Adicet Bio, Inc. (Nasdaq: ACET) has announced the expansion of its ADI-001 Phase 1 clinical trial to encompass six autoimmune disease indications. This strategic move aims to explore the potential of ADI-001 in treating conditions such as lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS), and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV). Preliminary clinical data for lupus nephritis is expected in the first half of 2025.
In parallel with the clinical trial expansion, Adicet Bio reported its financial results for the third quarter of 2024. The company recorded a net loss of $30.5 million, which translates to $0.34 per share. Research and development expenses amounted to $26.3 million, while general and administrative expenses reached $6.9 million. Despite the net loss, Adicet Bio maintains a robust financial footing with $202.1 million in cash, cash equivalents, and short-term investments as of September 30, 2024. The company anticipates that these funds will be sufficient to sustain operations into the second half of 2026.
ADI-001 Clinical Trial Expansion
The Phase 1 clinical trial of ADI-001 in autoimmune diseases has activated clinical sites, with enrollment for patients with lupus nephritis commencing in the fourth quarter of 2024. Enrollment for SLE, SSc, IIM, and SPS is slated to begin in the first quarter of 2025, followed by AAV in the second half of 2025. Adicet Bio plans to release preliminary clinical data from the lupus nephritis arm of the study in the first half of 2025, with data from other autoimmune diseases expected in the second half of 2025, contingent on site initiation and patient enrollment progress.
FDA Fast Track Designation for ADI-270
In July 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to ADI-270 for the potential treatment of patients with metastatic or advanced clear cell renal cell carcinoma (ccRCC) who have previously been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor. This designation is intended to expedite the development and review of ADI-270, addressing an unmet medical need in patients with limited treatment options.
Financial Overview
Adicet Bio's research and development expenses for the third quarter of 2024 remained relatively stable at $26.3 million, compared to $26.2 million for the same period in 2023. General and administrative expenses saw a slight increase to $6.9 million, up from $6.6 million year-over-year. The company's net loss improved from $49.9 million in Q3 2023 to $30.5 million in Q3 2024, primarily due to a one-time goodwill impairment expense in the previous year.
Management Commentary
Chen Schor, President and Chief Executive Officer of Adicet Bio, stated, “Our commitment to delivering best-in-class gamma delta 1 T cell therapies for patients battling autoimmune diseases and cancer is reflected in the expansion of our clinical pipeline in the third quarter... Looking ahead, we anticipate advancing enrollment in these trials and expect to share preliminary clinical data from both lupus nephritis with ADI-001 and metastatic/advanced ccRCC with ADI-270 in the first half of 2025.”
Additional Corporate Updates
Adicet Bio appointed Lloyd Klickstein, M.D., Ph.D., to its Board of Directors in August 2024. Dr. Klickstein brings extensive experience in the biopharmaceutical industry, with expertise in rheumatology and immunology.
