RE: Allogeneic off the shelf fast track designation29 Mar 2026 11:45
CAR‑T cell therapy has now received FDA Breakthrough Therapy Designation, and allogeneic approaches are progressing globally as part of the broader scientific effort to defeat cancer.
As I’ve mentioned before, and as the record shows, long before Hemogenyx entered the field there were already clinical trials and collaborations that had advanced further. Major biopharma companies continue to monitor developments carefully before making any commitments. It’s worth remembering that Hemogenyx initially pursued a lupus collaboration, which ultimately dissolved, and the company then shifted its focus toward CDX. That program remains at an early, preclinical stage, and once again Hemogenyx pivoted—this time toward CAR‑T.
Enrolling 3 out of 18 adult cohorts over a 12‑month period is a positive step, but it also highlights how much further the trial still needs to progress. With 15 adult cohorts remaining, not to mention the infant cohorts, the clinical pathway is long. By the time these studies mature, the broader scientific landscape will likely have evolved significantly, potentially leaving Hemogenyx’s platform overshadowed by faster‑moving or more advanced competitors/technologyEnrolling 3 out of 18 adult cohorts over a 12‑month period is a positive step, but it also highlights how much further the trial still needs to progress. With 15 adult cohorts remaining, not to mention the infant cohorts, the clinical pathway is long. By the time these studies mature, the broader scientific landscape will likely have evolved significantly, potentially leaving Hemogenyx’s platform overshadowed by faster‑moving or more advanced competitors.🐭