2023年5月12日

2023年5月12日,FDA已經批準了一個孤兒藥物名稱pyx - 201治療胰腺癌患者。FDA已經批準了一個孤兒藥物名稱(奇數)pyx - 201治療胰腺癌患者。1的初步數據進行第一階段pyx pyx - 201 - 201 - 101試驗在實體腫瘤(NCT05720117)月初預計2024.2“pyx - 201有潛力提供一種新方法針對多個腫瘤類型通過多管齊下的作用機製,實體腫瘤患者可能受益。從這項研究中,我們期望看到初步數據包括生物標誌物的結果和潛在的臨床活動的早期跡象,2024年初,”勞拉·蘇利文,醫學博士,總裁兼首席執行官羅盤座腫瘤,在一份新聞稿中說。“我驕傲的羅盤座腫瘤學團隊所做的工作在我們的第一個臨床試驗啟動加藥。劑量是一個重大成就和重要的裏程碑,標誌著羅盤座腫瘤臨床分期公司的轉型。“pyx - 201是一種新型抗體藥物共軛設計目標extradomain-B纖連蛋白(教育局),non-internalizing抗原,這是一個腫瘤細胞外基質的重要組成部分。教育局纖連蛋白過表達在許多實體腫瘤,最小的表達在大多數正常成人組織。代理目前正在研究非盲、多中心、pyx - 201 - 101劑量遞增試驗,其安全性、耐受性、藥代動力學、藥效學、初步及療效評估。才有資格登記,病人必須收到複發或難治性實體瘤的診斷,包括非小細胞肺癌、激素受體陽性乳腺癌,卵巢癌,甲狀腺癌,胰腺導管腺癌、軟組織肉瘤、肝癌和腎癌。 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