BOSTON, March 5,
2025 /PRNewswire/ -- 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, The Journal of the American
Society of Hematology, 2017, 129(9): 1134-1142.
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SOURCE Bioheng Therapeutics US LLC
