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Details:
On closing, AGTC will be Syncona’s third company focused on retinal gene therapy, and transitioning AGTC-501 to Syncona’s experienced stewardship with the goal of advancing this differentiated product candidate to patients with XLRP.
Lead Product(s): AGTC-501
Therapeutic Area: Genetic Disease Product Name: AGTC-501
Highest Development Status: Phase II/ Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Syncona
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 23, 2022
Details:
AGTC intends to use the net proceeds from this offering, to fund its ongoing Skyline and Vista clinical trials in its X-linked retinitis pigmentosa (XLRP) program, AGTC-501 (rAAV2tYF-GRK1-hRPGRco) and its ongoing Phase 1/2 clinical trials in its Achromatopsia program.
Lead Product(s): rAAV2tYF-GRK1-hRPGRco
Therapeutic Area: Genetic Disease Product Name: AGTC-501
Highest Development Status: Phase II/ Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering July 13, 2022
Details:
AGTC-501, recombinant AAV viral vector-based gene therapy targeting mutations in RPGR gene in patients with X-linked retinitis pigmentosa, demonstrated 62.5% of patients in dose group B were responders for improvements in visual sensitivity, study’s primary efficacy endpoint.
Lead Product(s): AGTC-501
Therapeutic Area: Genetic Disease Product Name: AGTC-501
Highest Development Status: Phase II/ Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
18 months after treatment, of eyes in study with visible foveal EZ at baseline underwent subretinal administration of AGTC-501 (rAAV2tYF-GRK1-hRPGRco), showed recovery of foveal EZ and nearly half had improved EZ appearance, correlated with improvement in macular sensitivity.
Lead Product(s): rAAV2tYF-GRK1-hRPGRco
Therapeutic Area: Genetic Disease Product Name: AGTC-501
Highest Development Status: Phase II/ Phase IIIProduct 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
Details:
Administration of AVrh10-Based Gene Therapy, in non-human primates resulted in a dose-dependent and sustained expression of human progranulin in cerebrospinal fluid and achieved levels above physiological level in normal humans, without any vector-associated adverse effects.
Lead Product(s): AVrh10-Based Gene Therapy
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Details:
AGTC-401, a recombinant AAV viral vector-based gene therapy targeting mutations in the CNGB3 gene in patients with achromatopsia demonstrated a favorable safety profile through second-highest dose (1.1E+12 vg/mL) in ACHMB3 pediatric patients.
Lead Product(s): rAAV2tYF-PR1.7-hCNGB3
Therapeutic Area: Ophthalmology Product Name: AGTC-401
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 April 04, 2022
Details:
AGTC intends to use the net proceeds from this offering, together with other available funds, to fund its ongoing Skyline and Vista clinical trials in its X-linked retinitis pigmentosa (XLRP) program and its ongoing Phase 1/2 clinical trials in its Achromatopsia program.
Lead Product(s): rAAV2tYF-GRK1-hRPGRco
Therapeutic Area: Genetic Disease Product Name: AGTC-501
Highest Development Status: Phase II/ Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Cantor Fitzgerald & Co.
Deal Size: $9.8 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 22, 2022
Details:
SKYLINE Trial of AGTC-501 (rAAV2tYF-GRK1-hRPGRco), on track to report three-month interim study results, including visual acuity, visual sensitivity, mobility and safety data, in Q2 2022 for the treatment of X-linked retinitis pigmentosa.
Lead Product(s): rAAV2tYF-GRK1-hRPGRco
Therapeutic Area: Genetic Disease Product Name: AGTC-501
Highest Development Status: Phase II/ Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2022
Details:
Adeno-associated virus (AAV)-based gene therapies for the treatment of rare inherited retinal diseases (IRDs), particularly dry-age related macular degeneration (AMD), including the relevance of expressing complement factor H as a therapeutic approach.
Lead Product(s): AAV-based Gene Therapy
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2021
Details:
Adeno-associated virus (AAV)-based gene therapies, subretinal gene therapy used for treatment of Achromatopsia, and AGTC-501 for X-Linked Retinitis Pigmentosa.
Lead Product(s): rAAV2tYF-GRK1-hRPGRco
Therapeutic Area: Genetic Disease Product Name: AGTC-501
Highest Development Status: Phase II/ Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
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