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

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 | "Clinical Trial Registration Number: NCT05188664; NCT05934331. The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

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

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

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

Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=20 | Terminated | Sponsor: LaNova Australia Pty Limited | N=50 ➔ 20 | Trial completion date: May 2024 ➔ Nov 2023 | Recruiting ➔ Terminated; Sponsor's decision

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial termination • Oncology • Solid Tumor • CLDN18

Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: LaNova Australia Pty Limited | Enrolling by invitation ➔ Recruiting | Trial primary completion date: Oct 2023 ➔ Feb 2024

Combination therapy • Enrollment status • Metastases • Trial primary completion date • Oncology • Solid Tumor • CLDN18

Study of LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov) - P1/2 | N=206 | Recruiting | Sponsor: LaNova Medicines Zhejiang Co., Ltd. | Enrolling by invitation ➔ Recruiting | N=128 ➔ 206

Enrollment change • Enrollment status • Metastases • Oncology • Solid Tumor • CLDN18

A LM-302 Combined With Toripalimab Phase II Study (clinicaltrials.gov) - P2 | N=276 | Recruiting | Sponsor: LaNova Medicines Zhejiang Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • PD-L1

Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Turning Point Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Phase classification: P1/2 ➔ P1 | Trial completion date: Aug 2024 ➔ Jan 2024 | Trial primary completion date: Aug 2024 ➔ Jan 2024

Enrollment closed • Metastases • Phase classification • Trial completion date • Trial primary completion date • Biliary Tract Cancer • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18 • MSI

A LM-302 Combined With Toripalimab Phase II Study (clinicaltrials.gov) - P2 | N=276 | Not yet recruiting | Sponsor: LaNova Medicines Zhejiang Co., Ltd.

Metastases • New P2 trial • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • PD-L1

Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Turning Point Therapeutics, Inc. | Trial completion date: May 2024 ➔ Aug 2024 | Trial primary completion date: Apr 2023 ➔ Aug 2024

Trial completion date • Trial primary completion date • Biliary Tract Cancer • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18 • MSI

Study of LM-302 in Patients With Advance Solid Tumors (clinicaltrials.gov) - P1/2 | N=128 | Enrolling by invitation | Sponsor: LaNova Medicines Zhejiang Co., Ltd. | Recruiting ➔ Enrolling by invitation

Enrollment status • Oncology • Solid Tumor • CLDN18 • CLDN8

Preclinical activity for TPX-4589 (LM-302), an antibody-drug conjugate targeting tight junction protein CLDN18.2 in solid tumors (AACR-NCI-EORTC 2022) - "In a CLDN18.2-high patient-derived xenograft (PDX) PC tumor model, increasing doses of TPX-4589 demonstrated superior tumor growth inhibition compared to gemcitabine and LM-102, a compound with identical anti-CLDN18.2 mAb component as LM-302, and similar efficacy to LM-102 + gemcitabine in combination. TPX-4589, a novel CLDN18.2-targeting ADC, showed potent inhibitory effects on tumor cell proliferation in vitro and reduced tumor volume in both high- and low-expressing CDLN18.2 tumor models, with superior internalization and efficacy to zolbetuximab in a GC tumor model. These data suggest that TPX-4589 is a promising therapeutic candidate that warrants further investigation in clinical studies."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

More than 40 products into the clinical! Claudin18.2 Target, who will dominate? (Echemi.com) - "On October 22, the clinical trial application of the first ADC new drug BA1301 injection submitted by Boan Bio was accepted, which may add another fire to the ADC track. BA1301 is a new ADC drug targeting Claudin18.2, which is indicated for gastric cancer, pancreatic cancer and esophageal cancer...Claudin18.2-ADC has been laid out successively by 10 pharmaceutical companies such as Henrui Pharmaceutical, Shipharmaceutical, Xinda Biological, including LM-302, JS-107, CMG901 and other drugs under research...Among the five biosimilar drugs under development, BA6101 (besumumab injection, Proliximab biosimilar) in the field of metabolism was accepted by the China Food and Drug Administration on October 14, 2021, and is currently under review and approval (supplementary task review). It is expected to be approved for marketing in the second half of 2022."

New trial • Non-US regulatory • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Turning Point Therapeutics Reports Second-Quarter 2022 Financial Results, Provides Operational Updates (GlobeNewswire) - "Upcoming Milestones: TPX-4589 - (i) Present preclinical data at a medical conference by early 2023; (ii) Provide additional guidance on clinical development plan by early 2023."

Pipeline update • Preclinical • Oncology

Study of LaNova Medicines(LM)-302 in Combination With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=50 | Enrolling by invitation | Sponsor: LaNova Australia Pty Limited | Active, not recruiting ➔ Enrolling by invitation

Combination therapy • Enrollment open • Oncology • Solid Tumor • CLDN18

"...and another Claudin18.2 deal! $TPTX licenses Lanova's LM-302 / TPX-4589 for $25m up front." (@JacobPlieth)

CLDN18 • CLDN8

Turning Point Therapeutics Announces Pipeline Expansion, Licensing of TPX-4589 (LM-302), A Clinical Stage Anti-Claudin18.2 Antibody Drug Conjugate for Gastrointestinal Cancers, From Lanova Medicines (GlobeNewswire) - "Turning Point Therapeutics, Inc...announced today that it has entered into an exclusive license agreement with LaNova Medicines Limited (LaNova) to develop and commercialize LM-302, a novel antibody drug conjugate (ADC) targeting Claudin18.2, in the U.S. and rest of the world, excluding Greater China and South Korea...Under the terms of the licensing agreement, LaNova will receive an upfront payment of $25 million and will be eligible to receive up to an additional $195 million in development and regulatory milestone payments..."

Licensing / partnership • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor