December 16, 2025 — Immunofoco, a clinical-stage biotech company, devoted to developing innovative immune cell therapies for patients with solid tumors worldwide, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to IMC002, the company’s investigational autologous CAR-T cell therapy targeting Claudin18.2 (CLDN18.2).
The RMAT designation covers IMC002 for the treatment of patients with CLDN18.2-positive, unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (GEJ) cancer who have failed at least two prior lines of systemic therapy, based on preliminary clinical evidence addressing a significant unmet medical need.
IMC002 is an autologous CAR-T cell therapy developed using a high-specificity nanobody-based CAR design targeting CLDN18.2, a validated tumor-associated antigen highly expressed in gastric and gastroesophageal cancers.
Preclinical data and an initial clinical case report involving a pathological complete response (pCR) have been published in the international oncology journal Molecular Cancer Therapeutics. The reported clinical case involved a patient with advanced gastric cancer who achieved pCR following a single infusion of IMC002 administered as monotherapy. As of nearly three years post-infusion, no tumor recurrence has been observed, and the patient continues to maintain durable complete remission.
In China, IMC002 has demonstrated a favorable safety profile and encouraging anti-tumor activity in a completed Phase I/IIa clinical trial. A Phase III pivotal trial is currently enrolling patients across more than 30 clinical centers nationwide. Immunofoco also received FDA feedback at an End-of-Phase I (EOP1) meeting in March 2025, supporting regulatory alignment for future U.S. clinical development.
RMAT designation, established under the 21st Century Cures Act, is intended to expedite the development of regenerative medicine therapies for serious or life-threatening diseases and provides benefits including early and frequent FDA interactions, rolling review, and potential eligibility for accelerated approval pathways.
“Receiving RMAT designation marks an important milestone in the global development of IMC002,” said Minmin Sun, Ph.D., Founder, Chairman, and CEO of Immunofoco. “It recognizes the early clinical evidence and supports our continued collaboration with the FDA as we advance IMC002 through late-stage development, while accelerating our Phase III program in China.”
About Immunofoco
Immunofoco is a clinical-stage biotech company, devoted to developing innovative immune cell therapies for patients with solid tumors worldwide. The company was established in September 2020 in Zhangjiang, Shanghai, by a team of renowned scientists and industry experts who achieved the approval of the first CAR-T product in China.
Immunofoco has developed several innovative platforms that overcome the treatment challenges of solid tumors. These platforms, such as Peri Cruiser, SNR, T-Booster, FOCO-CAR, Solid Guard are designed to improve the safety and efficacy of CAR-T products by 1) limiting CART entry to normal tissues, 2) counteracting tumor heterogeneity, 3) enhancing CART activation, proliferation and infiltration, We also developed iMagic platform that utilizes a noval fusogen and T-cell targeting modules to allow effecient T-cell transduction and CART generation in vivo.
Committed to addressing unmet clinical needs, our company has built a diverse and robust product pipeline. Notably, IMC002, a CLDN18.2-targeted CAR-T therapy, has progressed to a Phase III pivotal trial in China. This milestone follows the U.S. FDA and Chinese NMPA approvals of its Investigational New Drug (IND) applications in April 2023. IMC002 has also received significant regulatory recognitions from the U.S. FDA, including Fast Track Designation (FTD), Regenerative Medicine Advanced Therapy (RMAT) designation, and Orphan Drug Designation for both gastric cancer and pancreatic cancer. Similarly, our IMC001 (EpCAM CAR-T) product obtained ODD from the U.S. FDA in August 2023, and its IND application has been approved in both the U.S. and China in February 2024, followed by the approval of a second IND in China in March 2025. The IMC008 (SNR CAR-T) product has rapidly moved to the IIT stage and received two ODD approvals from the U.S. FDA in August 2023.
In December 2022, we successfully completed the construction validation of our nearly 2500m2 GMP plant in Suzhou and commenced operations. Additionally, our commercial manufacturing base in Chengdu is currently under construction. The company upholds the development concept of “collaboration, aspirations, striving for new heights,” by assembling industry talents and expert support to jointly develop innovative cell therapies that provide long-term survival benefits to patients with solid tumors. For more information about Immunofoco, please visit the company’s website at www.immunofoco.com.
