osemitamab (TST001) / Transcenta - LARVOL DELTA

CLDN18.2 targeting enhances chemotherapy sensitivity in pancreatic cancer cells and lung cancer organoids. (PubMed, Biochem Biophys Res Commun) - "In DAN-G cells, two independent CLDN18.2 siRNAs increased sensitivity to 5-fluorouracil. TST001 enhanced cisplatin-induced cytotoxicity in lung cancer patient-derived organoids...TST001 and IMAB362 reduced SLC7A11 mRNA, and TST001 increased RSL3 sensitivity in KATO III and NUGC4 cells...These findings support CLDN18.2 targeting as an approach to chemotherapy sensitization in the models tested. Reduced SLC7A11 expression and altered lipid-peroxidation responses are possible contributors, but their causal involvement in chemotherapy sensitization remains to be established."

Journal • Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18 • SLC7A11

Characterization of osemitamab in pancreatic cancer models and patients (AACR 2026) - P1/2 | "Promising efficacy of TST001 monotherapy in late line G/GEJ cancer patients or plus CAPOX with or without nivolumab as first-line treatment has been observed and reported. TST001 displayed significant anti-tumor activity in preclinical pancreatic cancer models and higher efficacy when combined with gemcitabine or TST003. A pretreated pancreatic cancer patient achieved complete response with TST001 monotherapy. These findings support further investigation of TST001 in CLND18.2 positive pancreatic cancer patients."

Clinical • Preclinical • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • KRAS • TGFB1

A Phase I/IIa clinical trial (TranStar101) to evaluate the safety, tolerability and pharmacokinetics of OSEMITAMAB administered as monotherapy or in combination with nivolumab or standard of care in patients with locally advanced or metastatic solid tumors (AACR 2024) - P1/2 | "Cohort A includes combination of osemitamab, nivolumab, and mFOLFOX6 as the 1st line treatment for G/GEJ cancer... Osemitamab as monotherapy or in combination with nivolumab or mFOLFOX plus nivolumab is well tolerated and safe with a PK profile consistent with other studies (TranStar 102 study -NCT04495296). TranStar 101 is currently ongoing. More information will be shared."

Clinical • Combination therapy • First-in-human • Metastases • Monotherapy • P1/2 data • PK/PD data • Oncology • Solid Tumor • CLDN18

ESP2E- Novel technologies for precision medicine: Agilent Avida targeted sequencing and Claudin 18.2 IHC assay for Transcenta Therapeutics' Osemitamab program (AACR 2024) - "In collaboration with Transcenta, Agilent is developing an IHC companion diagnostic for Claudin 18.2. The assay is being used for patient selection in Transcenta's clinical phase 3 program."

Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Development of Claudin 18.2 IHC 14G11 pharmDx as a clinical trial assay for the clinical development of anti-claudin 18.2 monoclonal antibody osemitamab (TST001) in gastric and gastroesophageal junction adenocarcinoma (AACR 2024) - "Analytical verification testing indicates Claudin 18.2 IHC 14G11 pharmDx is a sensitive, specific, and precise assay for detecting Claudin 18.2 in gastric and GEJ adenocarcinoma. Claudin 18.2 IHC 14G11 pharmDx for Investigational Use Only/for Performance Evaluation Only will be used for patient selection in the upcoming phase III trial of gastric/GEJ adenocarcinoma where applicable ethics committee and regulatory approvals have been granted."

Clinical • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

A case report of a patient with advanced gastric adenocarcinoma who demonstrated excellent long-term sustained efficacy even after discontinuation of treatment following chemotherapy combined with claudin18.2 and PD-1 therapy. (PubMed, Front Pharmacol) - "The patient received seven cycles of CAPOX (capecitabine + oxaliplatin), nivolumab, and TST001, achieving partial response (PR) after treatment. Surprisingly, despite no further antitumor therapy, follow-up imaging over 19 months revealed continued tumor shrinkage, culminating in a near complete response (CR). Therefore, the combination of chemotherapy, Claudin18.2-targeted therapy, and PD-1 inhibitor may be a good treatment strategy for gastric cancer."

Journal • Epstein-Barr Virus Infections • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor • CLDN18

TranStar102: A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: May 2025 ➔ Dec 2026 | Trial primary completion date: Feb 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Biliary Tract Cancer • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18 • HER-2

TransStar101: A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Sep 2025 ➔ Nov 2026 | Trial primary completion date: May 2025 ➔ May 2026

Monotherapy • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma (clinicaltrials.gov) - P3 | N=820 | Not yet recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Jan 2026 ➔ Jan 2030 | Trial primary completion date: Oct 2025 ➔ Oct 2029

Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

First-line osemitamab plus nivolumab and CAPOX for advanced G/GEJ cancer (TranStar102) – Updated efficacy analysis of cohort G by CLDN18.2 and PD-L1 expression from a phase I/II study (ESMO Asia 2025) - P1/2 | "The efficacy of Osemitamab combined with nivolumab and CAPOX as 1st-line treatment in patients with G/GEJ cancer is encouraging regardless the PD-L1 CPS level."

Clinical • IO biomarker • Metastases • P1/2 data • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • CLDN18 • PD-L1

Transcenta Therapeutics Presents Updated Efficacy Data from the Phase I/II Transtar102 Trial of Osemitamab plus Nivolumab and CAPOX in First-Line G/GEJ Cancer at ESMO Asia (GlobeNewswire) - "This new analysis reinforces the encouraging clinical benefit of the osemitamab triple combination regimen in the ongoing study. In the 26 patients with CLDN18.2 expression ≥40%, ≥2+ and known PD-L1 CPS, the median PFS reached 16.6 months, with an ORR of 68% and a median DoR of 18 months at a 25.8-month median follow-up. Notably, better PFS outcomes were observed in patients with higher CLDN18.2 expression compared to lower CLDN18.2 expressors in both PD-L1 CPS<1 and ≥1 subgroups, which indicated the potential treatment benefit of osemitamab is consistent regardless of PD-L1 expression."

P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Claudin18.2 as a Promising Therapeutic Target in Gastric Cancer. (PubMed, Cells) - "This narrative review presents the characterization and role of claudin 18.2 (CLDN18.2) as a promising biomarker in GC and a target for clinical therapies, more specifically CLDN18.2-targeted drugs and therapies including mABs (e.g., Zolbetuximab, Osemitamab, ZL-1211), bsAB, and CAR-T cell-based immunotherapies. We also summarize numerous ongoing worldwide clinical trials that are evaluating CLDN18.2 as a target for GC treatment. What seems to be crucial is that preclinical and clinical data indicate their high efficacy and safety."

Biomarker • IO biomarker • Journal • Review • Gastric Cancer • Oncology • Solid Tumor • CLDN18

First-line osemitamab (TST001) plus nivolumab and CAPOX for advanced G/GEJ cancer (TranStar102): Updated results of cohort G from a phase I/IIa study. (ASCO 2025) - P1/2 | "The updated data indicate that the combination of TST001 plus nivolumab and CAPOX for the first-line treatment of patients with G/GEJ cancer is safe and well tolerated with encouraging durable PFS and survivals, especially for the patients with high/medium CLDN18.2 expression."

Clinical • IO biomarker • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • CLDN18 • HER-2

BUSINESS UPDATE ON OSEMITAMAB (TST001) FOR G/GEJ CANCER WITH NEW OS DATA FROM FIRST-LINE TRIPLE COMBO TRIAL UNVEILED AT 2025 ASCO ANNUAL MEETING (HKEXnews) - P1/2a | N=320 | Transtar102 (NCT04495296) | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | "New data, reinforcing earlier encouraging results from the Osemitamab (TST001) triple combo trial, revealed a median overall survival (mOS) of 20.4 months in all the 82 patients enrolled in the study regardless of CLDN18.2 status at a median follow-up of 22.6 months. In the 26 patients who have CLDN18.2 expression on at least 40% of the tumor cells with 2+ or higher staining intensity (≥40%, ≥2+) per 14G11 IHC LDT assay and PDL1 known, the mOS reached 21.7 months and the median progression-free survival (mPFS) was 16.6 months. The confirmed objective response rate (cORR) was 68% with a median duration of response (mDoR) of 16.5 months in this population. The safety profile from the updated data was consistent with previously presented data..."

P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

TransStar101: A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Nov 2024 ➔ May 2025

Monotherapy • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

TranStar102: A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Nov 2024 ➔ May 2025 | Trial primary completion date: Aug 2024 ➔ Feb 2025

Metastases • Trial completion date • Trial primary completion date • Biliary Tract Cancer • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18 • HER-2

TransStar101: A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2024 ➔ Nov 2024

Combination therapy • Enrollment closed • Metastases • Monotherapy • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Claudin 1, 4, 6 and 18 isoform 2 as targets for the treatment of cancer (Review). (PubMed, Int J Mol Med) - "The human/humanized anti‑CLDN18.2 mAb osemitamab, and ADCs AZD0901, IBI343 and LM‑302, with single‑agent ORRs of 28‑60%, have been tested in phase III clinical trials. In addition, bsAbs, CAR T cells and their derivatives targeting CLDN4, 6 or 18.2 are in phase I and/or II clinical trials. AZD0901, IBI343, zolbetuximab and the anti‑CLDN1 mAb ALE.C04 have been granted fast track designation or priority review designation by the US Food and Drug Administration."

Journal • Review • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • CLDN1 • CLDN18 • CLDN4 • CLDN6

Transcenta Updates Encouraging Efficacy Data from First-line Triple Combo Trial of Osemitamab (TST001) for G/GEJ Cancer at ESMO 2024 (PRNewswire) - P1/2 | N=320 | Transtar102 (NCT04495296) | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | "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....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%)....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."

P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Osemitamab (TST001) plus nivolumab and CAPOX as the first-line therapy for the patients with advanced G/GEJ cancer (TranStar102) (ESMO 2024) - P1/2 | "Updated data indicate that the combination of TST001 plus nivolumab and CAPOX as the 1L treatment for patients with G/GEJ cancer is safe and well tolerated with very encouraging anti-tumor activities, especially for patients with high/medium CLDN18.2 expression when cross comparing to historical data."

Clinical • IO biomarker • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2 • PD-L1

First-line osemitamab (TST001) plus nivolumab and capox for advanced g/GEJ cancer (TranStar102): Results of cohort G from a phase I/IIa study. (ASCO 2024) - P1/2 | "Preliminary data indicate that the combination of TST001 6mg/kg Q3W plus nivolumab and CAPOX for the 1 st line treatment of patients with G/GEJ cancer is safe and well tolerated with encouraging preliminary anti-tumor activities. Updated clinical data, including PFS and DoR will be reported at the time of the conference."

Clinical • IO biomarker • Metastases • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2 • PD-L1

Transcenta Debuts Encouraging Phase II Data from First-line Triple Combo Trial of Osemitamab (TST001) for G/GEJ Cancer at ASCO 2024 (PRNewswire) - P1/2 | N=320 | TranStar102 (NCT04495296) | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | "Transcenta Holding Limited...today announced the results from the Phase I/IIa Cohort-G data for Osemitamab (TST001) plus Nivolumab and CAPOX as the first-line treatment of patients with advanced G/GEJ cancer...As of the cut-off date, 82 patients had been dosed with a median follow-up of 12.6 months...with mPFS of 12.6 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) respectively. Confirmed response rate was respectively 68%, 61.1% and 50% respectively...The main toxicities are on-target-off-tumor effects that are manageable, including nausea, hypoalbuminemia and vomiting, mostly grade 1 or 2."

P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

TranStar101: osemitamab, a novel CLDN18.2 inhibitor, in solid tumors (YouTube) - "Yelena Janjigian, MD...presents the results of the Phase I/IIa TranStar101 trial (NCT04396821) evaluating the safety, tolerability, and pharmacokinetics of the monoclonal antibody osemitamab with nivolumab. Osemitamab is a next generation inhibitor of claudin 18.2 (CLDN18.2), an important biomarker expressed in locally advanced or metastatic solid tumors. Dr Janjigan briefly highlights the findings of Phase III studies on zolbetuximab, another anti-CLDN18.2 monoclonal antibody, with promising results for progression free survival. This TranStar101 trial successfully employed a combinatory treatment approach to evaluate the use of chemotherapy, a checkpoint inhibitor targeting PD-1, and osemitamab."

Interview • Video

TranStar102: A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Apr 2024 ➔ Nov 2024 | Trial primary completion date: Dec 2023 ➔ Aug 2024

Metastases • Trial completion date • Trial primary completion date • Biliary Tract Cancer • Colorectal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18 • HER-2

Transcenta Announces Collaboration with Agilent to Develop a Claudin18.2 Companion Diagnostic to Support Osemitamab (TST001) Global Phase III Trial (PRNewswire) - "Transcenta Holding Limited...and Agilent Technologies, announce a collaboration to develop a Claudin18.2 (CLDN18.2) companion diagnostic to support TranStar301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma."

Diagnostic • Licensing / partnership • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology