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Catalent will offer materials from its gene therapy facilities in Maryland to support IND-enabling studies and a Phase I/II clinical trial of the product.
Catalent announced on Feb. 4, 2021 that it has signed an agreement with Decibel Therapeutics, a US-based clinical-stage biotechnology company, under which Catalent will provide Decibel with process and analytical development and current good manufacturing practices (CGMP) clinical manufacturing services for its lead investigational gene therapy product candidate, DB-OTO.
Under the terms of the agreement, Catalent will offer materials from its gene therapy facilities in Maryland to support investigational new drug (IND)-enabling studies and a Phase I/II clinical trial of the product, Catalent said in a company press release. DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals for patients with profound, congenital hearing loss caused by mutations in the otoferlin gene.
“There are currently no approved therapies that treat congenital deafness caused by genetic deficiencies. In our preclinical studies, we have delivered full-length, functional otoferlin protein under the control of a cell-selective promoter, which restored hearing function in a mouse model of otoferlin deficiency, demonstrated cell selective expression in non-human primates, and preliminary safety and tolerability of delivery of DB-OTO,” said John Lee, executive vice-president, Pharmaceutical Development, and interim chief scientific officer of Decibel, in the press release. “We look forward to working with Catalent on the development of DB-OTO as we progress towards clinical trials.”
"Partnering early with innovative companies allows us to develop and optimize robust, scalable manufacturing processes and the analytical methods to assess them," added Manja Boerman, PhD, president, Catalent Cell and Gene Therapy, in the press release. “Our Maryland development centers in Gaithersburg and the University of Maryland BioPark in Baltimore focus on providing process optimization services to meet our customers’ needs for early-stage clinical gene therapies.”