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Last update 14 Apr 2025

Osemitamab

Last update 14 Apr 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Claudin18.2 (CLDN18.2) humanized monoclonal antibody(MabSpace Biosciences (Suzhou) Co., Ltd.), Claudin18.2 monoclonal antibody, Claudin18.2 monoclonal antibody(Mabspace Biosciences)

+ [5]

Target

CLDN18.2

Action

inhibitors

Mechanism

CLDN18.2 inhibitors(Claudin 18.2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects

Therapeutic Areas

NeoplasmsDigestive System DisordersOther Diseases+ [2]

Active Indication

CLDN18.2 positive Gastroesophageal junction adenocarcinomaCLDN18.2 positive stomach adenocarcinomaGastroesophageal junction adenocarcinoma+ [15]

Inactive Indication-

Originator Organization

Suzhou Transcenta Therapeutics Co., Ltd.

Active Organization

Transcenta Therapeutics Co., Limited

Suzhou Transcenta Therapeutics Co., Ltd.

Transcenta Holding Ltd.

+ [2]

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (United States)

Structure/Sequence

Sequence Code 631397381H

Source: *****

Sequence Code 631397382L

Source: *****

Clinical Trials associated with Osemitamab

NCT06093425

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating Combination of TST001, Nivolumab and Chemotherapy as First-Line Treatment in Subjects With Claudin18.2 Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (Gastric/GEJ) Adenocarcinoma

Gastric/GEJ adenocarcinomas are aggressive tumors with a high probability of death. Current treatment guidelines include two-drug cytotoxic chemotherapy with a fluoropyrimidine (mFOLFOX6: capecitabine or fluorouracil) and a platinum-based agent (CapOx: oxaliplatin or cisplatin). In addition, the FDA has recently approved nivolumab, a PD-1 checkpoint inhibitor, in combination with chemotherapy as first line treatment for advanced or metastatic gastric/GEJ cancer. TST001 is a recombinant humanized monoclonal antibody against Claudin (a tumor marker found in gastric/GEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and nivolumab with and without TST001 (a novel recombinant humanized antibody) could provide additional benefits to the management of these tumors.

Start Date31 Oct 2023

Sponsor / Collaborator

Suzhou Transcenta Therapeutics Co., Ltd.

NCT05608785

/ Unknown statusPhase 1/2IIT

Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes

Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.
Evaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.
RECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).
Per-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.
Safety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.
Statistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.
Safety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.
Treatment protocol:
All subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.
Group 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.
Principal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital

Start Date01 Jan 2023

Sponsor / Collaborator

Henan Cancer Hospital

NCT05190575

/ CompletedPhase 2IIT

An Open-label, Single-arm Phase II Study to Evaluate the Efficacy and Safety of TST001 for Patients With CLDN18.2 Positive Previously Treated Unresectable Advanced or Metastatic Biliary Tract Cancer

TST001 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open-label, single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN18.2 positive previously treated unresectable advanced or metastatic Biliary Tract Cancer.

Start Date14 Jan 2022

Sponsor / Collaborator

Zhongshan Hospital Fudan University

100 Clinical Results associated with Osemitamab

100 Translational Medicine associated with Osemitamab

100 Patents (Medical) associated with Osemitamab

Literatures (Medical) associated with Osemitamab

01 Feb 2025·Journal of Gastrointestinal Oncology

Expression of Claudin18.2 in metastatic lesions in peritoneum of gastric cancer

Article

Author: Sata, Naohiro ; Hosoya, Yoshinori ; Matsumoto, Shiro ; Saito, Shin ; Ohzawa, Hideyuki ; Miyato, Hideyo ; Kawashima, Rie ; Yamaguchi, Hironori ; Saito, Akira ; Kitayama, Joji ; Kurashina, Kentaro

Background:

Patients with advanced gastric cancer (GC) with peritoneal involvement have a dismal prognosis. Recent clinical trials have shown that anti-Claudin18.2 (CLDN18.2) antibody (zolbetuximab) enhances survival in patients with GC expressing high levels of CLDN18.2. However, the effectiveness of the zolbetuximab in patients with peritoneal metastases (PMs) remains unclear. In this study, we aimed to evaluate the expression of CLDN18.2 in disseminated lesions to assess the clinical utility of zolbetuximab in the treatment of GC with PM.

Methods:

In 42 patients diagnosed with stage IV GC with PM, biopsy samples from the primary tumors and peritoneal metastatic nodules were collected and immunostained using the specific antibody (43-14A, Ventana). The expression of CLDN18.2 was comparatively evaluated based on staining intensity and the proportion of positive cells.

Results:

Positive immunoreactivity of CLDN18.2 was observed in 37 (88%) of the primary tumors. Specifically, CLDN18.2 positivity was identified in 26 (62%) or 12 (29%) patients based on moderate to strong membrane staining in at least 40% or 75% of tumor cells, respectively. In comparison, the staining intensity in tumor cells was consistently reduced in PM across all patients. CLDN18.2 expression was absent in PM of 29 (69%) patients, while 3 (7.1%) cases were determined to be CLDN18.2-positive based on a cutoff value of 40% for high staining. This trend was particularly pronounced in cases with undifferentiated type and human epidermal growth factor receptor 2 (HER-2) negative primary tumors.

Conclusions:

Although CLDN18.2 expression in PM mirrored that in primary lesions, the levels were generally reduced. When zolbetuximab is used for GC patients with peritoneal involvement, it is preferable to assess the expression of CLDN18.2 in the disseminated lesions.

01 Aug 2024·DRUGS

Zolbetuximab: First Approval

Review

Author: Keam, Susan J

Zolbetuximab (VYLOY™), a recombinant, chimeric, anti-claudin 18.2 (CLDN18.2) monoclonal antibody (mAb), is being developed by Astellas Pharma Inc. for the treatment of patients with HER2-negative (HER2^-), CLDN18.2-positive (CLDN18.2⁺) advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma and CLDN18.2⁺ advanced pancreatic adenocarcinoma. In March 2024, zolbetuximab was approved in Japan for the treatment of patients with HER2^-, CLDN18.2⁺ unresectable, advanced/recurrent gastric cancer (the gastric cancer indication includes GEJ cancer). Zolbetuximab is also undergoing regulatory review for HER2^-, CLDN18.2⁺ advanced gastric or GEJ adenocarcinoma in the USA, the EU, China, Australia and several other countries. This article summarizes the milestones in the development of zolbetuximab leading to this first approval for the treatment of patients with CLDN18.2⁺ gastrointestinal malignancies.

01 Apr 2024·European Journal of Nuclear Medicine and Molecular Imaging

[177Lu]Lu-labeled anti-claudin-18.2 antibody demonstrated radioimmunotherapy potential in gastric cancer mouse xenograft models

Article

Author: Li, Hongjun ; Tao, Jinping ; Zhu, Hua ; Qian, Xueming ; Li, Liqiang ; Liu, Jiayue ; Yang, Zhi ; Zeng, Ziqing

PURPOSE:

Gastric cancer (GC), one of the most prevalent and deadliest tumors worldwide, is often diagnosed at an advanced stage with limited treatment options and poor prognosis. The development of a CLDN18.2-targeted radioimmunotherapy probe is a potential treatment option for GC.

METHODS:

The CLDN18.2 antibody TST001 (provided by Transcenta) was conjugated with DOTA and radiolabeled with the radioactive nuclide ¹⁷⁷Lu. The specificity and targeting ability were evaluated by cell uptake, imaging and biodistribution experiments. In BGC823^CLDN18.2/AGS^CLDN18.2 mouse models, the efficacy of [¹⁷⁷Lu]Lu-TST001 against CLDN18.2-expressing tumors was demonstrated, and toxicity was evaluated by H&E staining and blood sample testing.

RESULTS:

[¹⁷⁷Lu]Lu-TST001 was labeled with an 99.17%±0.32 radiochemical purity, an 18.50 ± 1.27 MBq/nmol specific activity and a stability of ≥ 94% after 7 days. It exhibited specific and high tumor uptake in CLDN18.2-positive xenografts of GC mouse models. Survival studies in BGC823^CLDN18.2 and AGS^CLDN18.2 tumor-bearing mouse models indicated that a low dose of 5.55 MBq and a high dose of 11.10 MBq [¹⁷⁷Lu]Lu-TST001 significantly inhibited tumor growth compared to the saline control group, with the 11.1 MBq group showing better therapeutic efficacy. Histological staining with hematoxylin and eosin (H&E) and Ki67 immunohistochemistry of residual tissues confirmed tumor tissue destruction and reduced tumor cell proliferation following treatment. H&E showed that there was no significant short-term toxicity observed in the heart, spleen, stomach or other important organs when treated with a high dose of [¹⁷⁷Lu]Lu-TST001, and no apparent hematotoxicity or liver toxicity was observed.

CONCLUSION:

In preclinical studies, [¹⁷⁷Lu]Lu-TST001 demonstrated significant antitumor efficacy with acceptable toxicity. It exhibits strong potential for clinical translation, providing a new promising treatment option for CLDN18.2-overexpressing tumors, including GC.

News (Medical) associated with Osemitamab

19 Sep 2024

·www.prnewswire.com

Transcenta Updates Encouraging Efficacy Data from First-line Triple Combo Trial of Osemitamab (TST001) for G/GEJ Cancer at ESMO 2024

Updated results with longer follow-up reveal confirmed ORR of 68% and median PFS of 14.2 months in patients with CLDN18.2 high or medium expression, known PD-L1 CPS (n=66). PRINCETON, N.J. and SUZHOU, China, Sept. 18, 2024 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a global clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, today announced the updated results from the cohort-G data for Osemitamab (TST001) plus Nivolumab and CAPOX as the first-line treatment for the patients with advanced G/GEJ cancer (TranStar102). The updated data continues to show encouraging efficacy from previously disclosed data at ASCO 2024. The results showed that in patients with known CLDN18.2 and PD-L1 status, the median progression-free survival (mPFS) reached 14.2 months for those with H/M CLDN18.2 expression, with a confirmed objective response rate of 68%. The vast majority of these patients are PD-L1 CPS<5. Using the group of patients with very low or no CLDN18.2 expression as surrogate control, the HR for the triple combination is 0.505 (95% CI, 0.244-1.045) in favor of the CLDN18.2 H/M, any CPS expressers. The data corroborates the synergistic mechanism of action between CLDN18.2 targeting agent and checkpoint inhibitors reported by Transcenta last year at ESMO which showed that CLDN18.2 targeting antibody can induce PD-L1 expression in gastric cancer tumor cells (even in those with PD-L1 low or null expression) and T-cell infiltration. As of the cutoff date, the median OS was not reached because of the limited number of events, the 12-month survival rate for the overall population (82 patients) in this cohort was 73.8% (95% CI: 62.0- 82.4%). Previous studies have found that the combination of Zolbetuximab+CAPOX in CLDN18.2 positive patients, regardless of the PD-L1 status, leads to an improvement in PFS from 6.80 to 8.21 months (HR = 0.687 (95% CI, 0.544-0.866) (Source: Shah, Manish A et al. Nature Medicine 2023 Aug 29 (8): 2133-2141). This updated Cohort-G data shows that the efficacy from the triple combo therapy of Osemitamab (TST001) plus Nivolumab and CAPOX compares very favorably with the historical data of Nivolumab plus CAPOX combination or Zolbetuximab plus CAPOX combination. The updated data has been featured as a poster presentation (Abstract #1419p) on September 16, 2024 at the ESMO Congress 2024 in Barcelona, Spain. "The updated data from the Cohort-G trial of Osemitamab (TST001) in combination with Nivolumab and CAPOX as first-line treatment for advanced G/GEJ cancer are highly encouraging. The confirmed objective response rate and median progression-free survival in patients with high/medium CLDN18.2 expression, known PD-L1, as compared to patients with no CLDN18.2 expression, confirm the synergy between Osemitamab (TST001) and Checkpoint inhibitors and demonstrates the potential of this triple combination therapy, potentially including in low PD-L1 expressers," said Dr. Caroline Germa, Executive Vice President, Global Medicine Development and Chief Medical Officer at Transcenta, "These results highlight the promise of Osemitamab (TST001) in improving outcomes for patients with advanced G/GEJ cancer." "The Cohort-G data presented at ESMO 2024 provide compelling evidence of the clinical benefit of the triple combination therapy. The significant improvement in progression-free survival and objective response rate, particularly in patients with high/medium CLDN18.2 expression and low PD-L1 CPS, is a testament to the potential of this therapeutic approach," said Professor Lin Shen, Director, department of Gastrointestinal Oncology and Phase I Clinical Trial Center at Peking University Cancer Hospital; and Principal Investigator of the trial, "We are excited about the potential benefits this treatment could bring to our patients." A brief summary of the study is as follows: Study Design Cohort G from Transtar102 study (NCT04495296) was designed to explore the safety and efficacy of Osemitamab (TST001) plus Nivolumab and CAPOX as first-line treatment for advanced G/GEJ cancer, with a safety lead-in and expansion phase. Patients were alternately allocated to 3 or 6mg/ kg at expansion phase. Eligible patients include HER2 negative or unknown, unresectable locally advanced or metastatic G/GEJ cancer, regardless of CLDN18.2 or PD-L1 expression. CLDN18.2 and PD-L1 status were analyzed retrospectively using IHC 14G11 LDT assay and PD-L1 IHC 28-8 pharmDx at a central laboratory. The CLDN18.2 expression was divided into three subgroups: H/ M (high/medium), L (low) and R (rest: lower or negative) according to the tumor cells showing membranous CLDN18.2 staining per CLDN18.2 IHC 14G11 LDT assay. Encouraging ORR and mPFS As of the cut-off date, 82 patients had been dosed with a median follow-up of 15.2 months. The exploratory analysis of the subgroup efficacy of patients in overall, overall with/known CLDN18.2/ PD-L1, and in the subgroup with PD-L1 CPS<5 is as follows: Overall patients group: The mPFS is 12.6 months in patients with high or medium expression (H/M), 7.1 months in patients with low expression (L) and 8.5 months in the rest patients (R). Confirmed ORR was 58.1%, 52.4% and 55.6% respectively. 12 months survival rate for the overall population (n=82) is 73.8%. Overall patients with known CLDN18.2/PD-L1 (n=66): The mPFS is 14.2 months in the patients with high or medium expression (H/M), 8.5 months in patients with low expression (L) and 6.7 months in the rest patients (R). Confirmed ORR was 68.0%, 61.1% and 50.0% respectively. Subgroup with PD-L1 CPS<5 (n=56): The mPFS is 16.6 months in the patients with high or medium expression (H/M), 7.1 months in patients with low expression (L) and 5.7 months in the rest patients (R). Confirmed ORR was 71.4%, 60.0% and 47.1% respectively. Manageable Safety Profile All patients experienced treatment-related adverse events (TRAE). The most common TRAEs were hypoalbuminaemia, nausea and vomiting, most of them were of CTC AE grade 1 or 2 and manageable. The safety profile was similar to TST001 in combination with CAPOX which was presented previously (J Clin Oncol 41, 2023, suppl 16; abstr 4046). About Osemitamab (TST001) Osemitamab (TST001) is a high affinity humanized anti-CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC"). It has shown potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) was generated using Transcenta's Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (TranStar101/NCT04396821, TranStar102/NCT04495296). Osemitamab (TST001) has been granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic cancer. About Transcenta Transcenta (HKEX: 06628) 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 Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Princeton, US and in Beijing, Shanghai and Guangzhou of China, and External Partnering Center in Boston and Los Angeles, US. Transcenta is developing 14 therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders. CONTACT: Bryan Cheng, [email protected], 15067129733 SOURCE Transcenta Holding Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 1Orphan DrugADCImmunotherapy

29 Aug 2024

·www.prnewswire.com

Transcenta Holding Limited (Stock Code: 6628.HK) Announce 2024 Interim Results

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: This Press release is published by Intelligent Joy Limited on behalf of Transcenta Holding Limited. SOURCE Transcenta Holding Limited

Phase 3Clinical ResultASCOPhase 1Phase 2

11 Jun 2024

·www.echemi.com

The Treatment of Gastric Cancer Has Witnessed A Remarkable New Breakthrough

Recent advances in gastric cancer treatment, despite the increasing number of treatment options for advanced gastric cancer, have not yet led to significant improvements in overall survival rates. In the field, there are still many unsolved problems, with the issue of the sequence of using CLDN18.2 monoclonal antibody and immunotherapy in CLDN18.2-positive patients being particularly prominent. However, in the era of rapid development in the field of tumor treatment, these problems will eventually be overcome. At this year's ASCO conference, Creative Biolabs announced the clinical data of TST001 triple therapy, which may indicate that the dawn of solving this problem is approaching. According to the data, TST001 triple therapy shows significant potential to improve clinical benefits compared with chemotherapy monotherapy or chemotherapy plus inhibitors. Specifically, in patients with high or moderate CLDN18.2 expression, regardless of PD-L1 expression, the median progression-free survival (PFS) after TST001 triple therapy was 12.6 months, far exceeding the average level of existing treatment regimens. From the perspective of reducing the risk of disease progression or death, the triple therapy also shows more significant advantages. Moreover, the study found that TST001 treatment could upregulate PD-L1 expression and produce synergistic effects with immune checkpoint inhibitors. This means that regardless of PD-L1 expression level, the triple therapy is expected to bring better clinical benefits to patients. In summary, the clinical data of TST001 triple therapy provides a new option for the treatment of CLDN18.2-positive gastric cancer patients, not only with the potential to surpass the efficacy of existing treatment regimens, but also to address the key challenges in the field. This important breakthrough marks a solid step forward in the field of gastric cancer treatment and brings new hope for patients.

ImmunotherapyClinical Study

100 Deals associated with Osemitamab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
CLDN18.2 positive Gastroesophageal junction adenocarcinoma	Phase 3	-	Suzhou Transcenta Therapeutics Co., Ltd.	31 Oct 2023
CLDN18.2 positive stomach adenocarcinoma	Phase 3	-	Suzhou Transcenta Therapeutics Co., Ltd.	31 Oct 2023
Gastroesophageal junction adenocarcinoma	Phase 3	China	Suzhou Transcenta Therapeutics Co., Ltd.	01 Sep 2023
Gastroesophageal junction adenocarcinoma	Phase 3	South Korea	Suzhou Transcenta Therapeutics Co., Ltd.	01 Sep 2023
Bile Duct Neoplasms	Phase 2	China	Transcenta Therapeutics Co., Limited	28 Feb 2022
Advanced Bile Duct Carcinoma	Phase 2	China	Zhongshan Hospital Fudan University	14 Jan 2022
Metastatic Biliary Tract Carcinoma	Phase 2	China	Suzhou Transcenta Therapeutics Co., Ltd.	13 Aug 2020
Metastatic Solid Tumor	Phase 2	China	Suzhou Transcenta Therapeutics Co., Ltd.	13 Aug 2020
Pancreatic Ductal Adenocarcinoma	Phase 2	China	Suzhou Transcenta Therapeutics Co., Ltd.	13 Aug 2020
stomach adenocarcinoma	Phase 2	China	Suzhou Transcenta Therapeutics Co., Ltd.	13 Aug 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04495296 (TranStar102, ESMO2024) Manual	Phase 1/2	Advanced gastric carcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma First line CLDN18.2 \| PD-L1	32	Osemitamab 3mnivolumabvolumab + CAPOX	ngkzirlkxn(wbpjbpumsv) = All patients experienced treatment-related adverse events (TRAE). The most common TRAE were hypoalbuminaemia, nausea and vomiting, most of them were of CTC AE grade 1 or 2 and manageable. prkvwtanfx (mreojvdsxu ) View more	Positive	16 Sep 2024
				Osemitamab 6mnivolumabvolumab + CAPOX
NCT04495296 (TranStar102, ASCO2024) Manual	Phase 1/2	Gastrooesophageal junction cancer HER2 Negative	82	TST001	cafgyxdwvk(dlcpfgupbs) = shkafobutd ylhbopwazs (vmbpubxjfi ) View more	Positive	24 May 2024
NCT04495296 (Transtar102, ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	CLDN18.2 positive Gastroesophageal junction adenocarcinoma \| CLDN18.2 positive Stomach Cancer First line CLDN18.2 positive	64	TST001+capecitabine +oxaliplatin	zbaqplimcf(duzmwpzdes) = nausea (70.3%), vomiting (53.1%) and hypoalbuminemia (75%) with grade 3 being 1.6% each asjwzgdakh (vlunivxzan )	Positive	23 Oct 2023
				TST001+capecitabine +oxaliplatin (6 mg/kg in the dose expansion phase)
NCT04396821 \| NCT04495296 (Transtar102, ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	Solid tumor CLDN18.2 Positive	248	osemitamab	hivetbisyx(rnbxcdvval) = Model simulated steady state trough concentration will achieve in vitro ADCC assay EC95 and in vivo MKN45-CLDN18.2 tumor growth inhibition model EC50 in most subjects following 6mg/kg Q3W and 4mg/kg Q2W. pzxxingoth (bkecornfww ) View more	Positive	23 Oct 2023
NCT04495296 (TST001-1002 \| TranStar102, ESMO_GI2023) Manual	Phase 1/2	Advanced cancer First line CLDN 18.2 Positive	64	osemitamab+CAPOX	crbmbfiayj(iizedipgdl) = Most of them were grade 1 or 2, only one patient experienced grade 3 nausea and vomiting. glkjnbjdye (uoygsnmwle )	Positive	30 Jun 2023
NCT04495296 (TST001-1002, ASCO 12023 \| ASCO 22023) Manual	Phase 1	Advanced cancer First line	64	Osemitamab+CAPOX	izdfnrydkr(rdilbffwbv) = Nausea (65.4%), vomiting (46.2%) and hypoalbuminemia (65.4%) were the most common adverse events related to TST001 at dose of 6mg/kg in 52 patients (3 patients in dose escalation and 49 patients in dose expansion), most of them were grade 1 or 2 (only one patient experienced grade 3 nausea and vomiting, and one experienced grade 3 hypoalbuminemia). nbtmpxnozw (gutbkxycpk )	Positive	26 May 2023
				Osemitamab+CAPOX
NCT04495296 (Corporate Publications) Manual	Phase 1	Gastrooesophageal junction cancer First line	26	CAPOX+TST001	agjzigqhgj(zswbabybll) = Most are grade 1-2, including nausea, hypoalbuminemia, anemia, vomiting, and elevated AST fcvwviqeor (cdhompnrqw )	Positive	02 Jun 2022

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