ImmunoFocu's Nanobody-Based CLDN18.2 CAR-T Therapy Successfully Completes Phase I Dose Escalation in Pivotal Clinical Trial

Sep 27, 2024 10:02 CST Updated 10:02

Immunofoco

Developer of Novel Therapeutics for Solid Tumors

September 26, 2024, Shanghai·Suzhou·Chengdu, China – Immunofoco, a biotechnology company dedicated to developing breakthrough immunotherapy drugs for solid tumor treatments, announced the successful convening of the Safety Monitoring Committee meeting for the IMC002-RT01 clinical trial.Investigators from all eight clinical research centers participating in the project attended this meeting. During the meeting, experts unanimously acknowledged the excellent performance of the IMC002-RT01 clinical trial in terms of safety and efficacy through experience sharing and data discussion.The clinical trial successfully passed the low-dose stage.(1*10^8 CAR-T cells), Medium Dose(2.5*10^8 CAR-T cells)And high dose(5.0*10^8 CAR-T cells)Dose Escalation of Three Dose Cohorts.

This is "an open, multi-center, dose-escalation design clinical trial evaluating the safety and preliminary efficacy of IMC002 in subjects with advanced digestive system tumors positive for CLDN18.2 expression." In the Phase I dose escalation, a total of 9 patients were successfully enrolled and completed the 28-day safety evaluation. The trial results showed,No dose-limiting toxicity (DLT) events were observed in nine patients across low, medium, and high dose groups, demonstrating the excellent safety profile of IMC002, a CAR-T product for solid tumors.Preliminary data show that IMC002 has demonstrated excellent safety and efficacy in patients with advanced gastric cancer and pancreatic cancer after the failure of all standard treatments.

Professor Jianming Xu, Principal Investigator of the Phase I clinical trial of IMC002 in China, and Director of the Department of Medical Oncology at the First Medical Center of Chinese PLA General Hospital (Beijing 301 Hospital), stated:

Advanced inoperable gastric cancer and pancreatic cancer have limited treatment options after standard therapy fails, with a poor prognosis and a 5-year survival rate of less than 10%. The ongoing Phase I clinical trial of IMC002 has shown preliminary efficacy, particularly demonstrating partial responses even in late-line patients with advanced gastric cancer and liver metastases, along with excellent safety. We are highly confident in continuing to advance the clinical research of IMC002 alongside other investigators, bringing hope of long-term survival benefits and even potential cures to patients.

The Phase I registrational clinical research center for IMC002 includes the First Medical Center of the Chinese People's Liberation Army General Hospital.(Beijing 301 Hospital), Fujian Provincial Cancer Hospital(Fuzhou), The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Zhejiang University School of Medicine(Hangzhou)、Shandong Cancer Hospital(Jinan), West China Hospital of Sichuan University, The Second Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Naval Medical University(Shanghai Changhai Hospital)etc.,Recruiting Patients with Advanced Gastric Cancer。

About IMC002

IMC002 is an autologous CAR-T cell therapy targeting CLDN18.2 with highly specific VHH nanobodies. The highly specific VHH antibody is expected to enhance the tolerability of IMC002 and expand its clinical dosage range. This product received FDA Orphan Drug Designation in July 2022. Following its approval for clinical trials by the U.S. FDA, the IND application for IMC002 was granted implied permission by China's CDE in April 2023.

At this year's American Society of Clinical Oncology（ASCO）At the annual meeting, Immunofoco presented IMC002 in an investigator-initiated clinical study.（IIT）Preliminary clinical research data in China. As of January 17, 2024, three patients with advanced unresectable gastric cancer received IMC002 infusion, and no dose-limiting toxicity occurred during the treatment process.（DLT）Or Serious Adverse Events（SAE）, with good and controllable safety. Preliminary efficacy data show that, according to RECIST 1.1 assessment, all three patients achieved disease stabilization, with two of them showing tumor shrinkage. These two patients successfully underwent radical resection surgery at week 11 and week 44 after infusion of IMC002, respectively.The pathological examination of the patient who underwent surgery in the 44th week showed complete response (pCR). In July 2024, the imaging results of the follow-up examination at 6 months post-surgery indicated sustained complete response (CR), achieving cancer-free survival for over 6 months.

About Immunofoco

Immunofoco is a biotechnology company dedicated to breaking through solid tumor treatments and bringing long-term survival benefits to patients worldwide. The company, established in September 2020, was founded by scientists and industry elites. Its core team successfully advanced the first CAR-T drug's marketing application in China, boasting extensive experience in cell drug development and industrialization.

Immunofoco, starting from the pain points of solid tumor treatment and clinical benefits, proposed the clinical strategy of "transforming solid tumors into hematological tumors" for the first time globally, and on this basis, developed Peri Cruiser.^®Technical platforms, while also developing technical platforms such as SNR and T-Booster, aiming to enhance the safety of CAR-T products, counteract tumor heterogeneity, and improve their expansion and tumor infiltration capabilities.

The company always focuses on clinical value and has a rich product pipeline, including IMC002.（CLDN18.2 CAR-T）In July 2022, it received the FDA Orphan Drug Designation in the United States, and its IND application was approved by both China and the U.S. in April 2023; IMC001（EpCAM CAR-T）Two IIT clinical studies have been conducted, demonstrating good tolerability in terms of safety and preliminary efficacy. It received the U.S. FDA ODD designation in August 2023, and its IND application obtained dual approval in China and the U.S. in February 2024; IMC008（SNR CAR-T）It has rapidly advanced to the IIT clinical research stage and received two U.S. FDA ODD designations in August 2023, for the treatment of gastric cancer and pancreatic cancer, respectively.

The company adheres to the development philosophy of "collective efforts make light work, unity realizes aspirations, and courage leads to new heights," gathering top talents in the industry to jointly develop innovative drugs that can bring long-term survival benefits to patients with solid tumors. For more information, please visit the company website at www.immunofoco.com.

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