to sudden occasions and bills inflicting us to make use of our money extra rapidly than anticipated; that optimistic findings in early medical and/or nonclinical research of a product candidate will not be predictive of success in subsequent medical and/or nonclinical research of that candidate; that competing different therapies might adversely influence the business potential of OpRegen; that Roche and Genentech might not efficiently advance OpRegen or achieve success in finishing additional medical trials for OpRegen and/or acquiring regulatory approval for OpRegen in any explicit jurisdiction; that we might not set up new partnerships or develop present collaborations; that we don’t efficiently broaden consciousness of our mission or accomplishments; that Lineage might not be capable to manufacture ample medical portions of its product candidates in accordance with present good manufacturing apply; and people dangers and uncertainties inherent in Lineage’s enterprise and different dangers mentioned in Lineage’s filings with the Securities and Alternate Fee (SEC). Lineage’s forward-looking statements are primarily based upon its present expectations and contain assumptions that will by no means materialize or might show to be incorrect. All forward-looking statements are expressly certified of their entirety by these cautionary statements. Additional info concerning these and different dangers is included below the heading “Danger Components” in Lineage’s periodic stories with the SEC, together with Lineage’s most up-to-date Annual Report on Type 10-Ok and Quarterly Report on Type 10-Q filed with the SEC and its different stories, which can be found from the SEC’s web site. You might be cautioned to not place undue reliance on forward-looking statements, which converse solely as of the date on which they have been made. Lineage undertakes no obligation to replace such statements to replicate occasions that happen or circumstances that exist after the date on which they have been made, besides as required by regulation.