NANJING, China, May 13, 2024
/PRNewswire/ -- The 2024 American Society of Clinical Oncology
(ASCO) Annual Meeting will be held in Chicago from May
31 to June 4, 2024. As the largest and most
academically prestigious international oncology conference in the
world, the ASCO Annual Meeting gathers the latest and most
cutting-edge research findings in the field of oncology. Leads
Biolabs will present the exciting clinical data on its four
innovative clinical programs at the ASCO meeting. These
presentations will include one oral presentation, two posters, and
one online publication, showcasing advancements in various cancer
indications such as nasopharyngeal cancer (NPC), extrapulmonary
neuroendocrine carcinoma (EP-NEC), hepatocellular carcinoma (HCC),
and renal cell carcinoma (RCC).
Oral Presentation:A novel and uniquely designed
bispecific antibody (LBL-024) against PD-L1 and 4-1BB in patients
with advanced malignant tumors and neuroendocrine carcinoma: A
report of safety and robust efficacy of LBL-024 monotherapy in
phase Ⅰ/Ⅱ first in human, open-label, multicenter, dose
escalation/expansion Study
Date and
Time:2024.06.02 4:30 PM-6:00
PM CDT
Abstract Number:4010
LBL-024, a bispecific antibody composed of an anti-Programmed
Cell Death Ligand-1 (PD-L1) and an anti-4-1BB (CD137) antibody.
LBL-024 blocks the immunosuppressive pathway of tumor cells by
targeting PD-L1 and effectively localizes 4-1BB co-stimulation to
the tumor microenvironment, to improve the anti-tumor immune
response.
LBL-024 received IND approvals from FDA and NMPA on July 30, 2021 and September 9, 2021 respectively to conduct phase
Ⅰ/Ⅱ clinical research. Subsequently, the therapy has achieved
outstanding results. On April 30,
2024, it received approval from China's Center for Drug Evaluation (CDE) of
the National Medical Products Administration (NMPA) to conduct a
single-arm pivotal study for registration and market authorization.
According to the results in the oral presentation, LBL-024
demonstrated good safety profile and very promising antitumor
effects in patients with advanced malignant tumors, particularly
extrapulmonary neuroendocrine carcinomas (EP-NEC) patients who
failed at least one line of chemotherapy. Notably, the efficacy
observed in EP-NEC surpassed historic reports with immunotherapy
and chemotherapy. The extremely robust efficacy and good safety
profiles support the advancement to a pivotal study to accelerate
the development of LBL-024 in EP-NEC, a deadly disease of high
unmet medical need.
Poster:Anti-LAG-3 antibody LBL-007 in
combination with anti-PD-1 antibody Tislelizumab with or without
chemotherapy, in patients with advanced nasopharyngeal cancer and
other malignant tumors A phase Ⅰb/Ⅱ dose escalation/expansion
Study
Date and Time:2024.06.02 9:00 AM-12:00 PM CDT
Abstract
Number:6033
LBL-007 is a fully humanized monoclonal antibody against
Lymphocyte Activation Gene-3 (LAG-3). By specifically binding to
human LAG-3, it relieves the inhibitory effect of LAG-3 on T cells,
restores the immune function, and inhibits tumor growth.
Dual inhibition of programmed cell death receptor-1 (PD-1) and
LAG-3 is expected to synergistically increase immune response
against tumor growth while chemotherapy can enhance the efficacy of
immunotherapy through various mechanisms. This phase Ⅰb/Ⅱ study
indicates that the combination of LBL-007 and tislelizumab is
well-tolerated in patients with advanced malignant tumors.
Additionally, the combination of LBL-007, tislelizumab, and
gemcitabine and cisplatin had demonstrated a good safety profile
and robust antitumor activity in previously untreated and advanced
NPC patients. These promising clinical data support a pivotal study
to evaluate the combination of LBL-007, tislelizumab, and
gemcitabine and cisplatin for the treatment of NPC.
Poster:Anti-PD-1/TGF-βRII Bispecific Antibody Fusion
Protein LBL-015 in patients with advanced malignant
tumors:A phase Ⅰ, first-in-human, open-label,
multicenter, dose-escalation Study
Date and
Time:2024.06.01 9:00 AM-12:00
PM CDT
Abstract Number:2592
LBL-015 is a bifunctional antibody fusion protein targeting PD-1
and Transforming Growth Factor Beta Receptor 2 (TGF-βR2). LBL-015
blocks both PD-1/PD-L1 and TGF-β/TGF-βR2 signaling pathways to
reverse immunosuppression and boost immune responses. In addition,
LBL-015 can boost immune cell response and inhibit tumor metastasis
by blocking TGF-β in the tumor microenvironment. In a Phase 1
clinical study, LBL-015 has demonstrated a good safety profile and
encouraging preliminary efficacy signals in patients with advanced
solid tumors.
Online Publication:Anti-TNFR2 monoclonal
antibody LBL-019 in patients with advanced malignant tumors: A
phase Ⅰ, first-in-human, open-label, multicenter, dose escalation
Study
Date and Time:2024.05.23 5:00 PM EDT
Abstract
Number:e14580
LBL-019 is a humanized IgG1 monoclonal antibody against Tumor
Necrosis Factor Receptor 2 (TNFR2). LBL-019 binds specifically to
TNFR2 with high affinity and co-stimulates TNFR2 in an Fc
crosslinking-dependent manner. This leads to the activation of
NF-κB signaling, T cell activation and expansion, thereby promoting
antitumor immunity. The data from the Phase 1 study indicate that
LBL-019 is well tolerable and has demonstrated preliminary efficacy
in patients with advanced malignant tumors.
Dr. Charles Cai, Chief Medical
Officer of Leads Biolabs, said "Leads Biolabs will be presenting
four clinical projects at 2024 ASCO. Among them, the efficacy of
LBL-024 is significantly higher than the historic reports with
immunotherapy and chemotherapy, providing tremendous support for
the approval and accelerated development of our pivotal study. The
encouraging efficacy and safety profile of LBL-007 is impressive,
which is conducive to advancing the pivotal study of LBL-007 in
combination with tislelizumab, gemcitabine and cisplatin for NPC.
We have adopted a differentiated, innovative, and efficient
clinical development strategy, aiming to bring more effective
therapies to market sooner. This is a manifestation of Leads
Biolabs' unwavering commitment to addressing patient needs and
delivering clinical value, aligning with the company's mission of
'care for life'."
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SOURCE Leads Biolabs