LCTX Lineage Cell Therapeutics, Inc.

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Previous Close 0.79
Open 0.8
52 Week Low 0.5339
52 Week High 1.67
Market Cap $118,358,780
Shares 149,821,240
Float 107,005,592
Enterprise Value $125,413,944
Volume 629,286
Av. Daily Volume 1,507,581
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Upcoming Catalysts

Drug Stage Catalyst Date
AST-OPC1 SCiSTAR
Cervical spinal cord injury
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
OpRegen
Dry age-related macular degeneration (AMD)
Phase 1/2
Phase 1/2
Phase 1/2 interim data presented June 27, 2020 at ISSCR Annual Meeting.
VAC2
Non-small cell lung cancer (NSCLC)
Phase 1/2
Phase 1/2
Phase 1 trial ongoing.

Latest News

  1. Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that as a result of continued clinical progress, the Israel Innovation Authority (IIA) has extended its previously awarded development grant in support of OpRegen®, the Company's retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of dry age-related macular degeneration (AMD). The research & development grant of up to 9 million Israeli New Shekels (approximately $2.5 million) was awarded in 2019 by the IIA and has been extended for use through June 2021 based on promising clinical data from the ongoing Phase 1/2a clinical study of…

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that as a result of continued clinical progress, the Israel Innovation Authority (IIA) has extended its previously awarded development grant in support of OpRegen®, the Company's retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of dry age-related macular degeneration (AMD). The research & development grant of up to 9 million Israeli New Shekels (approximately $2.5 million) was awarded in 2019 by the IIA and has been extended for use through June 2021 based on promising clinical data from the ongoing Phase 1/2a clinical study of OpRegen. The IIA has provided annual grants totaling approximately $16 million for the development of the OpRegen program so far.

    "We are pleased that the IIA has elected to extend its financial support based on the positive momentum and clinical achievements we have demonstrated with our OpRegen program to date," stated Brian M. Culley, Lineage CEO. "We continue to generate promising data supporting the use of our RPE cells in dry AMD with GA. Notably, after moving into patients with less advanced disease, we announced the first known finding of retinal tissue regeneration alongside reductions in the growth of geographic atrophy, and improvements in visual acuity and reading speeds in some patients. We recently resumed patient enrollment in our OpRegen study, and our immediate efforts are focused on treating and monitoring the final three patients in Cohort 4 and utilizing these data to direct our clinical, regulatory, and partnership discussions for the program. The partnerships we have built with notable institutions like the IIA, the California Institute for Regenerative Medicine, and Cancer Research UK, provide not only capital, but also external validation of our programs, and we are working to strengthen and expand these alliances as we move forward. Concurrently, we are actively looking to identify new partnerships to help support the development of all of our programs."

    About Dry AMD

    Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.

    About The Israel Innovation Authority

    The Israel Innovation Authority, an independent publicly funded agency, was created to provide a variety of practical tools and funding platforms aimed at effectively addressing the dynamic and changing needs of the local and international innovation ecosystems. This includes early-stage entrepreneurs, mature companies developing new products or manufacturing processes, academic groups seeking to transfer their ideas to the market, global corporations interested in collaborating with Israeli technology, Israeli companies seeking new markets abroad and traditional factories and plants seeking to incorporate innovative and advanced manufacturing into their businesses. More information is available at: https://innovationisrael.org.il/en/contentpage/israel-innovation-authority.

    About OpRegen

    OpRegen is currently being evaluated a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study will enroll patients into 4 cohorts, with 18 of 21 expected patients enrolled to date. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort, which is currently enrolling, will include patients with vision as high as 20/64. Cohort 4 also includes patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing the Orbit Subretinal Delivery System (Orbit SDS), objectives will include the evaluation of the safety of delivery of OpRegen using the Orbit SDS.

    Recently, Lineage reported the first known finding of retinal tissue regeneration in a patient receiving OpRegen for the treatment of atrophic dry AMD. This unprecedented finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging. The Company also has observed evidence of benefit in other patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of GA, and increases in reading speed.

    OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology 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 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. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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    • Improvements Implemented in OPC1 Production Process
    • Patent Position Strengthened to Protect the Processes, Product, and Methods of Use
    • Company is Evaluating Novel Delivery Devices to Enhance and Ease Surgical Procedure
    • FDA RMAT Meeting Planned by Year End to Discuss Manufacturing and Clinical Development

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today provided an update on OPC1, the Company's oligodendrocyte progenitor cell (OPC) therapy for the treatment of acute spinal cord injury (SCI). The OPC1 program was obtained through Lineage's acquisition of Asterias Biopharmaceuticals in March 2019, and manufacturing has…

    • Improvements Implemented in OPC1 Production Process
    • Patent Position Strengthened to Protect the Processes, Product, and Methods of Use
    • Company is Evaluating Novel Delivery Devices to Enhance and Ease Surgical Procedure
    • FDA RMAT Meeting Planned by Year End to Discuss Manufacturing and Clinical Development

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today provided an update on OPC1, the Company's oligodendrocyte progenitor cell (OPC) therapy for the treatment of acute spinal cord injury (SCI). The OPC1 program was obtained through Lineage's acquisition of Asterias Biopharmaceuticals in March 2019, and manufacturing has been completely transferred to the Company's current Good Manufacturing Practice (cGMP) facility in Israel, where key process improvements have been developed and implemented. Lineage also has strengthened its patent position in order to protect the OPC1 processes, product and composition, and methods of use. Lineage intends to meet with the U.S. Food and Drug Administration (FDA) to discuss further development of the OPC1 program by the end of 2020.

    "We have worked diligently over the past year to transition all manufacturing activities for the OPC1 program to our in-house cGMP facility, where our experienced cell therapy production team could develop and deploy much-needed improvements and modernization to the production and analytical processes," stated Brian M. Culley, Lineage CEO. "This work has achieved significantly better efficiency and improved quality control, which we expect will enable a consistent supply of material to support a late-stage clinical trial of OPC1. With these necessary steps now completed, our focus turns to developing a "thaw-and-inject" formulation and superior delivery tools, to enable an easier surgical procedure and facilitate faster enrollment in the next clinical trial. We also are evaluating ways to return OPC1 to the clinic sooner than originally planned, reflecting our view of compelling clinical data which continues to read out from the 25-patient phase 1/2a SCiStar study. Our approach with OPC1 replicates our development strategy for OpRegen, our cell therapy program for dry AMD, in which we seek not only to provide cell-based regenerative benefits, but also commercially relevant solutions with competitive advantages in areas of scale-up, production costs, and delivery techniques. By analyzing every piece of the overall therapeutic landscape, we seek to position ourselves as the clear leader in the emerging field of cell therapy transplant medicine."

    Key OPC1 Program Milestones Achieved Since the Asterias Acquisition Include:

    • Technology transfer has been completed and cell production processes have been established at Lineage's cGMP cell therapy facility;
    • The production process was improved to achieve greater efficiency and higher quality control, becoming compatible with larger-scale manufacturing, and Biologics Review Application (BLA) readiness;
    • Multiple OPC1 batches have been successfully manufactured; GMP production is planned to begin in early 2021;
    • New master and working pluripotent cell banks have been produced to supply consistent clinical and commercial batches of OPC1;
    • New in-process controls and release testing have been introduced to the production and release process and have been updated to be more compatible with current and expected future FDA BLA review processes;
    • Issuance of two new patents in 2019 related to methods for utilizing pluripotent stem cell-derived OPCs for the treatment of SCI and reducing cavitation in patients with acute SCI. Additional patent applications are pending which may further protect the processes, product and composition, and methods of use of OPC1.

    Key 2020 Milestone and Development Plans for the OPC1 Program Include:

    • Meeting with the FDA to discuss manufacturing improvements and the design of a late-stage comparative clinical trial;
    • Introducing a new "thaw-and-inject" formulation to enable easier preparation and administration of cells to the spinal cord, avoiding the need for washing and other dose preparation steps one day prior to treatment and improving commercial positioning;
    • Identifying a novel delivery system, to make the surgical procedure easier, faster, and more compatible with a thaw and inject formulation of OPC1, improving overall end-user experience for the surgeon.

    About OPC1

    OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements to motor recovery in individuals with acute spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. and there currently are no FDA-approved drugs specifically for the treatment of SCI. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

    About the OPC1 Clinical Study

    The SCiStar Study of OPC1 is an open-label, 25-patient, single-arm trial testing three sequential escalating doses of OPC1 which was administered 21 to 42 days post-injury, at up to 20 million OPC1 cells in patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI). These individuals had experienced severe paralysis of the upper and lower limbs. The primary endpoint in the SCiStar study was safety as assessed by the frequency and severity of adverse events related to OPC1, the injection procedure, and immunosuppression with short-term, low-dose tacrolimus. Secondary outcome measures included neurological functions measured by upper extremity motor scores (UEMS) and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations through 365 days post-treatment. Enrollment is complete in this study; patients will continue to be evaluated on a long-term basis.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology 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 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. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage's plans for OPC1 development and clinical studies. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  2. Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that interim results from its Phase 1/2a clinical study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (dry AMD), will be presented at the International Society for Stem Cell Research (ISSCR) 2020 Annual Meeting, which will be held virtually June 23 to June 27, 2020. The abstract presentation, entitled, "Phase I/IIa Clinical Trial of Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form…

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that interim results from its Phase 1/2a clinical study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (dry AMD), will be presented at the International Society for Stem Cell Research (ISSCR) 2020 Annual Meeting, which will be held virtually June 23 to June 27, 2020. The abstract presentation, entitled, "Phase I/IIa Clinical Trial of Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results", will be presented on Saturday June 27, 2020 by Benjamin E. Reubinoff, M.D., Ph.D., Chairman and Professor at Hadassah Medical Center, Jerusalem, Israel. The presentation will provide data from patient cohorts 1 through 4 of the clinical study.

    About ISSCR 2020

    The International Society for Stem Cell Research has transformed its annual scientific meeting into a virtual experience, bringing the global stem cell community together to share knowledge, collaborate, and network. The ISSCR 2020 Virtual Meeting, co-sponsored by the Harvard Stem Cell Institute (HSCI), will deliver a comprehensive scientific education program that includes plenaries featuring world-renowned scientists in the field. For more information, please visit www.isscr.org or follow the association on Twitter @ISSCR.

    About Dry AMD

    Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.

    About OpRegen

    OpRegen is currently being evaluated a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study will enroll patients into 4 cohorts, with 18 of 21 expected patients enrolled to date. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort, which is currently enrolling, will include patients with vision as high as 20/64. Cohort 4 also includes patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing Gyroscope Therapeutics' Orbit Subretinal Delivery System (Orbit SDS), objectives will include the evaluation of the safety of delivery of OpRegen using the Orbit SDS.

    Recently, Lineage reported the first known finding of retinal tissue regeneration in a patient receiving OpRegen for the treatment of atrophic dry AMD. This unprecedented finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging. The Company also has observed evidence of benefit in other patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of GA, and increases in reading speed.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology 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 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. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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  3. First OpRegen Patient Dosed at Cincinnati Eye Institute

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage cell therapy company which manufactures and transplants specific cell types to treat diseases and serious medical conditions, today announced that it has restarted patient enrollment in a Phase 1/2a clinical study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), following a temporary pause in enrollment as a result of the COVID-19 pandemic. The first patient dosed in the re-start was at Cincinnati Eye Institute (CEI) under the direction of principal investigator Christopher

    First OpRegen Patient Dosed at Cincinnati Eye Institute

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage cell therapy company which manufactures and transplants specific cell types to treat diseases and serious medical conditions, today announced that it has restarted patient enrollment in a Phase 1/2a clinical study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), following a temporary pause in enrollment as a result of the COVID-19 pandemic. The first patient dosed in the re-start was at Cincinnati Eye Institute (CEI) under the direction of principal investigator Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, CEI and University of Cincinnati School of Medicine. CEI is a global leader in ophthalmology research and a clinical site where local health and safety regulations recently enabled and cleared clinical study recruitment and treatment. The patient enrolled at CEI was administered Lineage's new thaw-and-inject formulation of OpRegen with Gyroscope Therapeutics' Orbit Subretinal Delivery System (SDS). The Company anticipates that it will complete enrollment of the last 3 patients in Cohort 4 of the OpRegen clinical study in the third quarter of 2020.

    "OpRegen is a promising candidate for the future treatment of dry AMD and I am excited to have dosed the first patient at our institute," stated Christopher D. Riemann, M.D. "Delivering OpRegen RPE cells to the subretinal space using the Orbit SDS was straightforward and appears to offer superior dose control and safety compared to traditional delivery methods. We have resumed our patient screening efforts and I look forward to enrolling additional patients into the study as soon as possible."

    "We are pleased to safely resume patient enrollment in our OpRegen study under the direction of Dr. Riemann at CEI," stated Brian M. Culley, Lineage CEO. "Data collected from the OpRegen program continues to support the use of our cells in dry AMD with GA, particularly after we moved into treating patients with less advanced disease. Additionally, we recently announced the first known finding of retinal tissue regeneration alongside improvements in the progression of geographic atrophy, visual acuity, and reading speeds in some patients. With enrollment once again underway, our immediate objective is to treat and monitor the final three patients in Cohort 4 of the study and utilize these data to direct our clinical, regulatory, and partnership discussions. Our goal is to combine the best cell line, the best production process, and the best delivery system, to position OpRegen as the front-runner in the race to address the unmet need in the potential billion-dollar dry AMD market."

    Recently, Lineage reported the first known finding of retinal tissue regeneration in a patient receiving OpRegen for the treatment of atrophic dry AMD. This unprecedented finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. The loss of RPE cells over time creates progressively larger areas of geographic atrophy (GA) in the adult retina, leading to impaired vision or complete blindness. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which has led to a presumption that progression of GA may someday be slowed or halted but cannot be reversed. The unique finding from the ongoing OpRegen clinical trial supports a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. Lineage has reported evidence from a patient with atrophic end-stage disease who received a transplant of allogeneic RPE cells and showed substantial restoration of retinal tissue within the area of GA. Specifically, the area of GA assessed at 9 months was approximately 25% smaller than the patient's pre-treatment baseline. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging.

    The Company has also observed evidence of benefit in some patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of GA and increases in reading speed. The addition of signs of retinal tissue regeneration provides further support that OpRegen may be a viable treatment for the millions of individuals living with dry AMD, one of the leading causes of vision loss in the world.

    About the OpRegen Phase 1/2a Clinical Study

    This is a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study will enroll patients into 4 cohorts, with 18 of 21 expected patients enrolled to date. The first 3 cohorts enrolled solely legally blind patients, with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort, which is currently enrolling, will include patients with vision ranging from 20/250 to as high as 20/64. Cohort 4 also includes patients treated with one of two formulations of OpRegen, (i) a formulation which required preparation of cells one day prior to use in a dose preparation laboratory; or (ii) a new "off-the-shelf" or "thaw-and-inject" formulation of OpRegen which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing Gyroscope Therapeutics' Orbit Subretinal Delivery System (Orbit SDS), objectives will include the evaluation of the safety of delivery of OpRegen using the Orbit SDS.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology 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 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. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

    Forward-Looking Statements

    Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the anticipated completion of patient enrollment in Lineage's Phase 1/2a clinical study of OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage's business and other risks in Lineage's filings with the Securities and Exchange Commission (the SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC's website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  4. Presentation Begins at 9:40am Eastern Time

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced that Brian M. Culley, Chief Executive Officer, will be presenting tomorrow morning at the 2020 Raymond James Human Health Innovation Conference at 9:40 am Eastern Time. In addition to a corporate overview, Mr. Culley will provide an update on the status of Lineage's lead program, OpRegen®, an allogeneic retinal pigment epithelium (RPE) transplant therapy for dry age-related macular degeneration (AMD). Recently, the company provided details on the first known reported finding of retinal tissue regeneration in a patient with dry AMD…

    Presentation Begins at 9:40am Eastern Time

    Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced that Brian M. Culley, Chief Executive Officer, will be presenting tomorrow morning at the 2020 Raymond James Human Health Innovation Conference at 9:40 am Eastern Time. In addition to a corporate overview, Mr. Culley will provide an update on the status of Lineage's lead program, OpRegen®, an allogeneic retinal pigment epithelium (RPE) transplant therapy for dry age-related macular degeneration (AMD). Recently, the company provided details on the first known reported finding of retinal tissue regeneration in a patient with dry AMD with geographic atrophy. Interested investors can access the live presentation on the Events and Presentations section of Lineage's website.

    The archived presentation will be posted on the Events and Presentations section of Lineage's website the day following the event and will be available for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/.

    About Lineage Cell Therapeutics, Inc.

    Lineage Cell Therapeutics is a clinical-stage biotechnology 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 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. Lineage's clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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