IMPT-514 / Lyell Immunopharma - LARVOL DELTA

A Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: ImmPACT Bio | N=30 ➔ 0 | Trial completion date: Feb 2027 ➔ Jan 2025 | Recruiting ➔ Withdrawn | Trial primary completion date: Feb 2027 ➔ Jan 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Manufacturing of IMPT-514, a CD19/CD20 Bispecific CAR T Cell Product Candidate as a Potential Treatment of Patients with Autoimmune Diseases (ACR Convergence 2024) - P1/2 | "IMPT-514 has the potential to be an effective agent for the treatment of a variety of B-cell–driven autoimmune diseases such AAV, IIM, SSc, and SLE. These results have supported a clinical trial being opened for its use in SLE/LN (NCT06153095)."

CAR T-Cell Therapy • Clinical • IO biomarker • ANCA Vasculitis • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis • CD20 • IFNG

Lyell Immunopharma to Acquire ImmPACT Bio and Prioritizes its Pipeline to Focus on Next-Generation CAR T-cell Therapies (GlobeNewswire) - "Lyell Immunopharma...announced today that it has entered into a definitive agreement to acquire ImmPACT Bio USA....ImmPACT’s lead program, IMPT-314, is a CD19/20-targeting chimeric antigen receptor (CAR) T-cell product candidate that Lyell will continue to develop for hematologic malignancies....Upon closing, Lyell will acquire worldwide rights to ImmPACT’s pipeline, including the next- generation bispecific CD19/CD20 autologous CAR T-cell therapy...and an activating TGF-beta Claudin 18.2 CAR T-cell candidate, which is in preclinical development. Lyell will prioritize the development of IMPT-314 for patients with B-cell lymphoma....Data from ImmPACT’s multi-center Phase 1-2 clinical trial of IMPT-314 in patients with large B-cell lymphoma treated in the 3rd line CAR-naïve setting to be presented at a major medical conference later this year; initiation of a pivotal trial for IMPT-314 expected in 2025."

M&A • New trial • P1/2 data • Non-Hodgkin’s Lymphoma

ImmPACT Bio Announces FDA Clearance of IND Application for CD19/CD20 Bispecific CAR-T Cell Therapy in Multiple Sclerosis (PRNewswire) - "ImmPACT Bio USA Inc...announced the United States Food and Drug Administration (FDA) has cleared an investigational new drug application (IND) for IMPT-514, a CD19/CD20 bispecific chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with multiple sclerosis (MS)....'We expect to dose the first patient in the first half of 2025.'"

IND • New P1 trial • Immunology • Multiple Sclerosis

IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Enrolling by invitation ➔ Recruiting

Enrollment status • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Systemic Lupus Erythematosus • Vasculitis

IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy (clinicaltrials.gov) - P1 | N=36 | Enrolling by invitation | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Systemic Lupus Erythematosus • Vasculitis

Manufacturing of CD19/CD20 Bispecific CAR-T Cell Therapy (IMPT-514) for the Treatment of Multiple Sclerosis, ANCA Vasculitis, Inflammatory Myositis, and Systemic Sclerosis (FOCIS 2024) - "Standard of care therapies for these autoimmune diseases include immunosuppressive medications such as methotrexate, prednisone, azathioprine, etc., but these treatments are hindered by severe side effects and have demonstrated variable effectiveness with a high risk of disease recurrence. In addition, IMPT-514 products secreted interferon-gamma (IFN-γ) when cocultured with donor-matched B cells and effectively eliminated autologous B cells. In summary, IMPT-514 demonstrates good potency against the intended B cell target representing a key potential advancement in the evolution of CAR-T therapy in the autoimmune realm."

CAR T-Cell Therapy • IO biomarker • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Multiple Sclerosis • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis • CD20 • IFNG

IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

New P1 trial • ANCA Vasculitis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Systemic Lupus Erythematosus • Vasculitis

Manufacturing of CD19/20 Bispecific CAR T-Cell Therapy (IMPT-514) for the Treatment of Multiple Sclerosis (CMSC 2024) - "IMPT-514 demonstrates exceptional potency against the intended B-cell and CD20+ T-cell targets and represents a key potential advancement in CAR T-cell therapies for both relapsing and progressive forms of MS. IMPT-514 may enable a robust immune system reset and potential durable efficacy in MS."

CAR T-Cell Therapy • Late-breaking abstract • CNS Disorders • Immunology • Multiple Sclerosis • CD19 • IFNG • IL4 • TNFA

ImmPACT Bio to Present New Preclinical Data for CD19/CD20 Bispecific CAR-T Cell Therapy in Multiple Sclerosis (PRNewswire) - "ImmPACT Bio....today announced that it will present new preclinical data supporting the potential therapeutic benefit of IMPT-514 for the treatment of multiple sclerosis (MS). IMPT-514 is ImmPACT Bio's CD19/CD20 bispecific chimeric antigen receptor (CAR) T-cell therapy product candidate. These new data will be delivered in a poster presentation at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, taking place in Nashville, Tennessee from May 28 – June 1, 2024."

Preclinical • Multiple Sclerosis

ImmPACT Bio Awarded $8 Million CIRM Grant for Phase 1b/2 Development of IMPT-514, a CD19/CD20 Bispecific CAR T-Cell Therapy for Refractory Lupus Nephritis and Systemic Lupus Erythematosus (BioSpace) - "ImmPACT Bio...today announced that the Company has been awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to ImmPACT Bio's ongoing Phase 1b/2 study evaluating IMPT-514 for the treatment of refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE)...It is the same CAR construct as ImmPACT's IMPT-314, which is under development for certain types of non-Hodgkin's lymphoma. IMPT-314 and IMPT-514 are based on work by...Sarah Larson, M.D..."

Announcement • P1/2 data

A Study of IMPT-514 in Active Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: ImmPACT Bio | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

ImmPACT Bio Awarded $8 Million CIRM Grant for Phase 1b/2 Development of IMPT-514, a CD19/CD20 Bispecific CAR T-Cell Therapy for Refractory Lupus Nephritis and Systemic Lupus Erythematosus (PRNewswire) - "ImmPACT Bio USA....today announced that the Company has been awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to ImmPACT Bio's ongoing Phase 1b/2 study evaluating IMPT-514 for the treatment of refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE)....'We expect initial efficacy and safety data from our Phase 1b/2 dose escalation trial in the second half of 2024.'"

Financing • P1/2 data • Lupus Nephritis • Systemic Lupus Erythematosus

A Study of IMPT-514 in Active Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: ImmPACT Bio

New P1/2 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

ImmPACT Bio Granted FDA Fast Track Designation for IMPT-514 for the Treatment of Both Active, Refractory Lupus Nephritis and Systemic Lupus Erythematosus (PRNewswire) - "ImmPACT Bio USA, Inc...today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for IMPT-514...for the treatment of patients with active refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE)....We look forward to dosing the first patient in our Phase 1b/2 trial for the treatment of active, refractory SLE expected in early 2024."

Fast track designation • Trial status • Immunology • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus