Bioheng Gets FDA Nod for CD7 UCAR T Cell Therapy in T-ALL/LBL IND Application

BOSTON, MA, USA, March 5, 2025 – Bioheng Therapeutics US LLC, a biotech company in the clinical phase of development, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application concerning CTD402. The therapy, a CD7-targeted universal CAR-T (UCAR-T) cell treatment, is intended for both pediatric and adult patients dealing with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL). This approval paves the way for a single-arm, open-label Phase Ib/II clinical trial, which employs a streamlined approach to dose determination, aiming to enhance dosing strategies and expedite the advancement of clinical trials.

Jiangtao Ren, Ph.D., who serves as the President and Chief Scientific Officer (CSO) at Bioheng, expressed enthusiasm about the IND clearance from the FDA for the forthcoming Phase Ib/II trial. He emphasized the simplified dose-finding design as a significant milestone that will quicken the clinical development timeline within the U.S. Dr. Ren highlighted that previous studies had demonstrated an impressive overall response rate (ORR) and a commendable safety profile. These findings underscore the potential of Bioheng's ANSWER platform to offer rapid therapeutic benefits while minimizing patient risk, indicating CTD402's promise as a leading therapy option for T-cell malignancies.

CTD402 is a universal CAR-T cell therapy specifically targeting CD7, derived from healthy donors, and intended for T-ALL/LBL treatment. The therapy is genetically engineered to prevent complications such as fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG), all while boosting its anti-tumor effectiveness. Notably, CTD402 can be manufactured in a single batch that suits multiple patients, providing an "off-the-shelf" solution for individuals requiring CAR-T cell therapy.

T-ALL and LBL represent different clinical manifestations of the same disease, originating from immature T-cell lineage lymphoid cells. These are categorized based on the extent of bone marrow involvement. Although initial treatments often lead to high rates of complete remission (CR), most patients eventually face a relapse. Cases of relapsed or refractory (R/R) disease are typically linked with unfavorable outcomes, with a five-year overall survival (OS) rate falling below 20%.

Bioheng Therapeutics is dedicated to advancing allogeneic "off-the-shelf" universal CAR-T therapies. Established in 2017, the company aims to develop top-tier allogeneic cell therapy platforms and products, addressing some of the most pressing unmet medical needs. Bioheng's mission underscores its commitment to pioneering therapies that could revolutionize treatment approaches for challenging conditions such as T-cell malignancies.

CTD402's development and the subsequent FDA approval mark a significant milestone in Bioheng's quest to innovate within the sphere of CAR-T cell therapies. The new treatment approach holds promise not only in enhancing the efficacy of leukemia and lymphoma management but also in offering a new lease on life for patients facing dire prognoses with current treatment options. The company's efforts are poised to make a meaningful impact on the landscape of cancer treatment, specifically targeting diseases with historically poor outcomes.