Precigen Stock Surges On Positive AG019 Data for Chronic Treatment Of Type 1 Diabetes

Precigen Inc's PGEN subsidiary Precigen ActoBio announced topline results from the Phase 1b/2a study evaluating AG019 ActoBiotics to treat recent-onset type 1 diabetes (T1D).
Results were presented at the Federation of Clinical Immunology Societies 2021.
Phase 1b AG019 monotherapy and the Phase 2a AG019 combination therapy met their primary endpoint.
Following a single 8-week treatment cycle of oral AG019 as monotherapy, 56% of adult patients showed stabilization or higher C-peptide levels during the first six months post-treatment initiation.
Results indicated the potential of oral AG019 monotherapy to preserve insulin production in recent-onset T1D through its capacity to reduce autoreactive T cells and increase the frequency of memory Tregs to induce antigen-specific immune modulation.
Following treatment with the combination of AG019 and Provention Bio Inc's PRVB teplizumab, 70% of adult patients and 100% of adolescent patients showed stabilization or increase of C-peptide levels at six months post-treatment initiation, with overall stabilization of 79%.
AG019 was well tolerated and safe when administered to adults and adolescents either as monotherapy or in combination with teplizumab.
No serious adverse events were reported, and no AG019 treatment discontinuation occurred due to the adverse events.
Price Action: PGEN shares are up 38.3% at $9.67 during the premarket session on the last check Friday.