On September 27, 2024, Immunofoco Biotech, a company dedicated to developing cell therapy products for solid tumors, announced that the successful completion of the Safety Monitoring Committee (SMC) meeting for its IMC002-RT01 clinical trial. During this meeting, experts, after extensive experience sharing and thorough data discussions, unanimously affirmed the excellent safety performance of the IMC002-RT01 clinical trial, which smoothly passed the dose-escalation trials for low (1×10^8 CAR-T cells), medium (2.5×10^8 CAR-T cells), and high (5.0×10^8 CAR-T cells) dose groups.
This is an open-label, multicenter, dose-escalation study designed to evaluate the safety and preliminary efficacy of IMC002 in patients with advanced digestive system tumors expressing CLDN18.2. A total of 9 patients have successfully enrolled and completed Phase I dose-escalation and a 28-day safety assessment. The trial results indicate that no dose-limiting toxicities (DLTs) were observed in any of the 9 patients across low, medium, and high dose groups, demonstrating the excellent safety profile of IMC002 CAR-T product for solid tumors. Preliminary data has shown good safety and efficacy of IMC002 in advanced gastric and pancreatic cancers where standard treatments have failed.
Professor Jianming Xu, principal investigator for the IMC002 Phase I clinical trial in China and Chief Physician at Beijing 301 Hospital's Oncology Department, remarked: "For patients with advanced, unresectable gastric and pancreatic cancers, traditional treatments offer limited options, and the five-year survival rate is less than 10% after standard therapy has failed. The Phase I clinical trial results for IMC002 indicate preliminary efficacy, particularly in showing partial remission in late-stage gastric cancer patients who have failed all previous lines of therapy, including those with liver metastases. Moreover, the trial has demonstrated excellent safety profiles, and we are very confident in continuing the clinical research of IMC002 with other researchers, potentially offering long-term survival benefits or even hope for a cure to these patients."
The Phase I clinical trial of IMC002, initiated across several renowned hospital research centers such as the First Medical Center of the General Hospital of the Chinese People's Liberation Army (Beijing 301 Hospital), Fujian Provincial Cancer Hospital, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Zhejiang University School of Medicine in Hangzhou, Shandong Cancer Hospital, West China Hospital of Sichuan University, The Second Affiliated Hospital of Nanchang University, and The First Affiliated Hospital of the Naval Medical University (Changhai Hospital in Shanghai). These centers are currently enrolling patients with advanced gastric cancer.
About IMC002
IMC002, the first CAR-T product utilizing a highly specific VHH nanobody, is an autologous CAR-T product targeting CLDN18.2. The highly specific VHH antibodies have equipped the CAR-T with a better safety and wider clinical dose window. Recognized with Orphan Drug status by the FDA, the therapy received IND approval from China CDE in April 2023 following U.S. approval.
At this year's American Society of Clinical Oncology (ASCO) Annual Meeting, Immunofoco presented preliminary clinical data of IMC002 from an investigator-initiated trial (IIT). There were no dose-limiting toxicities (DLTs) or serious adverse events (SAEs) reported. All three patients experienced manageable cytokine release syndrome (CRS) at grade 1, with all adverse events resolving quickly. Preliminary efficacy data showed stable disease as the best overall response in all patients, as evaluated by RECIST 1.1 criteria. Two patients, who received a dosage of 3 million CAR-T cells/kg, underwent successful radical surgeries at 11 and 44 weeks following IMC002 infusion, respectively, after a reduction in tumor burden by CAR-T treatment. Notably, one patient achieved a pathological complete response (pCR) with surgery at 44 weeks. As of July 2024, medical imaging during the 6-month follow-up after surgery continued to show a complete response (CR) for this patient, indicating over six months of cancer-free survival.
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 www.immunofoco.com.
