tecotabart vedotin (LM-302) / Sino Biopharm, LaNova Medicines Limited - LARVOL DELTA

Antibody-Drug Conjugates in the Treatment of Esophageal Cancer. (PubMed, Curr Treat Options Oncol) - "For HER2-negative gastroesophageal adenocarcinoma, trophoblast cell-surface antigen 2 represents a promising target given its high prevalence of moderate to strong expression in nearly 80% of cases, and sacituzumab tirumotecan is currently under phase III investigation in this setting...For Nectin-4-expressing tumors, enfortumab vedotin may be considered as a later-line alternative despite modest activity. Notably, the bispecific ADC targeting both epidermal growth factor receptor and human epidermal growth factor receptor 3, BL-B01D1, has demonstrated compelling efficacy in immunotherapy-refractory esophageal squamous cell carcinoma, and I consider it a breakthrough option in this subtype. For claudin-18.2-positive gastroesophageal junction adenocarcinoma, several ADCs including CMG901, IBI343, and tecotabart vedotin represent promising later-line choices. I emphasize that patient selection should be guided by validated predictive biomarkers, and treatment decisions..."

Biomarker • IO biomarker • Journal • Review • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • CLDN18 • ERBB3 • HER-2 • NECTIN4

Efficacy and safety of tecotabart vedotin plus toripalimab with or without chemotherapy as first-line treatment for CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma: Phase II study results. (ASCO 2026) - P2 | "Funded by LaNova Medicines Limited Clinical Trial Registration Number: NCT05934331 Background: Tecotabart vedotin (TV; LM-302) is a novel and potent MMAE-based ADC targeting CLDN18.2...Pts received TV (1.8 mg/kg Q2W) plus T (3 mg/kg Q2W), with or without capecitabine or S-1... TV+T, with or without chemotherapy, demonstrated encouraging anti-tumor activity and manageable safety as first-line treatment for CLDN18.2-positive advanced G/GEJ cancer. The doublet shows comparable efficacy to the triplet with enhanced tolerability, supporting further large-scale clinical investigation."

Clinical • IO biomarker • Metastases • P2 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1

A phase 1/2 study of LM-302, an anti-claudin 18.2 (CLDN18.2) antibody-drug conjugate in patients with advanced gastric/gastroesophageal junction cancer. (ASCO 2024) - P1/2 | "LM-302 was well-tolerated with a manageable safety profile and demonstrated promising anti-tumor activity in CLDN18.2-positive patients with third-line and beyond gastric/GEJ cancer. The results support further investigation of LM-302 as a new therapeutic approach to treat CLDN18.2-positive gastric/GEJ cancer."

Clinical • Metastases • P1/2 data • Anemia • Biliary Cancer • Biliary Tract Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hematological Disorders • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov) - P3 | N=752 | Recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1

LaNova Medicines has had its new drug application for tecotabart vedotin, a CLDN18.2-targeting antibody-drug conjugate known as LM-302, accepted by China’s Center for Drug Evaluation for CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after at least two prior systemic therapies (TipRanks) - "The indication has entered priority review, backed by a pivotal Phase III trial that met its endpoints..."

China filing • Priority review • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Sino Biopharmaceutical Limited…announces that tecotabart vedotin…has successfully completed the enrollment of the first patient in its Phase III registrational clinical trial (LM302-03-101) for the first-line treatment of CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma (GC/GEJ) in combination with a PD-1 monoclonal antibody (HKEXnews) - "This Phase III clinical trial plans to enroll patients with locally advanced unresectable or metastatic GC/GEJ who are CLDN18.2-positive (≥25% tumor cell membrane with staining intensity of 2+/3+) and HER2-negative, and those who have not received prior systemic therapy. The primary endpoint is progression-free survival (PFS) assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria."

Enrollment status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

LM302-03-101: LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov) - P3 | N=387 | Active, not recruiting | Sponsor: LaNova Medicines Zhejiang Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2

Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov) - P3 | N=752 | Not yet recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1

Sino Biopharmaceutical’s subsidiary LaNova Medicines has completed patient enrollment in a Phase III registrational trial of tecotabart vedotin (LM-302), an antibody-drug conjugate targeting CLDN18.2 for third-line and later treatment of CLDN18.2-positive advanced gastric and gastroesophageal junction adenocarcinoma… (TipRanks)

Enrollment closed • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma

Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules. (PubMed, Front Mol Med) - "Enfortumab vedotin is an NECTIN4-targeting antibody-drug conjugate that is approved for the treatment of urothelial cancer, whereas other ADCs or derivatives that target NECTIN4, such as bulumtatug fuvedotin, SHR-A2102 and zelenectide pevedotin, are being studied in randomized phase III clinical trials. In contrast, arcotatug tavatecan, garetatug rezetecan, sonesitatug vedotin and tecotabart vedotin are anti-CLDN18.2 ADCs in phase III clinical trials for the treatment of CLDN18.2-positive gastric or gastroesophageal junction adenocarcinomas, and raludotatug deruxtecan is an anti-CDH6 ADC in a phase II/III clinical trial for the treatment of platinum-resistant ovarian cancer. ADCs that target cell-cell adhesion molecules are a rapidly emerging class of cancer therapeutics, and bispecific ADCs and longitudinal companion diagnostics are emerging to further improve the clinical benefits of conventional ADCs."

Journal • Review • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer • CDH17 • CDH6 • CLDN18 • CLDN6

Tecotabart vedotin in Claudin 18.2-positive advanced gastric/gastroesophageal junction cancer: A Bayesian phase 1/2 clinical trial. (PubMed, Eur J Cancer) - "Tecotabart vedotin demonstrated encouraging anti-tumor activity and manageable safety in CLDN18.2-positive G/GEJ cancer, supporting further clinical development in gastrointestinal malignancies."

Clinical • Journal • P1/2 data • Biliary Cancer • Biliary Tract Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study (clinicaltrials.gov) - P2 | N=276 | Recruiting | Sponsor: LaNova Medicines Zhejiang Co., Ltd. | Trial completion date: Jan 2026 ➔ Jul 2028 | Trial primary completion date: Jul 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

LM302-01-102: Study of LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov) - P1/2 | N=153 | Completed | Sponsor: LaNova Medicines Zhejiang Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Jan 2025

Trial completion • Trial completion date • Oncology • Solid Tumor • CLDN18

LM302-03-101: LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov) - P3 | N=375 | Recruiting | Sponsor: LaNova Medicines Zhejiang Co., Ltd. | Trial primary completion date: Aug 2026 ➔ Nov 2026

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

LM-302 “CLDN18.2 ADC”…has been included in the Breakthrough Therapeutic Designation (BTD) process by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (HKEXnews) - "The drug is used in combination with a PD-1 monoclonal antibody as first-line therapy for CLDN18.2- positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma."

Breakthrough therapy • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Efficacy and safety of LM-302 (anti-claudin 18.2 ADC) in combination with anti-PD-1 therapy for advanced gastric, gastroesophageal junction cancer and esophageal adenocarcinoma: Early-phase study results. (ASCO 2025) - P1/2, P2 | "LM-302 combined with toripalimab demonstrated encouraging anti-tumor activity and manageable safety as first-line treatment for patients with CLDN18.2-positive gastric, GEJ, and EAC, including those with low-to-moderate CLDN18.2 expression. These findings support further large-scale clinical trials to confirm efficacy, safety and clinical utility."

Clinical • Combination therapy • IO biomarker • Metastases • Anemia • Anorexia • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1

Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=20 | Completed | Sponsor: LaNova Australia Pty Limited | Terminated ➔ Completed

Trial completion • Oncology • Solid Tumor • CLDN18

GI Innovation-Lanova Medicine, MOU for Combination Therapy for Pancreatic Cancer [Google translation] (HIT News) - "GI Innovation...signed a business agreement (MOU) with LaNova Medicines for research and development of a combination therapy of the immunotherapy drug 'GI-102' and the antibody-drug conjugate (ADC) 'LM-302' for the treatment of pancreatic cancer...The two companies have been conducting a combination therapy study of GI-102 and LM-302 targeting Claudin18.2, and recently emphasized that they confirmed high anticancer efficacy in a preclinical model of pancreatic cancer....Through this agreement, the two companies plan to begin clinical development targeting patients with terminal pancreatic cancer."

Commercial • Pancreatic Cancer

LaNova Medicines Announces…Completion of $42 Million Series C1 Financing (PRNewswire) - "LaNova has recently initiated its Series C2 financing round. Proceeds will be primarily used to advance the clinical development of the Company's pipeline, including lead candidates: LM-302 (anti-CLDN 18.2 ADC): ongoing Phase III registrational clinical trial in China for gastric cancers, making it one of the top three candidates globally in terms of development progress for this target; US Phase II trial expected to start in H2 2025; LM-108 (anti-CCR8 mAb): ongoing Phase II clinical trials in China for multiple solid tumors, making it one of the top three most advanced projects worldwide targeting CCR8; US Phase II trial expected to start in H2 2024; LM-299 (anti-PD-1/VEGF BsAb): Phase I clinical trial in China is currently enrolling patients for advanced solid tumors."

Financing • New P2 trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Shanghai Zhongshan Hospital

Combination therapy • Metastases • New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

LM302-03-101: LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov) - P3 | N=375 | Recruiting | Sponsor: LaNova Medicines Zhejiang Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Two stage, multi-center trial of cadonilimab and LM-302 for patients with CLDN18.2+ biliary tract cancer (BTC) that failed chemotherapy and PD-(L)1 antibody (ZSAB-Calm). (ASCO 2024) - P1/2 | "Cadonilimab combined with LM-302 has manageable safety and promising antitumor activity in CLDN18. 2+ BTC. Clinical trial information: NCT05994001."

Clinical • IO biomarker • Anemia • Biliary Cancer • Biliary Tract Cancer • Cardiovascular • Cholangiocarcinoma • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Leukopenia • Myocardial Infarction • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CLDN18

Study of LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov) - P1/2 | N=206 | Active, not recruiting | Sponsor: LaNova Medicines Zhejiang Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Oncology • Solid Tumor • CLDN18

Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Turning Point Therapeutics, Inc. | Active, not recruiting ➔ Completed | N=42 ➔ 17

Enrollment change • Metastases • Trial completion • Biliary Tract Cancer • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18 • MSI

LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov) - P3 | N=375 | Not yet recruiting | Sponsor: LaNova Medicines Zhejiang Co., Ltd.

Metastases • New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor