IMC002 / Immunofoco - LARVOL DELTA

Phase I trial of efficacy and safety of IMC002, a VHH-based anti-CLDN18.2 CAR-T therapy, for gastroesophageal cancers. (ASCO-GI 2026) - P1 | "Funded by Suzhou Immunofoco Biotechnology Co., Ltd. Clinical Trial Registration Number: NCT05946226 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Preclinical development and a case report of a nanobody-based CLDN18.2 CAR-T IMC002 with reduced on-target off-tumor toxicity. (PubMed, Mol Cancer Ther) - "The highest non-severely toxic dose was 5×108 CAR-T cells/kg. In the clinical case report, we present a case with unresectable advanced gastric cancer achieved pathological complete response 10 months after IMC002 infusion and no signs of recurrence were indicated in subsequent clinical and radiological follow-ups. IMC002 shows effectiveness and safety in CLDN18.2-positive gastric and pancreatic cancer and its favorable profiles support further clinical development."

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

A promising readout from the phase I trial of IMC002, VHH-based anti-Claudin18.2 CAR-T cells for gastrointestinal cancers. [WITHDRAWN] (ESMO 2025) - No abstract available

CAR T-Cell Therapy • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Cancer-free survival exceeds 9 months! ImmunoFocos's nanoantibody CLDN 18.2 CAR-T therapy obtains US FDA fast track qualification [Google translation] (Sohu.com) - "Recently, ImmunoFeng Bio announced that its independently developed autologous CAR-T cell drug candidate IMC002 targeting CLDN 18.2 has obtained the fast track designation (FTD) from the US FDA and is intended to be used to treat patients with unresectable locally advanced, recurrent or metastatic CLDN 18.2-positive gastric cancer...IMC002 is the first solid tumor CAR-T drug candidate prepared from a nano-antibody sequence to complete Phase 1 registration clinical trials and obtain FDA fast track qualification..."

Fast track • Gastric Cancer

Immunofoco’s CLDN18.2 CAR-T Therapy Achieves Phase I Dose Escalation Milestone [Google translation] (Immunofoco Press Release) - P1 | N=30 | NCT05472857 | Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd | "...Immunofoco Biotech...announced that the successful completion of the Safety Monitoring Committee (SMC) meeting for its IMC002-RT01 clinical trial. During this meeting, experts, after extensive experience sharing and thorough data discussions, unanimously affirmed the excellent safety performance of the IMC002-RT01 clinical trial, which smoothly passed the dose-escalation trials for low (1×10^8 CAR-T cells), medium (2.5×10^8 CAR-T cells), and high (5.0×10^8 CAR-T cells) dose groups....The trial results indicate that no dose-limiting toxicities (DLTs) were observed in any of the 9 patients across low, medium, and high dose groups, demonstrating the excellent safety profile of IMC002 CAR-T product for solid tumors. Preliminary data has shown good safety and efficacy of IMC002 in advanced gastric and pancreatic cancers where standard treatments have failed."

DSMB • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Immunofoco’s CLDN18.2 CAR-T Therapy Receives FDA Orphan Drug Designation for Pancreatic Cancer [Google translation] (Immunofoco Press Release) - "Immunofoco Biotech...announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IMC002, a novel CAR-T therapy targeting CLDN 18.2, for the treatment of pancreatic cancer....Recently, IMC002 has completed the Phase I dose-escalation trial with low, medium, and high dose groups in China."

Orphan drug • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Outstanding safety and efficacy data of IMC002, an autologous CLDN18.2-targeting CAR-T, in CLDN18.2+ advanced solid tumors. (ASCO 2024) - P1 | "IMC002 showed a favorable safety profile, encouraging anti-tumor activities with observed pCR and persistent expansion in the tumor tissue at the low dosage levels in pts with advanced CLDN18. 2+ gastric cancer. In addition, our trial has successfully provided a surgical treatment opportunity after CAR-T therapy downstaging of unresectable gastric cancers."

Clinical • IO biomarker • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pruritus • Solid Tumor • CLDN18 • IFNG • IL10 • IL2 • IL6

Immunofoco Biotech to Unveil Solid Tumor CAR-T Programs Clinical Trial Data at 2024 ASCO Meeting (PRNewswire) - P1 | N=30 | NCT05472857 | Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd | "On June 1st, 2024, Immunofoco Biotech... announced that the clinical research data for two of its products have been accepted for presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting....As of January 17, 2024, three patients with advanced unresectable gastric cancer received IMC002 infusion. There was no dose-limiting toxicity (DLT) or serious adverse events (SAE) reported. All three patients experienced manageable cytokine release syndrome (CRS) at grade 1. In addition, all adverse events recovered quickly. Preliminary efficacy data showed that all three patients exhibited stable disease as their best overall response, as evaluated by RECIST 1.1 criteria."

P1 data • Gastric Cancer

A Phase I Trial to Evaluate the Safety of IMC002 in Advanced Digestive System Tumors (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • IL10 • IL2 • IL6

Orphan Designation: Treatment of gastric cancer (FDA) - Date Designated: 08/15/2023

Orphan drug • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase I Trial to Evaluate the Safety of IMC002 in Advanced Digestive System Tumors (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd

Metastases • New P1 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • IL10 • IL2 • IL6

Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2034 ➔ Dec 2024

CAR T-Cell Therapy • Enrollment open • Trial completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • CLDN18 • CLDN8

Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd

CAR T-Cell Therapy • New P1 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • CLDN18 • CLDN8