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Lumevoq (lenadogene nolparvovec) is a recombinant adeno-associated viral vector serotype 2 (rAAV2/2), investigational gene therapy containing the wild-type ND4 gene (rAAV2/2-ND4). It is being evaluated for the treatment of leber hereditary optic neuropathy.
Lead Product(s): Lenadogene Nolparvovec
Therapeutic Area: Genetic Disease Product Name: Lumevoq
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 March 20, 2024
Details:
Lumevoq® (lenadogene nolparvovec) targets LHON by leveraging a mitochondrial targeting sequence proprietary technology platform, allows it to specifically address defects inside the mitochondria using an AAV vector.
Lead Product(s): Lenadogene Nolparvovec
Therapeutic Area: Genetic Disease Product Name: Lumevoq
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 March 13, 2023
Details:
GS030 delivered via a single intravitreal injection, introduces a gene encoding for a light-sensitive protein (ChrimsonR-tdT) into retinal ganglion cells, making them responsive to light and bypassing photoreceptors killed off by diseases such as retinitis pigmentosa (RP).
Lead Product(s): GS030
Therapeutic Area: Genetic Disease Product Name: GS030
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 13, 2023
Details:
Safety findings at 5 years post-injection were consistent with previous readouts, which concluded that LUMEVOQ (GS010/lenadogene nolparvovec) is well-tolerated, no SAE were recorded among LUMEVOQ®-treated eyes, and no discontinuations occurred due to ocular events.
Lead Product(s): Lenadogene Nolparvovec
Therapeutic Area: Genetic Disease Product Name: Lumevoq
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 July 20, 2022
Details:
Safety findings at 4 years post-injection were consistent with previous readouts, which concluded that LUMEVOQ (lenadogene Nolparvovec) is well-tolerated with no serious adverse events were recorded among LUMEVOQ treated eyes, and no discontinuations occurred due to ocular events.
Lead Product(s): Lenadogene Nolparvovec
Therapeutic Area: Genetic Disease Product Name: Lumevoq
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 January 24, 2022
Details:
The REFLECT trial’s demonstration of a sustained, significant and safe improvement in visual acuity for LHON patients treated bilaterally with LUMEVOQ provides additional impetus for our push to gain regulatory approval.
Lead Product(s): Lenadogene Nolparvovec
Therapeutic Area: Genetic Disease Product Name: Lumevoq
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 December 14, 2021
Details:
LUMEVOQ® (GS010; lenadogene nolparvovec) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform.
Lead Product(s): Lenadogene Nolparvovec
Therapeutic Area: Genetic Disease Product Name: Lumevoq
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 June 30, 2021
Details:
Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ.
Lead Product(s): Lenadogene nolparvovec
Therapeutic Area: Ophthalmology Product Name: Lumevoq
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 October 05, 2020
Details:
GenSight submitted the MAA based on the benefit-risk balance established by results from a Phase-I/IIa study, two pivotal Phase-III efficacy studies and the long-term follow up study of RESCUE and REVERSET to demonstrate the efficacy of LUMEVOQ®.
Lead Product(s): Lenadogene nolparvovec
Therapeutic Area: Ophthalmology Product Name: Lumevoq
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 September 15, 2020
Details:
Statistical analysis of the visual acuity in 23 REALITY subjects aged 15 or older with a mutated ND4 gene shows that on average, vision failed to recover from an initial sudden decline, even several years after vision loss.
Lead Product(s): Lenadogene nolparvovec
Therapeutic Area: Ophthalmology Product Name: Lumevoq
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 July 21, 2020
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