China's TIL Therapy Pipeline: Multiple Candidates from Gracell, Juncell, Lanma Medical and Others Enter Pivotal Clinical Trials

▎WuXi AppTec Content Team Report

Recently,Another Milestone Achieved in the Field of Cell Therapy:FDA Accelerated ApprovalApprovalTumor Infiltrating Lymphocyte (TIL) therapy lifileucel for the treatment of advanced melanoma, this is not onlyThe first approved TIL therapy, as well as the first approved T-cell therapy for treating solid tumors. This breakthrough has once again drawn significant attention from the industry to TIL therapy.

In the field of cell and gene therapy (CGT), solid tumors represent a formidable challenge.Tumor-Infiltrating Lymphocytes (TIL) have become a new force in the field of solid tumor treatment due to their strong tumor specificity, good infiltration, and high safety.. In China,Currently, there are alsoMany companies are developing TIL therapies in the hope of bringing this cutting-edge treatment to patients as soon as possible. Based on publicly available information, this article shares more than 10 TIL therapies developed by Chinese companies that have entered the registered clinical trial stage.(Excluding investigator-initiated clinical studies)The TIL product information is for readers' reference only.(Sorted by the announced clinical approval time of enterprises. This article is an incomplete statistics, and any omissions are welcome to be supplemented.)

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Company: DISCOVERY TO CURE
Product: Undisclosed

DISCOVERY TO CURE was founded in 2020, focusing on the research and development of biotechnological innovations, particularly on the development and clinical trials of immunocyte therapeutic products for solid tumors as well as clinical translation. According to a press release from DISCOVERY TO CURE, the TIL cells developed by the company exhibit high cytotoxicity and have shown significant efficacy in some patients with advanced cancer. In February 2022,The company announced that a TIL drug it developed has been approved by the U.S. FDA to conduct clinical trials.。

Company: Grail Biotechnology
Product:GT101、GT201

Gracell Biotechnologies was founded in 2019, focusing on tumor immunotherapy and cell treatment. It has developed a pipeline represented by TIL drugs. In September 2023,Gravel BiotechCompleted a RMB 400 million Series B financing round. According to the official website of Grail Bio, the company has developed multiple TIL therapies, including:GT101 was granted clinical trial implied permission in China in April 2022 and is about to enter the pivotal Phase 2 clinical trial in China.；GT201 is a gene-edited TIL drug that has received implied clinical trial approval in China.; In addition, BioSyngen has also developed a series of next-generation gene-edited TIL drugs based on its technical platform.

Company: Juncell Therapeutics
Product:GC101

Juncell Therapeutics was founded in 2019 and is committed to the innovation of TIL therapy and new drug development. Currently, the company has developed a series of natural TIL cell drugs and non-viral vector genetically modified TIL cell drugs. Among them, theNatural TIL product GC101 under research received clinical trial implied permission in China in April 2022 and is currently conducting clinical trials for advanced solid tumors.。

In December 2023, researchers presented the clinical trial progress of GC101 at the 2023 European Society for Medical Oncology Immuno-Oncology Congress. All subjects in the study were patients with advanced solid tumors who had failed standard treatments (resistant to anti-PD-1 antibodies). Safety data showed that GC101 was well-tolerated, with no dose-limiting toxicity (DLT) occurring and no serious adverse events (SAE) directly related to GC101 TIL cells observed; participants also did not require transfer to a sterile ward for special care. Efficacy data indicated,Multiple patients have experienced significant tumor shrinkage, with an objective response rate exceeding 35%, covering various cancer types such as melanoma, cervical cancer, and non-small cell lung cancer.。

Company: CBMG
Product:C-TIL051

BioSyngen focuses on developing innovative cell therapy products for the treatment of malignant hematological tumors, solid tumors, as well as inflammatory and immune diseases. In October 2022, the company developedTIL Product C-TIL051 Receives FDA Approval for Phase 1 Clinical Trial to Treat Patients with Solid Tumors。

Company: Guangzhou Zhiling Biomedical Co., Ltd.

Product:ZLT-001

Guangzhou Zhiling Biomedical Co., Ltd. (BT Gillion Biotherapeutics) was established in 2016, focusing on the field of immune cell therapy. The company has developed a new generation of TIL products based on the intelligent TIL platform TILBO through collaboration with university and research institute teams. In January 2023, Guangzhou Zhiling Biomedical announced its self-developed innovativeTIL Cell Drug ZLT-001 InjectionReceived clinical trial implied permission in China, intended for development to treatAdvanced Recurrent or Metastatic Cervical Cancer。

Company: Houwu Biomedical/Tiankeya
Product:HV-101

Hangzhou Houwu Biomedical Technology Co., Ltd. was founded in 2021, focusing on the development of innovative therapies for solid tumors based on TIL, and currently has multiple TIL drug candidates. Beijing Tiankeya Biotechnology Co., Ltd. was established in 2016, concentrating on the innovative research and industrialization of tumor immunotherapy technologies. In January 2023, Hangzhou Houwu Biomedical Technology Co., Ltd. and Beijing Tiankeya Biotechnology Co., Ltd. jointly submittedSolid Tumor TIL Therapy HV-101 InjectionReceived clinical trial implied permission in China, intended for development to treatAdvanced recurrent or metastatic solid tumors。

Company: Suzhou Lanma Medical Technology Co., Ltd.
Product:LM103

Lanma Medical (LMBIO) was founded in December 2020 and focuses on developing cell immunotherapy products centered around TIL therapy. The company’s main pipeline products currently cover a variety of solid tumors, including cervical cancer, non-small cell lung cancer, malignant melanoma, and head and neck tumors. Among these, Lanma Medical has developedLM103 InjectionIt has received implied permission for clinical trials in China in July 2023 and is proposed for development to treat advanced solid tumors.

Company: BioSyngen
Product:BST02

BioSyngen focuses on immune cell therapy, established in Singapore with a branch in Guangzhou, China. In October 2023, the TIL product BST02 developed by the company received FDA approval for clinical trials. In January 2024, Guangzhou BioSyngen Pharmaceutical Co., Ltd. submittedBST02 InjectionHas also received implied permission for clinical trials in China,Intended for the treatment of liver cancerIn February 2024, BioSyngen announced that BST02 injection had also been granted Fast Track designation by the FDA.For the treatment of all types of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma.。

Company: Sino-cell Biomed
Product:HS-IT101

Sino-cell Biomed was founded in March 2019, dedicated to developing innovative cell therapies, with a focus on TIL cell drugs for solid tumors. In November 2023, the company's developedAutologous Natural TIL Cell Drug HS-IT101 InjectionIt has obtained the NMPA clinical trial implied permission and is proposed for development to treat advanced solid tumors. In addition, the company has also developed genetically modified TIL products HS-IT201 and HS-IT301. In January 2024, Sino-cell Biomed completed a multi-million yuan Series A financing round to advance the company’s TIL pipeline research and development progress.

Company: Yishou Technology
Product:Autologous Tumor-Infiltrating Lymphocyte Injection

According to the CDE official website, the Class 1 new drug jointly submitted by Wuhan Yishou Technology Co., Ltd. and Hainan Yishou Technology Co., Ltd.“Autologous Tumor-Infiltrating Lymphocyte Injection"Was approved for clinical use in 2023 and is proposed for development for"Treatment of Solid Tumors such as Liver Cancer。