Adicet Bio doubles prula-cel enrollment to 20+ patients, secures $74.8M and FDA outpatient dosing
Adicet Bio doubled prula-cel Phase 1 enrollment to over 20 patients by December 31, 2025 and secured FDA agreement for outpatient SLE and LN dosing. The company raised $74.8 million and plans a pivotal prula-cel study plus ADI-212 regulatory filing in H1 2026, extending its cash runway into H2 2027.
1. Corporate Update and Enrollment Growth
Adicet Bio reported that prula-cel Phase 1 enrollment has more than doubled since October 2025, with over 20 patients enrolled across seven autoimmune indications as of December 31, 2025. The Company highlighted rapid progress in systemic lupus erythematosus (SLE), lupus nephritis (LN), systemic sclerosis, idiopathic inflammatory myopathy, stiff person syndrome, ANCA-associated vasculitis and treatment-refractory rheumatoid arthritis. These enrollment figures lay the groundwork for a meaningful data readout expected in the first half of 2026.
2. Regulatory Milestones for Outpatient Dosing
In November 2025, Adicet secured FDA alignment permitting outpatient administration of prula-cel in LN and SLE trials. This regulatory agreement follows Fast Track Designation for prula-cel in relapsed/refractory Class III/IV LN, refractory SLE with extrarenal involvement and systemic sclerosis. The outpatient dosing pathway is expected to accelerate patient recruitment and reduce trial complexity.
3. Broader Pipeline Advancements
Beyond autoimmune programs, Adicet is advancing ADI-212, its next-generation, gene-edited gamma delta T cell candidate targeting prostate-specific membrane antigen. Preclinical data presented at the 32nd Annual Prostate Cancer Foundation Scientific Retreat in October 2025 demonstrated enhanced tumor-specific cytotoxicity via membrane-tethered IL-12 armoring and CRISPR/Cas9-mediated MED12 disruption. Adicet anticipates filing a regulatory application for ADI-212 in metastatic castration-resistant prostate cancer in the first half of 2026.
4. Financial Position and 2026 Strategic Priorities
In October 2025, Adicet raised approximately $74.8 million in net proceeds through an underwritten registered direct offering, extending its cash runway into the second half of 2027. Key objectives for 2026 include presenting updated Phase 1 safety and efficacy data for prula-cel in LN, SLE and systemic sclerosis in the first half, securing a pivotal trial design meeting with the FDA in Q2, and initiating a pivotal prula-cel study in the second half. The Company also plans to report interim results from its treatment-refractory rheumatoid arthritis study and advance clinical startup activities for ADI-212 in Q2 2026.