36Kr First Report: S丹赛 Secures Over $40 Million in Series C Funding and Receives FDA IND Approval for Solid Tumor CAR-T Therapy
ICT
Oncology Drug Developer
36Kr has learned that,Shanghai ICT Biotechnology Co., Ltd.(hereinafter referred to as: "ICT”）has completed a Series C financing round of over $40 million, led by CDH VGC (CDH Innovation and Growth Fund), with participation from multiple other investment institutions.
It is reported that this round of financing will be used for the research and development of the innovative CoupleCAR platform technology, to advance the development of cell therapy products for colorectal cancer and other solid tumors, and to accelerate clinical trials in the United States and China.
ICT is a global cell therapy company,36Kr has previously provided a detailed introduction to it.，Primarily engaged in the research and application of cutting-edge CAR-T and gene editing technologies.。In 2016, ICT completed a Series A financing round backed by CDH Investments and Genbridge Capital; by the end of 2017, the company closed a Series B financing round of RMB 180 million, with investors including Volcanic Rock Capital, GaoTeJia Investment, SoftBank China Capital, and others; in November 2019, the company completed a Series B+ financing round, led by Voyager CapitalNew TerritoriesLead investment.
It is reported that the novel CAR-T product developed by the company based on its independently developed CoupledCAR™ technology platform has achieved a major breakthrough in Chinese investigator-initiated trial (IIT) clinical trials targeting advanced colorectal cancer, advanced thyroid cancer, and advanced pancreatic cancer, with an overall response rate (ORR) of 50%.Additionally, clinical trials for the company's CAR-T products targeting liver cancer, prostate cancer, and other solid tumors are also being successively initiated.
It is reported that，CoupledCAR™Utilizes a dual-CAR approach to stimulate the immune system and promote CAR-T cell expansion; enhances the expression of genes associated with cell migration, thereby overcoming the challenge of impaired CAR-T cell trafficking and infiltration into tumors; further enhances the cytotoxic activity of CAR-T cells within the tumor microenvironment; and upon entering solid tumors, CoupledCAR™ stimulates the host to generate and recruit additional immune cells, eliciting a more potent and durable immune response.
It is worth noting that,On August 31 this year, the U.S. FDA approved the IND application for GCC19CART, a solid tumor cell therapy product developed by ICT based on the CoupledCAR technology platform., this is a Phase I multicenter clinical study evaluating GCC19CART in patients with relapsed or refractory (R/R) metastatic colorectal cancer.
Dr. Xiao Lei, Founder of the company, stated: The approval of the U.S. IND is a critical step in validating the company's platform technology. This round of financing will accelerate the accumulation of additional clinical data for the company's technology across multiple solid tumor indications.
According to Dr. Eugene Kennedy, the company's Chief Medical Officer,CompanyThe CAR-T solid tumor product has been validated in dozens of IIT clinical trials, demonstrating a significant objective response rate and manageable toxicities as a monotherapy regimen in patients with advanced colorectal cancer who have undergone multiple prior lines of treatment.. He expects that the clinical trial soon to be initiated in the United States will replicate these data.
36Kr previously analyzed，Historically, CAR-T research has been hampered by the persistent challenge of achieving breakthroughs in solid tumors. Consequently, a wave of followers have flocked to hematologic malignancies, opting for the “easy mode.” However, solid tumors account for 90% of cancer patients globally, representing a market scale that is orders of magnitude larger than that of hematologic malignancies. This also constitutes the greatest market opportunity for CAR-T therapies.
Therefore, currently, major cancer types such as liver cancer, lung cancer, breast cancer, colorectal cancer, and gastric cancer have attracted countless contenders, such as CARsgen Therapeutics,Legend Biotech、Kaidi Biotechnology、YongTai Biopharma... and others have currently established a presence in this field.
Regarding the investment rationale, Gao Jieliang, Partner at CDH VGC, stated that the application of cell therapy in solid tumors is a globally recognized challenge. The company’s proprietary universal CoupleCAR platform technology for solid tumors has achieved breakthrough progress in clinical studies across various major solid tumor indications. The U.S. FDA IND approval for the core product GCC19 CART further validates the company’s technology.