Gracell Biotechnologies to Present First-in-Class Dual-Target CRISPR-Edited TIL Therapy GT316 for Solid Tumors at ASCO 2024

The 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024) will be held in Chicago from May 31 to June 4. Grail Bio will participate in this conference and present the latest research findings in the field of cell therapy in the form of a poster:GT316, the world's first CRISPR dual-target gene-edited TIL injection, has demonstrated good safety and clinical efficacy in multiple patients with advanced solid tumors.。

TIL (Tumor-Infiltrating Lymphocytes) have shown promising therapeutic effects in various solid tumors and significantly extended the survival of patients with advanced-stage cancer. However, the preparation process of TIL makes TIL products prone to an "easily exhausted" state, and the tumor microenvironment commonly exhibits immunosuppressive signals, both of which affect the persistence and anti-tumor efficacy of TIL products in vivo.

Grail Bio has established the CRISPR screening platform ImmuT Finder.^®。Combined with multiple rounds of in vivo and in vitro screening and validation,Identified a CRISPR dual-target knockout pipeline that significantly improves TIL function and persistence——GT316Grit Bio presented preliminary safety and clinical efficacy data from the GT316 TIL injection clinical study, marking the world's first CRISPR double-knockout TIL product to enter the clinical stage.

As of January 22, 2024,A total of 4 gynecological cancer patients who failed multiple lines of treatment were enrolled., including ovarian cancer and cervical cancer. After patients complete the non-myeloablative lymphodepleting chemotherapy regimen, they receive an infusion of GT316 TIL cells and an injection of IL-2.

In terms of safety, GT316 demonstrated a good safety profile. No SAEs directly related to GT316 TIL cells were observed, and no dose-limiting toxicity (DLT) occurred. In terms of clinical efficacy, significant tumor reduction and disease remission have been observed in multiple patients.

One patient with refractory cervical cancer showed significant tumor reduction after 4 weeks of GT316 treatment, complete tumor elimination (CR) at 38 weeks, and the response was sustained. Another ovarian cancer patient, previously treated with 9 systemic therapies, showed partial tumor reduction (PR).75% of patients have an OS close to one year.. Data on disease remission are still being collected.

Moreover, in terms of cell persistence, T cells could be stably expanded in all patients after the infusion of GT316 TIL.

The preliminary clinical data from this study indicate that Grit Biotechnology's GT316 TIL injection demonstrates favorable safety and clinical efficacy. Clinical follow-up and data collection for GT316 are still ongoing.

MedChina will2024 IBI EXPO Biopharmaceutical Innovation Industry Conference to be held in Nanjing on June 14-15, 2024. At the conference,Liu Yarong, Co-founder and CEO of Grail BioAt the [6th Seminar on Tumor Immunotherapy and Cell Treatment Technology], we will jointly discuss the market opportunities and challenges of TIL therapy, global commercialization of cell drugs, and other related topics.

June 14-15

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