Grit Biotechnology’s TIL Therapy GT201 Cleared for US Trial in Advanced Solid Tumors

Grit Biotechnology has received clearance of an investigational new drug (IND) application from the FDA for GT201, an investigational genetically-engineered tumor infiltrating lymphocyte (TIL) therapy, for a clinical trial in patients with advanced solid tumors.¹

GT201 is based on the company’s StemTexp proprietary stemness TIL expansion platform and StaViral stable virus transduction system and expresses a membrane-bound cytokine complex intended to enhance T-cell survival and function. Furthermore, according to Grit, it does not depend on IL-2 as much as traditional TIL therapies and is expected to have better proliferation, tumor-killing ability, and long-term survival. GT201 previously received IND clearance from China’s Center for Drug Evaluation in July 2023.

Early clinical and preclinical data regarding GT201 was previously presented by Grit Biotechnology at the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual Meeting, held May 16-20, in Los Angeles, California and at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, held June 2-6, in Chicago, Illinois.² Grit noted that in a first-in-human trial, GT201 demonstrated stable in-vivo expansion and preliminary clinical efficacy in people with advanced solid tumors. Its safety profile in these patients was characterized as “good.”

"We are excited to showcase the development and clinical progress of GT201 at these 2 major conferences,” Yarong Liu, PhD, the founder and chief executive officer of Grit Bio, said in a statement made prior to the conferences.² “The clinical exploration of next-generation TIL products is still in its early stages globally, and the rapid advancement of the GT201 pipeline reflects our innovation and product development strength on a global scale. We look forward to presenting and sharing more detailed data and research results during the conferences. Moving forward, we will accelerate global clinical development to provide more treatment options for patients with advanced solid tumors."

In addition to GT201, Grit Biotechnology is also developing other TIL therapies, including GT101, a TIL product that is not genetically engineered.¹ GT101 is currently in the pivotal stage of clinical development, and Grit noted that as of August 2024 it is on track for submission of a biologics license application for GT101 in China in 2025.

The news follows a number of recent announcements from the past few weeks regarding positive updates for cell therapy products being evaluated for cancer indications in China. In late August, Orgenesis announced positive real-world data regarding ORG-101, its CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy, from 233 patients treated at a leading hematology center in China.³ The findings included a complete response (CR) rate in adults of 82% and a CR rate in children of 93%.

“Not only has the product shown initial signs of positive clinical outcomes, but our production data also validated that Orgenesis’ cost-effective decentralized cell processing has the potential to improve access to this treatment and reduce costs,” Vered Caplan, the CEO of Orgenesis, said in a statement.³ “We remain committed to bringing this and other potentially life-saving treatments to patients in need worldwide.”

In addition, earlier in August Legend Biotech's ciltacabtagene autoleucel (cilta-cel; marketed as Carvykti in the United States and Europe), a BCMA-directed CAR-T therapy was approved by China’s National Medical Products Administration (NMPA) for a new relapsed or refractory (r/r) multiple myeloma (MM) indication and JW Therapeutics’ relmacabtagene autoleucel injection (relma-cel; marketed as Carteyva), another CAR-T therapy, received approval of its supplemental biologics license application for the treatment of adults with r/r mantle cell lymphoma (MCL) from the NMPA.^4,5

REFERENCES
1. Grit Biotechnology receives U.S. FDA clearance of investigational new drug application for GT201, a genetically engineered TIL, following its Chinese IND approval. News release. August 31, 2024. Accessed September 3, 2024. https://www.prnewswire.com/news-releases/grit-biotechnology-receives-us-fda-clearance-of-investigational-new-drug-application-for-gt201-a-genetically-engineered-til-following-its-chinese-ind-approval-302235429.html
2. Preclinical and clinical research updates of GRIT’s next-generation gene-edited TIL product GT201 will be presented at the ASGCT and ASCO annual meetings. News release. May 17, 2024. Accessed September 3, 2024. https://www.grit-bio.com/newsinfo/5923599.html
3. Orgenesis announces positive results from a real-world study of ORG-101 CAR-T therapy in patients with CD19+ acute lymphoblastic leukemia. News release. Orgenesis Inc. August 29, 2024. Accessed September 3, 2024. https://ir.orgenesis.com/press-release-details?newsId=2937765
4. Genscript subsidiary Legend Biotech achieves breakthrough with cilta-cel approval in China, offering new hope for multiple myeloma patients. News release. GenScript Biotech Corporation. August 27, 2024. Accessed September 3, 2024. https://www.genscript.com/genscript-subsidiary-legend-biotech-achieves-breakthrough.html
5. JW Therapeutics announces NMPA approval of the supplemental biological license application for Carteyva® in adult patients with relapsed or refractory mantle cell lymphoma. News release. JW Therapeutics. August 27, 2024. Accessed September 3, 2024. https://www.jwtherapeutics.com/en/media/press-release/20240827/