As Caeregen's CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle,
CTR-107 is the first program to obtain
CTR-107 is a synthetic targeted growth-factor that mimics the properties of norrin, a naturally occurring human protein that promotes development of normal, organized blood vessels and neurons in the human eye, ear, and central nervous system. CTR-107 is first being developed for the treatment of Familial Exudative Vitreoretinopathy (FEVR), a genetic disorder of retinal blood vessel formation, resulting in partial or complete vision loss. When injected into the eye, CTR-107 may regenerate retinal blood vessels and neurons, restoring normal retinal function and counteracting vision loss due to FEVR. Caeregen intends to subsequently advance Noregen for other critical retinal disease indications including retinal vein occlusion (RVO), diabetic retinopathy (DR) and age-related macular degeneration (AMD).
In
Caeregen first contracted with Wacker Biotech in 2022 to support initial manufacturing and process development for CTR-107 and has now partnered with Wacker Biotech to manufacture active CTR-107 drug substance at its site in Halle,
'As a potential breakthrough program for a rare, devastating retinal disease with no therapeutic options for patients, we selected Wacker Biotech as our CDMO partner for CTR-107 development because of their long-standing experience and deep understanding of protein chemistry, and shared urgency in advancing transformative science,' says
The companies' shared goal is to initiate clinical development which will support progression to regulatory submission as an approved product for patients experiencing progressive vision loss leading to blindness.
'Through its unique structure, CTR-107 has the potential to repair and regenerate the neurovasculature to restore vision, with potential applications as well to reverse hearing loss and treat neurodegenerative diseases. We are pleased to support Caeregen Therapeutics in the development of this revolutionary regenerative drug candidate and product platform,' says
Wacker Biotech, a wholly owned subsidiary of
About CTR-107 (Noregen)
CTR-107 (Noregen) is a synthetic targeted growth-factor for retina-related vision loss modeled after norrin, a naturally occurring human protein that guides retinal formation in fetal development. CTR-107 may promote development of normal, organized blood vessels and neurons in the human eye, ear, and central nervous system for individuals with inherited or acquired retinal diseases and potential applications in other neurosensory disorders. As a first-in-class therapeutic candidate to regenerate and repair the retinal vasculature to restore and preserve vision in patients with ischemic vitreoretinopathies, CTR-107 is currently being developed for Familial Exudative Vitreoretinopathy (FEVR), a rare disease of urgent, unmet medical need.
About FAMILIAL EXUDATIVE VITREORETINOPATHY (FEVR)
Familial Exudative Vitreoretinopathy, or 'FEVR' is a rare inherited disorder of retinal angiogenesis, leading to incomplete vascularization of the peripheral retinal and poor vascular differentiation. FEVR most often presents in childhood but may progress at any age with sight-threatening manifestations (Ranchod et al., 2011). It is characterized by abnormal retinal vascular development with progressive vitreoretinal features, including retinal capillary dropout, vessel dragging; retinal folds, vessel leakage and exudation; hemorrhage, neovascularization, vitreoretinal interface changes, and serous, tractional, or combined retinal detachment (Wood et al., 2019) all contributing to or causing visual impairment and blindness. Currently there are no approved pharmacological therapies for FEVR.
About Caeregen Therapeutics
About Wacker Biotech
Contact:
Tel: +49 89 6279-1629
Email: manuela.dollinger@wacker.com
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