BOSTON,March 5,2025 --Bioheng Therapeutics US LLC ("Bioheng"),a clinical-stage biotech company dedicated to developing innovative universal CAR-T cell therapies,today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for CTD402,a CD7-targeted universal CAR-T (UCAR-T) cell therapy,for the treatment of pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL). The study approved by the FDA is a single-arm,open-label Phase Ib/II trial with a simplified dose-finding design,designed to optimize dosing and accelerate clinical development.

"We are delighted that CTD402 has received IND clearance from the U.S. FDA for a Phase Ib/II trial with a simplified dose-finding design,accelerating our clinical development timeline in the United States," stated Jiangtao Ren,Ph.D.,President & Chief Scientific Officer (CSO) of Bioheng. "IIT study results showed an impressive ORR,alongside a favorable safety profile. These results validate our ANSWER® platform's ability to deliver both rapid therapeutic impact and reduced patient risk,positioning CTD402 as a potential best-in-class therapy for T-cell malignancies."

About CTD402

CTD402 is a universal CAR-T cell product targeting CD7 derived from healthy donors and intended for the treatment of T-ALL/LBL. It is genetically modified to avoid fratricide,graft-versus-host disease (GvHD),and host-versus-graft rejection (HvG) while enhancing anti-tumor activity. CTD402 can be prepared in a single batch for multiple people,achieving an "off-the-shelf" capability for patients in need of CAR-T cell therapy.

About T-ALL/LBL

T-ALL/LBL are distinct clinical presentations of the same malignancy,originating from immature T-cell lineage lymphoid cells and classified based on the degree of bone marrow involvement. [1] While frontline therapy achieves high complete remission (CR) rates,the majority of patients ultimately experience relapse. Relapsed or refractory (R/R) disease is associated with poor outcomes,with a 5-year overall survival (OS) rate of less than 20%.[2]

About Bioheng

Bioheng Therapeutics is a clinical-stage company focused on allogeneic "off-the-shelf " universal CAR-T therapies. Founded in 2017,we aim to develop the world's leading allogeneic cell therapy platforms and products to address some of the most challenging unmet needs.

References:

[1] Swerdlow S H,Campo E,Pileri S A,et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms[J]. Blood,The Journal of the American Society of Hematology,2016,127(20): 2375-2390.

[2] Marks D I,Rowntree C. Management of adults with T-cell lymphoblastic leukemia[J]. Blood,2017,129(9): 1134-1142.