西雅圖和蘇州2023年11月4日 /美通社/ -- 普方生物,一家專注于開發(fā)新一代抗體偶聯(lián)藥物(以下簡稱"ADC")的臨床階段生物醫(yī)藥公司,今天宣布將在第38屆癌癥免疫治療學會(SITC 2023)年會上發(fā)表多個管線的積極數(shù)據(jù)。公司將發(fā)表其首選ADC藥物rinatabart sesutecan(Rina-S; PRO1184)正在進行的臨床1/2期試驗中劑量爬坡部分的初步結(jié)果,和另一項以蛋白酪氨酸激酶7(PTK7)為靶點的ADC藥物PRO1107的臨床前數(shù)據(jù),以及其ADC技術(shù)平臺最近的創(chuàng)新成果。
"我們很高興利用此次機會展示Rina-S的初步臨床結(jié)果,這是對我們新型載荷連接子sesutecan技術(shù)平臺最好的概念驗證。"普方生物首席醫(yī)學官Naomi Hunder醫(yī)學博士表示。"我們相信Rina-S在臨床1期試驗中展現(xiàn)出的積極活性和安全性數(shù)據(jù)使其在卵巢癌和子宮內(nèi)膜癌靶向治療領(lǐng)域具有差異化,因為在可耐受的劑量下Rina-S在FRα低表達的經(jīng)過多線治療后復發(fā)或難治性的患者中也觀察到了積極的客觀緩解。這些數(shù)據(jù)驗證了我們的技術(shù)平臺,也讓我們對開發(fā)出能為患者帶來更多治療新選擇的ADC藥物更有信心。"
Abstract #708: A Phase 1/2 Study of Rinatabart Sesutecan (PRO1184), a Novel Folate Receptor Alpha-Directed Antibody-Drug Conjugate, in Patients with Locally Advanced and/or Metastatic Solid Tumors
Presented by Justin A. Call, M.D., of START Mountain Region, West Valley City, UT, on Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m. to 8:30 p.m. PDT
Rina-S是一款以葉酸受體α(FRα)為靶點、以拓撲異構(gòu)酶1抑制劑依喜替康作為有效載荷,采用普方生物自主研發(fā)的新型親水性連接子的在研ADC藥物,目前正處于針對多種實體腫瘤的臨床1/2期開發(fā)階段。Rina-S臨床早期研究中納入了36名患者,劑量爬坡范圍為60 mg/m2至180 mg/m2,每21天給藥一次。
研究背景:
核心研究結(jié)果:
劑量優(yōu)化研究還在繼續(xù)開展。
LD343技術(shù)平臺和PRO1107臨床前數(shù)據(jù)展示,以及PRO1160一期臨床試驗的進展:
Abstract #1407: Expanding the Therapeutic Index of MMAE-Based Antibody-Drug Conjugates (ADCs) with a Novel Linker System (LD343)
Presented by Zhu Chen, Ph.D., ProfoundBio Chief Scientific Officer, on Friday, November 3, 2023, Exhibit Halls A and B1, 9 a.m. to 7:00 p.m. PDT
基于普方生物自主研發(fā)的新型親水性載荷連接子LD343技術(shù)平臺的ADC藥物,以在臨床中經(jīng)過廣泛驗證的MMAE為有效載荷,其抗體載荷比為8(DAR8),在臨床前研究中與DAR4的vedotin ADC進行了頭對頭的比較,展現(xiàn)出了更寬的治療窗口。
核心要點:
Abstract #1406: A Novel PTK7-Directed Antibody-Drug Conjugate (ADC) PRO1107 Demonstrated Broad Antitumor Activity with a Promising Safety Profile in Preclinical Models
Presented by Zhu Chen, Ph.D., ProfoundBio Chief Scientific Officer, on Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m. to 8:30 p.m. PDT
核心要點:
Abstract #718: Phase 1/2 Study of PRO1160, a CD70-Directed Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors and Hematologic Malignancies
Presented by Sharon Ma, MPH, ProfoundBio Director of Clinical Operations, on Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m. to 8:30 p.m. PDT