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The preclinical research demonstrated that lentiviral vector gene therapy LV-FAH was active in a large animal model of HT1 and the pigs did not experience adverse events from the integrating vector.
Lead Product(s): LV-FAH
Therapeutic Area: Genetic Disease Product Name: LV-FAH
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Paragon Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2022
Details:
The grant supports a meaningful portion of the Phase 3 clinical development of dabocemagene autoficel (FCX-007, D-Fi), an investigational gene therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Lead Product(s): Dabocemagene Autoficel
Therapeutic Area: Genetic Disease Product Name: FCX-007
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: U.S. Food & Drug Administration
Deal Size: $1.8 million Upfront Cash: Undisclosed
Deal Type: Funding October 21, 2021
Details:
first patient has been dosed in the DeFi-RDEB Phase 3 clinical trial evaluating debcoemagene autoficel (D-Fi), the company’s lead gene therapy candidate formerly designated FCX-007, in recessive dystrophic epidermolysis bullosa (RDEB).
Lead Product(s): Dabocemagene Autoficel
Therapeutic Area: Genetic Disease Product Name: FCX-007
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
The open label, single cohort Phase 1/2 clinical trial is evaluating the safety of FCX-013 as its primary objective. Secondary objectives include assessments of fibrosis at targeted sclerotic lesions at various time points through 26 weeks post-administration of FCX-013.
Lead Product(s): FCX-013,Veledimex
Therapeutic Area: Dermatology Product Name: FCX-013
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2020
Details:
The company plans to use the funding to advance and expand its gene therapy pipeline, led by the Phase 3 clinical development of FCX-007.
Lead Product(s): Dabocemagene Autoficel
Therapeutic Area: Genetic Disease Product Name: FCX-007
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Fidelity Management & Research Company
Deal Size: $55.0 million Upfront Cash: Undisclosed
Deal Type: Funding March 25, 2020
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