ImmuneOnco Presents Clinical Data of Two CAR-T Therapies for Solid Tumors at ASCO Annual Meeting

On May 31, Immunofoco announced that during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place from May 31 to June 4, the company will present clinical research data for IMC001 in a poster session and showcase the latest clinical research data for IMC002 online.

IMC002：TargetedCLDN18.2 CAR-T Autologous Cell Therapy

Indications: CLDN18.2-positive advanced solid tumors

IMC002 is an autologous CAR-T cell drug that targets CLDN18.2 based on highly specific VHH antibodies.，Highly specific VHH antibodies are expected to enhance the tolerability of IMC002 and expand its clinical dosage range. This product was granted orphan drug designation by the U.S. FDA in July 2022. Following FDA approval for clinical trials, the IND application for IMC002 received implied approval from China's CDE in April 2023.

This presentation showcases an open-label Phase 1 dose-escalation study designed to evaluateIMC002 in CLDN18.2-positive advanced solid tumorsin terms of safety, efficacy, pharmacokinetics, and pharmacodynamics, among other aspects.

As of January 17, 2024, three patients with advanced unresectable gastric cancer received IMC002 infusions. No dose-limiting toxicity (DLT) or serious adverse events (SAE) occurred during the treatment, demonstrating good and manageable safety. Preliminary efficacy data showed that all three patients achieved stable disease according to RECIST 1.1 evaluation. Notably, two of these patients successfully underwent radical surgery in the 11th and 44th weeks after IMC002 infusion, respectively. The postoperative pathological examination of the patient who had surgery at week 44 indicated complete pathological response (pCR).

In addition, significant expansion of CAR-T cells was observed in the peripheral blood of all three patients, with the number of CAR+ cells peaking between 7 to 11 days after infusion. CAR-T cell infiltration was also detected in the surgical samples of the two patients who underwent surgery.

IMC001: CAR-T Targeting EpCAM

Indications: Advanced Gastric Cancer

Epithelial Cell Adhesion Molecule (EpCAM) is highly expressed in various epithelial-derived tumor tissues, including gastrointestinal tumors, with expression rates exceeding 90% in both colorectal and gastric cancers. Additionally, EpCAM can serve as a therapeutic target for circulating tumor cells (CTCs). The expression of EpCAM in metastatic lesions is often higher than in primary tumors and does not lead to antigen loss due to metastasis. Therefore, EpCAM-targeted CAR-T can simultaneously target primary tumors, CTCs, and metastatic lesions. The development of IMC001 aims to address the challenges of metastasis and recurrence by targeting EpCAM, providing a new treatment option for advanced digestive system cancers.

From August 18, 2021, to March 31, 2023, a total of 11 patients received IMC001 CAR-T cell infusion, with 10 evaluable for efficacy and included in the efficacy analysis. The data shows:

• Most patients experienced CAR-T cell expansion, with IMC001 persisting for 4 to 12 weeks.

• Among 10 patients who had undergone at least one efficacy evaluation,IMC001 Infusion Shows 90% Disease Control Rate。

• One patient (1/3, 33.3%) in the low-dose group and two patients (2/5, 40%) in the medium-dose group achieved partial response (PR).

• In the medium-dose group, 3/5 of the patients had survived for more than 10 months at the time of the study cutoff. Among them, one patient confirmed to have reached PR at week 24 and underwent radical gastrectomy at week 27, surviving for over 22 months as of the cutoff date.

• Analysis of the tumor immune microenvironment suggests that an inflammatory tumor environment may enhance the anti-tumor effects of IMC001.