Gracell Biotechnologies Wins Overall Immunology Solution of the Year by BioTech Breakthrough Awards Program
08 Novembre 2023 - 2:30PM
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 Gracell’s FasTCAR-T GC012F was selected as the
winner of BioTech Breakthrough’s Overall Immunology Solution of the
Year award.
Since its founding, Gracell has been developing
a rich pipeline of transformational CAR-T therapies, aiming to
broaden the use of breakthrough cell therapies across hematological
malignancies, solid tumors and autoimmune conditions. GC012F,
developed with Gracell’s revolutionary next-day autologous CAR-T
cell manufacturing platform, FasTCAR, is a CAR-T therapy candidate
that stands to transform cancer and autoimmune treatment. In
recently announced data from an ongoing Phase 1
investigator-initiated trial (IIT), GC012F demonstrated a 100%
overall response rate and a 95% MRD- sCR rate among 22
transplant-eligible, high-risk patients with newly diagnosed
multiple myeloma (NDMM). Additional positive data has recently been
announced from studies evaluating GC012F for the treatment of
relapsed/refractory multiple myeloma (rrMM) and B-cell
non-Hodgkin’s lymphoma (B-NHL). An IIT has also been launched to
evaluate GC012F for the treatment of refractory systemic lupus
erythematosus (rSLE) in the second quarter of this year.
In 2022, FasTCAR was named the winner of the
Biotech Innovation category of the 2022 Fierce Life Sciences
Innovation Award for its potential to address major industry
obstacles.
"Over the last decade, the field of
immunotherapy has seen rapid progress and promising results,” said
Dr. William (Wei) Cao, Gracell’s Chief Executive Officer. “CAR-T
cell therapies has been transforming the treatment paradigm for
hematologic malignancies, and are showing emerging but compelling
potential in autoimmune indications. At the same time, challenges
have arisen around patient access and manufacturing time. Gracell
is dedicated to ameliorating both these issues through GC012F and
FasTCAR. With strong data reported in multiple myeloma and B-cell
non-Hodgkin’s lymphoma, and ongoing efforts to expand to treating
autoimmune conditions, we’re proud to be recognized for our
innovative approach, and look forward to bringing our treatments to
patients."
The BioTech Breakthrough Awards program was
founded in 2021 by BioTech Breakthrough, a leading independent
market intelligence organization that evaluates and recognizes
standout life sciences and biotechnology companies, products and
services around the globe. The mission of this annual award program
is to perform the most comprehensive evaluation of life sciences
and biotechnology tools, services and companies in the industry,
with thousands of nominations coming in from the best and brightest
biotechnology innovators around the world.
About BioTech BreakthroughPart of Tech
Breakthrough, a leading market intelligence and recognition
platform for global technology innovation and leadership, the
BioTech Breakthrough Awards program is devoted to honoring
excellence in life science and biotechnology solutions, services
and companies. The BioTech Breakthrough Awards provide public
recognition for the achievements of biotechnology companies and
products in categories including BioPharma, Genomics, Therapeutics,
Food Science and BioAgriculture, and more. For more information
visit BioTechBreakthroughawards.com
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/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 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 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 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 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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