- Oral Presentation:a Phase II study of
ATG-008 (mTORC1/2 Inhibitor) combined with PD-1
antibody in patients with cervical cancer
- Three Poster presentations: Phase I/II studies of ATG-031 (anti-CD24
monoclonal antibody), ATG-022 (Claudin 18.2 antibody-drug
conjugate), and selinexor (XPO1 Inhibitor)
- Journal Publication: the first-in-human Phase
I dose-escalation study of ATG-017 (ERK1/2 inhibitor) in patients
with advanced solid tumors
SHANGHAI and
HONG KONG, May 23, 2024
/PRNewswire/ -- Antengene Corporation Limited
("Antengene", SEHK: 6996.HK), a leading
innovative, commercial-stage global biopharmaceutical company
dedicated to discovering, developing and commercializing
first-in-class and/or best-in-class medicines for cancer, today
announced one oral presentation, three poster presentations
and a journal publication at the 2024 American Society of Clinical
Oncology (ASCO) Annual Meeting, taking place from May 31st to June 4th at the McCormick Place
Convention Center in Chicago, IL,
the United States.
Details of the Oral Presentation:
ATG-008 (mTORC1/2 Inhibitor)
Title: A phase I/II study of the TORC1/2
inhibitor onatasertib combined with toripalimab in patients with
advanced solid tumors: Cervical cancer cohort
Abstract: 5509
Session: Clinical Science Symposium – Stronger Together:
Novel Combinations Across the Gynecologic Cancer Spectrum
Date: June 1, 2024
Time: 1:15 PM - 2:45 PM (Central
Daylight Time)
2:15 AM - 3:45 AM, June 2,
2024 (Beijing Time)
- 31 checkpoint inhibitor (CPI)-naïve cervical cancer patients
who previously had at least one systemic line of chemotherapy were
enrolled in the TORCH-2 study as of Oct
20th 2023.
- ATG-008 (Onatasertib; oral TORC1/2 inhibitor) combined with
toripalimab (anti-PD-1 antibody) showed promising anti-tumor
activity and acceptable tolerability in cervical cancer patients,
achieving an overall response rate (ORR) of 53.3% and a disease
control rate of 86.7%.
- In general, ATG-008 in combination with toripalimab are very
well tolerated. The most common grade ≥ 3 treatment-related adverse
events (TRAEs) included rash (12.9%), decreased lymphocyte count
(9.7%), and decreased platelet count (6.5%).
- Encouraging response rates and disease stabilization were
observed in patients, regardless of PD-L1 expression, with further
data being collected in an ongoing expansion cohort for CPI-treated
cervical cancer.
Details of the Poster Presentations:
ATG-031 (anti-CD24 monoclonal antibody)
Title: A first-in-human phase I study of
ATG-031, anti-CD24 antibody, in patients with advanced solid tumors
or B-cell non-Hodgkin lymphomas (PERFORM)
Abstract: TPS2691
Session: Developmental Therapeutics—Immunotherapy
Date: June 1, 2024
Time: 9:00 AM - 12:00 PM (Central
Daylight Time)
10:00
PM, June 1 - 1:00 AM,
June 2, 2024 (Beijing Time)
- ATG-031 is a first-in-class CD24 antibody that promotes cancer
cell phagocytosis and T cell activity by disrupting the
CD24-Siglec-10 interaction on macrophages, while also triggering
antibody-dependent cell-mediated cytotoxicity (ADCC) and
complement-dependent cytotoxicity (CDC).
- The Phase I PERFORM study is designed to evaluate the safety
and preliminary efficacy of ATG-031 in patients with advanced solid
tumors or B-cell non-Hodgkin's lymphoma, employing a
dose-escalation phase with a Bayesian Optimal Interval (BOIN)
design and a dose-expansion phase with two or more dose levels to
determine the recommended phase II dose (RP2D).
- As of April 2024, the study is
underway in 4 U.S. sites, and the first dose level has been
cleared.
ATG-022 (Claudin 18.2 Antibody-drug Conjugate)
Title: An open-label, multicenter, phase I study of
ATG-022 in patients with advanced/metastatic solid tumors
(CLINCH)
Abstract: 3032
Session: Developmental Therapeutics—Molecularly Targeted
Agents and Tumor Biology
Date: June 1, 2024
Time: 9:00 AM - 12:00 PM (Central
Daylight Time)
10:00 PM, June 1 - 1:00
AM, June 2, 2024 (Beijing
Time)
- ATG-022 is a Claudin 18.2 (CLDN 18.2)-targeting antibody-drug
conjugate (ADC) with sub-nM high affinity that showed promising
tumor inhibition activity in vitro and in vivo. The
CLINCH Phase I trial is assessing its safety, tolerability, and
efficacy in patients with advanced/metastatic solid tumors.
- As of October 9th,
2023, 10 patients have been enrolled, receiving doses ranging from
0.3 to 2.4 mg/kg. The most common grade ≥ 3 TRAEs included nausea,
vomiting, and decreased appetite, each occurring in 30% of
patients. No dose-limiting toxicities (DLTs) were reported.
- Preliminary efficacy data among 7 gastric cancer patients
across multiple doses in the Phase I dose escalation demonstrated
one complete response (CR) in a patient with gastric cancer (2.4
mg/kg, CLDN 18.2-negative) and one partial response (PR) in another
patient (1.8 mg/kg, CLDN 18.2 expression undetermined). ATG-022
demonstrated tolerability, safety, and potential anti-tumor
activity. A Phase II trial is currently enrolling patients with
gastric cancer and other solid tumors.
Selinexor (XPO1 Inhibitor)
Title: Selinexor combined with tislelizumab
in patients with relapsed or refractory extranodal NK/T-cell
lymphoma (R/R ENKTL): Results of dose-escalation of cohort C, from
a multicenter, single-arm, phase I/II study (TOUCH)
Abstract: 7065
Session: Hematologic Malignancies—Lymphoma and Chronic
Lymphocytic Leukemia
Date: June 3, 2024
Time: 9:00 AM - 12:00 PM (Central
Daylight Time)
10:00
PM, June 3 - 1:00 AM,
June 4, 2024 (Beijing Time)
- The Phase I/II TOUCH study is investigating selinexor combined
with different drugs in relapsed/refractory extranodal NK/T-cell
lymphoma (R/R ENKTL). Cohort C of the study aims to evaluate the
safety, tolerability and preliminary efficacy of selinexor in
combination with anti-PD-1 antibody tislelizumab.
- As of December 25th,
2023, 12 patients were enrolled, with no DLTs observed, and the
maximum tolerated dose (MTD) was not reached. The most common
adverse events included asthenia, neutropenia, and nausea/vomiting.
Grade ≥ 3 adverse events occurred in 58.3% of patients.
- The ORR was 72.7% among 11 efficacy evaluable patients,
including a CR rate of 36.4%. The combination showed a tolerable
safety profile and promising efficacy.
Details of the Journal Publication:
ATG-017 (ERK1/2 Inhibitor)
Title: Results of a first-in-human,
dose-escalation phase I study of the ERK1/2 inhibitor ATG-017 in
patients with advanced solid tumors
Abstract: e15114
Session: Publication Only: Developmental Therapeutics –
Molecularly Targeted Agents and Tumor Biology
- ATG-017, an oral and selective ERK1/2 inhibitor, was evaluated
in a Phase I study to assess safety, pharmacokinetics, and MTD in
patients with refractory advanced solid tumors.
- At the 20 mg BID level, no DLTs were observed, and
pharmacokinetic analysis revealed effective ERK inhibition at this
dose. Common treatment-emergent adverse events (TEAEs) were
consistent with previously reported toxicities with other ERK
pathway inhibitors (gastrointestinal, skin, and ocular adverse
events).
- Efficacy data showed that one patient (4.8%) achieved a PR,
while 8 patients (38%) achieved stable disease (SD).
About Antengene
Antengene Corporation Limited
("Antengene", SEHK: 6996.HK) is a leading commercial-stage
R&D-driven global biopharmaceutical company focused on the
discovery, development, manufacturing and commercialization of
innovative first-in-class/best-in-class therapeutics for the
treatment of hematologic malignancies and solid tumors, in
realizing its vision of "Treating Patients Beyond
Borders".
Since 2017, Antengene has built a pipeline of 9
oncology assets at various stages going from clinical to
commercial, including 6 with global rights, and 3 with rights for
the APAC region. To date, Antengene has obtained 29 investigational
new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications
(NDAs) in multiple Asia Pacific
markets, with the NDA for XPOVIO® (selinexor) already
approved in Mainland of China,
Taiwan China, Hong Kong China,
Macau China, South Korea,
Singapore and Australia.
Forward-looking statements
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article relate only to the events or information as of the date on
which the statements are made in this article. Except as required
by law, we undertake no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise, after the date on which the statements
are made or to reflect the occurrence of unanticipated events. You
should read this article completely and with the understanding that
our actual future results or performance may be materially
different from what we expect. In this article, statements of, or
references to, our intentions or those of any of our Directors or
our Company are made as of the date of this article. Any of these
intentions may alter in light of future development. For a further
discussion of these and other factors that could cause future
results to differ materially from any forward-looking statement,
please see the other risks and uncertainties described in the
Company's Annual Report for the year ended December 31, 2023, and the documents subsequently
submitted to the Hong Kong Stock Exchange.
For more information, please contact:
Investor Contacts:
Donald Lung
E-mail: Donald.Lung@antengene.com
Mobile: +86 18420672158
PR Contacts:
Peter Qian
E-mail: Peter.Qian@antengene.com
Mobile: +86 13062747000
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