Gracell Biotechnologies Presents Longer-Term Results for FasTCAR-T GC012F in B-Cell Non-Hodgkin’s Lymphoma at EHA2023, Highlighting 100% Overall Response Rate
10 Junho 2023 - 11:30AM
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 presented
longer-term follow-up data from a first-in-human study evaluating
GC012F, a CD19 and B-cell maturation antigen (BCMA) dual-targeted
autologous CAR-T therapeutic candidate, in patients with
relapsed/refractory B-cell non-Hodgkin’s Lymphoma (r/r B-NHL) as an
oral presentation (abstract #S234) at the European Hematology
Association (EHA2023) Congress.
While CD19-directed CAR-T cell therapy has been
demonstrated to be a valuable treatment option for r/r B-NHL, other
studies have identified that 39% to 97% of clinical B-NHL samples
express BCMA as well.1,2,3 To further improve safety and efficacy
of NHL treatment, Gracell is exploring the clinical potential of
GC012F, a CD19 and BCMA dual-targeting CAR-T cell therapy, for
treatment of r/r B-NHL. GC012F is manufactured through a novel
next-day FasTCAR process and demonstrated a younger phenotype of
CAR-T cells and highly effective tumor killing activity in
preclinical animal models.
In the single-arm, open label
investigator-initiated trial (IIT), nine r/r B-NHL patients were
enrolled and treated with GC012F, and completed at least three
months of follow-up. Doses range between 3.7x104 to 3x105 CAR-T
cells/kg. All nine patients are classified as relapsed/refractory
DLBCL. All patients’ lymphoma samples expressed CD19, and samples
from seven out of eight tested patients expressed BCMA.
As of the April 12, 2023 data cutoff date, with
a median follow-up of 293 days (range: 131-546 days), patients
treated with GC012F achieved a high response rate and outstanding
durability of response:
- 100% (9/9) overall response rate
(ORR) at 3 months among nine patients with r/r DLBCL;
- 77.8% (7/9) complete response (CR)
rate at 3 months;
- 66.7% (6/9) CR rate at 6
months;
- GC012F CAR-T cells were detectable
in tumor biopsies from all tested patients, indicating the
infiltration of CAR-T cells into the tumor lesions.
GC012F also continued to show a favorable safety
profile:
- Cytokine release syndrome (CRS) was
mostly Grade 1 (56%; 5/9). Grade 3 CRS was observed in one patient
(duration of 2 days) with quick recovery after standard of care
treatment. No Grade 4/5 CRS events occurred;
- No neurotoxicity or immune effector
cell-associated toxicity (ICANS) of any grade were observed.
“One year after we reported initial data from
the IIT evaluating FasTCAR-T GC012F in B-NHL at EHA2022, we are
proud to be back at EHA presenting longer-term results from more
patients as an oral presentation,” said Dr. Wendy Li, Chief Medical
Officer of Gracell. “Durable responses, enhanced safety, and timely
access to cell therapy remain significant unmet needs for NHL
patients. With a 100% ORR at 3 months and CR rates of 78% at 3
months and 67% at 6 months, particularly among DLBCL patients, the
updated data further support the clinical potential and wide
applicability of GC012F, and the benefits of a CD19/BCMA
dual-targeting approach combined with FasTCAR next-day
manufacturing.”
Gracell is also evaluating GC012F in RRMM,
newly-diagnosed multiple myeloma (NDMM), and systemic lupus
erythematosus (SLE).
On June 9, Gracell also presented the following
during poster sessions:
- First results from a Phase 1 study
of the donor-derived allogeneic CAR-T GC007g (abstract #P369),
showing 100% ORR and a favorable safety profile for treatment of
r/r B-ALL;
- Updated results from the IIT
evaluating GC012F for the treatment of RRMM (abstract #P869), which
were also presented as an oral presentation at the 2023 ASCO Annual
Meeting. The data demonstrated 100% minimal residual disease (MRD)
negativity and 82.8% MRD negative stringent complete response (sCR)
in a predominantly high-risk RRMM population.
Additional information about the presentations and the EHA2023
Hybrid Congress is available on the EHA website.
[1] Blood Cancer Journal (2020); 10:73.[2] Blood (2017);
130:2755.[3] Hum Gene Ther (2018); 29(5): 585.
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. GC102F is currently being evaluated in
investigator-initiated trials in multiple hematological cancers as
well as autoimmune disease, and has demonstrated a consistently
strong efficacy and safety profile. In February 2023, Gracell
announced regulatory clearance of Investigational New Drug
applications in the United States 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 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. Leveraging its pioneering 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 disease. For more
information on Gracell, please visit www.gracellbio.com. Follow
@GracellBio on LinkedIn.
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factors, including factors discussed in the section entitled "Risk
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well as discussions of potential risks, uncertainties, and other
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