Porton Advanced Supports Immunofoco’s Second IND Clearance from China’s CDE for EpCAM CAR-T Therapy in Solid Tumors

March 21, 2025 – Porton Advanced is delighted to congratulate our partner, Immunofoco, on receiving clearance from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for its second Investigational New Drug (IND) application, with the acceptance number CXSL2400901. This IND application is aimed at treating EpCAM-positive epithelial advanced solid tumors.

Previously, IMC001 obtained IND approvals in both China and the United States in February 2024 for the treatment of EpCAM-positive advanced gastrointestinal tumors.

As Immunofoco’s trusted CDMO partner, Porton Advanced provided comprehensive services for this project, including CAR-T cell process development, GMP manufacturing, and production of samples for Investigator-Initiated Trials (IIT). Additionally, we successfully executed site transfer and comparability studies, ensuring seamless technology transition. Notably, the entire process development phase was completed in under four months, followed by first-time-right success in process transfer, scale-up production, and IIT batch manufacturing – all batches met stringent cell quality standards.

Our team’s expertise in cell therapy development and cGMP production ensured high-quality, on-time delivery, contributing to Immunofoco’s continued progress in bringing innovative oncology treatments to patients worldwide.

About EpCAM CAR-T Therapy

Epithelial cell adhesion molecule (EpCAM) is highly expressed on various epithelial-derived tumor tissues, including esophageal cancer, colorectal cancer, pancreatic cancer, ovarian cancer, lung cancer, gastric cancer, and breast cancer. In contrast, its expression is relatively low in normal tissues. Despite challenges such as the complexity of the solid tumor microenvironment and target heterogeneity, IMC001 has demonstrated favorable safety and preliminary efficacy in earlier clinical trials for gastrointestinal tumors, owing to its unique target selection and innovative design. This additional indication aims to further explore its clinical potential.

In the poster presentations at the 2024 ASCO and CSCO conferences, the IIT clinical study data of IMC001 demonstrated that among 10 evaluable patients with advanced gastric cancer, the disease control rate was 90%, with one patient in the low-dose group 33.3% and two in the middle-dose group 40% achieved a partial response (PR). The median overall survival (OS) in the medium-dose group exceeded 55 weeks. One patient in the middle-dose group achieved a confirmed PR by Week 24, leading to a radical gastrectomy at Week 27, and the patient had survived for more than 22 months by the cutoff date.

The clearance of this additional IND represents a pivotal milestone in expanding IMC001’s clinical exploration scope from gastrointestinal tumors to a broader spectrum of epithelial solid tumors, including small-cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and other malignancies.

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) has been granted Fast Track designation and orphan drug designations (ODDs) for gastric and pancreatic cancers by the U.S. FDA, and its IND application received approval in both the United States and China in April 2023. 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, 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.

About Porton Advanced

Porton Advanced Solutions is a subsidiary of the leading CDMO, Porton Pharma Solutions. Porton Advanced has headquarters in Cranbury, New Jersey, and two GMP sites in Suzhou, China, providing end-to-end CDMO solutions for ATMPs. We offer services from cell banking, process, and analytical method development, cGMP production to fill & finish, covering different stages of drug development from early research, IITs, Investigational New Drug (IND) applications, clinical trials, New Drug Applications (NDA), to commercialization.

Porton Advanced has developed specialized CRO and CDMO platforms focusing on plasmids, viral vectors (lentiviral vector, adenoviral vector, AAV,etc), cell therapy CMC services including CAR-T, TCR-T, CAR-NK, HSC, exosome, etc) and nucleic acid therapies. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector production lines, 12 GMP-compliant cell therapy production suites (including 2 suites for infectious donors), and a multitude of clean rooms. As of now, we have successfully supported our clients to secure 16 global IND approvals from NMPA, FDA, and Medsafe, with 5 ongoing Phase I/II ATMP projects. Additionally, Porton Advanced has supported the successful transition of several overseas clinical-stage pipelines into China.

Porton Advanced is committed to a customer-centric approach, offering excellent global, end-to-end CDMO services to our clients, enabling effective drugs to benefit the public sooner.