ALPHA3 Interim MRD Efficacy Signal
Interim futility analysis (24 patients) showed MRD clearance of 58.3% for cema-cel vs 16.7% for observation — an absolute difference of 41.6 percentage points, supporting biological activity in first-line consolidation for LBCL.
Strong ctDNA Pharmacodynamic Response
At day 45 median circulating tumor DNA (ctDNA) decreased by ~98% in the cema-cel arm versus an increase of >26% in the observation arm, indicating rapid tumor burden reduction.
Favorable Early Safety and Outpatient Feasibility
No CRS, ICANS or treatment-related hospitalizations reported in the interim ALPHA3 cohort; majority of patients managed entirely in the outpatient setting, supporting potential community administration.
ALLO-329 Early Activity and Tolerability
RESOLUTION Phase I basket trial has treated 9 patients across initial cohorts (3 at 20M with LD, 3 at 40M with LD, 3 at 20M without LD). Investigators report early signs of clinical activity and favorable tolerability despite substantially lower cell doses than many competitors.
Dose Escalation Progress and Next Cohort
Dose escalation is ongoing for ALLO-329 with the next cohort at 80 million cells enrolling; company expects to include higher-dose patients in the Q4 2026 update.
Dagger Technology Validation and Supporting Data
ALLO-329 leverages Dagger technology designed to reduce allogeneic rejection; approach has prior clinical validation in ALLO-316 and supportive preclinical data published in Nature Communications.
Operational and Global Trial Expansion
ALPHA3 is scaling rapidly: enrolling across >60 sites with regulatory approvals and activations begun in Australia and South Korea and plans to expand the Asia-Pacific footprint to over 80 sites; community centers contributed ~1/3 of screening and treatments in the interim cohort.
Strengthened Balance Sheet and Extended Runway
Cash, cash equivalents and investments of $266.9M as of March 31, 2026, plus ~ $200.4M gross proceeds from April public offering, extending cash runway into Q1 2029.
Planned Milestones and Timelines
Company expects ALPHA3 enrollment completion end of 2027, interim EFS analysis mid-2027, primary EFS mid-2028 and plans to pursue a BLA based on those analyses; comprehensive ALLO-329 update planned for Q4 2026.