Lineage Cell Therapeutics

Lineage Announces Submission of OPC1 Investigational New Drug Amendment for Treatment of Chronic and Subacute Spinal Cord Injury

Retrieved on: 
Monday, December 18, 2023
Stem Cells, Biotechnology, FDA, Health, Pharmaceutical, Neurology, Medical Devices, Research, Surgery, Science, Clinical Trials, Regenerative medicine, Delivery, Safety, Food, Therapy, Journal of Neurosurgery, IND, Lineage Cell Therapeutics, Inda, Proposition 71, Spinal cord, Patient, Journal, Injury, Spine, Investigational New Drug, NYSE American, Person, Trial of the century, Quality of life, TASE, SCI, Pharmaceutical industry, Neurosurgery

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that the Company has submitted an Investigational New Drug amendment (INDa) to the U.S. Food and Drug Administration (FDA), for OPC1 , its investigational allogeneic oligodendrocyte progenitor cell transplant, for the treatment of spinal cord injury (SCI).

Key Points: 
  • Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that the Company has submitted an Investigational New Drug amendment (INDa) to the U.S. Food and Drug Administration (FDA), for OPC1 , its investigational allogeneic oligodendrocyte progenitor cell transplant, for the treatment of spinal cord injury (SCI).
  • Receipt of FDA clearance of the INDa would enable the Company to initiate its DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study, to evaluate the safety and utility of a novel spinal cord delivery device in both subacute and chronic SCI patients.
  • “The submission of our IND amendment for OPC1 and its return to clinical testing represents a significant milestone for this program and a diligent effort by our team,” stated Brian M. Culley, Lineage CEO.
  • We are encouraged by the meaningful quality of life and safety results observed with OPC1 in previous trials, and we look forward to building on that promising work.

Sofinnova Partners Launches Biovelocita, the First Pan-European Investment Strategy Dedicated to the Creation and Acceleration of Biotech Startups

Retrieved on: 
Wednesday, December 13, 2023
Professional Services, Health, Start-Up, Other Science, Finance, Science, Biotechnology, EOS, Harvard University, Acquisition, Luisa Seghezzi, Therapy, Acceleration, Lineage Cell Therapeutics, Ewing Marion Kauffman Foundation, Systems biology, Sofinnova, Partner, Growth, Doctor of Philosophy, Clovis Oncology, Pharmaceutical industry, Management

Sofinnova Partners (“Sofinnova"), a leading European life sciences venture capital firm based in Paris, London, and Milan, announced today the launch of Biovelocita , an investment strategy dedicated entirely to the creation and acceleration of biotech startups in Europe.

Key Points: 
  • Sofinnova Partners (“Sofinnova"), a leading European life sciences venture capital firm based in Paris, London, and Milan, announced today the launch of Biovelocita , an investment strategy dedicated entirely to the creation and acceleration of biotech startups in Europe.
  • The strategy builds upon Sofinnova’s established track record of nurturing innovative ventures within the healthcare and sustainability sectors.
  • Graziano Seghezzi, Managing Partner of Sofinnova Partners, said: “With Sofinnova Biovelocita, we are doubling down on our commitment to innovation and company creation in the life sciences.
  • Zhizhong (Joel) Yao , Partner, a former Principal in the Sofinnova Capital Strategy, and a Kauffman Fellow, instrumental in the launch of several biotech start-ups.

Lineage Cell Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 9, 2023
Stem Cells, Biotechnology, Pharmaceutical, Optical, Oncology, Health, Health Technology, Clinical Trials, Webcast, RPE, Interest, B2M, Research, VAC, D, Therapy, Visual acuity, OCT, IND, Lineage Cell Therapeutics, Eterna, INL, Patient, FDA, Collaboration, G&A, OPL, Expense, Investigational New Drug, NYSE American, Trial of the century, ELM, AMD, Geographic atrophy, Roche, Survival, Partnership, Congress, Letter, TASE, NK, Pharmaceutical industry, Fine chemical, Vaccine, Genentech

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the third quarter ended September 30, 2023 and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business update.

Key Points: 
  • Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the third quarter ended September 30, 2023 and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business update.
  • “The Lineage team has continued to advance our clinical and preclinical pipeline of differentiated cell transplant programs, supporting our alliances and working to establish new collaborations,” stated Brian M. Culley, Lineage CEO.
  • Interested parties may access today’s conference call and webcast, by dialing (800) 715-9871 from the U.S. and Canada and should request the “Lineage Cell Therapeutics Call”.
  • A live webcast of the conference call will be available online in the Investors section of Lineage’s website.

Lineage Cell Therapeutics to Report Third Quarter 2023 Financial Results and Provide Business Update on November 9, 2023

Retrieved on: 
Wednesday, November 1, 2023
Health, Genetics, Health Technology, Clinical Trials, Pharmaceutical, Biotechnology, TASE, Interest, NYSE American, Therapy, Webcast, Lineage Cell Therapeutics, Pharmaceutical industry

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its third quarter 2023 financial and operating results on Thursday, November 9, 2023, following the close of the U.S. financial markets.

Key Points: 
  • Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its third quarter 2023 financial and operating results on Thursday, November 9, 2023, following the close of the U.S. financial markets.
  • Lineage management will also host a conference call and webcast on Thursday, November 9, 2023, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2023 financial and operating results and to provide a business update.
  • Interested parties may access the conference call on November 9th, 2023, by dialing (800) 715-9871 from the U.S. and Canada and should request the “Lineage Cell Therapeutics Call”.
  • A live webcast of the conference call will be available online in the Investors section of Lineage’s website.

RG6501 (OpRegen®) Phase 1/2a Results to Be Featured at Eyecelerator at 2023 American Academy of Ophthalmology (AAO) Annual Meeting

Retrieved on: 
Tuesday, October 24, 2023
Health, Clinical Trials, Research, Science, Pharmaceutical, Optical, Biotechnology, Janus, Medical Affairs Bureau, Lineage Cell Therapeutics, AMD, AAO, Cell, Geographic atrophy, OD, RPE, Division, San Francisco Marriott Marquis, American Academy, GA, American Academy of Ophthalmology, Lineage, Annual general meeting, Macular degeneration, Roche, TASE, CFA, NYSE American, San Francisco, Therapy, Patient, Food and Drug Administration, Pharmaceutical industry, Ophthalmology, Genentech

In addition, the results of imaging analyses demonstrating evidence of rapid improvement in outer retinal structure and continued clinical benefit in subjects from a Phase 1/2a clinical study of RG6501 ( OpRegen ) (ClinicalTrials.gov Identifier: NCT02286089 ), have been accepted for presentation at Eyecelerator 2023 .

Key Points: 
  • In addition, the results of imaging analyses demonstrating evidence of rapid improvement in outer retinal structure and continued clinical benefit in subjects from a Phase 1/2a clinical study of RG6501 ( OpRegen ) (ClinicalTrials.gov Identifier: NCT02286089 ), have been accepted for presentation at Eyecelerator 2023 .
  • Eyecelerator will occur prior to the American Academy of Ophthalmology (AAO) 2023 Annual Meeting and will be held at the San Francisco Marriott Marquis on Thursday, November 2nd, 2023.
  • RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD).
  • OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function.

Lineage Announces Issuance of U.S. Patent Covering Proprietary Manufacturing and Differentiation Process for Retinal Pigmented Epithelial Cells

Retrieved on: 
Wednesday, October 11, 2023
Health, Other Science, Clinical Trials, Science, Pharmaceutical, Optical, Biotechnology, Patent, Lineage Cell Therapeutics, Iris (anatomy), Roche, Lineage, Therapy, AMD, NYSE American, GA, Growth, TASE, RPE, Patient, Geographic atrophy, Pharmaceutical industry, Genentech

11,746,324, entitled “Large Scale Production of Retinal Pigment Epithelial Cells”.

Key Points: 
  • 11,746,324, entitled “Large Scale Production of Retinal Pigment Epithelial Cells”.
  • The patent, which has been exclusively licensed to Lineage, has an expected expiration date of July 28, 2036.
  • Subretinal delivery of OpRegen has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function.
  • The program is being developed under an exclusive worldwide collaboration between Lineage, Roche , and Genentech , a member of the Roche Group.

RG6501 (OpRegen®) Phase 1/2a Results Show Evidence of Rapid Improvement of Outer Retinal Structure in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Retrieved on: 
Thursday, October 5, 2023
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Congress, Lineage Cell Therapeutics, Tel Aviv Sourasky Medical Center, Letter, Trial of the century, Cell, Maintenance, OPL, OCT, Therapy, AMD, NYSE American, GA, INL, TASE, RPE, Patient, Geographic atrophy, ELM, Fine chemical, Medical imaging, Genentech, Ophthalmology, Lineage

RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD).

Key Points: 
  • RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD).
  • OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function.
  • “We are extremely pleased to see these additional observations of rapid improvements to outer retinal structure in the initial clinical study of OpRegen.
  • Durability of retinal structure improvements beyond the 12-month primary endpoint is still being evaluated in other patients.

Lineage to Present at Cantor Fitzgerald 2023 Global Healthcare Conference on September 27, 2023

Retrieved on: 
Tuesday, September 19, 2023
Oncology, Health, Infectious Diseases, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, NYSE American, Interest, Lineage Cell Therapeutics, Therapy, InterContinental New York Barclay Hotel, Lineage, Conference, TASE, Pharmaceutical industry, Online shopping, Media

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the Cantor Fitzgerald 2023 Global Healthcare Conference , in a fireside chat hosted by Kristen Kluska, Managing Director, Biotechnology Equity Research, Cantor Fitzgerald & Co., on September 27th, 2023 at 9:10am ET.

Key Points: 
  • Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the Cantor Fitzgerald 2023 Global Healthcare Conference , in a fireside chat hosted by Kristen Kluska, Managing Director, Biotechnology Equity Research, Cantor Fitzgerald & Co., on September 27th, 2023 at 9:10am ET.
  • The Cantor Fitzgerald 2023 Global Healthcare Conference is being held at the InterContinental New York Barclay Hotel.
  • Interested parties can register to view a replay of the presentation on the Events and Presentations section of Lineage’s website.
  • Additional videos are available on the Media page of the Lineage website.

RG6501 (OpRegen®) Phase 1/2a Additional Results to Be Featured at 23rd EURETINA Congress

Retrieved on: 
Wednesday, September 13, 2023
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Lineage, AMD, Geographic atrophy, GA, Cell, RAI Amsterdam, Congress, Patient, TASE, Tel Aviv Sourasky Medical Center, NYSE American, Lineage Cell Therapeutics, RPE, Therapy, Pharmaceutical industry, Fine chemical, Genentech, Ophthalmology

The meeting will be held in the RAI Amsterdam, The Netherlands from October 5-8, 2023.

Key Points: 
  • The meeting will be held in the RAI Amsterdam, The Netherlands from October 5-8, 2023.
  • RG6501 (OpRegen) is a suspension of human allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of GA secondary to age-related macular degeneration (AMD).
  • OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function.
  • It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114 ).

Lineage to Present at 2023 International Spinal Research Trust Network Meeting

Retrieved on: 
Monday, September 11, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Physical Therapy, Park, Medical Affairs Bureau, International Spinal Cord Society, Lineage, GMT, Life, Christopher and Dana Reeve Foundation, Wings for Life World Run, Interest, TASE, NYSE American, SCOPE, Lineage Cell Therapeutics, SCI, Therapy, Pharmaceutical industry, Online shopping, Media

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Gary S. Hogge, D.V.M., M.S., Ph.D., Lineage’s Senior Vice President, Clinical & Medical Affairs, will present at the 2023 International Spinal Research Trust (ISRT) Network Meeting , being held September 14 to 16, 2023, at the Holiday Inn Regent's Park, London, UK.

Key Points: 
  • Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Gary S. Hogge, D.V.M., M.S., Ph.D., Lineage’s Senior Vice President, Clinical & Medical Affairs, will present at the 2023 International Spinal Research Trust (ISRT) Network Meeting , being held September 14 to 16, 2023, at the Holiday Inn Regent's Park, London, UK.
  • Both presentations are part of the SCI Clinical Trials Session, sponsored by The International Spinal Research Trust , Spinal Cord Outcomes Partnership Endeavor (SCOPE), Wings for Life and the Christopher and Dana Reeve Foundation .
  • Interested parties can register to view replays of the presentations on the Events and Presentations section of Lineage’s website.
  • Additional videos are available on the Media page of the Lineage website.