HONG
KONG, July 29, 2024 /PRNewswire/ -- Akeso
(9926.HK) is delighted to announce that the supplemental biologics
license application (sBLA) for its independently developed, world's
first-in-class PD-1/VEGF bispecific antibody drug, 依达方®
(generic name: ivonescimab Injection), as a monotherapy for
first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally
advanced or metastatic non-small cell lung cancer (NSCLC), has been
accepted by the China National Medical Products Administration
(NMPA).
Ivonescimab is the world's first bispecific antibody drug
approved for the "tumor immunotherapy + anti-angiogenesis"
mechanism. The first-line monotherapy treatment of PD-L1 positive
(PD-L1 TPS ≥1%) locally advanced or metastatic NSCLC is
ivonescimab's second indication, following its approval for the
treatment of EGFR-mutant non-squamous NSCLC that has progressed
after EGFR-TKI therapy. Ivonescimab is also expected to become a
new standard of care treatment option for both first-line and
second-line lung cancer therapy.
This new indication application for ivonescimab is based on
the HARMONi-2 (AK112-303) study. The Independent Data Monitoring
Committee (IDMC) conducted a pre-specified interim analysis of the
HARMONi-2 study, showing highly positive results. In the
intent-to-treat (ITT) population, ivonescimab monotherapy
significantly prolonged progression-free survival (PFS) compared to
pembrolizumab monotherapy, with a hazard ratio (HR) significantly
better than expected.
"As a researcher and clinician, we eagerly anticipate
ivonescimab becoming the new standard treatment for first-line lung
cancer, providing a superior 'chemotherapy-free' option for
patients," said Professor Zhou
Caicun, principal investigator of the HARMONi-2 study and
director of the Oncology Department at East Hospital Affiliated To
Tongji University. "The success of the HARMONi-2 study underscores
the immense value of ivonescimab's synergistic dual anti-tumor
mechanism of 'tumor immunotherapy + anti-angiogenesis.'"
Professor Zhou also emphasized that clinicians are looking
forward to Akeso seizing the opportunity to establish ivonescimab
as the new standard treatment for first-line lung cancer. He
encouraged continuous exploration of combination therapies and
ongoing global upgrades to standard treatment options, aiming to
provide patients with better therapeutic choices.
Dr. Michelle Xia, Founder,
Chairwoman, President, and CEO of Akeso, said: "We are thrilled
that ivonescimab has achieved a significant milestone in first-line
lung cancer therapy shortly after its approval for second-line
treatment. We sincerely thank all our colleagues at Akeso for their
decade-long dedication and craftsmanship, the experts for their
meticulous contributions, and all the participants involved in the
projects."
According to Dr. Xia, the approval of ivonescimab for
second-line lung cancer therapy and its potential as a superior,
chemotherapy-free new standard for first-line treatment fills a
clinical unmet need in global lung cancer immunotherapy with
bispecific antibodies, providing a more effective solution for
patients and fulfilling Akeso's commitment.
Dr. Xia also emphasized that the HARMONi-2 study showcases
ivonescimab's superior efficacy and safety, further solidifying its
potential as a cornerstone product in tumor immunotherapy (IO).
This includes its broad clinical development value and market
prospects when used in combination with ADC drugs or other novel
anti-cancer drugs. "We look forward to sharing ivonescimab's robust
clinical research data with global regulatory agencies to achieve
worldwide approval and provide more effective solutions for
patients around the globe."
About Ivonescimab
Ivonescimab, known as SMT112 in Summit's license territories,
the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential
first-in-class investigational bispecific antibody combining the
effects of immunotherapy via a blockade of PD-1 with the
anti-angiogenesis effects associated with blocking VEGF into a
single molecule. Ivonescimab displays unique cooperative binding to
each of its intended targets with higher affinity when in the
presence of both PD-1 and VEGF.
This could differentiate ivonescimab as there is potentially
higher expression (presence) of both PD-1 and VEGF in tumor tissue
and the tumor microenvironment (TME) as compared to normal tissue
in the body. Ivonescimab's tetravalent structure (four binding
sites) enables higher avidity (accumulated strength of multiple
binding interactions) in the tumor microenvironment with over
18-fold increased binding affinity to PD-1 in the presence of VEGF
in vitro, and over 4-times increased binding affinity to VEGF in
the presence of PD-1 in vitro.1 This tetravalent
structure, the intentional novel design of the molecule, and
bringing these two targets into a single bispecific antibody with
cooperative binding qualities have the potential to direct
ivonescimab to the tumor tissue versus healthy tissue. The intent
of this design, together with a half-life of 6 to 7
days,1 is to improve upon previously established
efficacy thresholds, in addition to side effects and safety
profiles associated with these targets.
Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK)
and is currently engaged in multiple Phase III clinical trials.
Over 1,600 patients have been treated with ivonescimab in clinical
studies globally. Summit has begun its clinical development of
ivonescimab in non-small cell lung cancer (NSCLC), commencing
enrollment in 2023 in two Phase III clinical trials, HARMONi and
HARMONi-3.
Ivonescimab is an investigational therapy that is not approved
by any regulatory authority in Summit's license territories,
including the United States and
Europe. Ivonescimab was approved
for marketing authorization in China in May
2024.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company
committed to the research, development, manufacturing and
commercialization of the world's first or best-in-class innovative
biological medicines. Founded in 2012, the company has created a
unique integrated R&D innovation system with the comprehensive
end-to-end drug development platform (ACE Platform) and bi-specific
antibody drug development technology (Tetrabody) as the core, a
GMP-compliant manufacturing system and a commercialization system
with an advanced operation mode, and has gradually developed into a
globally competitive biopharmaceutical company focused on
innovative solutions.
With fully integrated multi-functional platform, Akeso is
internally working on a robust pipeline of over 50 innovative
assets in the fields of cancer, autoimmune disease, inflammation,
metabolic disease and other major diseases, with 19 drug candidates
in the clinical stage ,including 8 multispecific antibodies. Akeso
has successfully promoted the commercialization of three innovative
biological drugs, and marketing applications of multiple
indications are submitted for 4 new drugs. 安尼可®,
approved for marketing in August
2021, is currently the only differentiated PD-1 monoclonal
antibody that applies the IgG1 subtype with modified Fc-nulldomain.
开坦尼® (PD-1/CTLA-4 bi-specific antibody, Cadonilimab
injection) has been granted marketing approval in June 2022, making it the world's first
bi-specific antibody drug for tumor immunotherapy and the first
bi-specific antibody new drug in China.In May 2024,依达方®
(PD-1/VEGF bi-specific antibody,Ivonescimab injection) ,the
first-in-class PD-1/VEGF bi-specific antibody independently
developed by the Company, has been granted marketing approval for
the treatment of epidermal growth factor receptor ("EGFR") mutated
locally advanced or metastatic non-squamous non-small cell lung
cancer ("nsq-NSCLC") ,making it the world's first approved
PD-1/VEGF bi-specific antibody. The drug had been granted three
Breakthrough Therapy Designations for the treatment of lung cancer
by the Center for Drug Evaluation (CDE) .In December 2022, a license agreement with total
potential deal value of USD5 billion,
plus a low double-digit royalty of product net sales in the
authorized countries of the new drug, 依达方®, set a new
record in overseas licensing for the transaction amount of an
single innovative drug in China.
Through efficient and breakthrough R&D innovation, Akeso
always integrate superior global resources, develop the
first-in-class and best-in-class new drugs, provide affordable
therapeutic antibodies for patients worldwide, and continuously
create more commercial and social values so as to become a global
leading biopharmaceutical enterprise.
1 Zhong, et
al, SITC 2023
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SOURCE Akeso, Inc.