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    [{"orgOrder":0,"company":"Opus Genetics","sponsor":"RD Fund","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"RD Fund Launches Opus Genetics with $19M Seed Funding to Advance Gene Therapy Treatments for Blinding Conditions","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Preclinical"},{"orgOrder":0,"company":"Opus Genetics","sponsor":"Massachusetts Eye and Ear and Harvard Medical School","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Opus Genetics Announces Agreement with Massachusetts Eye and Ear and Harvard Medical School to License Third Program for Inherited Retinal Disease","therapeuticArea":"Genetic 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Enabling"},{"orgOrder":0,"company":"Opus Genetics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opus Genetics Receives FDA Clearance of IND Application for OPGx-001, a Gene Therapy Candidate Intended for the Treatment of Rare Inherited Retinal Disease LCA5","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Opus Genetics","sponsor":"IVERIC bio","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$0.5 million","newsHeadline":"Opus Genetics Announces Acquisition of the Rights to Two Gene Therapy Product Candidates for Inherited Retinal Diseases","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"Opus Genetics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opus Genetics Announces First Patient Dosed in Phase 1\/2 Trial of Gene Therapy OPGx-LCA5 in Patients with Rare Inherited Retinal Disease LCA5","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Opus Genetics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opus Genetics Announces Completion of Dosing in First Cohort of Phase 1\/2 Trial of Gene Therapy OPGx-LCA5 in Patients with Rare Inherited Retinal Disease LCA5","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase I\/ Phase II"}]

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              Opus Genetics

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              Opus Genetics Announces Completion of Dosing in First Cohort of Phase 1/2 Trial of Gene Therapy OPGx-LCA5 in Patients with Rare Inherited Retinal Disease LCA5

              Details:

              OPGx-LCA5, an adeno-associated virus 8 (AAV8) vector designed to precisely deliver a functional LCA5 gene to the outer retina in patients with Leber congenital amaurosis resulting from biallelic mutations in the LCA5 gene (LCA5).

              Lead Product(s): OPGx-LCA5

              Therapeutic Area: Rare Diseases and Disorders Product Name: OPGx-LCA5

              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 March 26, 2024

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              Opus Genetics

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              Opus Genetics Announces First Patient Dosed in Phase 1/2 Trial of Gene Therapy OPGx-LCA5 in Patients with Rare Inherited Retinal Disease LCA5

              Details:

              OPGx-LCA5, an adeno-associated virus 8 (AAV8) vector designed to precisely deliver a functional LCA5 gene to the outer retina in patients with Leber congenital amaurosis (LCA) resulting from biallelic mutations in the LCA5 gene (LCA5).

              Lead Product(s): OPGx-LCA5

              Therapeutic Area: Rare Diseases and Disorders Product Name: OPGx-LCA5

              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 September 07, 2023

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              Opus Genetics

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              Opus Genetics Announces Acquisition of the Rights to Two Gene Therapy Product Candidates for Inherited Retinal Diseases

              Details:

              Opus Genetics' AAV-based gene therapy portfolio tackles some of the most neglected forms of inherited blindness while creating novel orphan manufacturing scale and efficiencies.

              Lead Product(s): AAv-based Gene Therapy

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              Highest Development Status: Preclinical Product Type: Cell and Gene therapy

              Recipient: IVERIC bio

              Deal Size: Undisclosed Upfront Cash: $0.5 million

              Deal Type: Acquisition December 28, 2022

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              Opus Genetics

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              Opus Genetics Receives FDA Clearance of IND Application for OPGx-001, a Gene Therapy Candidate Intended for the Treatment of Rare Inherited Retinal Disease LCA5

              Details:

              OPGx-001 is an adeno-associated virus 8 (AAV8) vector to precisely deliver a functional LCA5gene to retinal photoreceptors. Preclinical studies in in vitro and in vivo models of LCA5 have provided support for the safety and efficacy of OPGx-001.

              Lead Product(s): AAV8.hLCA5

              Therapeutic Area: Rare Diseases and Disorders Product Name: OPGx-001

              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 December 01, 2022

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              Opus Genetics

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              Opus Genetics Announces Promising New Data Highlighting Potential of AAV-based Gene Therapies for the Treatment of Rare Inherited Retinal Diseases

              Details:

              Preclinical data, including faithful animal and human iPSC models, have demonstrated preservation of visual function when OPGx-001 was administered prior to peak disease severity, indicating the potential for a broad therapeutic window for patients with LCA5.

              Lead Product(s): OPGx-001

              Therapeutic Area: Genetic Disease Product Name: OPGx-001

              Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 04, 2022

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              New Data on Potential of Opus AAV-based Gene Therapies for Rare Inherited Retinal Diseases to be Presented at Association for Research in Vision and Ophthalmology Annual Me...

              Details:

              Data support continued development of OPGx-001, designed to address mutations in LCA5 gene and OPGx-002, restoring protein expression caused by mutations in RDH12 gene, to address mutations in genes causing forms of Leber congenital amaurosis.

              Lead Product(s): OPGx-002

              Therapeutic Area: Genetic Disease Product Name: OPGx-002

              Highest Development Status: Preclinical Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 28, 2022

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              Opus Enters Strategic Collaboration with Resilience for AAV-based Gene Therapy Development and Manufacturing for Inherited Retinal Diseases

              Details:

              Resilience will provide process and analytical development, quality control testing, and GMP manufacturing services for IND-enabling toxicology and first-in-human material for Opus’ adeno-associated viral (AAV) vector-based gene therapies including OPGx-001, OPGx-002 and OPGx-003.

              Lead Product(s): OPGx-001

              Therapeutic Area: Genetic Disease Product Name: OPGx-001

              Highest Development Status: Preclinical Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: National Resilience

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Collaboration April 11, 2022

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              Opus Genetics Announces Agreement with Massachusetts Eye and Ear and Harvard Medical School to License Third Program for Inherited Retinal Disease

              Details:

              Agreement signed by Opus Genetics to license its third preclinical program OPGx-003, to address mutations in the NMNAT1 gene which cause a specific form of Leber congenital amaurosis (LCA) program.

              Lead Product(s): OPGx-003

              Therapeutic Area: Genetic Disease Product Name: OPGx-003

              Highest Development Status: Preclinical Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Massachusetts Eye and Ear and Harvard Medical School

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement November 11, 2021

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              RD Fund Launches Opus Genetics with $19M Seed Funding to Advance Gene Therapy Treatments for Blinding Conditions

              Details:

              The initial seed funding will allow Opus to advance the preclinical research including the lead program, OPGx-001, which is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein.

              Lead Product(s): OPGx-001

              Therapeutic Area: Rare Diseases and Disorders Product Name: OPGx-001

              Highest Development Status: Preclinical Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: RD Fund

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Financing September 22, 2021

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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