Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : LV-FAH
Therapeutic Area : Genetic Disease
Study Phase : Preclinical
Sponsor : Paragon Biosciences
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : LV-FAH
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 30, 2022
Lead Product(s) : LV-FAH
Therapeutic Area : Genetic Disease
Highest Development Status : Preclinical
Sponsor : Paragon Biosciences
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dabocemagene Autoficel
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : U.S. Food & Drug Administration
Deal Size : $1.8 million
Deal Type : Funding
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).
Brand Name : FCX-007
Molecule Type : Cell and Gene therapy
Upfront Cash : Undisclosed
October 21, 2021
Lead Product(s) : Dabocemagene Autoficel
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : U.S. Food & Drug Administration
Deal Size : $1.8 million
Deal Type : Funding
Lead Product(s) : Dabocemagene Autoficel
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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).
Brand Name : FCX-007
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
October 28, 2020
Lead Product(s) : Dabocemagene Autoficel
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : FCX-013,Veledimex
Therapeutic Area : Dermatology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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-administr...
Brand Name : FCX-013
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
October 15, 2020
Lead Product(s) : FCX-013,Veledimex
Therapeutic Area : Dermatology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dabocemagene Autoficel
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Fidelity Management & Research Company
Deal Size : $55.0 million
Deal Type : Funding
Castle Creek Biosciences Announces $75 Million Investment
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.
Brand Name : FCX-007
Molecule Type : Cell and Gene therapy
Upfront Cash : Undisclosed
March 25, 2020
Lead Product(s) : Dabocemagene Autoficel
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Fidelity Management & Research Company
Deal Size : $55.0 million
Deal Type : Funding
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