2023年5月12日

2023年5月12日,FDA已经批准了一个孤儿药物名称pyx - 201治疗胰腺癌患者。FDA已经批准了一个孤儿药物名称(奇数)pyx - 201治疗胰腺癌患者。1的初步数据进行第一阶段pyx pyx - 201 - 201 - 101试验在实体肿瘤(NCT05720117)月初预计2024.2“pyx - 201有潜力提供一种新方法针对多个肿瘤类型通过多管齐下的作用机制,实体肿瘤患者可能受益。从这项研究中,我们期望看到初步数据包括生物标志物的结果和潜在的临床活动的早期迹象,2024年初,”劳拉·苏利文,医学博士,总裁兼首席执行官罗盘座肿瘤,在一份新闻稿中说。“我骄傲的罗盘座肿瘤学团队所做的工作在我们的第一个临床试验启动加药。剂量是一个重大成就和重要的里程碑,标志着罗盘座肿瘤临床分期公司的转型。“pyx - 201是一种新型抗体药物共轭设计目标extradomain-B纤连蛋白(教育局),non-internalizing抗原,这是一个肿瘤细胞外基质的重要组成部分。教育局纤连蛋白过表达在许多实体肿瘤,最小的表达在大多数正常成人组织。代理目前正在研究非盲、多中心、pyx - 201 - 101剂量递增试验,其安全性、耐受性、药代动力学、药效学、初步及疗效评估。才有资格登记,病人必须收到复发或难治性实体瘤的诊断,包括非小细胞肺癌、激素受体阳性乳腺癌,卵巢癌,甲状腺癌,胰腺导管腺癌、软组织肉瘤、肝癌和肾癌。 For the dose-escalation portion of the study, the population will include those who have developed disease progression through standard therapy and those for whom standard-of-care therapy associated with survival benefit is unavailable or unsuitable. In addition, patients must have an ECOG performance status of 0 or 1, at least 1 measurable lesion per RECIST v1.1 criteria––with the exception of patients with bone-only metastatic breast cancer––life expectancy of at least 3 months, and archived or fresh tumor samples for screening. The primary end points of the study include the determination of the number of patients who experience a dose-limiting toxicity and any adverse effect.3 Key secondary efficacy end points include objective response rate, duration of response, progression-free survival, disease control rate, time to response, and overall survival. “We are always looking for potential new treatments for patients who have limited or no options available. I am particularly excited about PYX-201 because it was designed to offer several important safety and efficacy improvements compared to traditional ADCs, and we look forward to evaluating it in this phase 1 study,” Alexander Spira, MD, director of NEXT Oncology Virginia, co-director of VCS Research Institute, and director of the Thoracic and Phase I Program and clinical assistant professor at Johns Hopkins University, said. The company’s other drug candidate, PYX-106, will also undergo evaluation in tumor-specific expansion cohorts following dose selection. Clinical sites are open and patient screening is underway for the phase 1 PYX-106-101 trial (NCT05718557). Dosing is expected to begin during the second quarter of 2023. “The first quarter of 2023 was marked by the transition of Pyxis Oncology to a clinical-stage company as we initiated two Phase 1 trials for PYX-201 and PYX-106,” Sullivan said. “Receipt of ODD for PYX-201 in pancreatic cancer is an important achievement highlighting the need for new treatment options, and we remain focused on execution as our two clinical programs advance. We continue to anticipate preliminary data, including biomarker results and early signs of potential clinical activity, from both trials in the late-2023 to early-2024 timeframe.” References Pyxis Oncology reports financial results for the first quarter 2023 and provides corporate update. News release. May 11, 2023. Accessed May 12, 2023. https://ir.pyxisoncology.com/news-releases/news-release-details/pyxis-oncology-reports-financial-results-first-quarter-2023-and Pyxis Oncology announces dosing of first subject in phase 1 trial of PYX-201, a novel ADC for solid tumors. News release. March 16, 2023. Accessed May 12, 2023. https://ir.pyxisoncology.com/news-releases/news-release-details/pyxis-oncology-announces-dosing-first-subject-phase-1-trial-pyx Study of PYX-201 in solid tumors. ClinicalTrials.gov. Updated March 9, 2023. Accessed May 12, 2023. https://clinicaltrials.gov/ct2/show/NCT05720117 Related Videos