Chinese biopharmaceutical company Mabwell (SH:688062) announced on Friday that its proprietary CDH17-targeting antibody-drug conjugate (ADC), 7MW4911, has received Investigational New Drug (IND) application acceptance from China's National Medical Products Administration (NMPA) and an IND Acknowledgement Letter from the US Food and Drug Administration (FDA).
7MW4911 is an investigational CDH17-targeting ADC developed using Mabwell's proprietary IDDC platform. The company says that its highly optimised structure integrates three key elements: Mab0727, a highly specific CDH17 monoclonal antibody with rapid internalisation properties, cross-species (human/monkey) moderate affinity, and minimal off-target binding; novel cleavable linker, ensuring precise payload release in tumour tissues; and MF-6 payload, a proprietary DNA topoisomerase I inhibitor designed to overcome multidrug resistance (MDR), exhibiting superior plasma stability, controlled drug release, and potent bystander effects.
Mabwell claims that with this profile, 7MW4911 is a promising therapeutic candidate for advanced gastrointestinal cancers.
FDA lifts pause on Valneva's chikungunya vaccine IXCHIQ for elderly, updates prescribing information
Jazz Pharmaceuticals' Modeyso approved by US FDA for H3 K27M-mutant diffuse midline glioma treatment
Freenome and Exact Sciences agree licensing deal for CRC blood test
Intas Pharmaceuticals and Accord BioPharma acquire UDENYCA (pegfilgrastim-cbqv)
FDA approves Teva's AJOVY for paediatric episodic migraine prevention
Galapagos receives FDA RMAT designation for CAR-T therapy in mantle cell lymphoma
Novo Nordisk expands legal action over compounded 'semaglutide'
US FDA approves Innovent's IND application for IBI3032 oral GLP-1R agonist
Mabwell's 7MW4911 IND application accepted by regulators in China and US
Novartis' new Leqvio (inclisiran) indication receives FDA approval
Novo Nordisk's Alhemo haemophilia treatment receives expanded US FDA approval
Zenara Pharma's Sertraline Hydrochloride Capsules generic receives US FDA approval