Zhuhai Grit Biotechnology Co. Ltd.

SHANGHAI, Aug. 30, 2024 /PRNewswire/ -- Grit Biotechnology, a leading clinical-stage cell therapy company focusing on tumor-infiltrating lymphocyte (TIL) therapies, has achieved a major milestone with its genetically engineered TIL product, GT201. Following its investigational new drug (IND) approval in China in July 2023, GT201 has now also received IND clearance from the U.S. FDA, paving the way for clinical trials in the United States. GT201, an advanced genetically engineered TIL product developed by Grit Biotechnology's platform StemTexp® and StaViral®, boosts T cell survival and function by expressing a vital membrane-bound cytokine complex. GT201 surpasses traditional TIL therapies in proliferation, tumor-killing efficacy and long-term survival with reduced dependence on IL-2. Now, GT201 IND is approved by both U.S. FDA and China Center for Drug Evaluation (CDE) to enter clinical trials in both countries for advanced solid tumor patients. Grit Biotechnology is a clinical stage cell therapy company leading TIL therapy development based in China. Core technology platforms supporting its TIL and other cell therapy development include StemTexp® (proprietary stemness TIL expansion platform), StaViral® (stable virus transduction system), KOReTIL® (efficient CRISPR KO system) and ImmuT Finder® (genome-wide CRISPR/Cas screening platform). These platforms have enabled the development of next-generation gene-edited TIL products and other cell therapies. In addition, Grit's non-gene-engineered TIL program, GT101, is currently in Phase 2 (pivotal) trials and is on track to file for Biologics License Application (BLA) in 2025, making it the leading TIL pipeline in China. SOURCE Grit Biotechnology

A tumour-infiltrating lymphocyte therapy of Grit Biotechnology, GT101 is set to enter the Phase II trial by year-end. Credit: CI Photos/Shutterstock.com. Cell therapy company Grit Biotechnology has secured more than $60m (436.72m yuan) in a Series B funding round to support the development of its pipeline programmes . China International Capital Corporation led the financing round, which saw investments from Liando Group, Qianhai Ark, Yuanhe Capital and HeFangTian Venture Partnership. Recommended Reports Reports LOA and PTSR Model - ustekinumab biosimilar GlobalData Reports LOA and PTSR Model - tenecteplase biosimilar GlobalData View all Companies Intelligence China International Capital Corp Ltd Matrix Partners China Decheng Capital LLC Yuanhe Capital Grit View all Grit’s existing investors, namely Sherpa Healthcare Partners, Matrix Partners China and Decheng Capital, also took part in the financing round. Grit plans to utilise the investment proceeds to support the development of its tumour-infiltrating lymphocyte (TIL) pipeline. These funds will also be used for the Phase II clinical trial of TIL therapy, GT101, and progress next-gen gene-edited TIL products. GT101 is set to enter the Phase II trial by year-end. Grit Biotechnology was established in 2019 and is focused on offering transformative therapies for cancer. The company uses four technology platforms for developing gene-edited TIL products: StemTexp, StaViral, KOReTIL and genome-wide CRISPR/Cas9 screening platform ImmuT Finder. Apart from GT101, the company is developing GT201, a genetically engineered TIL product, and a next-gen TIL product, GT316. GT201 has received new drug application clearance from the China Food and Drug Administration and is currently being evaluated in Phase I trials while GT316 is in investigator-initiated trials in the region. Grit has a 10,000m² GMP-level cell therapy production facility in Suzhou with a workforce of more than 100 specialists. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

Grit Biotechnology said Friday that it closed a Series B, raising more than $60 million from several Chinese investors. The financing came from several new investors, including Qianhai Ark, Liando Group, Yuanhe Capital and HeFangTian Venture Partnership, in addition to previous investors: Sherpa Healthcare Partners, Decheng Capital and Matrix Partners China. Shanghai-based Grit said the funding would go toward developing its pipeline, including advancing its tumor-infiltrating lymphocyte (TIL) candidates and supporting a planned pivotal Phase II in China for its lead candidate, GT101. That therapy is currently being tested in melanoma and cervical and lung cancer. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.