On April 9, 2024, - Immunofoco, a company dedicated to developing cell therapy products for solid tumors, 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. The company will feature the latest clinical trial data for IMC001 in a poster presentation and for IMC002 in an online presentation during the ASCO event, which runs from May 31 to June 4, 2024.


I.  Abstract Title: Efficacy of EpCAM CAR-T IMC001 in advanced gastric cancers

Abstract Number for Publication: 4043

Session Type and Title: Poster Session – Gastrointestina Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary

Poster Board Number is: 23

Session Date and Time: 6/1/2024 1:30 PM-4:30 PM CDT

II. Abstract Title: Outstanding safety and efficacy data of IMC002, an autologous CLDN18.2-targeting CAR-T, in CLDN18.2+advanced solid tumors

Abstract Number for Publication: e16012

About IMC001

Epithelial cell adhesion molecule (EpCAM) is highly expressed on various epithelial-derived tumor tissues, including digestive tract tumors, with expression rates exceeding 90% in colorectal cancer and gastric cancer. Additionally, EpCAM can serve as a therapeutic target for circulating tumor cells (CTCs), and the expression of EpCAM in metastatic lesions is often higher than that in primary lesions, without antigen loss due to metastasis. Therefore, EpCAM CAR-T can target primary lesions, CTCs, and metastatic lesions simultaneously. By genetically engineering chimeric antigen receptors (CARs) into a patient’s autologous T cells, CAR-T cells can recognize and kill tumor cells expressing EpCAM, achieving anti-tumor effects.

The development of IMC001 aims to target EpCAM to address the challenges of metastasis and recurrence, providing a new treatment option for advanced digestive system tumors.

IMC001 received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in August 2023 and became the first CAR-T product targeting EpCAM to receive IND approval in both China and the U.S. Additionally, it has demonstrated promising safety and efficacy in Investigator Initiated Trials (IIT) studies.

About IMC002

IMC002, the first CAR-T product based on a highly specific VHH nanobody, is an autologous CAR-T product targeting CLDN18.2. The highly specific VHH antibodies have equipped the CAR-T with a better safety and wider clinical dose window. Recognized with Orphan Drug status by the FDA, the therapy received IND approval from China CDE in April 2023 following U.S. approval. The product has since shown positive results in investigator-initiated trials (IIT) and is currently in Phase I of its registration clinical trials, where it continues to exhibit good safety and efficacy.

IMC002 trials are being conducted at leading medical centers, including:

The First Medical Center of the Chinese People's Liberation Army General Hospital (Beijing 301)

The Second Affiliated Hospital of Nanchang University

Shandong Cancer Hospital (Jinan)

Fujian Cancer Hospital (Fuzhou)

The First Affiliated Hospital of Zhejiang University School of Medicine (Hangzhou)

Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine

West China Hospital of Sichuan University

These institutions are actively recruiting patients diagnosed with advanced gastric and pancreatic cancers to participate in the clinical trials.

About Immunofoco

Immunofoco has pioneered a clinical strategy focused on “curing the solid tumors by treating them as hematologic malignancies”, addressing the challenges in solid tumor treatment, and the clinical advantages of treating hematologic malignancies. To improve the safety of CAR-T products, counteract tumor heterogeneity, and to enhance their effectiveness in tumor amplification and infiltration, we have developed innovative platforms such as Peri Cruiser^®, SNR, and T-Booster. Driven by the clinical outcomes, our company maintains an extensive spectrum of product pipeline. Notably, our IMC002 (CLDN18.2 CAR-T) product obtained ODD from the U.S. FDA in July 2022, and its IND application has been approved in both the U.S. and China in April 2023. Similarly, our IMC001 (EpCAM CAR-T) product obtained ODD from the U.S. FDA in August 2023, with its IND application has been approved in both the U.S. and China in February 2024. The IMC008 (SNR CAR-T) product has rapidly moved to the IIT stage and received two ODD approval from the U.S. FDA in August 2023, for the treatment of gastric cancer and pancreatic cancer, respectively. Embodying the ethos of “collaboration, aspiration, and dedication for the best clinical results,” our company brings together industry talents and experts to develop innovative cell therapies that offer enduring survival benefits for patients with solid tumors. For further details about Immunofoco, please visit our website at www.immunofoco.com.