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Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.
Catalent Pharma Solutions announced on May 31, 2018 that InterveXion, a pharmaceutical company developing antagonist therapies, has enrolled the first patient in a Phase IIa study of the effect of IXT-m200, a first-in-class anti-methamphetamine antibody, on methamphetamine pharmacokinetics and subjective effects in methamphetamine users.
Catalent reports that the company engineered the cell line that expresses the drug’s antibody, employing its proprietary GPEx technology and completing process development. Catalent provided cGMP manufacturing for the clinical trial at the company’s Madison, WI, biomanufacturing facility.
IXT-m200, a monoclonal antibody that specifically binds methamphetamine in the blood, is being developed as a pharmacological treatment for use in conjunction with behavioral therapies. IXT- m200 is expected to alter methamphetamine pharmacokinetics in human subjects resulting in reduced or blocked subjective effects that reinforce methamphetamine use. STAMPOUT will provide proof-of-concept that IXT-m200 can alter methamphetamine disposition. This will be the first clinical study of a biological medication in methamphetamine users.
Catalent’s GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, through to commercial-scale production. To date, seven GPEx-based antibody and protein products are approved and marketed, and more than 40 therapeutic candidates are currently in the clinic across the world.
Source: Catalent Pharma Solutions