Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Primary endpoint is impact on annualized bleeding rate through 15 months following treatment with PF-07055480 (giroctocogene fitelparvovec). Secondary endpoints include FVIII activity level after onset of steady state.
Brand Name : PF-07055480
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
September 22, 2022
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Sangamo Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Company updated data from the Phase 1/2 Alta study of PF-07055480 (giroctocogene fitelparvovec), an investigational gene therapy for patients with moderately severe to severe hemophilia A.
Brand Name : PF-07055480
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
December 12, 2021
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Sangamo Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Sangamo Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Pfizer and Sangamo Announce Updated Phase 1/2 Results of Hemophilia A Gene Therapy
Details : When administered at the highest dose, giroctocogene fitelparvovec (SB-525 or PF-07055480) prevented bleeds and the use of clotting factor VIII (FVIII) in men with severe hemophilia A, according to follow-up data from the Alta Phase 1/2 clinical trial.
Brand Name : PF-07055480
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
December 07, 2020
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Sangamo Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Sangamo Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : AFFINE is a global Phase 3, open-label, multicenter, single arm study that will evaluate the efficacy and safety of giroctocogene fitelparvovec in patients with moderately severe to severe hemophilia A.
Brand Name : SB-525
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
October 07, 2020
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Sangamo Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Sangamo Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : All five patients with severe hemophilia A who received the 3e13 vg/kg dose showed sustained factor VIII (FVIII) activity levels, with a median of 64.2% via chromogenic assay (patient-level geometric means after week 9 post-infusion).
Brand Name : Undisclosed
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
June 18, 2020
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Sangamo Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Biogen
Deal Size : $2,720.0 million
Deal Type : Collaboration
Sangamo Announces Closing of Biogen Collaboration Agreement
Details : The agreement strengthens Sangamo's balance sheet to execute on its wholly owned and partnered development programs through multiple important milestones, including the potential filing of the BLA for SB-525 for hemophilia A.
Brand Name : SB-525
Molecule Type : Cell and Gene therapy
Upfront Cash : $125.0 million
April 09, 2020
Lead Product(s) : Giroctocogene fitelparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Biogen
Deal Size : $2,720.0 million
Deal Type : Collaboration
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