Ophthalmology | Phase I/ Phase II Developments | UNITED STATES

Lineage Cell Therapeutics

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Lineage Cell Therapeutics Announces Extension of OpRegen® Development Grant From Israel Innovation Authority

Lead Product(s): Retinal pigment epithelium cell transplant therapy

Therapeutic Area: Ophthalmology Product Name: OpRegen

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Israel Innovation Authority

Deal Size: $16.0 million Upfront Cash: Undisclosed

Deal Type: Funding July 06, 2020

Details:

As a result of continued clinical progress, the Israel Innovation Authority has extended its previously awarded development grant in support of OpRegen®, Company’s retinal pigment epithelium cell transplant therapy in development for the treatment of dry AMD.

Lineage Cell Therapeutics

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Lineage Cell Therapeutics Reinitiates Patient Enrollment in Clinical Study of OpRegen® for the Treatment of Dry AMD With Geographic Atrophy

Lead Product(s): Retinal pigment epithelial cells

Therapeutic Area: Ophthalmology Product Name: OpRegen

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 18, 2020

Details:

The company has restarted patient enrollment in a Phase 1/2a study of OpRegen a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration.

Lineage Cell Therapeutics

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Lineage Cell Therapeutics to Present Tomorrow at 2020 Raymond James Human Health Innovation Conference

Lead Product(s): Retinal pigment epithelial cells

Therapeutic Area: Ophthalmology Product Name: OpRegen

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 17, 2020

Details:

Lineage Cell Therapeutics 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).

Lineage Cell Therapeutics

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Lineage Cell Therapeutics Reports Regeneration of Retinal Tissue in Patient Treated With OpRegen RPE Cells for Dry AMD With Geographic Atrop...

Lead Product(s): OpRegen RPE Cells

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2020

Details:

Restoration of retinal tissue was observed in a patient enrolled in a Phase 1/2a study of its lead product candidate, OpRegen®, a retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of dry age-related macular degeneration (AMD).

Lineage Cell Therapeutics

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Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy

Lead Product(s): OpRegen

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 06, 2020

Details:

The presentation showcases results from a Phase I/IIa study of Lineage's lead product, OpRegen®, a retinal pigment epithelium cell transplant therapy for the treatment Dry AMD with Geographic Atrophy.

Regenxbio

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Regenxbio Announces Additional Positive Long-Term and Interim Phase I/Iia Trial Update for RGX-314 for the Treatment of Wet AMD

Lead Product(s): Rgx-314

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 22, 2020

Details:

RGX-314 continues to be well-tolerated at all dose levels . Long-term, durable treatment effect demonstrated over two years in Cohort 3.

Editas Medicine

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First patient treated with CRISPR medicine in phase 1/2 trial

Lead Product(s): AGN-151587

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 04, 2020

Details:

The BRILLIANCE clinical trial is evaluating AGN-151587 (EDIT-101) in patients with Leber congenital amaurosis 10 (LCA10). It is the first gene editing medicine to be evaluated inside the body.

Agtc

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AGTC Completes Enrollment in the Two Highest Dose Groups of its Ongoing Phase 1/2 Clinical Trial for X-Linked Retinitis Pigmentosa

Lead Product(s): AGTC-501

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 19, 2020

Details:

The Phase 1/2 clinical trial is evaluating the safety and efficacy of sub-retinal injection of AGTC-501 for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene.

Lineage Cell Therapeutics

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Lineage Provides Positive Update on Clinical Study of OpRegen®

Lead Product(s): Retinal pigment epithelial cell

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 06, 2020

Details:

All five patients in Cohort 4, those with better baseline vision and which represent the Company’s intended patient population, have shown increases in best corrected visual acuity (BCVA).

Agtc

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AGTC Reports Encouraging Interim Six-Month Data from the Dose Escalation Cohorts of its Ongoing Phase 1/2 Clinical Trials in Achromatopsia

Lead Product(s): Adeno-associated virus-based gene therapy

Therapeutic Area: Ophthalmology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 23, 2020

Details:

Encouraging preliminary signs of biologic activity and a favorable safety profile are outcomes that are clinically relevant to patients.

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Lineage Cell Therapeutics

Lineage Cell Therapeutics Announces Extension of OpRegen® Development Grant From Israel Innovation Authority

Lineage Cell Therapeutics

Lineage Cell Therapeutics Reinitiates Patient Enrollment in Clinical Study of OpRegen® for the Treatment of Dry AMD With Geographic Atrophy

Lineage Cell Therapeutics

Lineage Cell Therapeutics to Present Tomorrow at 2020 Raymond James Human Health Innovation Conference

Lineage Cell Therapeutics

Lineage Cell Therapeutics Reports Regeneration of Retinal Tissue in Patient Treated With OpRegen RPE Cells for Dry AMD With Geographic Atrop...

Lineage Cell Therapeutics

Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy

Regenxbio

Regenxbio Announces Additional Positive Long-Term and Interim Phase I/Iia Trial Update for RGX-314 for the Treatment of Wet AMD

Editas Medicine

First patient treated with CRISPR medicine in phase 1/2 trial

Agtc

AGTC Completes Enrollment in the Two Highest Dose Groups of its Ongoing Phase 1/2 Clinical Trial for X-Linked Retinitis Pigmentosa

Lineage Cell Therapeutics

Lineage Provides Positive Update on Clinical Study of OpRegen®

Agtc

AGTC Reports Encouraging Interim Six-Month Data from the Dose Escalation Cohorts of its Ongoing Phase 1/2 Clinical Trials in Achromatopsia