NANJING, China, June 20,
2021 /PRNewswire/ -- Nanjing
Bioheng Biotech Co., Ltd. Announced UCAR T cell therapy
product targeting CD7, code CTD401, received Orphan Drug
Designation (ODD) from the U.S. Food and Drug Administration (FDA)
for the treatment of T-cell acute lymphoblastic leukemia
(T-ALL).
"CTD401 is the first innovative product based on our
next-generation generic CAR-T technology platform. It has excellent
efficacy and superior safety in exploratory clinical studies," said
Dr. JiangTao Ren, Co-founder and
Chief Scientific Officer of Bioheng, "Orphan drug accreditation not
only reflects the confidence of the international authority FDA on
CTD401, but also is an important milestone of Bioheng gradual
globalization."
CTD401 is a universal CAR-T (UCAR-T) cell therapy product
developed by Bioheng for the treatment of patients with T-ALL. The
product is prepared by collecting peripheral blood mononuclear
cells (PBMC) from healthy donors, using a virus encoding a CD7 CAR
gene for transduction, and using CRISPR/cas9 technology to knock
out key genes.
About ODD
The Orphan Drug Designation program provides orphan
status to drugs and biologics which are defined as those intended
for the treatment, prevention or diagnosis of a rare disease or
condition, which is one that affects less than 200,000 persons in
the US or meets cost recovery provisions of the act. After
obtaining the ODD, pharmaceutical companies could receive various
incentives for the drug development, including 25% federal tax
credit for expenses incurred in conducting clinical research within
the United States, Waiver of Prescription Drug User Fee Act
(PDUFA) fees for orphan drugs, qualifed to compete for
research grants from the Office of Orphan Products Development
(OOPD) to support clinical studies for orphan drugs, eligibility to
receive regulatory assistance and guidance from the FDA in the
design of an overall drug development plan and 7-year
marketing exclusivity.
About Bioheng
Bioheng is a clinical-stage biotech company focused on
developing novel cellular immunotherapy. The main development
pipelines include allogeneic CAR T, which is used for the treatment
of hematologic and solid tumors, so as to solve the dilemma of high
cost, long time, difficult manufacturing and individualization of
traditional CAR T, realize the affordability, accessibility and
popularity of cancer treatment, build the bridge of life and
health, and let more patients get the cure opportunity. Currently,
a high standard GMP-level clinical transformation center has been
established to meet the requirements of clinical development and
post marketing manufacturing.
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SOURCE Bioheng Biotech Co., Ltd