Gracell announces start of investigator-initiated trial to
expand clinical evaluation of FasTCAR-T GC012F into autoimmune
disease
GC012F pioneers the use of CD19/BCMA dual-targeting
CAR-T in SLE, aiming for deeper and wider depletion of
autoantibodies producing B-cells and plasma cells
SAN
DIEGO, Calif., SUZHOU
and SHANGHAI, China, May 15, 2023
/PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the
"Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical
company dedicated to developing highly efficacious and affordable
cell therapies for the treatment of cancer and autoimmune diseases,
today announced the initiation of an investigator-initiated trial
(IIT) in China of GC012F, the
Company's autologous FasTCAR therapeutic candidate dual-targeting B
cell maturation antigen (BCMA) and CD19, for the treatment of
refractory SLE.
"Our lead candidate GC012F leverages several next-generation
CAR-T technologies including CD19/BCMA dual-targeting and the
FasTCAR next-day manufacturing. This cell therapy candidate has
demonstrated strong efficacy and consistently favorable safety in
the treatment of several hematological malignancies, and we look
forward to extending this potentially curative treatment option to
patients with autoimmune diseases, such as SLE," said William Cao, founder, Chairman and Chief
Executive Officer of Gracell. "Patients with refractory SLE have
limited options to treat their wide-ranging and often debilitating
symptoms. This study of GC012F in SLE marks an important next step
in GC012F's development as we look to confirm its potential in
autoimmune diseases and prepare the IND submission in both U.S. and
China."
SLE is a chronic autoimmune disease, in which the autoantibodies
produced by the immune system attack the patient's own tissues,
causing multi-organ damage. SLE affects over three million people
worldwide,[1] with disproportionate burden of disease seen among
young women.[2] While immunosuppressants are used as the current
standard of care, SLE remains a chronic condition that is difficult
to manage, significantly impacts quality of life, and has no cure.
Furthermore, refractory/severe SLE could lead to permanent organ
damage, resulting in serious morbidity and even death. As such,
there is urgent, high unmet medical need for more effective – and
even curative – therapies, particularly to help manage refractory
SLE.
GC012F has been studied in more than 50 patients across three
hematological malignancy indications. In two studies on
relapsed/refractory multiple myeloma (RRMM) and newly-diagnosed
multiple myeloma (NDMM), GC012F has demonstrated fast, deep and
durable responses and achieved 93.1% and 100% overall response rate
(ORR), respectively. SLE is a new therapeutic area of interest for
Gracell, as CD19 CAR-T has been reported in recent clinical
research to be potentially "feasible, tolerable, and highly
effective in this indication".[3]
Gracell's GC012F represents a novel approach entering human
study for refractory SLE and pioneers the use of CD19/BCMA
dual-targeting CAR-T in autoimmune disease. By targeting both CD19
and BCMA, GC012F could potentially enable deeper and wider
depletion of autoantibodies producing B-cells and plasma cells,
hence enhancing therapeutic outcomes in comparison to CD19-only
approaches.
GC012F has a proven safety record in patients with RRMM, NDMM
and B-NHL. No neurotoxicity or immune effector cell-associated
neurotoxicity syndrome (ICANs) has been observed in any patients
treated across three studies. 75% of patients in the NDMM study has
not experienced cytokine release syndrome (CRS) of any grade, and
in the RRMM study, patients experienced mostly low-grade
CRS.
The FasTCAR next-day manufacturing platform technology could
bring additional benefits to SLE patients as it shortens patient
wait time, enhances CAR-T cell fitness, and reduces costs.
For more information on the study, please visit
ClinicalTrials.gov using the identifier: NCT05846347.
About GC012F
GC012F is Gracell's FasTCAR-enabled BCMA/CD19 dual-targeting
autologous CAR-T cell therapy, which aims to transform cancer and
immunology treatment by driving fast, deep and durable responses
with improved safety profile. GC102F is currently being evaluated
in trials in multiple myeloma and B-cell non-Hodgkin's lymphoma
(B-NHL), and has demonstrated a consistently strong efficacy and
safety profile. In February 2023,
Gracell announced regulatory clearance of Investigational New Drug
applications in the U.S. and China
to commence clinical trials evaluating GC012F for the treatment of
relapsed/refractory multiple myeloma. Gracell has also initiated an
investigator-initiated trial evaluating GC012F for the treatment of
SLE.
About FasTCAR
Introduced in 2017, FasTCAR is Gracell's revolutionary next-day
autologous CAR-T cell manufacturing platform. FasTCAR is designed
to lead the next generation of cancer and autoimmune therapy and
improve outcomes for patients by enhancing efficacy, 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 and are more robust than traditional CAR-T
cells, making them more proliferative and effective at killing
cancer cells. In November 2022,
FasTCAR was named the winner of the Biotech Innovation category of
the 2022 Fierce Life Sciences Innovation Awards for its ability to
address major industry obstacles.
About Refractory SLE
Systemic lupus erythematosus (SLE) is a chronic autoimmune
disease in which the immune system attacks its own tissues, causing
widespread inflammation and tissue damage throughout the body,
potentially impacting the joints, skin, brain, lungs, kidneys and
blood vessels. SLE affects over 3 million people worldwide,[4] with
disproportionate burden of disease seen among young women.[5]
Immunosuppressants are the current standard of care, but early
study data suggests that CAR-T cell therapy may be a potential
treatment option.
About Gracell
Gracell Biotechnologies Inc. ("Gracell") is a global
clinical-stage biopharmaceutical company dedicated to discovering
and developing breakthrough cell and gene therapies. Leveraging its
pioneering FasTCAR and TruUCAR technology platforms and SMART
CARTM 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. For more information on Gracell, please visit
www.gracellbio.com. Follow @GracellBio on LinkedIn.
Cautionary Noted Regarding Forward-Looking Statements
Statements 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. These statements include,
but are not limited to, statements relating to the expected trading
commencement and closing date of the offering. The words
"anticipate," "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
Securities and Exchange Commission. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Gracell specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Readers should not rely upon the
information on this page as current or accurate after its
publication date.
[1] Tian, J., Zhang,
D., Yao, X., Huang, Y., & Lu, Q. (2023). Global epidemiology of
systemic lupus erythematosus: a comprehensive systematic analysis
and modelling study. Annals of the Rheumatic Diseases, 82(3),
351-356
|
[2] Dall'Era M.
Systemic lupus erythematosus. In: Imboden JB, Hellman DB, Stone JH.
(Eds). Current Rheumatology Diagnosis and Treatment. 3rd ed. New
York, NY:McGraw-Hill; 2013.
|
[3] Mackensen A, Müller
F, Mougiakakos D, et al. Anti-CD19 CAR T cell therapy for
refractory systemic lupus erythematosus. Nat Med 28,
2124–2132 (2022).
https://doi.org/10.1038/s41591-022-02017-5
|
[4] Tian, J., Zhang,
D., Yao, X., Huang, Y., & Lu, Q. (2023). Global epidemiology of
systemic lupus erythematosus: a comprehensive systematic analysis
and modelling study. Annals of the Rheumatic Diseases, 82(3),
351-356
|
[5] Dall'Era M.
Systemic lupus erythematosus. In: Imboden JB, Hellman DB, Stone JH.
(Eds). Current Rheumatology Diagnosis and Treatment. 3rd ed. New
York, NY:McGraw-Hill; 2013.
|
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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