178:●OpRegen®, a single-injection retinal pigment epithelium cell replacement therapy currently in a Phase 1/2a multicenter clinical trial for the treatment of advanced dry age-related macular degeneration (“AMD”) with geographic atrophy (GA). There currently are no therapies approved by the U.S. Food and Drug Administration (“FDA”) for dry AMD, which accounts for approximately 85-90% of all AMD cases and is the leading cause of blindness in people over the age of 60. Interim data from 9 months of follow-up post-injection for Cohort 4 was reported in September 2021, highlights improved baseline visions and smaller areas of GA compared to prior cohorts. Overall, OpRegen has proven to be well tolerated to date with no serious adverse events not previously reported. Overall, 8/12 of Cohort 4 patients' treated eyes showed above baseline visual acuity at the last assessment, while 9/12 of the patients' untreated eyes were below baseline visual acuity at the same assessment interval. In May 2022, data was presented at the 2022 Association for Research in Vision and Ophthalmology Annual Meeting: OpRegen Phase 1/2a clinical results support the potential for OpRegen to slow, stop or reverse disease progression in geographic atrophy secondary to age-related macular degeneration. 12-month primary endpoint data suggested OpRegen was well tolerated with an acceptable safety profile. Preliminary evidence of visual function and outer retinal structure improvements observed in five Cohort 4 patients with GA and impaired vision. In December 2021, Lineage announced that the company entered a $ 670 million exclusive worldwide collaboration Genentech, a member of the Roche Group, for the development and commercialization of OpRegen.
172:, the acquisition of Asterias Biotherapeutics and conducting management changes which altogether focused the company mission on developing novel therapies based on directed differentiation and transplant of specific cell types. Since then, Lineage’s focus has been to develop therapies for degenerative retinal diseases, neurological conditions associated with demyelination, and aiding the body in detecting and combating cancer. Specifically, Lineage is testing therapies to treat dry age-related macular degeneration, spinal cord injuries, non-small cell lung cancer, auditory neuropathy, and vision loss. Lineage’s programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. From this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are transplanted into a patient either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. In October 2022, Lineage announced the establishment of a new R&D facility in Carlsbad, California, as well as an expansion to the company’s existing GMP manufacturing facility in Israel. The new facility in Carlsbad will broaden Lineage’s R&D capabilities in the U.S. and support the development of current and future allogeneic cell transplant programs, while the expansion in Israel will increase the company’s infrastructure, including development and optimization of larger-scale clinical manufacturing processes.
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differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer.
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clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage.
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Lineage is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. The company changed its name from BioTime Inc. to
Lineage Cell Therapeutics less than one year following its appointment of a new CEO, Brian Culley, in August 2018 and completing a series of
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Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, an allogeneic dendritic cell therapy produced from
Lineage's VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1
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company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform
Lineage develops and manufactures specialized, terminally
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198:â—ŹPNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. Process development and preclinical activities in support of ongoing and planned preclinical testing for the program are ongoing.
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195:â—ŹANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy. Process development and preclinical activities in support of planned preclinical testing for the program are ongoing.
555:"A Cancer Research UK Phase I Trial of AST-VAC2 (Allogeneic Dendritic Cell Vaccine) Administered Weekly Via Intradermal Injection in Patients With Non-small Cell Lung Cancer (NSCLC) in the Advanced and Adjuvant Settings"
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181:●OPC1, an oligodendrocyte progenitor cell therapy currently in a Phase 1/2a multicenter clinical trial for acute spinal cord injuries (“SCI”). This clinical trial has been partially funded by the
860:"RG6501 (OpRegen®) Phase 1/2a Clinical Results Support the Potential for OpRegen to Slow, Stop or Reverse Disease Progression in Geographic Atrophy Secondary to Age-Related Macular Degeneration"
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188:â—ŹVAC2, a cancer immunotherapy of antigen-presenting dendritic cells currently in a Phase 1 clinical trial in non-small cell lung cancer. This clinical trial is being funded and conducted by
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1167:"AgeX Therapeutics Sublicenses Stem Cell Line ESI-053 to ImStem Biotechnology for Development of Cell Therapy Candidate IMS001 for COVID-19 and Acute Respiratory Distress Syndrome"
884:"Lineage Establishes Exclusive Worldwide Collaboration With Genentech for the Development and Commercialization of OpRegen® RPE Cell Therapy for the Treatment of Ocular Disorders"
460:"Lineage Establishes Exclusive Worldwide Collaboration With Genentech for the Development and Commercialization of OpRegen® RPE Cell Therapy for the Treatment of Ocular Disorders"
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1069:"Lineage Announces a Fifth Cell Therapy Program: Allogeneic Photoreceptor Transplants for the Treatment of Diseases Which May Lead to Blindness"
662:"Lineage Announces a Fifth Cell Therapy Program: Allogeneic Photoreceptor Transplants for the Treatment of Diseases Which May Lead to Blindness"
488:"Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration – Full Text View – ClinicalTrials.gov"
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146:(“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy for the treatment of dry
934:"A Phase I/IIa Dose Escalation Safety Study of AST-OPC1 in Patients with Cervical Sensorimotor Complete Spinal Cord Injury"
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1021:"Lineage Announces Pipeline Expansion to Include Auditory Neuronal Cell Therapy for Treatment of Hearing Loss"
614:"Lineage Announces Pipeline Expansion to Include Auditory Neuronal Cell Therapy for Treatment of Hearing Loss"
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Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five
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784:"Lineage Establishes New R&D Facility in U.S. and Expands Current GMP Manufacturing Facility in Israel"
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516:"A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury"
1094:"Lineage Cell Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update"
1045:"Lineage Cell Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update"
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Lineage has five allogeneic, or “off-the-shelf,” cell therapy programs in clinical development:
1118:"Lineage Cell Therapeutics Provides Update on OPC1 Cell Therapy Program for Spinal Cord Injury"
1233:"LCTX Company Profile & Executives – Lineage Cell Therapeutics Inc. – Wall Street Journal"
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760:"Lineage Cell Therapeutics Acquires Asterias Biotherapeutics | Mergr"
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Dipti Amin, MBBS, FFPM, MRCGP, DCPSA, DCH, DRCOG, DGM – Director
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Counsel & Corporate Strategy
711:"BioTime Announces Name Change to Lineage Cell Therapeutics"
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183:California Institute for Regenerative Medicine
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836:"Dry Age-related Macular Degeneration – AMDF"
347:(1) Includes shares owned by Lineage and ESI
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894:2022-11-16
869:2022-11-16
845:2020-12-16
821:2020-12-16
812:"OpRegen®"
794:2022-11-16
769:2021-09-22
745:2021-09-22
721:2021-09-22
696:2022-11-16
687:"Pipeline"
672:2022-11-16
647:2022-11-16
638:"Pipeline"
623:2022-11-16
599:2022-11-16
497:2020-12-14
470:2022-11-16
445:2020-12-14
421:2020-12-14
395:References
359:includes:
355:Lineage’s
327:Singapore
248:2015-2018
237:2015-2018
226:2007-2015
144:allogeneic
102:Key people
1314:Bloomberg
764:mergr.com
412:"Company"
152:Genentech
46:Traded as
1171:BioSpace
1098:BioSpace
1049:BioSpace
1025:BioSpace
952:cite web
618:BioSpace
310:99% (1)
285:Country
185:(CIRM).
69:Industry
1324:Reuters
313:Israel
163:History
116:Website
83:Founded
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1334:Yahoo!
1319:Google
972:"VAC2"
909:"OPC1"
590:"VAC2"
338:99.8%
245:Co-CEO
234:Co-CEO
38:Public
324:100%
296:100%
212:Title
156:Roche
134:is a
958:link
576:help
537:help
341:USA
299:USA
209:Name
123:.com
86:1990
63:LCTX
59:TASE
56:LCTX
52:AMEX
256:CEO
223:CEO
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