PAP CAR-T Therapy Demonstrates 80% PSA Response Rate in Desmoplasia-Resistant Prostate Cancer at SITC 2024

Sep 05, 2024 21:00 CST Updated 21:00

ICT

Oncology Drug Developer

Guide

The 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) will be held from November 6 to 10, 2024, in Houston, USA. The SITC Annual Meeting is one of the premier international conferences dedicated to cancer immunotherapy, providing a multidisciplinary platform for thousands of international industry leaders and representatives from academia, regulatory agencies, and government institutions. It aims to collectively advance scientific progress, discover breakthrough developments, and improve outcomes for cancer patients.

ICT (hereinafter referred to as "ICT") is a company focused on developing CAR-T cell therapies for solid tumors.Clinical-stage biotechnology company for therapeutic products,The company's collaboration with Shanghai Tenth People's Hospital on the leading therapy for solid tumors, PAP CAR-T clinical trialsThe research abstract was honored to be selected.Will be presented in poster format at this year's SITC Annual Meeting.PAP CAR-T Cell Therapy is one of the product pipelines developed by ICT based on its self-developed CoupledCAR platform technology, used to treat patients with refractory prostate cancer.

Abstract Information

Abstract Title:A Phase I clinical trial evaluating the safety and preliminary efficacy of PAP CAR-T cells for the treatment of desmoplasia-resistant prostate cancer(Phase I Clinical Trial Study on the Safety and Preliminary Efficacy Evaluation of PAP CAR-T Cell Therapy for Refractory Prostate Cancer)
Abstract Number:5611

This is a Phase I clinical trial initiated by investigators, conducted in collaboration between ICT and the Shanghai Tenth People's Hospital. It is an open-label, single-arm, single-drug, single-infusion study in which three patients received infusion treatment and completed evaluation. According to the standards of the Prostate Cancer Working Group 3 (PCWG3) guidelines, two patients achieved PSA response (Note: PSA response refers to a reduction of more than 50% in the level of PSA, a prostate cancer-specific marker, compared to baseline). The PSA levels decreased by 82.70% and 83.38%, respectively, resulting in a PSA response rate of 66.7%.In terms of side effects,Two patients experienced Grade 1 cytokine release syndrome (CRS), and no patients developed neurotoxicity.

The IRB clinical trial in China for this prostate cancer product enrolled a total of 5 patients (with 2 additional patients enrolled at other centers), out of which 4 achieved PSA remission, resulting in an 80% PSA remission rate.

The above data show that PAP CAR-T demonstrates promising preliminary clinical efficacy and manageable safety in patients with refractory prostate cancer.

Global Leading Solid Tumor CAR-T Platform Technology and Products

ICT's Self-Developed CoupledCAR Technology Breaks the Limitations of Traditional CAR-T Technology in Solid Tumors, Achieving Effective Treatment of Solid Tumors with Single-Agent, Single Infusion of CoupledCAR-T Cells. With Over 300 Global Patents and Patent Applications in the CAR-T Technology Field, ICT is at an Internationally Leading Level. Moreover, CoupledCAR is a Platform Technology that Can Be Extended to Multiple Solid Tumor Targets and Indications. In Addition to Prostate Cancer, ICT’s Lead Candidate Product GCC19CART Has Demonstrated Significant Efficacy in Treating Patients with Advanced Colorectal Cancer and Is Expected to Become the World’s First Approved CAR-T Product for Colorectal Cancer Treatment.

The multi-center Phase I dose-escalation clinical trial of GCC19CART, initiated by investigators in China, showed that the objective response rate (ORR) was 15.4% in the low-dose group (1x10^6 CAR-T/kg) and 50% in the medium-dose group (2x10^6 CAR-T/kg). Currently, GCC19CART is undergoing a Phase I clinical trial in the United States. The low-dose group has completed enrollment, with a total of 4 patients receiving infusion treatment and completing evaluation. According to the RECIST 1.1 criteria assessed by an independent third-party in the U.S., the ORR for the low-dose group was 50%. The medium-dose group clinical trial is ongoing, with 5 patients having completed infusion treatment, achieving an ORR of 80%. The above data indicate that the efficacy of GCC19CART in the U.S. clinical trial is significant, and the results are superior to those of the same dose groups in Chinese clinical studies, further validating the Chinese data. Moreover, the clinical efficacy is much better than the standard third-line therapy approved by the U.S. FDA (with an ORR of only 1%-2%).

The excellent clinical efficacy of colorectal cancer and prostate cancer products demonstrates the effectiveness and scalability of ICT's CoupledCAR platform technology. It is believed that in the future, it can be used to treat more other indications and benefit 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 treating advanced solid tumors (such as colorectal cancer). The company’s CAR-T cell therapy product for advanced colorectal cancer, GCC19CART, has received clinical trial approval and Fast Track designation from the U.S. Food and Drug Administration (FDA). Currently, the U.S. clinical trial CARAPIA-1 is underway, with the clinical trial identifier: NCT05319314. ICT is also advancing a robust pipeline of CAR-T candidates targeting other solid tumors, including prostate cancer and pancreatic cancer.. For more information, please visitwww.ictbio.com。

Investor Contact Information

Email: ir@ictbioinc.com

Contact Number: 021-58959719