The world's first nano-preparation for the treatment of non-small cell lung cancer and head and neck cancer IND approved
December 29, 2017 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On December 26, the French nano-preparation company NANOBIOTIX, which pioneered a new method of cancer treatment, announced that the US FDA approved the company's clinical trial application (IND) for the drug candidate NBTXR3, which is activated by stereotactic radiotherapy (SABR). The first in class of nanoparticle drugs that directly inject cancerous tumors, patients will be given anti-PD-1 antibody nivolumab or pembrolizumab, and the indications for patients with non-small cell lung cancer (NSCLC) and head and neck cancer (HNSCC) Treatment.
NBTXR3 is an injectable aqueous suspension of cerium oxide nanoparticles as an innovative treatment for solid tumors. After intratumoral injection, NBTXR3 can store high energy in the tumor only when the ionizing radiation source is activated (usually radiation therapy). After radiation activation, high-energy radiation kills tumor cells by triggering DNA damage and cell destruction, thereby improving clinical outcomes.
Laurent Levy, CEO of NANOBIOTIX, said: "The approval of FDA approval for NBTXR3 clinical trials is a milestone for the company. We are able to conduct the first clinical trial of cancer immunotherapy with NBTXR3 combined with immunological checkpoint inhibitors in the United States. Point-inhibitor non-responders are converted to responders by administering NBTXR3, which is our focus of development, and is a major advance in the industry, which can solve the problem of unmet medical needs. According to existing clinical and clinical Previous data, NBTXR3 has the potential to become the cornerstone of cancer immunotherapy."
Following the IND approval, the company will be able to conduct a clinical phase 1/2 trial of NBTXR3-1100, a multicenter, prospective, open-label, non-randomized clinical trial evaluating SABR-activated NBTXR3 combined immunological checkpoint inhibitor nivolumab Or pembrolizumab for the effectiveness and safety of cancer patients. The study will be divided into three cohorts, with patients enrolled in patients with relapsed and/or metastatic HNSCC or metastatic NSCLC. The study will be conducted in two consecutive phases, the first being dose escalation followed by the dose escalation phase. The clinical phase 1 of the study was planned to enroll 36-72 patients, and the second phase was planned to enroll 40 patients.
The dose escalation phase of NBTXR3-1100 will be based on the classical 3+3 study and is planned as a Level 3 procedure to determine the appropriate dose of NBTXR3 injected into the tumor and the activation dose of SABR. When NBTXR3 and radiation doses are increased, the dose of anti-PD1 antibody will remain unchanged. Based on the initial risk-benefit ratio observed in Phase 1 trials, an approved anti-PD1 antibody for the dose expansion phase will be selected.
The primary and secondary endpoints of this study will evaluate efficacy and safety, as well as an exploratory endpoint that further describes previously reported treatments leading to genomic alterations, including enrichment of cytokine activity, adaptive immune response, and T cell receptors. The marking of the signal path. The enrollment time of the first patient in the clinical study is expected to be in the second quarter of 2018, and the results are expected to be available in the summer of 2019.
The potential of tumor immunopharmaceuticals to attack cancer cells by activating the patient's immune system activity has been a point of interest in drug discovery. "Hot" tumors that are infiltrated by T cells and have inflammatory features, their response to immune checkpoint inhibitors have shown significant long-lasting efficacy in some cancer patients who have little response to existing treatments.
According to published data, only 15%-20% of NSCLC patients and 13%-22% of NHSCC patients respond to current immunotherapy.
The mechanism of action of NBTXR3 is that it can induce different immunogenicities, which may be the key to significantly increasing the number of cancer patients benefiting from immuno-oncology treatment. Like the data published earlier this year at ASCO & SITC 2017, radioactively activated NBTXR3 has been shown to induce specific adaptive immune patterns with the potential to convert non-responders into checkpoint inhibitors for the treatment of immune response patients. (Sina Pharmaceutical Compilation / David)
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