Gracell Biotechnologies to Present Updated Results from BCMA/CD19 Dual-Targeting FasTCAR-T GC012F in Newly Diagnosed Multiple Myeloma at the 65ᵗʰ American Society of Hematology Annual Meeting & Exposition
November 02 2023 - 9:00AM
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 updated results from its clinical investigator-initiated
trial (IIT) of GC012F for treatment of newly diagnosed multiple
myeloma (NDMM) will be presented as an oral presentation at the
65th American Society of Hematology (ASH) Annual Meeting &
Exposition taking place in San Diego, California and online during
December 9-12, 2023.
The ongoing Phase 1 IIT (NCT04935580) in China
is evaluating the safety and efficacy of GC012F, a FasTCAR-enabled
autologous BCMA and CD19 dual-targeted CAR-T cell therapy, in the
frontline setting for transplant-eligible, high risk NDMM patients.
The first results from this study on 13 initial patients were
presented at the ASH Annual Meeting in 2022. Updated results,
including longer-term follow-up and data from additional patients
in the study, will be shared at this year’s ASH conference.
“We are pleased to present updated results from
the Phase 1 IIT study of GC012F in NDMM. During last year’s ASH
meeting, we unveiled the first results for the initial 13 patients,
marking a pioneering moment for CAR-T clinical data within the
frontline setting,” said Dr. Wendy Li, Gracell’s Chief Medical
Officer. “With additional patients enrolled and longer follow-up,
we are encouraged to report that FasTCAR-T GC012F has continued to
demonstrate impressive depth of responses and a highly favorable
safety profile. We firmly believe that GC012F represents a next
generation CAR-T therapy that has the potential to revolutionize
the treatment landscape for multiple myeloma patients in front- and
early-line settings.”
Oral presentation details are as follows:
- Presentation
title: Updated Results of a Phase I Open-Label Single-Arm
Study of Dual Targeting BCMA and CD19 FasTCAR-T Cells (GC012F) As
First-Line Therapy for Transplant-Eligible Newly Diagnosed
High-Risk Multiple Myeloma
- Abstract number:
1022
- Presentation
category: 704. Cellular Immunotherapies: Early Phase and
Investigational Therapies
- Presentation time:
Monday, December 11, 2023, 4:45 PM PT
- Presentation
location: Room 6A, San Diego Convention Center
Additional information about Gracell’s oral presentation at ASH
will be available on the ASH conference website at 9 a.m. ET
today.
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 refractory
systemic lupus erythematosus (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
Gracell Biotechnologies (NASDAQ:GRCL)
Historical Stock Chart
From May 2024 to Jun 2024
Gracell Biotechnologies (NASDAQ:GRCL)
Historical Stock Chart
From Jun 2023 to Jun 2024