Wednesday, October 11, 2023
ImmPACT Bio USA, Inc. ("ImmPACT Bio") has obtained Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for their novel therapeutic candidate, IMPT-514. This treatment is a groundbreaking CD19/CD20 CAR-T therapy developed for addressing active refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE), both of which are complex autoimmune conditions. The company had previously received FDA clearance to initiate clinical trials for IMPT-514 in patients with active, refractory SLE.
Dr. Sumant Ramachandra, the CEO of ImmPACT Bio, emphasized the urgent need for improved treatments for SLE and LN. He pointed out that these conditions are associated with significant risks, including organ damage and reduced quality of life. Current treatment options are hampered by broad immune suppression, limited tissue penetration, and the requirement for long-term administration. IMPT-514 has been designed as a potential one-time treatment aiming to reset the immune system by deeply depleting B-cells, offering hope for enhanced disease management and renal outcomes for lupus patients. The FTD from the FDA underscores the potential therapeutic benefits of IMPT-514.
Fast Track Designation is a program established to expedite the development and review of drugs intended to address unmet medical needs in patients with serious or life-threatening conditions. It provides the benefit of close collaboration with the FDA throughout the clinical development process, and in some cases, allows for the review of parts of a marketing application prior to its complete submission.
Systemic Lupus Erythematosus (SLE), commonly referred to as lupus, is a severe autoimmune disease characterized by chronic inflammation and damage to healthy tissues throughout the body. B-cells play a central role in the development of the disease. In the United States, over 200,000 individuals are affected by lupus, with approximately 50% of them experiencing lupus nephritis, the most severe form of SLE, which can lead to end-stage renal disease and increased mortality. Despite various therapies, including approved biologics, there remains a significant need for safe and highly effective treatments for this condition.
IMPT-514 is a chimeric antigen receptor (CAR) T-cell therapy that targets CD19 and CD20. It employs a potent bispecific CAR and a 4-1BB costimulatory domain. This CAR construct is the same as ImmPACT's IMPT-314, which is being developed for certain types of non-Hodgkin's lymphoma. Preclinical studies have demonstrated the successful and efficient manufacturing of IMPT-514 from patients with lupus nephritis and systemic lupus erythematosus, showing promising elimination of autologous B cells and a moderate cytokine profile. The company anticipates the dosing of the first patient in the Phase 1b/2 trial for active, refractory SLE in early 2024.