Homepage > Company > Media > Pharma News > 2024 > AbelZeta

AbelZeta

AbelZeta Pharma, Inc., a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that preclinical data from its C-CAR168 study has been presented as a podium presentation at the American College of Rheumatology (ACR) Convergence 2024 held in Washington, DC, November 14-19, 2024.

C-CAR168 is a novel autologous bi-specific CAR-T therapy targeting both CD20 and B-cell maturation antigen (BCMA) for the treatment of resistant and refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) patients. The Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application to proceed with the Phase 1 clinical development of C-CAR168 in May 2024.

Key Highlights:

 Scientific Rationale in Targeting B Cells and Plasma Cells: C-CAR168 is engineered to selectively target CD20 and BCMA, markers associated with pathogenic B cells and long-lived plasma cells (LLPCs) involved in autoimmune responses. Studies showed that C-CAR168 effectively induced cell death in CD20 and/or BCMA-positive cells, including the age-associated B cell (ABC) subset that is highly expanded in autoimmune conditions.
 Potent In Vivo Cytotoxicity: In immunodeficient mouse models, a single dose of C-CAR168 demonstrated significant activity across multiple dosage levels, effectively inhibiting the growth of CD20 and BCMA single-positive or double-positive in various xenograft models.
 Minimal Off-Target Toxicity: Comprehensive assays, including membrane proteome array, confirmed that C-CAR168 specifically targets CD20 and BCMA proteins, with no significant binding to non-target cells.
 Safety Profile: In vitro assays showed minimal risk of carcinogenicity or unintended cell transformation, supporting the potential safety of C-CAR168 as a therapeutic option.
 Clinical Development for C-CAR168: In an investigator-initiated trial in China targeting refractory/relapsing LN patients, 7 patients have been treated in a suboptimal dose and a potentially optimal dose. Depletion of both B cells and plasma cells in the blood in all patients were observed, accompanied by a favorable safety profile and early positive clinical signals at the suboptimal dose from patients that have had at least 3 months of follow up.
 Actively looking to expand into new indications such as Neuromyelitis Optica Spectrum Disorder (NMOSD), Immune-Mediated Necrotizing Myopathy (IMNM), and Systemic Sclerosis (SSc) to provide guidance for global trial to be initiated around mid 2025.
 US IND submission was cleared on May 31, 2024 November, 15 2024

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with Centers of Excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focused on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies.

Read also

Dr Reddy's Laboratories, FDC recall products in US market

India is the largest supplier of generic medicines with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.

FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

Novo Nordisk Insulin Plans Spark Angst Among Diabetes Patients

(Bloomberg) -- About 400 people marched to the South African headquarters of Novo Nordisk A/S in Johannesburg this week demanding greater access to its human insulin and lower prices, while al...

FDA approves novel gene therapy for rare neurometabolic disorder

The FDA has approved an adeno-associated virus vector-based gene therapy to treat both adult and pediatric patients with aromatic L-amino acid decarboxylase deficiency.