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Decibel Therapeutics
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U.S.A
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1325 Boylston Street, Suite 500 Boston, MA 02215
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(617) 370-8701

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Through the acquisition, Regeneron will strengthen its gene therapy and heraing loss programs by gaining Decibel's lead candidate, DB-OTO, which is currently in Phase 1/2 and is an investigational cell-selective, AAV gene therapy to treat congenital, monogenic hearing loss.


Lead Product(s): DB-OTO

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

Deal Size: $213.0 million Upfront Cash: $213.0 million

Deal Type: Acquisition September 25, 2023

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Through the acquisition, Regeneron will strengthen its gene therapy and heraing loss programs by gaining Decibel's lead candidate, DB-OTO, which is currently in Phase 1/2 and is an investigational cell-selective, AAV gene therapy to treat congenital, monogenic hearing loss.


Lead Product(s): DB-OTO

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

Deal Size: $213.0 million Upfront Cash: $213.0 million

Deal Type: Acquisition August 09, 2023

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DB-OTO is a gene therapy product candidate designed to provide durable restoration (selectively express functional OTOF in the inner hair cells) of hearing to individuals born with profound hearing loss due to mutation of the OTOF gene.


Lead Product(s): DB-OTO

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 12, 2023

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Details:

DB-OTO is a gene therapy product candidate designed to provide durable restoration (selectively express functional OTOF in the inner hair cells) of hearing to individuals born with profound hearing loss due to mutation of the OTOF gene.


Lead Product(s): DB-OTO

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

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 March 30, 2023

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Details:

DB-OTO is a gene therapy product candidate designed to provide durable restoration (selectively express functional OTOF in the inner hair cells) of hearing to individuals born with profound hearing loss due to mutation of the OTOF gene.


Lead Product(s): DB-OTO

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

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 January 24, 2023

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DB-OTO uses a proprietary, cell-selective promoter to express the otoferlin transgene in hair cells, with the goal of enabling the ear to transmit sound to the brain and provide hearing.


Lead Product(s): DB-OTO

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 17, 2022

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DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals and is an adeno-associated virus (AAV)-based dual-vector gene therapy designed to provide durable hearing to individuals with profound congenital hearing loss caused by mutations of the otoferlin gene.


Lead Product(s): Otoferlin

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

Highest Development Status: IND EnablingProduct Type: Large molecule

Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 20, 2022

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87% of patients who experienced ototoxicity in their placebo-treated ear were protected from ototoxicity in their DB-020, a novel, proprietary formulation of sodium thiosulfate treated ear.


Lead Product(s): Sodium Thiosulfate

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-020

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 28, 2022

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DB-OTO is a gene therapy product candidate designed to provide durable restoration of hearing to individuals born with profound hearing loss due to mutation of the OTOF gene.


Lead Product(s): DB-OTO

Therapeutic Area: Genetic Disease Product Name: DB-OTO

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

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Podium presentation at ARO annual midwinter meeting highlighting DB-OTO, gene therapy cell-selective promoter to control otoferlin transgene expression in hair cells, dose-ranging studies with expression analysis, functional recovery, and tolerability data.


Lead Product(s): DB-OTO

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

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 February 09, 2022

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