HONG
KONG, Aug. 6, 2024 /PRNewswire/ -- Akeso has
announced the completion of the first patient enrollment in the US
for the phase II clinical trial of its innovative CD47 monoclonal
antibody, ligufalimab (AK117), in combination with azacitidine for
patients with newly diagnosed higher-risk myelodysplastic syndrome
(HR-MDS).
Preliminary studies show that combining AK117 with azacitidine
for treating MDS is safe and significantly effective. In response
to the urgent need for new therapies among global MDS patients and
the evolving market landscape, Akeso has launched an international
multicenter Phase II clinical trial. This initiative aims to
expedite AK117's global approval and commercialization process.
CD47-targeted drug development for treating MDS shows promising
potential. AK117, a next-generation humanized IgG4 anti-CD47
antibody, effectively blocks the CD47-SIRPα interaction to enhance
phagocytic activity against tumor cells by phagocytes.
Recent data presented at the 65th American Society of Hematology
(ASH) Annual Meeting demonstrated that AK117 combined with
azacitidine significantly reduces anemia and transfusion
requirements in MDS patients, with favorable safety and notable
efficacy. This positions AK117 as a promising treatment option for
MDS patients worldwide.
In the United States alone,
approximately 40,000 new cases of MDS are diagnosed annually.
High-risk MDS patients typically start with azacitidine as standard
therapy, but only 20% to 30% achieve complete remission,
underscoring significant unmet clinical needs in global MDS
treatment.
In addition to ongoing clinical trials for MDS globally, a Phase
II study is underway to evaluate AK117 in combination with
venetoclax and AZA as frontline therapy for AML patients who are
not eligible for intensive chemotherapy.
Akeso is also actively progressing the global market development
of AK117 for solid tumors. Multiple clinical trials exploring
AK117's efficacy with other agents, such as PD-1/VEGF bispecific
antibodies and PD-1/CTLA-4 bispecific antibodies, are enrolling
participants efficiently.
About Ligufalimab (AK117)
AK117, independently
developed by Akeso, is a next-generation humanized lgG4 anti-CD47
antibody without hemagglutination effect. AK117 can bind to CD47
expressed on tumor cells and block the interaction between CD47 and
SIRPα, to enhance the phagocytic activity of phagocytes on tumor
cells, thereby inhibiting the growth of tumors.
Currently, several phase II clinical trials are underway to
investigate the potential of AK117 in combination with azacitidine
for hematological tumors, as well as AK117 alone or in combination
with ivonescimab and cadonilimab for various solid tumors.
Preliminary studies have shown promising efficacy and safety
profiles, with no observed dose-limiting toxicity events.
Additionally, international multicenter clinical studies evaluating
AK117 for treating MDS and AML are enrolling patients.
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) was
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, was 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 a single innovative drug in
China.
Through efficient and breakthrough R&D innovation, Akeso
always integrates superior global resources, develops the
first-in-class and best-in-class new drugs, provides affordable
therapeutic antibodies for patients worldwide, and continuously
creates more commercial and social values to become a global
leading biopharmaceutical enterprise.
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SOURCE Akeso, Inc.