ICT Announces Breakthrough in Solid Tumor CAR-T Therapy with GCC19CART, Submits IPO Prospectus

Apr 18, 2024 20:08 CST Updated 20:08

ICT

Oncology Drug Developer

ICT (hereinafter referred to as "Si Dan Race") recently participated in the AACR Annual Meeting in the United States and presented a poster showcasingProgress of the U.S. Phase I Clinical Trial for GCC19CART, a Leading Solid Tumor Therapy Developed Based on the Self-Developed CoupledCAR Platform Technology; This Product is Being Developed for the Treatment of Patients with Relapsed/Refractory Metastatic Colorectal Cancer (R/R mCRC)。

Dr. Bridget Keenan, a clinical research physician in the United States, commented on the Twitter platform after the meeting, praising GCC19CART as "a beacon of hope for desperate diseases."

Twitter Post by Dr. Bridget Keenan After the Conference

AbstractContent Overview

GCC19 CART is an autologous CAR-T product specifically designed to target GCC for the treatment of advanced colorectal cancer. A multi-center Phase I dose-escalation clinical trial initiated by investigators in China showed that, according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the objective response rate (ORR) was 15.4% (2/13) in the low-dose group (1x10^6 CAR-T/kg) and 50% (4/8) in the medium-dose group (2x10^6 CAR-T/kg).

In August 2022, the Phase I clinical trial of GCC19CART was initiated in the United States. As of November 1, 2023 (data cutoff date), dose level 1 (1x10^6 CAR-T/kg) has completed enrollment (dose level 1 is the low-dose level), with a total of 4 subjects receiving infusion treatment and completing evaluation. Imaging results were assessed by an independent U.S. third-party imaging evaluation agency. According to the RECIST 1.1 criteria, the independently reviewed ORR was 50% (2/4), with 2 subjects showing partial response (PR). Based on the clinicians' assessment, the median progression-free survival (PFS) for dose level 1 was 3.8 months; dose level 2 (2x10^6 CAR-T/kg) is currently ongoing.

Conclusion: The preliminary results of the Phase I clinical trial in the United States indicate that GCC19CART demonstrates significant clinical efficacy and favorable safety in patients with relapsed/refractory metastatic colorectal cancer. Combined with clinical trial data from China, it can be seen that the clinical efficacy is positively correlated with the dosage. The trial is still ongoing. Clinical trial information: NCT05319314.

Colorectal Cancer: HugeUnmet Medical and Market Needs

The latest global cancer burden data shows that in 2022, there are expected to be nearly 20 million new cancer cases globally. Among the common newly diagnosed cancers, colorectal cancer ranks third, with approximately 1.92 million cases. It is estimated that there will be 9.7 million cancer deaths globally, with colorectal cancer accounting for the second highest number of deaths, approximately 902,000. According to relevant statistics, about 286,000 people die from colorectal cancer annually in China, ranking fourth in terms of cancer mortality rate; in the United States, about 54,000 people die from colorectal cancer each year, ranking second in terms of mortality rate. These concerning figures reflect a significant medical and market demand.

The Dawn of Cure: The World's Leading CoupledCAR Proprietary Solid Tumor CAR-T Platform

Currently, nine CAR-T therapies have been approved worldwide, but all are for the treatment of hematologic tumors; CAR-T therapy for solid tumors still awaits breakthroughs.

This is attributed to several factors: the difficulty of CAR-T expansion in solid tumors, insufficient infiltration into tumor tissues, immune suppression by the tumor microenvironment, and the scarcity of safe and effective targets for solid tumors. To address these issues, ICT has developed the CoupledCAR platform technology, specifically designed for solid tumor CAR-T through continuous technological updates and iterations, combined with newly screened tumor-specific and safe targets to treat various solid tumors. ICT owns more than 300 global patents and patent applications in the CAR-T technology field, placing it at an internationally leading level.

GCC19CART is the first candidate product developed by ICT based on this platform technology. Currently, ICT is the only company in the world with promising clinical data using CAR-T therapy for colorectal cancer. With substantial clinical trial data support, ICT is expected to provide the world's first approved CAR-T product for the treatment of colorectal cancer.

In addition to colorectal cancer, the CoupledCAR technology has also demonstrated clinical efficacy in prostate cancer clinical trials. PAPCART, a prostate cancer product targeting PAP, is advancing in clinical trials in China. Among the five subjects who have been infused, four achieved a PSA response (Note: PSA response refers to a reduction of more than 50% in the level of PSA, a specific marker for prostate cancer, compared to baseline). The efficacy of the prostate cancer product further demonstrates that CoupledCAR, as a platform technology, has excellent scalability and can potentially treat more indications in the future, benefiting more patients.

About ICT

ICT is a clinical-stage biotechnology company focused on developing CAR-T cell therapy products for solid tumors. ICT's unique CoupledCAR platform technology aims to overcome the key challenges in treating solid tumors, and CAR-T products developed based on this platform have already achieved promising clinical outcomes in the treatment of advanced solid tumors such as colorectal cancer. The company’s CAR-T cell therapy product for advanced colorectal cancer, GCC19CART, received clinical trial approval from the U.S. Food and Drug Administration (FDA) in August 2021 and was granted Fast Track designation by the FDA in April 2022. Clinical trials in the United States are currently ongoing. ICT is also developing a robust pipeline of CAR-T candidates targeting other solid tumors, including prostate cancer and pancreatic cancer.

E.N.D

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Disclaimer: The content is sourced from the official ICT. This article aims to share knowledge, and all content is for reference only and does not constitute any advice.