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Opvika (Esonadogene Imvoparvovec) is a MT-ND4 modulator. It is being evaluated for the treatment of Leber hereditary optic neuropathy caused by ND4 mutation (ND4-LHON).
Lead Product(s): Esonadogene Imvoparvovec
Therapeutic Area: Genetic Disease Product Name: Opvika
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 February 19, 2024
Details:
NFS-02 is Neurophth’s second gene therapy, currently evaluating in multi-region, multi-center Phase I/II clinical trial for the treatment of Leber hereditary optic neuropathy caused by ND1 mutation.
Lead Product(s): NFS-02
Therapeutic Area: Genetic Disease Product Name: NFS-02
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 August 17, 2023
Details:
The net proceeds will advance clinical trials for Neurophth's core products, enhancing the firm's R&D capabilities and expanding its pipeline, including NFS-01 (esonadogene imvoparvovec), a rAAV2-ND4 gene therapy being developed to treat Leber's hereditary optic neuropathy.
Lead Product(s): Esonadogene Imvoparvovec
Therapeutic Area: Genetic Disease Product Name: NFS-01
Highest Development Status: Phase II/ Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Yangtze River-CMB International Industry Fund
Deal Size: $95.0 million Upfront Cash: Undisclosed
Deal Type: Series C Financing August 11, 2023
Details:
NR082 (rAAV2-ND4), a novel recombinant AAV2, containing a mitochondria codon-optimized NADH-dehydrogenase subunit 4 gene which delivers the correct genes to the patients' damaged optic ganglion cells. It is being developed for LHON associated with mtND4 mutations.
Lead Product(s): NR082
Therapeutic Area: Genetic Disease Product Name: NR082
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2023
Details:
Investigational NFS-02, a novel recombinant adeno-associated viral serotype 2 vector (rAAV2) containing a codon-optimized of NADH-dehydrogenase subunit 1 gene, is a novel ophthalmic injection that is being developed for the treatment of Leber hereditary optic neuropathy.
Lead Product(s): rAAV2-ND1
Therapeutic Area: Genetic Disease Product Name: NFS-02
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 December 19, 2022
Details:
NR082 (rAAV2-ND4), a recombinant adeno-associated viral vector, serotype 2, containing human ND4 codon-optimized gene under the control of the cytomegalovirus promoter and enhancer, is a novel gene therapy.
Lead Product(s): rAAV2-ND4
Therapeutic Area: Genetic Disease Product Name: NR082
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 July 15, 2022
Details:
INDA Clearance received from USFDA for NFS-01 (NR082), a novel recombinant adeno-associated viral serotype 2 on the basis of results from three investigator-initiated trials which demonstrated favorable results in patients LHON associated ND4 mutation.
Lead Product(s): NR082
Therapeutic Area: Ophthalmology Product Name: NFS-01
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 18, 2022
Details:
The financing will be used to progress its lead clinical program in LHON to ex-China, enrich R&D pipeline and programs through business development and continue to expand the international standard gene therapy manufacturing platform.
Lead Product(s): rAAV-ND4
Therapeutic Area: Genetic Disease Product Name: NFS-01
Highest Development Status: IND EnablingProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: CMG-SDIC Capital
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Series C Financing November 22, 2021
Details:
NR082, a novel recombinant adeno-associated viral serotype 2 containing a codon-optimized of ND4 gene under the control of the cytomegalovirus promoter and enhancer, is a novel ophthalmic injection that is being developed for the treatment of LHON in ND4 mutations.
Lead Product(s): NR082
Therapeutic Area: Ophthalmology Product Name: NFS-01
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 April 01, 2021
Details:
Subject to the terms of the agreement, Neurophth will make an initial cash payment to AAVnerGene to test ~100 AAV capsids. Within 6-12 months upon receiving the AAV capsids, Neurophth is responsible for completing the preclinical studies on these capsids.
Lead Product(s): AAV capsids-gene therapy
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Discovery PlatformProduct Type: Cell and Gene therapy
Recipient: Aavnergene
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 19, 2021
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