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Find Clinical Drug Pipeline Developments & Deals by Thermo Fisher Scientific
The collaboration aims to develop next-generation sequencing-based companion diagnostic assays to identify patients who may benefit from Bayer’s portfolio of precision cancer therapies, including Nubeqa (darolutamide), a medication for certain prostate cancers (mHSPC, nmCRPC).
Under the terms of the agreement, Thermo Fisher will provide GMP manufacturing as well as BioServices and Specialty Logistics for Galapagos’ CAR-T hemato-oncology clinical program, GLPG-5101, being developed for the treatment of Non-Hodgkin’s lymphoma.
ASLAN004 (eblasakimab) is a potential first-in-class monoclonal antibody targeting the IL-13 receptor that has the potential to deliver a differentiated efficacy and safety profile for the treatment of moderate-to-severe atopic dermatitis (AD).
As part of this expanded agreement, Thermo Fisher will now provide dedicated capacity for a range of aseptic fill-finish services including lyophilized and liquid filling for Spikevax. In addition, the company will provide inspection, labeling and final packaging services.
This agreement is part of Merck’s commitment to make this investigational medicine widely available globally, if approved for use by regulatory agencies. Molnupiravir is being developed by Merck in collaboration with Ridgeback Biotherapeutics.
Thermo Fisher’s commercial manufacturing site in Greenville, North Carolina will be used for aseptic fill/finish, labeling and packaging to support the production of millions of doses of mRNA-1273. Production will begin in the third quarter of 2021.
The Partnership will support the clinical development and commercial manufacturing of leading CAR-T (Chimeric Antigen Receptor T-Cells) therapies in China, including JW Therapeutics’ lead product relmacabtagene autoleucel (“relma-cel”).
Freeline has established the manufacturing process for FLT180a at Thermo Fisher’s Cambridge facility over the past two years, most recently initiating clinical supply production there for its planned Phase 2b/3 pivotal clinical trial of FLT180a.
The partnership adds to Humanigen’s large scale commercial production efforts, including collaborations with Lonza and Catalent, for a potential 2020 EUA and subsequent commercialization of lenzilumab.
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