Md Ariful Islam / iStock via Getty Images
Precigen, Inc. (NASDAQ:PGEN), a biotech focused on gene and cell therapies, has published Phase 1 data from the Phase 1/1b clinical study for autologous CAR-T therapy PRGN-3006 in patients with Relapsing or refractory cause Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are at higher risk.
The dataset presented at the ongoing American Society of Hematology (ASH) Annual Meeting includes the full results from the Phase 1 dose escalation portion of the study, which included 26 patients (N= 10 without lymphatic depletion; N=16 with lymphatic depletion).
Highlights of the findings indicate that the experimental therapy was well tolerated by patients in both the non-lymphatic and lympho-depleted cohorts without dose-limiting toxicity. Most treatment-emerging adverse events (TEAEs) were Grade 1 or 2.
Each cohort had a grade 3 event of cytokine release syndrome (CRS). One case without lymphatic depletion resolved in 24 h and the other in the lymphatic insufficiency group was subsequently downgraded to Grade 1 by the investigator.
Based on 15 evaluable patients in the lymphatic depletion cohort, a single infusion of PRGN-3006 resulted in myeloblast depletion in 60% (9 out of 15) of the treated patients. before. In the non-lymphatic depletion cohort, 3 out of 10 patients had stable disease (SD), lasting more than three months, including more than seven months of SD for one patient.
The lymphatic depletion cohort indicated an objective response rate (ORR) of 27% in patients who had received a median of four previous treatments (range: 1-9).
PRGN-3006 is currently in Phase 1b . multicenter dose expansion phase of the study after lymphatic depletion in the patient.
Sir (PGEN) stock rallied in April after the company announced that the FDA had issued an expedited designation for PRGN-3006 as treatment of R/R AML.
