Domestic TCR-T Therapy Landscape: Overview of 20 Chinese Companies and Their Pipeline Progress

Aug 26, 2024 08:29 CST Updated 08:30

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In August, there were two major milestone events in the TCR-T field:

Approved by the U.S. FDAAdaptimune'sThe TCR-T cell therapy Tecelra (afami-cel) under research is used for second-line treatment of adult patients with unresectable or metastatic synovial sarcoma who have previously received chemotherapy.Afami-cel is the first engineered T-cell therapy for the treatment of solid tumors,The drugThe selling price is 727,000 USD (approximately 5.18 million RMB), and the peak annual sales of the product may reach 400 million USD.
GuangDong XIANGXUE LIFE SCIENCES LTD's TAEST16001 Injection Included in the Breakthrough Therapy Designation List, IndicationAdvanced Soft Tissue Sarcoma. ThisMarks a major breakthrough for this product as the first TCR-T cell therapy new drug in China to receive IND approval for clinical trials. It is expected to become the first TCR-T cell therapy drug to be launched in China. Influenced by this news,The stock surged over 150%.

In addition to the above two indications, TCR-T therapy is also being applied in ovarian cancer, head and neck cancer, gastric cancer,Non-Small Cell Lung Cancer...has shown potential in the treatment of various solid tumors. As a rising star in the field of tumor therapy, TCR-T cell therapy is leading a new era of cancer treatment with its unique advantages and potential. Currently, there are 20 companies in China that have invested in TCR-T therapy, and the editor has summarized the progress of each company's TCR-T product development as follows:

1. SCG SCIENCE (DALIAN) CO., LTD

SCG SCIENCE (DALIAN) CO., LTD focuses on developing novel immunotherapies for infections and their associated cancers. The company is developing a broad and unique range of TCR-T cell therapies targeting the most common cancer-causing infections: Helicobacter pylori, human papillomavirus, and hepatitis B, with the goal of preventing and curing infections and their related cancers.

SCG SCIENCE (DALIAN) CO., LTD has three TCR-T products in its pipeline, with SCG101 being the most advanced:

SCG101 Injection is a First-in-Class (FIC) autologous TCR-T cell therapy product targeting hepatitis B surface antigen (HBsAg) specificity. This therapy received clinical trial approvals from China's NMPA, the U.S. FDA, Singapore's Health Sciences Authority, and Hong Kong's Department of Health between 2022 and 2023 for the treatment of hepatitis B virus (HBV)-related hepatocellular carcinoma. In November 2023, the indication for SCG101 was further expanded to include HBV-related intrahepatic cholangiocarcinoma.

On July 1, SCG Science announced that the U.S. FDA had approved the IND application for Phase I/II clinical trials of its next-generation human papillomavirus (HPV)-specific TCR-T cell therapy (SCG142). It is reported that SCG142 is being developed for the treatment of patients with HPV-related solid tumors.

2. XIANGXUE LIFE SCIENCES

Xiangxue Life Sciences Technology (Guangdong) Co., Ltd. ("Xiangxue Life Sciences" for short) is a subsidiary controlled by Xiangxue Pharmaceutical. It is a leading company in the research and development of cell immunotherapy products and technologies in the TCR field, specializing in TCR-T cell immunotherapy.

Recently, the Center for Drug Evaluation (CDE) of China's NMPA agreed with Xiangxue Life Sciences'TAEST16001 InjectionIncluded in the list of breakthrough therapies, it is expected to become the first TCR-T cell therapy drug to be launched in China, marking a milestone for the development of innovative immunotherapy drugs in China.

TAEST16001 is the first TCR-T cell product in China to receive an IND approval and commence clinical research. The first indication targets advanced soft tissue sarcoma that is HLA-A*02:01 positive and expresses the NY-ESO-1 antigen. If the product is successfully approved for marketing, it will establish the company’s leading position in TCR-T immunocyte therapy and enhance its core competitiveness.

In June this year, the IND for "TAEST1901 Injection" from GuangDong XIANGXUE LIFE SCIENCES LTD has been approved by the CDE. The indication is intended for the treatment of advanced hepatocellular carcinoma or other advanced tumors with the HLA-A*02:01 genotype and positive AFP tumor antigen expression.

3. TianKeYa Bio

TianKeYa Bio was founded in 2016, focusing on the innovative research and development and industrialization of tumor immunotherapy cell treatment technology. Currently, TianKeYa Bio has developed more than ten product pipelines through its unique technology, involving TCR-T products, TIL products, NK products (universal type), cancer vaccines, etc.

The company's clinical trial for the TCR-T therapy "TC-N201 Injection," loaded with anti-PD-1 antibody for the treatment of advanced cervical cancer, has been approved by the CDE. This is the first TCR-T clinical trial approved in China for the treatment of cervical cancer and also the world's first approved HPV TCR-T clinical trial loaded with anti-PD-1 antibody. It is currently in Phase 1 clinical research for the treatment of solid tumors.

TC-E202 InjectionTC-E202 is a TCR-T product targeting HPV loaded with anti-PD-1 single-chain antibody developed by Tiankeya.A Phase I study of this drug in HPV16-positive patients with recurrent or metastatic cervical cancer who have failed prior treatments is being conducted to evaluate the safety and tolerability of TC-E202 and determine the recommended dose for Phase II clinical studies.

4. Laien Bio

Lion TCR is a cellular immunotherapy developer dedicated to the development and commercialization of innovative T-cell immunotherapy products. Its key immunotherapy technology platforms include a TCR discovery platform related to TCR-T, autologous and allogeneic cell platforms, as well as a gene-editing technology platform. Notably, its world-first (First in Class) TCR technology targeting HBV viral antigens has been granted global exclusive commercial rights by Singapore’s Agency for Science, Technology and Research (A*STAR).

The company's first productLioCyx-MHBV-specific TCR-T cell therapy, which uses mRNA technology to encode TCR for the treatment of hepatocellular carcinoma. LioCyx-M is currently in Phase 2 clinical trials. In the completed Phase 1 clinical trial involving recurrent or refractory HBV-related liver cancer patients who underwent hepatectomy or radiofrequency ablation, it demonstrated good safety: no cytokine storms or neurotoxicity occurred, and tumor responses were observed: the disease control rate was 60%, the duration of response was 27.7 months, and the median survival time reached 33.1 months. Based on these clinical results, the product has received Fast Track designation from the U.S. FDA.

In addition, Lion TCR has further developed different TCR discovery platforms, autologous TCR-T cell platforms, allogeneic TCR cell platforms, and gene editing technologies based on its core product LioCyx-M and the TCR-T cell platform technology. The company is expanding into various solid tumor indications including nasopharyngeal cancer, gastric cancer, and infectious diseases such as chronic hepatitis B infection and post-transplant infections.

5. Huaxia Yingtai

Huaxia Yingtai focuses on the development and commercialization of innovative gene-edited T-cell immunotherapy products, aiming to address "unmet clinical needs" for patients with cancer and other diseases. The company currently owns two innovative T-cell modification platforms, STAR-T and enTCR-T, and has established a rich product pipeline targeting hematological tumors, solid tumors, and viral infections.

The CD19/CD20 dual-target STAR product YTS101, which is currently in the fastest progress, is in Phase 1 clinical trials for the treatment of lymphoma.On January 23, 2024, the IND for "YTS104 Cell Injection," a LILRB4-specific innovative target developed by Huaxia Yingtai based on its proprietary STAR-T platform, was approved by the CDE for the treatment of relapsed/refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and other indications.

6. Innolmmune

Shenzhen Innolmmu Co., Ltd. was established in July 2016, mainly focusing on the development of a series of products such as TCR-T cells, CAR-T cells, and TIL for the treatment of various advanced cancer patients. It possesses internationally advanced key technology platforms for the discovery of tumor-specific antigens and production preparation platform technologies for novel TCR-T, CAR-T cells, and TIL.

SIIT-T002 is a TCR-T cell therapy drug co-developed by Innolmmune and Genbase Biotechnology. According to the strategic cooperation agreement, Genbase Biotechnology provides preclinical pharmaceutical research services for this product to ensure a smooth IND submission, and offers CMC services for IND applications related to the subsequent development of a series of TCR-T cell therapy products.

Shenzhen Innolmmu Co., Ltd. and its subsidiary Hangzhou Superme Bio-Technology Co., Ltd. have independently developed the TCR-T cell product "Innocyte-ESO Cell Injection," for which two IND applications have been accepted (Acceptance Nos.: CXSL2200337; CXSL2200338). The indications are for various advanced malignant solid tumors that are positive for the human major histocompatibility antigen HLA-A2 supertype and express the tumor antigen NY-ESO-1.

7. Bintie Bio

Bintie Bio was established in January 2021, located within the Kangqiao Industrial Zone of Shanghai's Zhangjiang Science City. It is a clinical-stage biopharmaceutical innovation company focused on the research, development, and production of breakthrough immunotherapy drugs. Its main product is a novel immune cell preparation targeting solid tumors. In October 2023, Bintie Bio completed an A-round financing of over 100 million yuan.

On July 12, the official website of China's CDE announced that the IND application for IX001 TCR-T injection submitted by Bintie Bio has been accepted. According to publicly available information from Bintie Bio, this is the company’s first R&D product to enter a clinical trial registration process. It is a TCR-T cell therapy targeting the KRAS G12V mutation and is being developed for the treatment of pancreatic cancer, often referred to as the "king of cancers."

According to publicly available data, the clinical research on IX001 TCR-T for the treatment of advanced pancreatic cancer and colorectal cancer induced by KRAS mutations is currently underway (NCT06487377). This is a single-arm, single-center, open-label clinical study aimed at evaluating the safety and efficacy of IX001 TCR-T.

8. Keshihua

Koshva Bio is a technology-based enterprise that integrates the discovery of innovative TCR sequences, the research and development of new anti-tumor T-cell drugs, and clinical sample production. The company has established an efficient TCR sequence screening platform, TCRX-FinderTM, which, through the accumulation of big data on T-cells, artificial intelligence algorithms, and cutting-edge sequencing technologies, has built an efficient TCR drug PCC POC screening system. It is one of the few companies worldwide capable of simultaneously developing personalized and fixed-target TCR-T drugs.

Currently, the company has launched three pipelines. In April this year, the KSH01 TCR T-cell new drug for treating solid tumors, developed by Coscience Biotech, was approved for clinical trials by the National Medical Products Administration (NMPA). The indications include advanced solid tumors such as esophageal cancer, gastric cancer, and urothelial carcinoma.It is the first TCR T-cell drug in China that targets the MAGE-A4 antigen.In March 2023, the U.S. FDA officially granted KSH01 HD-TCR T Orphan Drug Designation to GuangDong XIANGXUE LIFE SCIENCES LTD, marking the first TCR T-cell drug developed by a Chinese company to receive U.S. FDA Orphan Drug Designation.

Currently, the personalized and fixed-target TCR-T drug pipelines of GuangDong XIANGXUE LIFE SCIENCES LTD have obtained safety and efficacy data from the first phase of investigator-initiated clinical trials in humans. Patient recruitment is ongoing at the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, the Second Affiliated Hospital of Zhejiang University, and the First Affiliated Hospital of Guangxi Medical University.

9. New Vision Bio

Neovision Biotherapeutics is an innovative company focused on developing TCR-T immunotherapy drugs for solid tumors, as well as researching clinical technologies and their translation. Relying on years of professional expertise and technological innovation, Neovision Biotherapeutics has developed an ultra-high sensitivity target-TCR discovery and validation platform, addressing the bottleneck in the TCR-T industry's development. Additionally, it has established the world’s largest database of target-TCR specificity pairings, significantly expanding treatment targets and options for patients with solid tumors, transforming the development of TCR-based drugs from "finding a needle in a haystack" to a process that is "systematic and methodical."

Currently, there are four pipelines under research. NW-101, which targets the TAA antigen, is the most advanced and has entered the early clinical stage. NW-101 is a T-cell receptor genetically engineered T-cell (TCR-T) therapy targeting the PRAME antigen. It is intended for treating advanced recurrent ovarian cancer patients who are HLA-A*02:01 positive and PRAME expression positive. Recruitment for Phase I clinical trials involving ovarian cancer patients is currently underway.

10、Hengrui Yuanzheng

Hengrui Yuanzheng is committed to developing immunocyte treatment technologies for solid tumors and also dedicated to developing combination therapies that can bring valuable and long-term benefits to cancer patients.

The company's R&D pipeline includes MASCT and HRYZ-T. Among the MASCT series, MASCT-I has entered Phase II clinical trials. This product is the world’s first clinically approved multi-target T cell therapy for solid tumors. The first TCR-T product, HRYZ-T101, incubated through the company’s self-developed ReGET platform, has also received IND approval and entered Phase I clinical trials.

11. Kerui Bio

Beijing KER Gene Technology Co., Ltd. was co-founded by several Peking University alumni and returned overseas students, and is committed to the development of innovative drugs based on T-cell receptors (TCR).

Through technological innovation, CareBio has established a systematic TCR R&D platform that addresses a series of technical challenges in TCR cloning and optimization, enabling high-efficiency, large-scale development of TCR-based innovative drugs. In the future, CareBio will develop various indications for treating cancer, chronic infections, and autoimmune diseases through two types of products: cell therapy and soluble TCR protein drugs, targeting a trillion-level disease market.

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, is conducting a Phase I clinical study on the "Safety, Tolerability, and Preliminary Efficacy of CRTE7A2-01 TCR-T Cell Injection in Treating HPV16-positive, HLA-A*02:01-positive Advanced Solid Tumors (Cervical Cancer, Head and Neck Tumors, Anal Cancer, and Other Tumor Types)." This study has received implied permission for a new drug clinical trial (IND) from the Center for Drug Evaluation of the National Medical Products Administration and has been approved by the Ethics Committee of Peking Union Medical College Hospital. It is now recruiting participants from the public.

12、Pan-Eng Bio

Pan-Immune Bio is an innovative biopharmaceutical company mainly engaged in the development of immunotherapy drugs for solid tumors and related businesses.CompanyIndependently developed several original product pipelines, including "Personalized TCR-T Cell Therapy," "Super TCR-T Cell Therapy for Reversing the Solid Tumor Microenvironment," and "TAL-T Cell Therapy." The fastest progressing pipeline is TAL (Tumor-Associated Lymph Node T Cells), which is currently undergoing IIT clinical research, demonstrating excellent safety and significant efficacy.

In addition to the TAL pipeline, Pan-E Bio is also developing several other TCR-T cell therapy products. These products target various types of solid tumors, leveraging the specific recognition and killing capabilities of TCR-T cells to achieve effective tumor treatment.

In order to support the current preclinical experiments and subsequent clinical trials, Pan-E Bio has established cooperative relationships with multiple medical institutions, including the Cancer Hospital of Sun Yat-sen University, Guangdong Provincial People's Hospital, Cancer Hospital of Fudan University, First Affiliated Hospital of Sun Yat-sen University, Peking University Cancer Hospital, and Guangdong Provincial Traditional Chinese Medicine Hospital. These collaborations will help Pan-E Bio accelerate the clinical development and commercialization process of its TCR-T cell therapy products.

13. SCG SCIENCE (DALIAN) CO., LTD

BindBio Group, with Shenzhen BindBio Technology Co., Ltd. as its core, uses the International Joint Research Center for Immunotherapy as its research base, Shanghai as its global commercial base, and is a high-tech biotechnology group company primarily focused on cancer immunotherapy using the latest generation of CAR-T and TCR-T immune cell treatment technologies internationally.

The company has a drug, Anti-NY-ESO-1 TCR-T, for clinical trials in lung cancer, esophageal cancer, and melanoma, currently recruiting.

14. Puregin

Purigin was established in 2012 and positioned as a leading company in cell and gene therapy drugs with core industrialization technologies.The company has achieved significant R&D results in the fields of CAR-T and TCR-T cell therapy, and is committed to transforming these achievements.For clinical treatment solutions, benefiting a wide range of patients.

Prugene's TCR-T R&D Platform targets HLA-A*02:01/NY-ESO-1157-165, starting from wild-type T-cell clones to ultimately obtain high-affinity, specific TCRs. These high-affinity TCRs are further transduced into T cells via a third-generation lentiviral vector. The modified T cells (TCR-T) can specifically recognize the NY-ESO-1 antigen peptide complex presented by HLA-A*02:01 and effectively kill tumor cells.

PRJ's Self-Developed TCR-T Cell Injection Targeting HLA-A*02:01/NY-ESO-1Clinical Trial Application Accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This product targets patients with unresectable, recurrent, or metastatic solid tumors such as soft tissue sarcoma. Prugene's TCR-T Cell Injection is undergoing clinical trials at medical institutions including Henan Cancer Hospital to evaluate its safety and efficacy in treating metastatic solid tumors such as esophageal cancer, melanoma, and synovial sarcoma.

15. JW Therapeutics

JW Therapeutics is a CAR-T cell immunotherapy technology developer jointly established in China by Juno Therapeutics, a global leader in tumor cell immunotherapy, and WuXi AppTec. The company focuses not only on the research and development of CAR-T therapies but also has actively expanded into the TCR-T therapy field.The company is developing TCR-T candidate products for various types of solid tumors to meet the treatment needs of different patients.

Previously, JW Therapeutics registered an IIT clinical trial for a MAGE-A4 TCR-T cell therapy on the ClinicalTrials website. The trial will be conducted at Beijing Tumor Hospital, targeting solid tumors, with Vice Dean Shen Lin as the Principal Investigator (PI), planning to enroll 20 participants.This project is a collaboration between JW Therapeutics and 2seventybio reached in September 2022. It involves the fourth-generation TCR-T technology, incorporating a TGFb receptor to inhibit TGFb in the tumor microenvironment, significantly enhancing anti-tumor activity.

In addition, JW Therapeutics collaborates with partners such as Eureka and Lyell to co-develop TCR-T candidate products targeting hepatocellular carcinoma. These collaborations are based on the globally leading EUREKA platform and LYELL technology, aiming to explore the potential of TCR-T therapy in the treatment of solid tumors.

16. Laiyang Bio

Laymon Bio is a biotechnology company focused on the research, development, production, and commercialization of innovative immunometabolism drugs. The company was co-founded by Professor Li Tang's team from EPFL (École Polytechnique Fédérale de Lausanne), Switzerland.XtalPiCo-founded in July 2021 and officially operational in February 2022. The company's core technology, Meta 10, has demonstrated significant potential in curing solid tumors, with related results published in top international academic journals such as Nature Immunology and Nature Biotechnology.

Laymon Bio has establishedMetabolic ReprogrammingThe three major pipelines—large molecule pipeline, metabolic-enhanced cell therapy pipeline, and AI super-factor pipeline—are driving the development of new antibodies through AI algorithms and optimizing various components of CAR-T, which will be key future developments. In the TCR-T field, the company is actively exploring the integration of Meta 10 metabolic reprogramming technology to fully enhance the therapeutic potential of TCR-T cells.

In addition, LaMont Bio and Xiangxue Life Sciences have signed a comprehensive strategic cooperation agreement. Both parties will leverage their respective technological advantages to comprehensively explore the combined application of Meta 10 metabolic reprogramming technology and TCR-T cell therapy products in the treatment of solid tumors. This collaboration aims to prevent or reverse TCR-T cell exhaustion through Meta 10 metabolic reprogramming technology, further enhancing the sustained proliferation and cytotoxic activity of TCR-T cells in solid tumors, thereby improving the therapeutic potential of TCR-T cells in curing solid tumors.

17. Liling Bio

Liling Bio was founded in 2020 and is located in the core area of bioBAY in Suzhou Industrial Park. It is an innovative technology company focusing on intracellular targets and dedicated to the research and development of personalized TCR-T cell therapies and TCR bispecific antibody drugs. The company's core team comes from well-known universities and biotech companies both in China and abroad, with extensive experience in early discovery and IIT clinical research for cell therapy drug projects.

Liling Bio has established a differentiated and advantageous R&D pipeline. The personalized TCR-T cell therapy for head and neck tumors has completed concept validation both in vitro and in animal models, and is about to enter investigator-initiated clinical research (IIT). In the direction of TCR protein drugs, the company has also developed multiple candidate drugs, including a TCR protein drug targeting PRAME, which has the potential to treat various solid tumors such as ovarian cancer.

18. GeneChem

GeneChem (Shanghai GeneChem Co., Ltd.) is a leading company specializing in the gene therapy field, possessing strong research and development capabilities and a wealth of technical platforms. The company is committed to developing innovative cell therapy products through genetic engineering technology to meet clinical needs and improve patients' quality of life. In the TCR-T therapy field, GeneChem has achieved significant R&D results thanks to its profound scientific research background and advanced technical platforms.

Genechem has multiple TCR-T cell therapy products at various stages of development, including TCR-T cell drugs targeting specific tumor antigens. These products are expected to receive market approval in the future and be applied in clinical treatments. Genechem collaborates with multiple medical institutions to conduct clinical trials of TCR-T therapies. These trials aim to evaluate the safety and efficacy of TCR-T cells in treating different types of tumors and provide data support for the subsequent registration and market launch of the products.

Reference: Official websites of various companies

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