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Akouos
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Akouos, Inc. 645 Summer Street Suite 200 Boston, MA 02210
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AK-OTOF is a dual adeno-associated viral (AAV) vector-based gene therapy intended to treat patients with OTOF-mediated hearing loss by delivering transgenes encoding OTOF to the inner hair cells (IHCs) of the cochlea.


Lead Product(s): AK-OTOF

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AK-OTOF

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

Partner/Sponsor/Collaborator: Eli Lilly

Deal Size: $1,097.0 million Upfront Cash: $1,097.0 million

Deal Type: Acquisition December 01, 2022

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Proposed acquisition will accelerate gene therapies that aim to restore, improve, and preserve hearing for patients living with disabling hearing loss worldwide including lead product, AK-OTOF, a treatment of hearing loss due to mutations in the otoferlin gene.


Lead Product(s): AK-OTOF

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AK-OTOF

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

Partner/Sponsor/Collaborator: Eli Lilly

Deal Size: $487.0 million Upfront Cash: $487.0 million

Deal Type: Acquisition October 18, 2022

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AK-OTOF is a dual adeno-associated viral (AAV) vector-based gene therapy intended to treat patients with OTOF-mediated hearing loss by delivering transgenes encoding OTOF to the inner hair cells (IHCs) of the cochlea.


Lead Product(s): AK-OTOF

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AK-OTOF

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 September 13, 2022

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Nonclinical data demonstrated that an AAVAnc80 vector led to durable restoration of auditory function and was well tolerated, supporting planned clinical development of AK-OTOF for treatment of OTOF-mediated hearing loss.


Lead Product(s): AK-OTOF

Therapeutic Area: Genetic Disease Product Name: AK-OTOF

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 19, 2022

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AK-OTOF is designed to treat underlying cause of OTOF-mediated hearing loss through delivery of a transgene using a dual vector technology that results in expression of normal, functional otoferlin protein in the affected cells, namely inner hair cells, in the cochlea.


Lead Product(s): AK-OTOF

Therapeutic Area: Genetic Disease Product Name: AK-OTOF

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 03, 2022

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AK-OTOF and AK-antiVEGF, continue to advance preclinical development of potential gene therapies for inner ear conditions, such as GJB2-mediated hearing loss, and to develop platform capabilities that can be applied to regenerative medicine approaches in the inner ear.


Lead Product(s): AAVAnc80-antiVEGF Vector

Therapeutic Area: Rare Diseases and Disorders Product Name: AK-antiVEGF

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 07, 2022

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Details:

AK-OTOF is designed to treat the underlying cause of OTOF-mediated hearing loss through delivery of a transgene using a dual vector technology that results in expression of normal, functional otoferlin protein in the affected cells, namely inner hair cells, in the cochlea.


Lead Product(s): AK-OTOF

Therapeutic Area: Genetic Disease Product Name: AK-OTOF

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 August 11, 2021

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Details:

AK-OTOF is designed to treat the underlying cause of OTOF-mediated hearing loss through delivery of a transgene using a dual vector technology that results in expression of normal, functional otoferlin protein in the affected cells, namely inner hair cells, in the cochlea.


Lead Product(s): AK-OTOF

Therapeutic Area: Genetic Disease Product Name: AK-OTOF

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 April 13, 2021

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Details:

Akouos' pipeline contains lead candidate AK-OTOF, a gene therapy for the treatment of hearing loss due to mutations in the otoferlin gene.


Lead Product(s): AK-OTOF

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed

Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: BofA Securities

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 05, 2020

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Proceeds will be used to advance Akouos’s lead program, AK-OTOF, to first-in-human clinical studies subject to IND filing and to establish the company’s in-house GMP manufacturing capabilities.


Lead Product(s): AK-OTOF

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Pivotal bioVenture Partners

Deal Size: $105.0 million Upfront Cash: Undisclosed

Deal Type: Series B Financing March 03, 2020

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