Gracell Biotechnologies Doses First Patient in Phase 1b/2 Clinical Trial in U.S. Evaluating GC012F for Treatment of Relapsed/Refractory Multiple Myeloma
26 Septembre 2023 - 10:00PM
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 first patient has been dosed in a Phase 1b/2
clinical trial evaluating its lead candidate, GC012F, in patients
with relapsed or refractory multiple myeloma (RRMM) in the United
States. GC012F is the Company’s autologous therapeutic candidate
dual-targeting B cell maturation antigen (BCMA) and CD19, developed
on the proprietary FasTCAR next-day manufacturing platform.
The Phase 1b portion of the open-label
multi-center trial has been initiated and will be conducted at
several top medical centers in the United States. The study expects
to enroll approximately 12 patients at two dose levels and is
designed to evaluate the safety and tolerability of GC012F in RRMM
patients, determine the recommended dose of GC012F for Phase 2 and
characterize the pharmacokinetics of GC012F in RRMM patients. The
Phase 2 portion is intended to evaluate the efficacy of GC012F in
RRMM patients and further characterize the safety of GC012F. For
more information about the Phase 1b/2 trial, please visit
www.clinicaltrials.gov (identifier NCT05850234).
“Gracell has amassed a body of compelling
evidence supporting the dual-targeting approach of GC012F for
treatment of RRMM. Based on its fast, deep and durable responses as
well as the differentiated safety profile observed in prior
clinical studies, we firmly believe that GC012F has the potential
to emerge as a leading treatment option and benefit patients across
disease stages,” said Dr. William Cao, founder, Chairman and Chief
Executive Officer of Gracell. “Dosing the first patient in the
Phase 1b portion of the U.S. trial is another important step toward
validating this treatment for RRMM patients. We are grateful to
everyone involved in this clinical study, including the
investigators, clinical and manufacturing teams and many others who
collaborated seamlessly to expedite the prompt treatment of the
first patient. Most of all, I’d like to thank the patients, and
their loved ones, for participating in this trial.”
GC012F has been studied in more than 50 patients
across three hematological malignancy indications, RRMM, newly
diagnosed multiple myeloma (NDMM) and B-cell non-Hodgkin's lymphoma
in investigator-initiated trials (IIT), demonstrating fast, deep
and durable responses. It is also being evaluated for treatment of
refractory systemic lupus erythematosus (rSLE) in an IIT. Latest
clinical data from GC012F in the treatment of RRMM has been
presented at the American Society for Clinical Oncology (ASCO) and
the European Hematology Association (EHA) annual meetings. As of
the data cutoff date of April 12, 2023, among 29 predominantly
high-risk RRMM patients, GC012F achieved a 93.1% overall response
rate (ORR), a stringent complete response rate of 82.8%, with a
median progression free survival of 38 months (95% CI: 11.8-NR).
The safety profile was consistently favorable, with no
neurotoxicity of any grade, and no second primary malignancy
reported with this longer-term follow-up.
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 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 RRMM in the United States and a Phase
1/2 clinical trial in China is to be commenced imminently. Gracell
has also launched an IIT evaluating GC012F for the treatment of
rSLE.
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 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 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 CAR™ 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 systemic lupus erythematosus (SLE). For more
information on Gracell, please visit
www.gracellbio.com. Follow @GracellBio on LinkedIn.
Cautionary Noted 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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