Made Scientific Inc, a US-based clinical- and commercial-stage cell therapy contract development and manufacturing organisation (CDMO), announced on Monday that it has entered into a manufacturing partnership with Cellergy Therapeutics Ltd, an Israeli biotechnology company developing first-in-class mitochondrial transplantation therapies.
The collaboration is aimed at advancing Cellergy's mitochondrial therapy CLG-001 toward first-in-human clinical studies.
Cellergy Therapeutics will leverage Made Scientific's GMP manufacturing capabilities to implement and scale Cellergy's proprietary mitochondrial isolation and purification process. This work will support the production of clinical-grade CLG-001 for upcoming trials under Israel's Ministry of Health compassionate-use framework and a Phase I clinical study with the US Food and Drug Administration (FDA).
CLG-001 is based on mitochondria purified from healthy donors and developed to restore cellular energy production, a novel therapeutic approach for conditions driven by mitochondrial dysfunction. These include metabolic disorders, neurodegenerative diseases, and age-related conditions.
Made Scientific enters manufacturing partnership with Cellergy Therapeutics
Novartis' Itvisma granted US FDA approval for spinal muscular atrophy treatment
Avidity Biosciences announces US Managed Access Program for delpacibart zotadirsen (del-zota)
Nuvalent's zidesamtinib NDA filing accepted by US FDA
Mycovia Pharmaceuticals publishes long-term efficacy results from extension study of VIVJOA
BioNet receives positive opinion from EMA for VacPertagen marketing authorisation in EU
AbbVie receives approval for EPKINLY, rituximab and lenalidomide combination
European Commission approves Celltrion's Remsima IV liquid formulation
Incyte receives positive CHMP opinion for Minjuvi in relapsed or refractory follicular lymphoma
Henlius and Organon secure first US approval for pertuzumab biosimilar POHERDY
BioInvent secures EMA positive opinion for Orphan Drug Designation of BI-1808 in CTCL
Lupin launches Risperidone long-acting injectable with 180-day CGT exclusivity in US market