August 12, 2026 — Immunofoco today announced that the Investigational New Drug (IND) application for its CLDN18.2-targeted autologous CAR-T cell therapy, IMC002, for the treatment of CLDN18.2-positive advanced pancreatic cancer in patients who have not previously received systemic therapy has been accepted by China’s National Medical Products Administration (NMPA).
Pancreatic cancer remains one of the most aggressive gastrointestinal malignancies, characterized by late diagnosis, rapid disease progression, and limited treatment options. According to Global Cancer Statistics 2022, the number of deaths from pancreatic cancer remains close to the number of newly diagnosed cases, underscoring the significant unmet medical need. Most patients are diagnosed with locally advanced or metastatic disease, and only a small proportion are eligible for surgical resection, contributing to poor long-term survival.
CAR-T cell therapy has demonstrated clinical potential in solid tumors; however, pancreatic cancer presents unique challenges, including an immunosuppressive tumor microenvironment, limited CAR-T cell persistence, and potential safety concerns associated with target expression on normal tissues. The planned clinical study will evaluate the safety and efficacy of IMC002 in CLDN18.2-positive advanced pancreatic cancer patients who have not previously received systemic therapy.
IMC002 incorporates a high-specificity VHH nanobody-based targeting design intended to enhance tumor antigen recognition specificity and potentially support a broader therapeutic window for combination treatment strategies. CLDN18.2 is highly expressed in multiple gastrointestinal malignancies, including gastric and pancreatic cancers, making it an attractive target for therapeutic development. IMC002 received IND approval from China’s NMPA and IND clearance from the U.S. FDA in 2023 for the treatment of CLDN18.2-positive advanced digestive system tumors, including but not limited to advanced gastric cancer, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer.
IMC002 is currently being evaluated in a pivotal Phase III clinical study in patients with CLDN18.2-positive advanced G/GEJ adenocarcinoma, with patient enrollment underway. For the pancreatic cancer indication, the IND application for IMC002 for the treatment of CLDN18.2-positive advanced pancreatic cancer in patients who have not previously received systemic therapy has been accepted by China’s NMPA. Immunofoco will advance the clinical development program upon receiving approval to initiate the clinical trial.
About Immunofoco
Founded in 2020, Immunofoco is an innovative cell therapy company pursuing a dual-platform strategy spanning autologous CAR-T therapies for solid tumors and in vivo CAR-T platforms across multiple disease areas, with a mission to deliver durable long-term survival benefits to patients with high unmet medical needs.
Its lead program, IMC002 (CLDN18.2 CAR-T), is currently in a pivotal Phase III trial in China. IMC001 (EpCAM CAR-T therapy) is the only candidate worldwide with IND clearance from both the U.S. FDA and China’s NMPA and is currently being evaluated in Phase I/IIa basket trials in China. The in vivo CAR-T pipeline includes IMV101 (CD19), IMV102 (BCMA), and IMV103 (CLDN18.2), targeting hematologic malignancies, solid tumors, and autoimmune diseases, with IMV101 and IMV102 currently being evaluated in investigator-initiated trials (IITs).
Immunofoco has developed several proprietary platforms—Peri Cruiser, SNR, T-Booster, SolidGuard, and FOCO-CAR—designed to enhance the safety and efficacy of CAR-T products by addressing key challenges. The company has also developed the iMAGIC platform, which leverages novel fusogen and T-cell targeting modules to enable efficient in vivo T-cell transduction and CAR-T generation.
For more information, please visit www.immunofoco.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the potential safety, efficacy, and clinical development of IMC002. These statements are based on current expectations and assumptions and are subject to risks and uncertainties. Actual results may differ materially from those expressed or implied by such statements. Immunofoco undertakes no obligation to update any forward-looking statements except as required by applicable laws and regulations.
