Accompanied by UW School of Medicine and Public Health physician scholars Sara McCoy and Randall Kimple, Jacques Galipeau presented on October 7th at Alliance for Regenerative Medicine on the MESA meeting in Phoenix the results of of a Phase 0 study NCT04489732 of 6 subjects MSCG-001 (autologous MSC(M) activated with INFγ) to treat xerostomia. A call for partnership with CGT partners and funders was made to launch a new clinical stage biopharma spinoff arising from this academic IND sponsored trial.
UW Program for Advanced Cell Therapy is an academic CGT incubator that vertically integrates clinical trial expertise, in-house GMP cell therapy manufacturing and FDA regulatory competencies bundled to advance IIT INDs through Phase I clinical trials. MSCG-001 provides an excellent safety profile and displays an anecdotal signal of efficacy as measured by QOL and saliva production outcomes and serves as the inaugural test case for our de-risking of academic CGTs on a trajectory for commercial development. A pipeline of academic INDs and IDEs enabled by a crack multidisciplinary PACT team are forthcoming.