Immunofoco Biotech to Present Solid Tumor CAR-T Trial Data at 2024 ASCO

CHICAGO, June 1, 2024** — Immunofoco Biotech, a pioneering firm in cell therapy for solid tumors, has announced that its latest clinical research findings will be featured at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Scheduled from May 31 to June 4, 2024, the event will host Immunofoco’s data on two key products, IMC001 and IMC002, through a poster and an online presentation.

IMC002: Targeting CLDN18.2 in Advanced Solid Tumors

IMC002 is an autologous CAR-T cell therapy targeting Claudin 18.2 (CLDN18.2), a promising marker for advanced solid tumors. Extensive preclinical studies have demonstrated that IMC002 has high tumor specificity and efficacy, without compromising safety. The product utilizes a specific anti-CLDN18.2 VHH to direct CAR-T cells, confirmed by a membrane proteome array assay.

As of January 17, 2024, three patients with advanced, unresectable gastric cancer received IMC002 infusions. These patients experienced manageable cytokine release syndrome (CRS) at grade 1, with no serious adverse events (SAEs) or dose-limiting toxicity (DLT). Preliminary efficacy data indicated a stable disease response in all three patients, assessed using RECIST 1.1 criteria. Furthermore, two patients who received a dosage of 3 million CAR-T cells/kg underwent successful surgeries 11 and 44 weeks post-infusion, with one achieving pathological complete response (pCR).

Additionally, significant CAR-T cell expansion was observed in peripheral blood, with peaks between days 7 and 11 post-infusion. CAR-T cell infiltration into tumor tissues was also confirmed in surgical samples. Serum levels of IFN-y, IL-10, IP-10, IL-2, and IL-6 increased significantly in all patients, indicating the therapy’s potent anti-tumor activity. The trial is ongoing, showing promising results.

IMC001: Advancements in EpCAM CAR-T Therapy

IMC001 targets EpCAM, another significant marker in advanced gastrointestinal cancers. Clinical trial results, presented in a poster, revealed the product’s favorable safety and preliminary efficacy. Conducted in collaboration with Shanghai Changhai Hospital and Zhejiang University, the trial included 11 patients treated between August 2021 and May 2023.

As of March 31, 2024, IMC001 demonstrated a 90% disease control rate among 10 evaluable patients. Partial responses (PR) were observed in the low- and middle-dose groups, leading to the determination of the middle dose as the recommended dose. Median progression-free survival (PFS) was 18.1 weeks, and median overall survival (OS) was 55.1 weeks. Notably, one patient in the middle-dose group achieved a confirmed PR by Week 24 and underwent successful surgery at Week 27, surviving more than 22 months post-infusion.

Expert Insights and Future Directions

Dr. Tianhang Luo, the principal investigator for IMC001 and IMC002 trials, highlighted remarkable cases where patients with previously unresectable gastric cancers became eligible for surgery post-CAR-T therapy. One notable case showed complete remission with no tumor cells detected during pathological examination 10 months after IMC002 infusion.

Dr. Minmin Sun, Founder, Chairman, and CEO of Immunofoco Biotech, emphasized the promising safety and efficacy of IMC002 and IMC001. He stressed the potential of these therapies to provide innovative treatment options for cancer patients worldwide. The company aims to advance to registrational phase II clinical trials, driven by the encouraging clinical results.

About Immunofoco Biotech

Immunofoco Biotech focuses on addressing the challenges in solid tumor treatment by leveraging its innovative platforms, including Peri Cruiser®, SNR, and T-Booster. Their IMC002 and IMC001 products have received Orphan Drug Designation (ODD) from the U.S. FDA and have progressed through various regulatory stages in the U.S. and China. Upholding the ethos of collaboration and dedication, Immunofoco continues to develop cell therapies offering substantial survival benefits for patients with solid tumors.

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