Adicet Bio | MedPath

Adicet Bio's ADI-001 Receives FDA Fast Track for Refractory SLE, Expands Autoimmune Pipeline

6 months ago

• Adicet Bio's ADI-001 receives FDA Fast Track designation for refractory systemic lupus erythematosus (SLE) with extrarenal involvement, expediting its development. • A Phase 1 trial is underway, evaluating ADI-001 across six autoimmune indications, including lupus nephritis (LN), SLE, systemic sclerosis (SSc), and others, with preliminary data expected in 2025. • ADI-001, an allogeneic gamma delta CAR T-cell therapy targeting CD20, has shown promising B-cell depletion in preclinical studies, suggesting potential as an off-the-shelf treatment. • Adicet Bio is also advancing ADI-270, a CAR T-cell therapy for metastatic clear cell renal cell carcinoma (ccRCC), with Phase 1 data anticipated in the first half of 2025.

Adicet Bio Initiates Phase 1 Trial of ADI-270, a Novel CAR T-cell Therapy for Advanced Kidney Cancer

6 months ago

• Adicet Bio has commenced a Phase 1 clinical trial for ADI-270, an allogeneic gamma delta CAR T-cell therapy, in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC). • ADI-270 targets CD70-positive cancers and is engineered to overcome the immunosuppressive tumor microenvironment, potentially offering a new treatment option for solid tumors. • The open-label, multicenter trial will assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of ADI-270, with preliminary data expected in the first half of 2025. • The trial design includes dose escalation and expansion phases, allowing for a second dose of ADI-270 based on pre-defined criteria, to optimize treatment response.

Stoke Therapeutics' STK-001 Shows Promising Results in Dravet Syndrome Trials

a year ago

• Stoke Therapeutics' STK-001 demonstrated substantial reductions in convulsive seizure frequency in children and adolescents with Dravet syndrome. • The treatment also showed improvements in cognition and behavior, suggesting potential disease modification in this patient population. • The FDA has allowed Stoke to proceed with a dosing regimen of 70mg followed by 45mg, paving the way for registrational studies. • Stoke Therapeutics is preparing to meet with regulatory agencies to discuss a registrational study based on the encouraging data.