Immunofoco Achieves Historic Dual IND Approval for Groundbreaking EpCAM CAR-T Therapy

26 February 2024 | Monday | News

Immunofoco, a pioneer in cell therapy for solid tumors, has announced the dual approval of its Investigational New Drug (IND) applications by both the U.S. Food and Drug Administration (FDA) and China's Center for Drug Evaluation (CDE). This marks a critical milestone for IMC001, the first EpCAM-targeted CAR-T cell therapy aimed at tackling advanced solid tumors, including advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).
Image Source : Public Domain

Image Source : Public Domain


EpCAM, known for its presence in circulating tumor cells (CTCs) and high expression in primary and metastatic lesions of gastrointestinal tumors, represents a novel and promising therapeutic target. Unlike its limited expression in normal tissues, EpCAM's prevalence in GI tumors makes it an ideal candidate for targeted CAR-T therapy. Immunofoco's IMC001 leverages this strategy, positioning the product as a pioneer in treating solid tumors with techniques traditionally reserved for hematologic malignancies. This approach received further validation in August 2023 when IMC001 was awarded Orphan Drug Designation (ODD) by the U.S. FDA.

The clinical potential of IMC001 has been underscored by its impressive results in Investigator-Initiated Trial (IIT) clinical studies. Notably, at the prestigious European Society of Medical Oncology (ESMO) annual meeting in 2022 and the American Society of Clinical Oncology (ASCO) in 2023, IMC001's clinical findings were highlighted, showcasing its safety, efficacy, and significant promise in advanced gastric cancer treatment.

Early trial results are promising, with a safe and effective recommended dose established, leading to partial remission (PR) in 40% of the patients within a specific dose group. Remarkably, one patient underwent successful radical surgery 30 weeks post-IMC001 infusion, surviving 85 weeks after treatment. Another patient demonstrated a 48% tumor size reduction by week 16.

Dr. Crystal Sun, Founder, Chairman, and CEO of Immunofoco, expressed profound gratitude towards the team's efforts and highlighted the significance of achieving dual IND approval from both the U.S. and China. This approval not only advances the clinical trials of IMC001 but also sets the stage for international collaborations, offering a beacon of hope for patients with advanced GI tumors worldwide.

"Securing dual IND approval for our second CAR-T product targeted at solid tumors is not just a testament to our team's dedication but also a promising step forward in cancer treatment," Dr. Sun stated. "With EpCAM's high expression in primary, metastatic, and circulating tumor cells, targeting it for CAR-T therapy fulfills an urgent clinical need, potentially benefiting approximately 90% of patients with gastrointestinal tumors."

As Immunofoco gears up for further clinical trials, the global medical community watches eagerly, anticipating the transformative impact IMC001 could have on the future of solid tumor treatment.


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