SUZHOU and SHANGHAI, China,
April 10, 2021 /PRNewswire/
-- Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a
global clinical-stage biopharmaceutical company dedicated to
developing highly efficacious and affordable cell therapies for the
treatment of cancer, today presented updated long-term follow-up
data on their TruUCAR-enabled allogeneic product candidate GC027
for the treatment of adult patients with relapsed/refractory T-cell
acute lymphoblastic leukemia (r/r T-ALL) in an e-poster
presentation at the 2021 American Association for Cancer Research
(AACR) Annual Meeting on April
10.
TruUCAR-enabled GC027 is a first-in-human, off-the-shelf
allogeneic CAR-T stand-alone therapy targeting CD7. An ongoing,
multi-center investigator-initiated Phase 1 trial in China is evaluating the safety and efficacy of
GC027 for the treatment of adults with r/r T-ALL. We first reported
results as oral presentation at the AACR 2020 Annual Meeting.
The updated data with a February 4,
2021 data cut-off represents long-term follow-up as well as
additional patients treated. Patients had received a median of six
prior lines of therapy and received a single infusion
of TruUCAR GC027 in one of three dose levels:
0.6x107cells/kg, 1.0x107cells/kg or
1.5x107cells/kg. Six patients (100%) treated achieved a
complete remission with or without complete blood count recovery
(CR/CRi) and five of the six patients (83%) achieved minimum
residual disease negative complete remission (MRD- CR). At 6
months post treatment, three out of five patients (60%) had
maintained MRD- CR. After 18.5 months of follow up for the initial
patients treated, one patient continued to be MRD- CR at 16.8
months. One patient maintained MRD- CR until 9 months and one
patient with primary refractory disease (no response to VDP)
maintained his MRD- CR status until month 7. One additional patient
treated presented initially with a high tumor burden and extensive
extramedullary (EM) disease. After treatment with GC027 and as
confirmed by PET CT scan, all EM lesions resolved. The patient
achieved MRD- CR at day 28.
All six patients tolerated a single infusion of TruUCAR
GC027. No neurotoxicity events (ICANS) or acute graft-versus-host
disease (aGvHD) were observed. Cytokine release
syndrome (CRS) occurred in all patients and was managed with
standard of care including Tocilizumab. Overall safety findings
were consistent with previous observations.
"These data show promising long-term follow-up results in r/r
T-ALL patients who have very limited treatment options available,"
commented Dr. Martina Sersch, M.D.,
Chief Medical Officer of Gracell. "With these findings, GC027 may
have the potential to be developed as a single-infusion stand-alone
allogeneic CAR-T therapy. We are looking forward to expediting the
clinical development of our TruUCAR-enabled GC027 globally, as well
as expanding into additional indications beyond T-ALL."
Presentation
link: https://cattendee.abstractsonline.com/meeting/9325/Presentation/4633
Abstract link:
https://www.abstractsonline.com/pp8/#!/9325/presentation/4633
About GC027
TruUCAR-enabled GC027 is a first-in-human,
off-the-shelf allogeneic CAR-T therapy targeting CD7, currently
being developed for the treatment of T-ALL in adults. GC027 is
manufactured from T cells of human leukocyte antigen (HLA)
unmatched healthy donors. Developed on our proprietary TruUCAR
platform, GC027 utilizes dual-function CAR to specifically target a
patient's own T cells and natural killer (NK) cells that would
otherwise be directed against the foreign, or allogeneic, CAR-T
cells resulting in rejection by the patients. This novel design
allows this allogeneic cell therapy to survive a patient's immune
system without the need for combination treatment with additional
potent immunosuppressant and represents a differentiated
monotherapy approach.
About T-ALL
T cell malignancies are a group of cancers
involving T lymphocytes, including acute T cell lymphoblastic
leukemia or T-ALL. Standard of care treatment for T-ALL includes
chemotherapy, radiation therapy and stem cell transplantation.
Standard chemotherapy regimens only result in 30% - 40% response
rate with 6 months median Overall Survival among responders.
Patients with T cell malignancies usually have high relapse and
mortality rates. Relapsed patients have dismal prognosis with very
limited treatment options and <10% of patients surviving beyond
5 years. Due to shared common surface antigens and potential
contamination by malignant cells, development of CAR-T cell
therapies for T-ALL is lagged behind. In addition, no new therapies
have been approved for the treatment of T-ALL since the approval of
Nelarabine (marketed by GlaxoSmithKline) by the FDA in 2005.
Globally, approximately 64,000 patients are diagnosed with ALL
every year with over approximately 6,000 expected to be diagnosed
in the United States in 2020.
T-ALL accounts for approximately 25% of ALL diagnoses in adults.
1
About TruUCAR
TruUCAR is Gracell's
proprietary technology platform and is designed to generate
high-quality allogeneic CAR-T cell therapies that can be
administered "off-the-shelf" at lower cost and with greater
convenience. With differentiated design enabled by gene editing,
TruUCAR is designed to control host vs graft rejection (HvG) as
well as graft vs host disease (GvHD) without the need of being
co-administered with immunosuppressive drugs.
The lead program of TruUCAR platform, GC027, is manufactured
using T cells from non-HLA matched healthy donors. The TruUCAR
platform utilizes novel designs of a dual-function CAR or dual-CAR
to reduce HvG, eliminating the need of combination therapy with
additional potent immunosuppressant to induce deeper immune
suppression and enabling stand-alone allogeneic CAR-T cell
therapy.
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, 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 production quality, high therapy cost and lack of
effective CAR-T therapies for solid tumors. For more information on
Gracell, please visit www.gracellbio.com
Follow @GracellBio on LinkedIn
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specifically disclaims any obligation to update any forward-looking
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Media contact
Marvin
Tang
marvin.tang@gracellbio.com
Investor contact
Gracie
Tong
gracie.tong@gracellbio.com
1 D.I. Marks, C. Rowntree, Management of adults
with T-cell lymphoblastic leukemia, Blood 2017
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