SAN
DIEGO, Calif., and SUZHOU and SHANGHAI, China, Sept. 6,
2023 /PRNewswire/ -- 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 it will present
updated, longer-term results from the ongoing
investigator-initiated Phase 1 trial in China evaluating FasTCAR-enabled GC012F in
transplant-eligible, high-risk patients with newly diagnosed
multiple myeloma (NDMM). The findings will be presented in a poster
presentation at the 20th International Myeloma Society (IMS) Annual
Meeting, taking place September 27-30,
2023, in Athens, Greece and
virtually.
"We look forward to presenting the latest findings from our
clinical study evaluating GC012F for patients with newly diagnosed
multiple myeloma at this year's IMS Annual Meeting," said Dr.
Wendy Li, Gracell's Chief Medical
Officer. "There remain significant opportunities to improve outcome
for front-line high-risk multiple myeloma patients. With a
demonstrably impressive safety profile, differentiated BCMA/CD19
dual-targeting design and FasTCAR next-day manufacturing, we
believe GC012F is a compelling, innovative candidate to address the
unmet needs for this patient population."
Poster presentation details are as follows:
- Abstract title: 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: P-136
- Abstract category: Treatment of Newly
Diagnosed Myeloma – Transplant Eligible
- Presentation time: 1:30-2:30PM EEST, Wednesday, September 27, 2023
Additional information about the poster and the IMS Annual
Meeting is available on the IMS website.
About GC012F
GC012F 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 relapsed/refractory
multiple myeloma in the United
States and a Phase 1/2 clinical trial in China is to be commenced imminently. Gracell
has also launched an investigator-initiated trial (IIT) evaluating
GC012F for the treatment of refractory systemic lupus erythematosus
(rSLE).
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 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. 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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