Dec. 23 at 2:07 PM
$SABS Any thoughts on this article, 142 progress or hurdles ahead? A lot of information here and great results seems. Still a long road ahead:
“Labeling the trial “registrational” signals an intent to compress the path to approval if the magnitude and durability of C-peptide and glycemic endpoints are strong. It also puts manufacturing and regulatory scrutiny front and center: SAB-142 is produced via transchromosomic cattle, yielding polyclonal, fully human IgG, a distinctive CMC profile that must demonstrate lot-to-lot consistency, pathogen safety, and robust potency assays. The company references Phase 1 safety, immunogenicity, and pharmacodynamic data presented earlier this year, but without quantitative detail, the burden shifts to this mid-stage program to validate tolerability, re-dosing feasibility, and mechanistic biomarkers relative to legacy ATG.”
https://www.clinicaltrialvanguard.com/news/new-hope-for-t1d-first-patient-dosed-in-safeguard-trial/
