CHINEO Medical Submits IPO Prospectus for Its Breakthrough Super TIL Therapy Targeting Solid Tumors

Report (by Tian Yanjun, Integrated Media Center Reporter): Recently, the list of 2019 Zhongguancun Disruptive Technology R&D and Achievement Transformation Projects was publicized. After undergoing multiple stages including correspondence review, on-site defense, expert evaluation, and academician team assessment, eight disruptive technology transformation projects were ultimately selected from hundreds of candidates. Among them, Chineo’s project, “Development of Anti-Cancer Drugs Based on Super TIL (Tumor-Infiltrating Lymphocyte) Cell Technology,” is the only disruptive technology in the field of immune cell therapy targeting solid tumors on the publicized list.

Chineo has organically integrated TIL technology, CAR-T (chimeric antigen receptor T-cell) technology, and gene-editing technologies that overcome tumor microenvironment-mediated immunosuppression to develop disruptive anticancer drugs targeting solid tumors. Clinical trial data demonstrate that Super TIL achieves a disease control rate of nearly 100% and an objective response rate of 30% in patients with advanced solid tumors refractory to multiple lines of therapy, using only one ten-thousandth of the dosage required for conventional TIL therapy. Furthermore, Super TIL exhibits the potential for application across all cancer types and disease stages, along with technical advantages including low manufacturing costs and short production cycles.

Despite the remarkable success of CAR-T therapy in hematologic malignancies, it has yet to achieve breakthroughs in the treatment of solid tumors due to the significant differences between solid and hematologic cancers. To overcome solid tumors using immune cell therapy, five major challenges must be addressed: how to obtain T cells capable of recognizing heterogeneous tumors, the immunosuppressive effects of the tumor microenvironment on T cells, the expansion of T cell quantities, and the high costs associated with cell sourcing that depends on surgical tissue preparation.

Chineo boasts a research and development team composed of overseas-returnee scholars and local young scientists, with its technological lineage tracing back to pioneering global experts in immune cell therapy from institutions such as the National Institutes of Health (NIH) and the University of Pennsylvania (UPENN). As early as 2015, when the company was established in the Economic-Technological Development Area, the team recognized that solid tumor treatment technologies like CAR-T and TCR-T had limitations and could not simultaneously overcome the five major challenges in solid tumor therapy. After five years of arduous exploration, Chineo’s scientific team integrated TIL technology, CAR-T technology, and genetic engineering techniques designed to counteract the immunosuppressive effects of the tumor microenvironment. This effort culminated in the development of a “Super TIL” cellular product for solid tumor treatment, successfully conquering the aforementioned five major challenges.

Upon entering the human body, Super TILs can precisely locate tumor tissues, overcome the immunosuppressive effects of the tumor microenvironment to achieve enhanced cytotoxicity, and undergo robust in vivo expansion. This ensures that the “troops” (TIL cells) are sufficiently numerous to defeat the “enemy” (cancer cells). Furthermore, the design featuring in vivo expansion instead of ex vivo expansion addresses challenges related to manufacturing timelines and costs, making Super TIL therapy affordable for all in the future. In addition, Chineo has developed a technology for preparing Super TILs using only peripheral blood cells, without reliance on surgically resected tumor tissue. This advancement makes the therapy accessible to everyone, thereby significantly expanding its future market potential.

Currently, Chineo is collaborating with clinical research centers to conduct investigator-initiated clinical studies on its anti-cancer drug development project based on super TIL cell technology, and has enrolled 13 cancer patients. According to Professor Zhao Jie, a relevant executive at Chineo, these 13 patients represented 10 common types of cancer. All were late-stage tumor patients with multiple systemic metastatic lesions and rapidly progressing disease, who had failed multiple prior lines of therapy. Clinical treatment data from these 13 patients showed that the super TIL cell therapy achieved a disease control rate (i.e., halt in tumor progression) of nearly 100% and an objective response rate (i.e., significant tumor shrinkage) of 30%. Preliminary assessments indicate that this efficacy is far superior to that of most current cancer therapies. The study also revealed that super TIL cell therapy has the potential to be effective regardless of cancer type or disease stage, which will significantly expand the clinical indications for super TIL therapy.

“Super TIL cell therapy drug is expected to file for new drug clinical trial approval by the end of next year. ‘The investigator-initiated clinical trials currently underway are also being conducted in accordance with Phase I clinical trial standards,’ said Professor Zhao Jie. The project is expected to be exempt from Phase I clinical trials, accelerating the clinical trial process. It is preliminarily estimated that the super TIL cell anti-cancer drug will be submitted for market approval in 2022. Super TIL is poised to disrupt the future market landscape of solid tumor treatment.”