SHANGHAI and HONG KONG, Aug. 23,
2024 /PRNewswire/ -- Antengene Corporation (6996.HK) today
announced its interim results for the period ending June 30, 2024, along with several significant
milestones achieved in recent months.
Dr. Jay Mei, Antengene's
Founder, Chairman, and CEO, stated, "In the first half of 2024,
the company has made significant progress in both R&D and
commercialization. Our four global rights assets — ATG-022 (Claudin
18.2 ADC), ATG-037 (CD73 small molecule), ATG-101 (PD-L1/4-1BB
bispecific antibody), and ATG-031 (CD24 monoclonal antibody) have
all advanced steadily as planned. Among them, ATG-022, currently in
Phase II dose expansion stage, has demonstrated efficacy not
only in gastric cancer patients with moderate-to-high Claudin 18.2
expression but also in those with low and ultra-low expression
levels. This unprecedented data reinforces our belief that
ATG-022 is poised to become a globally best-in-class molecule
targeting Claudin 18.2. While we remain focused on building a
differentiated and innovative pipeline, the company has also
established a robust self-sustaining revenue-generating capability.
XPOVIO® has achieved three significant milestones
within the past six months, including a supplementary new drug
approval (NDA) for diffuse large B-cell lymphoma (DLBCL) in the
Mainland of China, National Health
Insurance Service Approval for Reimbursement in South Korea, and NDA approvals for multiple
myeloma (MM) in Malaysia. To
date, XPOVIO® has been approved for marketing in eight
countries and regions across the Asia-Pacific markets and included in the
national health insurance of four of these markets, generating
product revenue of RMB 60.8 million
in the first half of 2024." Dr. Mei continued, "Antengene's
innovative R&D capabilities, strategic approach to drug
discovery and development, and rigorous cost-efficiency measures
ensure the company is well positioned for sustained operations and
growth in the coming years. With a cash and bank balance of
RMB 1.024 billion, we have sufficient
runway to provide strong support to the continuous growth,
development, and operations of Antengene. We look forward to
sharing more of our progress in the second half of 2024, with a key
highlight being the latest research results of ATG-037, which will
be presented in a mini oral presentation at the ESMO Annual Meeting
on September 16."
1. Global Rights Assets with Advancing Steadily at
Clinical Stage
ATG-022 (Claudin 18.2 Antibody-Drug Conjugate, ADC):
Currently at Phase II Dose Expansion Stage, Effectively Targeting
Gastric Cancer with both High and Ultra-low Claudin 18.2 (CLDN18.2)
Expression
- ATG-022 is a highly differentiated asset demonstrating activity
across a wide range of CLDN18.2 expression levels, including both
high and low/ultra-low expression level. ATG-022 has received two
Orphan Drug Designations (ODD) from the U.S. Food and Drug
Administration (FDA) for the treatment of gastric cancer and
pancreatic cancer.
- The Phase I CLINCH dose escalation study was completed earlier
this year, 2.4 mg/kg was selected as the recommended Phase II dose
(RP2D). ATG-022 has now progressed to the Phase II monotherapy
dose expansion stage.
- As of Aug 21st 2024, Data from the on-going
Phase II CLINCH dose expansion study, shows that 21 CLDN18.2
positive gastric cancer patients have been treated with ATG-022.
Among the 12 patients who at least underwent their first tumor
assessment after study treatment, 5 achieved partial response (PR),
resulting in an overall response rate (ORR) of 41.7% (including one
patient with ultra-low CLDN18.2 expression), and a disease control
rate (DCR) of 100%. The Phase II CLINCH study is currently
progressing smoothly in China and
Australia.
ATG-037 (CD73 Small Molecule Inhibitor): Demonstrated
Potential in Reversing Resistance to anti-PD-1 Therapies during
Dose Escalation
- Inhibiting CD73 is intended to stop the production of
adenosine, a key immunosuppressive molecule in the tumor
microenvironment. As a small molecule inhibitor of CD73, ATG-037
has demonstrated pre-clinically the ability to overcome the "hook
effect" that can limit efficacy and is commonly seen in anti-CD73
antibodies. Antengene entered into a global clinical collaboration
with MSD and is currently evaluating this molecule in combination
with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab),
in patients with locally advanced or metastatic solid tumors.
- ATG-037 demonstrated an excellent safety profile during the
dose escalation stage. Notably, four partial responses in patients
previously treated with a checkpoint inhibitor were observed — two
in melanoma patients and two in non-small cell lung cancer
patients. With the Phase I dose escalation now complete, the
company plans to initiate the Phase II dose-expansion of the
STAMINA study in China and
Australia in the third quarter of
2024.
ATG-101 (PD-L1/4-1BB Bispecific Antibody): Durable Responses
and Preliminary Efficacy in "Cold Tumors" Observed at Low Doses
Without Off-target Liver Toxicity
- ATG-101's differentiated approach to targeting PD-L1 resistant
cancers incorporates the conditional activation of the T-cell
co-stimulatory receptor 4-1BB. The bispecific antibody utilizes
high PD-L1 affinity and conditional 4-1BB activation, to reduce the
risk of hepatotoxicity.
- ATG-101 is currently undergoing dose-escalation studies in the
US, the Mainland of China, and
Australia. The treatment has
demonstrated excellent tolerability, with no significant liver
toxicity observed to date. Encouragingly, durable stable disease
has been observed even at low dose levels, as along with a partial
response in a patient with microsatellite stable (MSS)
colorectal cancer. The Phase I dose escalation phase is on track
for completion by the first half of 2025.
ATG-031 (Anti-CD24 Monoclonal Antibody): First-in-Class
Macrophage Activator Targeting CD24
- ATG-031 is the first-in-class humanized anti-CD24 monoclonal
antibody to enter clinical trials for cancer in the U.S.
ATG-031 works by blocking CD24-Siglec10 and enhancing
macrophage-mediated phagocytosis of cancer cells. Key study sites
of ATG-031 include four renowned cancer centers in the United States: MD Anderson Cancer Center
at the University of Texas,
University of California, San Francisco
(UCSF), University of Colorado, and
Yale Cancer Center.
- In the Phase I PERFORM study, 19 late-stage cancer patients
have been treated with early low doses in the dose escalation
segment, with no dose-limiting toxicities (DLTs) observed.
Observations include stable disease (SD), objective tumor
shrinkage, and clinical improvements among enrolled patients. The
company targets a Phase I data readout in the first half of
2025.
Promising Pre-clinical Programs:
- Antengene is committed to advancing its proprietary "2+1"
T-cell engager platform, AnTenGagerTM. T cell engagers
developed from this platform are designed to induce
disease-associated antigen (DAA)-dependent T-cell binding and
activation, delivering strong therapeutic activity while minimizing
the risk of cytokine release syndrome (CRS).
- The development of preclinical candidates, including ATG-042, a
selective PRMT5 inhibitor targeting MTAP-null tumors, and
ATG-201, a CD19 x CD3 T-cell engager, is ongoing.
2. Expanding APAC Presence with Inclusion in Multiple
National Health Insurance Programs
- In June 2024, South Korea's National Health Insurance
Service (NHIS) has approved the reimbursement of
XPOVIO®, effective from July 1,
2024. This marks the fourth Asia-Pacific market, following the Mainland of
China, Australia, and Singapore, where the company has secured
reimbursement/insurance coverage for XPOVIO®. The
company is actively working to secure health insurance inclusion
for XPOVIO® in more Asia-Pacific markets.
- In July 2024, XPOVIO® received approval for a
new indication in the Mainland of China, offering a new treatment option for
patients with DLBCL. This is the second indication approved for
XPOVIO® in the Mainland of China, following its approval for
relapsed/refractory multiple myeloma (R/R MM).
- In August 2024, XPOVIO® was officially approved
for marketing in Malaysia. To
date, XPOVIO® has received multiple new drug approvals
across eight countries and regions in the Asia-Pacific market (the Mainland of
China, Taiwan, Hong
Kong, Macau, Australia, South
Korea, Malaysia, and
Singapore). The company has also
submitted NDA for XPOVIO® in other ASEAN markets such as
Thailand and Indonesia, with approvals expected later this
year.
- Since being included in the National Reimbursement Drug List
(NRDL) in December 2023,
XPOVIO® has shown impressive revenue performance in the
first half of 2024. As of June 30,
2024, XPOVIO® sales revenue has reached
RMB 60.8 million.
3. Strong Cash and Bank Balance to Support Strategic
Objectives
As of June 30, 2024, the company
held RMB 1.024 billion in cash and
bank balance. The steady growth in revenue, strong cash and bank
balance coupled with careful spending, will provide strong support
to the continuous growth, development, and operations of
Antengene.
For more details on the 2024 interim financial results, please
refer to the full announcement available in the "Investor
Relations" section of the company's official website.
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, Malaysia and Australia.
Forward-looking statements
The forward-looking
statements made in this 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/antengene-announces-2024-interim-financial-results-highlights-progress-in-rd-and-commercialization-302229260.html
SOURCE Antengene Corporation Limited