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CHICAGO, June 1, 2024 /PRNewswire/ -- On June 1st, 2024, Immunofoco Biotech, 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 showcase the latest clinical trial findings for IMC001 in a poster presentation and for IMC002 in an online presentation during the ASCO event, scheduled from May 31 to June 4, 2024. Outstanding safety and efficacy data of IMC002, an autologous CLDN18.2-targeting CAR-T, in CLDN18.2+ advanced solid tumors (e16012) Claudin 18.2 (CLDN18.2) is a promising therapeutic target for treating advanced solid tumors. IMC002 is an autologous CLDN18.2-targeting CAR-T cell directed by a high specific anti-CLDN18.2 VHH, the specificity of which was confirmed by a membrane proteome array assay. Preclinical studies showed that IMC002 exhibited high tumor specificity, potent anti-tumor efficacy, and excellent safety profile in both cellular and animal models. As of January 17, 2024, three patients with advanced unresectable gastric cancer received IMC002 infusion. There was no dose-limiting toxicity (DLT) or serious adverse events (SAE) reported. All three patients experienced manageable cytokine release syndrome (CRS) at grade 1. In addition, all adverse events recovered quickly. Preliminary efficacy data showed that all three patients exhibited stable disease as their best overall response, as evaluated by RECIST 1.1 criteria. Among the two patients who received a dosage of 3 million CAR-T cells/kg, successful radical surgeries were performed at week (W) 11 and 44 post-IMC002 infusion respectively when CAR-T treatment reduced the tumor burden. Notably, pathological complete response (pCR) was achieved in one patient with surgery at W44. Noteworthy expansion of CAR-T cells in peripheral blood was observed in all three patients, with peak CAR+cell counts recorded between day 7-11 in the peripheral blood post-infusion. Moreover, CAR-T cell infiltration in the tumor tissues was detected in the surgical samples obtained at weeks 11 and 44. Significant increases of serum levels of IFN-y, IL-10, IP-10, IL-2 and IL-6 were observed in all three patients. The trial remains ongoing. IMC002 demonstrated a promising safety profile, along with encouraging anti-tumor effects, including observed pCR and sustained expansion within tumor tissues, even at the low dosage levels among patients with advanced CLDN18.2+ gastric cancer. In addition, our trial has successfully facilitated a surgical treatment intervention following CAR-T therapy, enabling the downstaging of previously deemed unresectable gastric cancers. Efficacy of EpCAM CAR-T IMC001 in advanced gastric cancers (Poster #4043) An exciting phase I clinical trial was presented, showcasing the innovative application of CAR-T cell therapy targeting EpCAM for the treatment of advanced gastrointestinal (GI) cancers. Led by a collaborative team of physicians and scientists from Shanghai Changhai Hospital, The First Affiliated Hospital of Zhejiang University, and Suzhou Immunofoco Biotechnology Co., Ltd, the trial demonstrated promising safety and preliminary efficacy findings for IMC001. Between August 18, 2021, and May 8, 2023, a total of 11 patients underwent IMC001 CAR-T cell infusion. As of the cutoff date (March 31st, 2024), infusions of low- and middle-dose IMC001 demonstrated a favorable safety profile. Among 10 evaluable patients, the disease control rate was 90%, with one patient in the low-dose group (1/3, 33.3%) and two in the middle-dose group (2/5, 40%) achieved a partial response (PR). The middle-dose was determined as the Recommended Dose, the median progression-free survival (PFS) was 18.1 weeks (95% CI 7.97, --) and the median overall survival (OS) was 55.1 weeks (95% CI 23.78, --) for this group; within the middle-dose group, 3/5 patients survived for more than 10 months. 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. Analysis of tumor immune microenvironment suggested that an inflamed tumor environment may favor the anti-tumor effects of IMC001. In this phase I dose-escalation trial, IMC001 exhibited a favorable safety profile and encouraging efficacy in patients with advanced, pre-treated gastric cancer (GC). Further investigation is needed to further evaluate the potential of IMC001 for patients with advanced GC. Dr. Tianhang Luo, a distinguished chief physician from Shanghai Changhai Hospital and principal investigator for the IMC001 and IMC002 trials, commented, "We have witnessed remarkable cases at our institution where patients, after receiving infusion with IMC001 or IMC002 CAR-T cell products, became eligible for surgical treatment by downstaging previously unresectable gastric cancers. Notably, there was a case where a patient treated with IMC002 underwent surgery about 10 months after CAR-T infusion, and the pathological examination of the resected tumor tissues showed only fibrous and adipose tissues without any tumor cells. This indicates successful infiltration of CAR-T cells into the solid tumor, effectively eliminating the tumor cells. A single infusion of CAR-T cells achieved disease control for over a year, with the tumor shrinking to complete remission, greatly reducing the need of other medication for the patient. This demonstrates the tremendous potential of CAR-T cell therapy in treating solid tumors." Dr. Minmin Sun, Founder, Chairman, and CEO of Immunofoco Biotech, stated in an interview: "IMC002 and IMC001 have shown good safety and significant anti-tumor effects in treating patients with advanced gastric cancer. CAR-T cells have shown ongoing expansion within tumor tissues, with one patient achieving complete remission upon pathological examination. These encouraging results have greatly strengthened our commitment to expanding the scope of clinical trials and quickly advance to registrational phase II clinical trials. We firmly believe that IMC002 & IMC001 will offer more innovative treatment options to cancer patients worldwide." 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, and 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 . SOURCE Immunofoco

- The first EpCAM targeted CAR-T product obtained US/CN IND approval. - Acceptable safety profiles and preliminary efficacy were observed in Investigator-Initiated Trial (IIT) clinical studies of IMC001. SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell therapy products for solid tumors, announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ). EpCAM serves as a biomarker for circulating tumor cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while its expression in normal tissues is low. It has been identified as a promising therapeutic target for GI tumors with a wide range of expandable indications. IMC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of "curing the solid tumors by treating them as hematologic malignancies ". In August 2023, the product was granted Orphan Drug Designation (ODD) by the U.S. FDA. The impressive clinical results of IMC001 have been shared at prestigious medical conferences, including being orally presented at the annual meeting of the European Society of Medical Oncology (ESMO) in 2022 and updated during the American Society of Clinical Oncology (ASCO) in 2023. As of January 31, 2024, in the IIT clinical trial for advanced gastric cancer, a safe and effective recommended dose has been identified, with two (2) out of five (5) patients in this dose group achieved partial remission (PR), with an overall response rate (ORR) of 40%. Among them, one PR patient underwent a successful radical surgery for gastric cancer 30 weeks after a single infusion of IMC001 and is still alive 85 weeks after IMC001 treatment. Another PR patient exhibited a 48% reduction in tumor size by week 16. Dr. Crystal Sun, Founder, Chairman, and CEO of Immunofoco, expressed her congratulations and gratitude to the entire team. She highlighted the significance of Immunofoco's achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China. Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells. About 90% of the patients with gastrointestinal tumors exhibit EpCAM expression, which satisfies a broader clinical need. With the US/CN approval of this IND application, IMC001 is now poised to undertake further clinical trials and forge international collaborations, positioning itself as a promising new therapeutic option for patients with advanced GI tumors on a global scale. 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 . SOURCE Immunofoco