CAR031 study at 9.03-mo median follow up
achieves disease control rate (DCR) of 91.3% and objective response
rate (ORR) of 56.5% for patients across all dose levels (DLs) and
ORR of 75.0% at DL4
ROCKVILLE, Md., June 4, 2024
/PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the
"Company"), a global clinical-stage biopharmaceutical company
focused on the discovery and development of innovative and
proprietary cell-based therapeutic products, today announced
preliminary safety and efficacy results from its first time in
human investigator-initiated trial (IIT) of C-CAR031 in connection
with the Company's oral presentation at the 2024 American Society
of Clinical Oncology (ASCO) Annual Meeting. The presentation shared
data indicating a manageable safety profile and encouraging
anti-tumor activity of C-CAR031 in patients with heavily pretreated
advanced hepatocellular carcinoma (HCC) (1-6 lines of prior
therapy). C-CAR031 is based on a novel GPC3-targeting CAR-T
designed by AstraZeneca (LSE/STO/Nasdaq: AZN) and is manufactured
by AbelZeta. C-CAR031 is being co-developed in China by AbelZeta and AstraZeneca.
"We are encouraged by the first clinical
results of C-CAR031 in advanced hepatocellular carcinoma (HCC)
patients"
"We are encouraged by the first clinical results of C-CAR031 in
advanced hepatocellular carcinoma (HCC) patients," said Tony
(Bizuo) Liu, Chairman and CEO of AbelZeta. "The early data
presented today provide compelling proof-of-concept to potentially
redefine therapeutic paradigms in HCC and other GPC3-expressing
solid tumors."
Principal Investigator (PI) of the study, Professor Tingbo Liang
from the First Affiliated Hospital of Zhejiang University, stated "C-CAR031
showed a good safety profile and promising efficacy in
late-stage hepatocellular carcinoma patients, who typically
have a limited number of treatment options available.
The observed tumor shrinkage in the large/vast majority
(91.3%) of the patients suggests that C-CAR031 has the potential to
bring clinical value and offer hope to these
patients."
As of March 14, 2024, 23 of 24
patients on the study were eligible for efficacy assessment. Tumor
reductions were observed in 91.3% patients, in both intrahepatic
and extrahepatic lesions, with a median reduction of 42.2% (range,
-28.1% 94.4%). The disease control rate was 91.3% and the ORR was
56.5% for patients across all DLs. In DL4, the ORR was 75.0%. With
9.03-month median follow-up, Kaplan-Meier estimation of median
overall survival (mOS) is 11.14 months (95% CI, 7.56-NE).
No dose-limiting toxicity or immune effector cell associated
neurotoxicity syndrome (ICANS) was observed. Cytokine release
syndrome (CRS) was observed in 22 (91.7%) patients with the
majority (87.5%) grade 1/2 CRS and only 1 (4.2%) grade 3
CRS.
About C-CAR031
C-CAR031 is an autologous, armored GPC3-targeting chimeric
antigen receptor T-Cell (CAR-T) therapy, being studied for the
treatment of HCC. It is based on a novel GPC3-targeting CAR-T
designed by AstraZeneca using their dominant negative transforming
growth factor-beta receptor II dominant negative (dnTGFβRII)
armoring discovery platform and is manufactured by AbelZeta in
China. C-CAR031 is being developed
in China under a co-development
agreement
between AbelZeta and AstraZeneca.1
About the Study
A Phase I clinical study (NCT05155189) aiming to assess the
safety and anti-tumor activity of C-CAR031 injection in
advanced/unresectable HCC patients is being conducted in
China. As of March 14, 2024, a total of 24 patients received
C-CAR031 infusion at 4 dose levels (DLs). 83.3% (20/24) had
extrahepatic metastasis. The median number of prior lines of
systemic therapy was 3.5 (range 1-6).
Abstract Title: "Phase I study of C-CAR031, a
GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with
advanced hepatocellular carcinoma (HCC)."
Abstract Number: 4019
Session Type and Title: Rapid Oral
Abstract – Gastrointestinal
Cancer – Gastroesophageal, Pancreatic, and
Hepatobiliary
Session Date and Time: 6/3/2024; 9:45 AM-11:15 AM CDT
About AbelZeta Pharma, Inc.
AbelZeta is a global clinical-stage biopharmaceutical company
with centers of excellence in Rockville,
Maryland and Shanghai,
China. AbelZeta is focusing on developing innovative and
proprietary cell-based therapeutic products and is committed to
ushering in bespoke treatments that harness the body's own immune
system to fight against hematological malignancies and solid
tumors, as well as inflammatory and immunological diseases.
AbelZeta advances research and development in its own GMP
facilities at its centers of excellence for early-stage clinical
studies, with a pipeline comprised of CAR-T and TIL therapies.
Forward-Looking Statements
Statements in this communication relating to plans, strategies,
specific activities, and other statements that are not descriptions
of historical facts are forward-looking statements. Forward-looking
information is inherently subject to risks and uncertainties,
and actual results could differ materially from those
currently anticipated due to a number of factors, which include any
risks detailed from time to time in the Company's reports. Such
statements are based on the management's current beliefs and
expectations and are subject to significant risks and uncertainties
outside of management and the Company's control. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
Except as otherwise required by law, the Company does not undertake
any obligation, and expressly disclaims any obligation, to update,
alter or otherwise revise any forward-looking statements, whether
written or oral, that may be made from time to time, whether as a
result of new information, future events or otherwise.
Company Contact:
Sarah
Kelly
Director of Communications
AbelZeta Pharma, Inc.
+1 (240) 552 5870
sarah.kelly@abelzeta.com
www.abelzeta.com
References
1. AbelZeta Pharma Announces Agreement with AstraZeneca to
Co-Develop a novel Glypican 3 (GPC3) Armored CAR-T Therapy in
China. December 2023.
https://www.abelzeta.com/abelzeta-pharma-announces-agreement-with-astrazeneca-to-co-develop-a-novel-glypican-3-gpc3-armored-car-t-therapy-in-china/
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