The Phase II trial will continue to assess the safety and efficacy of C-CAR168 in this patient group facing major unmet medical needs.

"The FDA clearance to advance this multi-center registrational Phase II trial for C-CAR168 in LN marks a key milestone in developing this promising new approach for patients with severe, treatment-resistant lupus. This population has substantial unmet medical needs," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "Along with the RMAT and PRIority MEdicines (PRIME) designations from the FDA and European Medicines Agency (EMA), this regulatory progress highlights the strong potential of C-CAR168 to tackle a major unmet need in autoimmune diseases. We are eager to move the program forward on a global scale. We aim for this therapy to provide deep and lasting clinical benefits for LN patients. We are also actively exploring the potential of C-CAR168 in additional major disease areas."

About C-CAR168
C-CAR168 represents a novel autologous bi-specific CAR-T therapy directed at both CD20 and BCMA. It is designed to achieve deep depletion of disease-driving B cells and plasma cells, aiming to induce an immune reset in patients with severe autoimmune conditions such as refractory Systemic Lupus Erythematosus (SLE) and LN, progressive Multiple Sclerosis (MS), and others. The FDA and EMA have respectively granted RMAT and PRIME designations to C-CAR168 for treating refractory SLE including LN.

About SLE and LN
SLE is a chronic autoimmune condition marked by systemic inflammation and involvement across multiple organs. LN constitutes a serious form of SLE that causes kidney inflammation and may result in progressive kidney damage or failure. Even with current standards of care, patients with refractory disease encounter ongoing unmet needs, such as persistent disease activity, organ damage risks, and cumulative toxicity from prolonged immunosuppressive therapy.

About AbelZeta Pharma, Inc.
AbelZeta operates as a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai. The company focuses on creating innovative proprietary cell-based therapeutic products and is dedicated to delivering tailored treatments that leverage the body's immune system to combat hematological malignancies, inflammatory and immunological diseases, and solid tumors. AbelZeta conducts research and development in its own GMP facilities at these centers, supporting a pipeline of multiple CAR-T therapies.

Forward-Looking Statements
Statements in this communication concerning plans, strategies, specific activities, and other items that are not descriptions of historical facts constitute forward-looking statements. Forward-looking information is subject to inherent risks and uncertainties, and actual results may differ materially from those currently expected due to numerous factors. These forward-looking statements reflect current beliefs and management's expectations and are subject to significant risks and uncertainties beyond AbelZeta Pharma, Inc.'s ("AbelZeta" or the "Company") control. In light of these uncertainties, readers should not place undue reliance on these forward-looking statements, which are made only as of the date herein. Except as required by law, AbelZeta undertakes no obligation and expressly disclaims any duty to update, alter, or otherwise revise any forward-looking statements, whether written or oral, that may be issued from time to time due to new information, future events, or other reasons.

Company Contact:
Sarah Kelly
Director of Communications
AbelZeta Pharma, Inc.
+1 (240) 552 5870
[email protected]
www.abelzeta.com

SOURCE AbelZeta Pharma, Inc.