2024 Interim Result
Highlights (For the six months
ended June 30,
2024)
- Company published the efficacy and safety data of
Cohort-G of TranStar102 study for osemitamab
(TST001), plus
checkpoint inhibitor and CAPOX as the first-line treatment of
patients with locally advanced or metastatic G/GEJ cancer at ASCO
annual meeting, showing that high/medium Claudin18.2 expression is
associated with a median PFS of 12.6 months.
- Company published the safety and PK data of
TranStar101 study at the 2024 AACR annual meeting. The safety and
pharmacokinetic profile of osemitamab
(TST001) in the U.S.
patients, is consistent with the profile reported in Chinese
patients from TranStar102 study.
- Company continued the collaboration with Agilent
Technologies, Inc.
(Agilent), a world
leader in CDx development, for Claudin18.2 specific IHC CDx Assay
to support TranStar301 global Phase III pivotal trial of
osemitamab (TST001)
in combination with checkpoint inhibitor and
chemotherapy.
- For Company's lead non-oncology asset, the
anti-sclerostin antibody blosozumab
(TST002), has been
published Single Ascending Dose
(SAD) study result in
the 2024 World Congress on Osteoporosis, Osteoarthritis and
Musculoskeletal Diseases (WCO-IOF-ESCEO
Congress) in April. After a single dose
of blosozumab
(TST002) up to 1,200
mg, the average increase of lumbar spine BMD at day 85
(D85) ranged from
3.52% to 6.20% and total hip BMD from 1.30% to 2.24% across dose
cohorts. The lumbar spine BMD increase exceeded the least
significant difference level
(2.77%) and was
clinically meaningful.
- Company has completed the enrolment of patients in the
dose-escalation part for the First-in-Human
(FIH) trial of
the first-in-class anti-GREMLIN-1 antibody
TST003 and the trial is ongoing at multiple clinical centers in the
U.S. and China.
Presented one Trial in Progress
(TiP) poster of
TST003-1001 study at the 2024 American Association for Cancer
Research (AACR)
annual meeting in April.
HONG
KONG, Aug. 29, 2024 /PRNewswire/ -- A clinical
stage biopharmaceutical company – Transcenta Holding Limited
("Company"; stock code: 6628.HK) is pleased to announce the
unaudited consolidated results of the Company and its subsidiaries
(collectively, the "Group") for the six months ended June 30, 2024 (the "Reporting Period")
In the first half of 2024, the Company continued to accelerate
clinical progress across both the oncology and non-oncology
pipelines.
For company's lead oncology asset, the
Claudin18.2-targeting antibody osemitamab (TST001, A Humanized
ADCC Enhanced Claudin18.2 mAb for Solid
Tumors), reached key milestones for the treatment
of gastric or gastroesophageal junction (G/GEJ) cancer.
Company published the encouraging Phase II data of
osemitamab (TST001) in combination with checkpoint
inhibitor and standard chemotherapy as first-line treatment of
G/GEJ cancer at American Society of Clinical Oncology annual
meeting (ASCO), showing that high/medium Claudin18.2
expression is associated with a median PFS of 12.6 months. At the
same period, Company published the safety and PK data of
TranStar101 study at the 2024 AACR annual meeting. The safety and
pharmacokinetic profile of osemitamab (TST001) in the U.S.
patients, is consistent with the profile reported in Chinese
patients from TranStar102 study.
Worked with Agilent Technologies, Inc. (Agilent), a world
leader in CDx development, and developed a Claudin18.2 companion
diagnostic test that can fully support the global pivotal trial of
osemitamab (TST001). Successfully received regulatory
clearances from the U.S. Food and Drug Administration (FDA),
China Center for Drug Evaluation (CDE) and South Korea
Ministry of Food and Drug Safety (MFDS). All the achievements
validate and further support strategy for the Global Phase III
trial (TranStar301). Osemitamab (TST001) is on track to
become the first global therapy that delivers the next wave of
innovation in the first-line treatment of patients with Claudin18.2
expressing locally advanced or metastatic G/GEJ cancer.
Company also plans to explore several Claudin18.2
expressing advanced solid tumors other than G/GEJ cancer.
For lead non-oncology asset, the anti-sclerostin antibody
blosozumab (TST002, A Humanized Sclerostin mAb for
Osteoporosis), published Single Ascending
Dose (SAD) study result in the 2024 World Congress on
Osteoporosis, Osteoarthritis and Musculoskeletal
Diseases (WCO-IOF-ESCEO Congress) in April. After a single
dose of blosozumab (TST002) up to 1,200 mg, the average
increase of lumbar spine BMD at day 85 (D85) ranged from 3.52%
to 6.20% and total hip BMD from 1.30% to 2.24% across dose cohorts.
The lumbar spine BMD increase exceeded the least significant
difference level (2.77%) and was clinically meaningful.
In addition, Company has completed the enrolment of patients in
the dose-escalation part for the First-in-Human (FIH) trial of
first-in-class anti-GREMLIN-1 antibody TST003 and the trial is
ongoing at multiple clinical centers in the U.S. and China. Have presented one Trial in
Progress (TiP) poster of TST003-1001 study at the 2024
American Association for Cancer Research (AACR) annual meeting
in April.
Furthermore, progress had been made in improving the continuous
bioprocessing platform technology HiCB (Highly Intensified
Continuous Bioprocessing) and the technology was successfully
implemented in the GMP manufacturing of
osemitamab (TST001).
Research/Early Development Update:
- TST013 (An ADC Candidate Targeting a Validated
Tumor Antigen)- TST013 displayed significantly improved
anti-tumor activity relative to benchmark ADC and improved
tolerability profile which warrants further development
- TST808 (A Humanized Antibody Neutralizing One of
the Validated Key Targets Regulating B/Plasma Cell Proliferation
and Survival) - TST808 has the potential to treat
multiple autoimmune renal disorders including
IgA nephropathy. Company has obtained the lead molecules and
initiated the IND-enabling studies
Business Development Achievements:
- Company has continued the collaboration with Agilent
for the Claudin18.2 specific IHC CDx Assay to support
TranStar301 global Phase III pivotal trial of osemitamab (TST001)
in combination with checkpoint inhibitor and chemotherapy
- Company has continued the clinical trial collaboration with
BMS, and completed the enrolment with
osemitamab (TST001),checkpoint inhibitor and
chemotherapy combination in TranStar102 in China and in TranStar101 in the
U.S.
Technology Partnership & Advancement:
- Company has formed a strategic alliance with a company
specialized in siRNA drug substance synthesis, to provide CDMO
services in siRNA formulation development and F&F
- Company's in-house cell culture media ExcelPro CHO are being
evaluated for its performance against market standards for
fed-batch, intensified fed-batch and perfusion processes by several
external partners including a global leading company of media. This
is part of potential collaboration for global commercialization of
ExcelPro CHO
About Transenta Holding Limited
Transcenta is a clinical stage biopharmaceutical company with
fully integrated capabilities in antibody-based biotherapeutics
discovery, research, development and manufacturing. Transcenta has
established global footprint, with Clinical Development Centers in
Princeton, US, Beijing, Shanghai and Guangzhou in China, External Partnering Center in
Boston and Los Angeles, US, Headquarters and Discovery,
Clinical and Translational Research Center in Suzhou, Process and
Product Development Center and Manufacturing Facility in
Hangzhou. Transcenta has also
initiated the construction of the Group Headquarters and the second
high-end biopharmaceutical facility with ICB as its core technology
in Suzhou Industrial Park. Transcenta is developing fourteen
therapeutic antibody molecules for oncology and selected
non-oncology indications including bone and kidney disorders.
For more information, please browse the website of Transcenta
Holding Limited: www.transcenta.com
This Press release is published by Intelligent Joy Limited on
behalf of Transcenta Holding Limited.
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SOURCE Transcenta Holding Limited