Capital University of Medical Sciences

BEIJING--(BUSINESS WIRE)-- Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone), an innovative biotechnology company focused on precision oncology therapeutics, announced results from the two presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Details and highlights from the presentations are as follows: Oral Presentation: Title: Efficacy and safety of the Vebreltinib in previously treated, secondary glioblastoma / IDH mutant glioblastoma patients with PTPRZ1-METFUsion GENe (FUGEN): a randomised, multicentre, open-label, phase II/III trial Presenter: Zhaoshi Bao, MD, PhD Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, China Session Title: Central Nervous System Tumors Published Abstract Number: 2003 Isocitrate dehydrogenase (IDH)-mutant gliomas carry a high risk of malignant transformation from low-grade gliomas into high-grade gliomas within 10 years, resulting in poor prognosis. Effective targeted drugs for high-grade gliomas are still lacking. In this open-label, phase II/III trial, 84 patients with histologically confirmed secondary GBM or IDH-mutant GBM were assigned in a 1:1 ratio to receive twice-daily oral vebreltinib at a 300 mg dose or the investigator's choice of chemotherapy (temozolomide [100-150 mg/m2/day, 7 days on followed by 7 days off ]) or cis-platinum [80-100 mg/m2 for 3 days] combined with etoposide [100mg/m2/day for 3 days]) every 28 days. The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS) and objective response rate (ORR). 42 patients of the vebreltinib group and 39 patients of the chemotherapy group were included in the full analysis set. After a median follow-up of 4.44 months, the median OS in the vebreltinib group and chemotherapy group was 6.31 months (95% CI, 4.44-8.77) and 3.38 months (95% CI, 2.37-4.27), respectively. The HR for OS was 0.52 (90% CI, 0.32-0.85; P = 0.009). The median PFS in the vebreltinib group and chemotherapy group was 1.87 months (95% CI, 1.41-2.76) and 1.05 months (95% CI, 0.95-1.77), respectively. The HR for PFS was 0.54 (95% CI, 0.33-0.88; P = 0.014). No significant differences were observed in ORR (9.5% vs. 2.6%) for the vebreltinib group and chemotherapy group. Treatment-related adverse events of grade 3 or 4 were reported in 7% of the patients in the vebreltinib group, as compared with 12.2% of those in the chemotherapy group. No treatment-related deaths were observed. These results of the FUGEN trial support the use of vebreltinib as the first target therapy in patients with previously treated, PTPRZ1-MET fusion gene positive, secondary glioblastoma / IDH-mutant glioblastoma, and shed light on a novel therapeutic pathway in the landscape of IDH-mutant high-grade gliomas. "The development of drugs for indications related to MET targets has always been a difficult one. This is not only a victory for translational medicine, but also marks the advent of the era of targeted therapy in the field of brain glioma,” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. Clinical Trials Information: NCT06105619 and ChiCTR2300077783 Poster Presentation: Title: Efficacy and Safety of Vebreltinib in Patients with Advanced NSCLC Harboring MET Exon 14-Skipping: Results of 2.5-year follow-up in KUNPENG Presenter: Jin-Ji Yang, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China Session Title: Lung Cancer - Non-Small Cell Metastatic Abstract Number: 8557 MET exon 14 skipping mutation is present approximately 3% to 4% of non-small cell lung cancers (NSCLCs) and is associated with poorer survival rates. Vebreltinib (PLB1001), a potent and highly selective c-MET inhibitor, demonstrated superior objective response rate (ORR) benefits in locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients (pts) with MET exon 14 (METex14) skipping mutations in the previous analysis of the phase II KUNPENG study. In this Phase II, open-label, multicenter, and multi-cohort study, tumor tissue was assessed for METex14 skipping mutation using next-generation sequencing (NGS) from CAP or CLIA certificated local or central laboratories. Patients in Cohort 1 received 200 mg of vebreltinib twice daily (28 days per cycle) until discontinuation criteria were met. The primary endpoint was ORR assessed by blinded independent review committee (BIRC). Between Jan 17, 2020 and Feb 09, 2021, 52 patients were enrolled in Cohort 1. As of the data cutoff date (Aug 09, 2023), the median duration of follow-up was 19.1 months (range, 1.0-42.7) and the median duration of treatment was 9.9 months (range, 0.6-42.7). Per BIRC assessment, the ORR was 75% (95% CI: 61.1-86.0), the disease control rate (DCR) was 96.2% (95% CI 86.8-99.5), the median duration of response (DoR) was 16.5 months (95% CI 9.2-19.4), the median time to response (TTR) was 1.0 month (95% CI 1.0-2.8), the median progression-free survival (PFS) was 14.3 months (95% CI 6.4-18.2), and the median overall survival (OS) was 20.3 months (95% CI 16.2-29.7). The 3-year OS rate was 35.1%. Subgroup analyses showed the ORR was 100.0%, 66.7%, 85.7% and 100.0% among pts with any baseline brain metastases (N=5), pts with any baseline liver metastases (N=6), pts aged 75 years and older (N=21) and pts with co-occurring of MET amplification (N=12), respectively. The most common (≥20%) treatment-related adverse events (TRAEs) in all of the 135 patients enrolled in this study were peripheral edema (56.3%), hypoalbuminemia (27.4%), hypoproteinemia (25.9%) and anemia (20.7%). "With this study, we continue to see best-in-class potential of Vebreltinib in patients with MET exon 14 skipping mutation NSCLC,” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. Clinical trial information: NCT04258033 About Avistone Biotechnology Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone) is an innovative biotechnology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive portfolio and pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and in other solid tumors.

“Currently More Than 180 Oncolytic Virus Immunotherapies Are In Clinical Trials” Conventionally, the management of cancer was predominantly restricted to surgery, radiation therapy, in addition to chemotherapy. Even though these therapies have shown significant abolition of primary tumors, their allied systemic toxicities and the high incidences of relapse are the foremost limitations. The escalation in prevalence of cancer and the curbs of conventional therapies have propelled the demand of novel targeted therapies which can overcome the limitations and have enhanced specificity and target ability towards the disease. One such approach is using the virus as a therapeutic approach to deliver cancer fighting genes to the tumor cell and thereby inducing an immuno modularity response that will aid to cause death in cancerous cell. This led the development of oncolytic virus therapy as a promising treatment to cure rising cancer malignancies. The oncolytic virus therapy clenches long history which can be backpedalled the late 1950s to 1970s epoch in which the multiple clinical trials and studies were ongoing with the wild type viruses in order to understand a novel approach to treat tumor cells. Moreover, oncolytic viral therapy provides enormous advantage such as higher response towards cancer cells owing to the presence of impaired antiviral defense in addition to better delivery of therapeutic payloads to tumor cells as compared to the conventional treatment which aims to reduce or delays the symptoms of cancer. Download Oncolytic Virus Immunotherapies Clinical Trials Landscape Research: The research and development picked up its pace ever since the oncolytic virus therapy called Oncorine was approved by the National Medical Products Administration (NMPA) to treat Head and neck cancer in the year 2005. However, the drug was only accessible in China owing to the strict rules and regulations. Nevertheless, the approval of Oncorine has provided surplus thrust to the research and development across the globe which led to the approval by FDA for the first viral therapy, T- VEC (Imlygic) to treat melanoma. One of the primary impetuses for the growth of oncolytic virus therapy domain was due to the rising ascendancy of these therapies in the clinical studies. Preliminary data from the clinical trial studies demonstrates that more than 150 clinical researches are currently ongoing for the treatment of innumerable seldom and common diseases such as Alzheimer disease, herpes simplex 1, advanced biliary tract cancer, chronic hepatitis b, refractory malignant ascites as well as hepatocellular carcinoma. The clinical pipeline for the domain of viral therapy is mounting at an incredible gait. For instance, a modified human recombinant type 5 adenovirus with genetic modifications H101 is a novel treatment regimen used to provide treatment for patients suffering from advanced biliary tract cancer. The study is lately in the phase I clinical stage which is sponsored and collaborated by Fudan University. To further enhanced in addition to improve the efficacy, novel viral oncolytic therapy are used in combination with other drugs with the purpose to provide improved and advanced treatment regimen to the patients suffering from cancer. For instance, a novel Telomerase-specific Type 5 Adenovirus OBP-301 viral therapy in conjugation with Carboplatin, Paclitaxel as well as radiation therapy is used to cure adenocarcinoma. The clinical studies in lately in the phase I clinical stage which is sponsored and collaborated by NRG Oncology and National Cancer Institute (NCI). Researches believed that the oncolytic virus therapy clench potential as well as long lasting promising therapeutic effects. As a consequence, multiple pharmaceutical companies along with centers such as City of Hope Comprehensive Cancer Center, New York Medical College, Children's Hospital of Pennsylvania, Mayo Clinic in Arizona, Peking University First Hospital as well as Beijing Tiantan Hospital, Capital Medical University are working recklessly for the purpose to develop advanced oncolytic virus therapy that controls the prognosis of cancer diseases along with other indications such as advanced bladder carcinoma, pancreatic cancer, solid tumor and gastrointestinal cancer. All these examples mentioned above demonstrate that the clinical and translational market for oncolytic virus therapy is growing at an absurd pace.

SHENZHEN, China, March 18, 2024 /PRNewswire/ -- On March 18 2024, Shenzhen chipscreen biosciences Co., Ltd. (hereinafter referred to as "chipscreen biosciences", stock code: 688321. SH) announced that the Phase II clinical trial (CGZ203 study) of chiglitazar monotherapy for non-alcoholic steatohepatitis (NASH) was successfully completed with data cleaning and database locking on February 22, 2024. The primary efficacy endpoint of the trial has been achieved, and further data analysis is currently underway. The incidence of non-alcoholic fatty liver disease (NAFLD) or metabolic associated fatty liver disease (MAFLD) in the general population of China exceeds 25%, of which about 25% will progress to NASH, and this proportion is even higher in patients with metabolic syndrome. Currently, there is only one thyroid receptor β (TRβ) agonist approved worldwide. The CGZ203 study is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial aimed to evaluate the safety and preliminary efficacy of chiglitazar monotherapy in diagnosed NASH patients. The CGZ203 study was led by Beijing Friendship Hospital affiliated to Capital Medical University and conducted in 24 clinical sites nationwide. Preliminary results showed that both dose groups of chiglitazar produced significant and dose-dependent reductions at the primary efficacy endpoint (the proportion of changes from baseline in liver fat content evaluated by MRI-PDFF after 18 weeks of treatment), compared to placebo control group. In terms of secondary efficacy endpoints such as the proportion of patients with an over 30% decrease in liver fat content, non-invasive indicators related to hepatocyte damage, inflammation, and fibrosis and so on, both dose groups of chiglitazar also showed significant or dose-dependent trend of improvements. The overall safety is good. The detailed research results will be presented on an upcoming scientific conference or in research article. About Chiglitazar: Chiglitazar (Carfloglitazar) is a novel peroxisome proliferator activation related receptor (PPAR) pan-agonist, independently discovered and developed by Shenzhen chipscreen biosciences with global patent protection. It was firstly approved in China in October 2021, for clinical treatment of type 2 diabetes patients who cannot be effectively controlled by exercise and diet control. It is also the first approved PPAR pan-agonist in the world. Chiglitazar has already completed a phase III trial of combination with metformin to treat type 2 diabetes patients (RECAM study) and the current phase II trial in NASH patients (CGZ203) in China. About CGZ203: CGZ203 is an exploratory phase II trial aimed at treating NASH patients. It was designed as a randomized, double-blind, placebo-controlled multicenter clinical trial. The clinically diagnosed NASH patients were randomly enrolled in a ratio of 2:2:1 to receive oral administration of chiglitazar 48 mg, 64 mg, and placebo once a day respectively, with a treatment period of 18 weeks. The primary efficacy endpoint is the percentage of changes from baseline in liver fat content (LFC) evaluated by magnetic resonance proton density fat fraction (MRI-PDFF) after 18 weeks of treatment. Secondary endpoints include the absolute value of LFC changes, the proportion of people with a decrease of more than 30% in LFC, changes in other non-invasive indicators of liver cell damage, inflammation, and fibrosis, and the patient safety during the trial period. About Chipscreen: Shenzhen Chipscreen biosciences is a modern biopharmaceutical enterprise founded by a senior overseas Returnees team in 2001. The company specializes in the discovery and development of original new molecular entity drugs, focus on five major disease fields of cancer, metabolic diseases, autoimmune diseases, central nervous system diseases. With the independently created "integrated drug discovery and early evaluation platform based on chemical genomics", chipscreen has developed multiple original new drugs including two marketed products Chidamide (Tucidinostat) and Chiglitazar (Carfloglitazar), several clinical stage drug candidates Chiauranib (phase III), CS12192 (phase I), CS23546 (phase I), and CS32582 (Phase I). Till now, chipscreen has established a global industrial layout consisting of its headquarters, R&D center, a wholly-owned subsidiary of GMP production base (Shenzhen chipscreen Pharmaceutical Co., Ltd.) in Shenzhen, a wholly-owned subsidiary of its Chengdu regional headquarters/R&D center/innovative drug production base (Chengdu chipscreen Pharmaceutical Co., Ltd.) in Chengdu, Beijing branch (clinical research center), Shanghai branch (commercial center), and chipscreen Biosciences (USA) Co., Ltd. Chipscreen is one of the first batch of national "innovative drug incubation bases" and a national high-tech enterprise, independently undertakes dozens of national "863", "10th/11th/12th/13th five year plan of major scientific and technological special projects", and "major new drug creation" projects. A total of over 600 domestic and foreign invention patents have been applied, and over 160 have been authorized. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.