SHANGHAI and HONG KONG, July 22,
2021 /PRNewswire/ -- Antengene Corporation Limited
("Antengene", SEHK: 6996.HK), a leading innovative
biopharmaceutical company dedicated to discovering, developing and
commercializing global first-in-class and/or best-in-class
therapeutics in hematology and oncology, today announced that the
Bellberry Human Research Ethics Committee (HREC) in Australia has approved the clinical trial
application of the phase 1 trial of ATG-101 in patients with
metastatic/advanced solid tumors and B-cell non-Hodgkin's lymphoma
(B-NHL). This approval marks an important milestone for Antengene
as ATG-101 is the in-house developed innovative molecule with
global rights entering clinical stage. In addition, ATG-101 is the
first PD-L1/4-1BB bispecific antibody entering clinical stage in
Australia. This multi-center,
open-label, Phase I trial is designed to evaluate the safety and
tolerability of ATG-101 as a single agent in patients with advanced
solid tumors and NHL.
According to the World Health Organization's (WHO) estimates,
there were approximately 19.3 million diagnoses of cancer and 10
million cancer-related deaths worldwide in 2020 and most of the top
10 cancer types were solid tumors. As the most common blood cancer,
non-Hodgkin lymphoma accounted for 544,000 new cases and 260,000
deaths in 2020 globally with some of the highest incidence rates
reported in Australia and
New Zealand. Since the majority of
cancers become resistant or refractory to conventional therapies
(including hormonal treatments, chemotherapy regimens and
monoclonal antibodies), there remains enormous unmet needs in the
treatment of patients with this disease. While immuno-oncology
therapy has improved patient outcomes dramatically over the last 10
years, a growing body of evidence also has shown that bispecific
antibodies have the potential to be effective treatments for
multiple malignant cancers.
ATG-101, a novel PD-L1/4-1BB bi-specific antibody, can activate
anti-tumor immune effectors by blocking the immunosuppressive
binding of PD-L1 to PD-1 while at the same time activating 4-1BB
immunostimulatory signals, thereby enhancing safety and efficacy.
Preclinical studies showed that ATG-101 could activate 4-1BB in a
very controlled manner in human peripheral blood mononuclear cells
(PBMC). Testing in various animal models, including those resistant
to or progressing on anti-PD(L)1 treatment, has confirmed the
potent in vivo anti-tumor activity and safety of ATG-101. In
addition, in vivo testing has shown that ATG-101 can increase the
number of CD8+ T-cells and reduce regulatory T-cells (Treg), a
unique mechanism of action that enhances anti-cancer immune profile
and can potentially improve treatment outcomes.
Dr. Jay Mei, Founder, Chairman
and CEO of Antengene, said "Having gained approval for this
first-in-human trial of ATG-101 as planned marks a milestone
achievement that validates Antengene's capability in effectively
advancing preclinical programs. Exploring a novel mechanism of
action, multiple bispecific antibodies have begun entering clinical
development in recent years. Compared to monoclonal antibodies,
bispecific antibodies have the advantages of being able to target
multiple epitopes, with a lower production cost and shorter
production cycle than using a combination of conventional
monoclonal antibodies, therefore representing a novel therapeutic
approach with enormous clinical potential. We have observed that
ATG-101 has anti-tumor activities in vivo and in vitro and so we
are very enthusiastic to test this approach in the clinic. We will
advance the clinical development program and prepare to submit
Investigational New Drug (IND) applications for ATG-101 in the U.S.
and China this year."
About ATG-101
ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being
developed for the treatment of cancer. ATG-101 can activate
anti-tumor immune effectors by simultaneously blocking PD-L1/PD-1
binding and inducing 4-1BB stimulation. In the presence of PD-L1
over-expressed cancer cells, ATG-101 has shown a significant and
PD-L1 crosslinking-dependent 4-1BB agonist activity, thus enhancing
therapeutic efficacy, and mitigating hepatoxicity
simultaneously.
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a
leading clinical-stage R&D driven biopharmaceutical company
focused on innovative medicines for oncology and other
life-threatening diseases. Antengene aims to provide the most
advanced anti-cancer drugs to patients in the Asia Pacific Region
and around the world. Since its establishment in 2017, Antengene
has built a broad and expanding pipeline of clinical and
pre-clinical stage assets through partnerships as well as in-house
drug discovery and obtained 15 investigational new drug (IND)
approvals and submitted 6 new drug applications (NDA) in multiple
markets in Asia Pacific.
Antengene's vision is to "Treat Patients Beyond Borders". Antengene
is focused on and committed to addressing significant unmet medical
needs by discovering, developing and commercializing
first-in-class/best-in-class therapeutics.
Forward-looking statements
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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.
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SOURCE Antengene Corporation Limited