Our company participated in the 6th China Venture Capital Conference and released the Phase II clinical trial results
On September 25, 2021, the highly anticipated sixth "China Pharmaceutical Innovation and Investment Conference" was successfully held in Suzhou. Clinical data Global Debut special (hereinafter referred to as the "clinical debut special") as the star of the conference has been held for 6 consecutive sessions, in the beginning of preparation has received attention from all walks of life, the report site is often a difficult to find. This year, nine new drugs in research and marketing made an amazing debut, and key clinical data of each phase were disclosed for the first time. The project involved the latest research and development progress of innovative drugs for glioblastoma, nasopharyngeal cancer, infant rotavirus infection, diabetes and alopecia areata and other related diseases, which was widely concerned and praised by the investment community and medical professionals attending the meeting. At this venture capital conference, our company reported on the process of target discovery of chlorogenic acid and the progress of phase I/II clinical trials for the treatment of recurrent glioblastoma.
Glioma is the most common primary malignant tumor of the central nervous system, among which glioblastoma of WHO grade IV has the highest malignant degree and the worst prognosis, accounting for about 46% of all gliomas. According to the literature, the median survival of newly diagnosed glioblastoma patients is only 14.6 months, and the median survival of first-time recurrent glioblastoma patients is only 7-9 months. The current standard treatment is surgery + postoperative concurrent chemoradiotherapy + temozolomide adjuvant chemotherapy. There is only one temozolomide first-line treatment, and patients with temozolomide resistance or tumor recurrence often have a dilemma of no drug treatment. Chlorogenic acid, as an innovative drug for the treatment of brain glioma, has been widely concerned in the industry since its advent.
Report recipient: Professor Chen Xiaoguang, Institute of Materia Medica, Chinese Academy of Medical Sciences
Professor Chen Xiaoguang, Institute of Materia Medica, Chinese Academy of Medical Sciences, introduced the target and discovery process of "chlorogenic acid" to the participants. According to Prof. Chen, by using PAL-CHA, a photoaffinity labeled probe molecule modified with diacriproridine and alkynyl labels, the researchers labeled the active protein in the mitochondria of human malignant melanoma cells A375, and then conducted enzymolysis, mass spectrometry detection and Uniprot protein database query and comparison. The target of chlorogenic acid was ACAT1. Through a series of interaction experiments, the direct interaction between chlorogenic acid and ACAT1 protein was verified. The specific binding sites of chlorogenic acid and ACAT1 were obtained by structural biological techniques such as protein crystal culture and cryo-electron microscopy, and the mechanism of chlorogenic acid's anti-tumor effect through regulation of ACAT1 was further clarified. It provides the experimental basis for the clinical application of chlorogenic acid, and also provides a new target for the research and development of novel anti-tumor drugs.
Reporting author: Li Wenbin, Director of Tumor Comprehensive Treatment Center, Beijing Tiantan Hospital Affiliated to Capital Medical University
Li Wenbin, Director of the Tumor Comprehensive Treatment Center of Beijing Tiantan Hospital affiliated to Capital Medical University, brought a "Report on the progress of Phase I/II clinical trial for the treatment of recurrent glioblastoma with chlorogenic acid Injection". Phase I trials showed that chlorogenic acid was safe, well tolerated and had a high benefit rate. At 3mg/kg(n=9), the median post-treatment OS of the nine patients was 20.3 months, much higher than the overall survival reported in the literature. In addition, Director Li also introduced the patient enrollment of the Phase II clinical trial, the baseline characteristics of the subjects, and some of the Phase II clinical trial results. At present, 52 patients in the chlorogenic acid group and 52 in the CCNU control group have been enrolled. The therapeutic effect (overall survival after treatment) of both groups far exceeded the median survival of conventional treatment. The expected median OS in the chlorogenic acid group was significantly superior to CCNU in the control group. The results of Phase II clinical trials showed that the survival of patients in the chlorogenic acid group, including OS after diagnosis, OS after recurrence, OS after treatment, and PFS, were not worse than those in the CCNU group, and many of them were longer than previous clinical studies. In addition, all adverse reactions in the chlorogenic acid group were injection site hardening, and the incidence of serious adverse reactions was only 6%, while 67% of patients in the CCNU group had thrombocytopenia, 44% had leukopenia, and the incidence of serious adverse reactions was 50%. In conclusion, the therapeutic effect of chlorogenic acid is satisfactory, and the safety and tolerability are obvious.
