Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus
December 21 2023 - 7:00AM
Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ:
GRCL), a global clinical-stage biopharmaceutical company dedicated
to developing innovative and highly efficacious cell therapies for
the treatment of cancer and autoimmune disease, today announced
that the Center for Drug Evaluation (CDE) of China's National
Medical Products Administration (NMPA) has cleared Gracell's
Investigational New Drug (IND) application for GC012F, an
autologous CAR-T therapeutic candidate, for the treatment of
refractory systemic lupus erythematosus (rSLE).
Under the IND, Gracell plans to initiate a Phase
1/2 clinical study in China to further evaluate GC012F in rSLE
patients. As announced Nov. 27, the Company will also commence
Phase 1/2 clinical study in the U.S. An IIT is underway to evaluate
GC012F for the treatment of rSLE.
“This milestone marks our rapid progress in
advancing development of GC012F in rSLE, an autoimmune disease with
high unmet need,” said Dr. William Cao, founder, Chairman and Chief
Executive Officer of Gracell. “With an IIT well-underway and two
IND studies planned in the U.S. and now China, we’re relentlessly
pursing clinical development of an innovative CD19/BCMA
dual-targeting approach, which seeks to offer differentiated
efficacy over other investigational therapies that only target
CD19. Combined with GC012F’s consistently favorable safety profile,
based on the data from 60 patients treated in IIT studies across
three oncology indications, we have reason to believe that our
candidate may offer promising advantages for people living with
rSLE.”
Several patient case studies in academia have
shown CD19 CAR-T cell therapy to be feasible, tolerable and highly
effective in a number of autoimmune diseases, including SLE. By
targeting both CD19 and BCMA, it is believed that GC012F could
enable deeper and wider depletion of disease-causing B-cells and
plasma cells, potentially offering a more effective and
longer-lasting treatment option for rSLE patients, especially those
in severe and complicated disease condition.
GC012F is an autologous CAR-T therapeutic
candidate dual-targeting B cell maturation antigen (BCMA) and CD19
and utilizes Gracell’s proprietary FasTCAR next-day manufacturing
platform. In addition to the upcoming rSLE IND studies, GC012F is
being evaluated in a Phase 1b/2 IND study for the treatment of
relapsed/refractory multiple myeloma (RRMM) in the U.S., and in
four IIT studies for the treatment of rSLE, RRMM, newly-diagnosed
multiple myeloma (NDMM) and B-NHL. In updated clinical results from
the NDMM IIT, which were presented at the 65ᵗʰ American Society of
Hematology Annual Meeting & Exposition in December 2023, GC012F
demonstrated an overall response rate (ORR) of 100% and minimal
residual disease negative stringent complete response (MRD- sCR)
rate of 95.5%.
About GC012FGC012F is Gracell’s
FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell
therapy, which aims to transform cancer and autoimmune disease
treatment by driving fast, deep and durable responses with an
improved safety profile. GC012F is currently being evaluated in
clinical studies in multiple hematological cancers as well as
autoimmune diseases and has demonstrated a consistently strong
efficacy and safety profile. Gracell has initiated a Phase 1b/2
trial evaluating GC012F for the treatment of relapsed or refractory
multiple myeloma in the United States and a Phase 1/2 clinical
trial in China is to be commenced imminently. An IIT has also been
launched to evaluate GC012F for the treatment of refractory
systemic lupus erythematosus (rSLE) and Investigational New Drug
applications to study GC012F in rSLE have been cleared by the U.S.
FDA and China NMPA.
About FasTCARIntroduced in
2017, FasTCAR is Gracell’s revolutionary next-day autologous CAR-T
cell manufacturing platform. FasTCAR is designed to lead the next
generation of therapy for cancer and autoimmune diseases, and
improve outcomes for patients by enhancing effect, reducing costs,
and enabling more patients to access critical CAR-T treatment.
FasTCAR drastically shortens cell production from weeks to
overnight, potentially reducing patient wait times and probability
for their disease to progress. Furthermore, FasTCAR T-cells appear
younger than traditional CAR-T cells, making them more
proliferative and effective at killing cancer cells. In 2022 and
2023, FasTCAR was named the winner of the Biotech Innovation
category of the 2022 Fierce Life Sciences Innovation Awards and the
Overall Immunology Solution of 2023 by BioTech Breakthrough Awards,
for its ability to address major industry obstacles.
About Gracell Gracell
Biotechnologies Inc. (“Gracell”) is a global clinical-stage
biopharmaceutical company dedicated to discovering and developing
breakthrough cell therapies for the treatment of cancers and
autoimmune diseases. Leveraging its innovative FasTCAR and TruUCAR
technology platforms and SMART CART™ technology module, Gracell is
developing a rich clinical-stage pipeline of multiple autologous
and allogeneic product candidates with the potential to overcome
major industry challenges that persist with conventional CAR-T
therapies, including lengthy manufacturing time, suboptimal cell
quality, high therapy cost, and lack of effective CAR-T therapies
for solid tumors and autoimmune diseases. The lead candidate
BCMA/CD19 dual-targeting FasTCAR-T GC012F is currently being
evaluated in clinical studies for the treatment of multiple
myeloma, B-NHL and SLE. For more information on Gracell, please
visit www.gracellbio.com. Follow @GracellBio on LinkedIn.
Cautionary Note Regarding
Forward-Looking StatementsStatements in this press release
about future expectations, plans, and prospects, as well as any
other statements regarding matters that are not historical facts,
may constitute “forward-looking statements” within the meaning of
The Private Securities Litigation Reform Act of 1995. The words
“anticipate,” “look forward to,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “will,” “would” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including factors discussed in the
section entitled “Risk Factors” in Gracell’s most recent annual
report on Form 20-F, as well as discussions of potential risks,
uncertainties, and other important factors in Gracell’s subsequent
filings with the U.S. Securities and Exchange Commission. Any
forward-looking statements contained in this press release speak
only as of the date hereof. Gracell specifically disclaims any
obligation to update any forward-looking statement, whether due to
new information, future events, or otherwise. Readers should not
rely upon the information on this page as current or accurate after
its publication date.
Media Contacts
Marvin Tang
marvin.tang@gracellbio.com
Jessica Laub
jessica.laub@westwicke.com
Investor Contacts
Gracie Tong
gracie.tong@gracellbio.com
Stephanie Carrington
stephanie.carrington@westwicke.com
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