Precision Bio Announces Promising Phase I Results of Hypoxia-Responsive CEA-Targeted CAR-T Therapy with 88% Disease Control Rate in Solid Tumors at ASCO 2024

Jun 05, 2024 07:21 CST Updated 07:21

Precision Biotech

Gene and Cell Therapy Developer

June 5, 2024

eMedClub News

On June 3 local time, during the rapid oral report session on "Gastrointestinal Tumors - Colorectal and Anal Tumors," Professor Fang Weijia's team from the First Affiliated Hospital of Zhejiang University reported the latest clinical trial results of a novel CEA-targeted CAR-T cell preparation for treating CEA-positive advanced/metastatic solid tumors. This study, conducted in collaboration with Chongqing Precision Biotech Co., Ltd., utilized intraperitoneal injection, offering new strategies and insights for the treatment of solid tumors.

Research Title:

Phase I trial of hypoxia-responsive CEA CAR-T cell therapy in patients with heavily pretreated solid tumor via intraperitoneal or intravenous transfusion

A Phase I Clinical Trial of Hypoxia-Responsive CEA CAR-T Cell Therapy Administered via Intraperitoneal or Intravenous Injection for Patients with Solid Tumors Who Have Failed End-of-Line Treatment

Study Design:

Colorectal cancer is one of the most common malignant tumors worldwide, with 1.932 million new cases diagnosed globally in 2020, resulting in nearly 935,000 deaths. The prognosis for colorectal cancer patients whose disease continues to progress despite extensive treatment is extremely poor, with current treatments showing an efficacy rate of only around 6% for such patients.

This trial mainly targets patients with advanced colorectal cancer who have undergone extensive treatment and is an open, single-arm clinical study. It is divided into two subgroups based on the infusion method (intravenous infusion and intraperitoneal local infusion). Each subgroup includes a dose exploration phase (Part A) and a dose expansion phase (Part B). In the dose exploration phase, three patients per group are explored, starting from the low-dose group and increasing incrementally. After completing the dose exploration, the appropriate recommended dose will be expanded to further verify its safety and efficacy.

Research Results:

The results showed that a total of 40 patients received targeted CEA CAR-T cell preparation treatment, including 24 cases in the intravenous infusion group and 16 cases in the intraperitoneal injection group.

Effectiveness:The objective response rate (ORR) of the intraperitoneal injection group was 25%, and the disease control rate (DCR) was 88%.Among them, the ORR of the high-dose intraperitoneal injection group was 28.5%. Moreover, the patients who achieved remission in the high-dose group maintained their tumor relief for over 5 months, including one patient whose tumor lesion continued to shrink by 76% at the 6-month follow-up.

The objective response rate of the intravenous infusion group was 8%, and the disease control rate was 67%.

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Safety: While achieving significant efficacy, no patients experienced grade 3 or higher cytokine release syndrome, and no neurotoxicity occurred in any of the patients. The incidence rates of immune-related diarrhea and colitis were 32.5%, with grade 3 adverse events occurring at a rate of 17.5%.

This study demonstrated the excellent clinical safety and efficacy of the CEA-targeted CAR-T cell therapeutic product.

Research Conclusion:

Targeted CEA CAR-T cell preparation shows considerable efficacy and controllable safety in treating CAE-positive patients with advanced/metastatic solid tumors; no Grade 3 or higher CRS events occurred, and no ICANS events were reported. In CEA-positive patients, intraperitoneal infusion achieved an ORR of 25% and a DCR of 88%, while intravenous infusion reached an ORR of 8% and a DCR of 67%, demonstrating encouraging anti-tumor effects.

Report link: https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3514

CEA (Carcinoembryonic Antigen) is a glycoprotein typically expressed during the development of cancer embryos and also present in normal colonic mucosa. CEA is overexpressed on the surface of many cancer cells, including colorectal cancer, 70% of non-small cell lung cancers, and approximately 50% of breast cancers. Except for low expression in gastrointestinal epithelial cells, CEA is hardly expressed in other normal cells.

Solid tumors, due to their high heterogeneity and complex tumor microenvironment, have always been a key and difficult point in clinical treatment that needs to be addressed. Developing new technologies to resist and/or reverse the immunosuppressive tumor microenvironment is a common challenge in the current field of cancer immunotherapy. Chongqing Precision Biotech Co., Ltd. has conducted in-depth research on CAR-T cell therapy for solid tumors, developing the PhiCAR® and RESCAR® technology platforms to counteract the tumor microenvironment in solid tumors. The CAR-T product targeting the CEA antigen is based on the above two platform technologies.

About Precision Biotech

Chongqing Precision Biotech Co., Ltd. was established in 2016 as a high-tech enterprise jointly founded by a technical team led by renowned precision medicine scientist Professor Qian Cheng and listed company Zhifei Biological (Zhirui Investment). The company focuses on gene and cell drug development and application, using gene editing and synthetic biology technology as its starting point. It has now become one of the leading enterprises in China’s CAR-T/NK field and aims to become a global, innovative, and pioneering biopharmaceutical company.

References:

[1]Chongqing Precision Biotech Co., Ltd. Official WeChat

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