Qualigen Therapeutics Announces Poster Featuring Positive Early Clinical Experience With QN-302, a Novel First-in-Class G-Quadruplex Experimental Anti-Cancer Drug, at the American Association of Cancer Research (AACR) 2024 Annual Meeting
Qualigen Therapeutics Announces Poster Featuring Positive Early Clinical Experience With QN-302, a Novel First-in-Class G-Quadruplex Experimental Anti-Cancer Drug, at the American Association of Cancer Research (AACR) 2024 Annual Meeting
CARLSBAD, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. ("Qualigen" or the "Company," Nasdaq: QLGN) today announces that a poster featuring its early clinical experience with a novel first-in-class G-Quadruplex experimental anti-cancer drug, QN-302, was presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 held April 5 – 10 in San Diego, California.
加利福尼亞州卡爾斯巴德，2024年4月9日（GLOBE NEWSWIRE）——Qualigen Therapeutics, Inc.（“Qualigen” 或 “公司”，納斯達克股票代碼：QLGN）今天宣佈，在4月5日至10日在聖地亞哥舉行的美國癌症研究協會（AACR）2024年年會上發佈了一張海報，展示了其在同類首創的新型G-四聯實驗抗癌藥物 QN-302 方面的早期臨床經驗，加利福尼亞州。
"These early clinical data from this multi-center Phase 1 study in patients with metastatic pancreatic cancer are encouraging and further corroborate our approach for utilizing QN-302 as a potential treatment for advanced pancreatic cancer," commented Michael Poirier, Qualigen's Chairman and Chief Executive Officer. "The three pancreatic cancer patients in the trial to date had ultimately failed extensive prior therapy including Standard of Care and subsequently received the lowest dose of QN-302, with no Dose Limiting Toxicity (DLTs) or Significant Adverse Events (SAEs) observed, leading to reportedly "good" quality of life during the dosage period. In addition, two patients showed no disease progression over months of treatment."
Qualigen董事長兼首席執行官邁克爾·普瓦里爾評論說：“這項針對轉移性胰腺癌患者的多中心1期研究的這些早期臨床數據令人鼓舞，進一步證實了我們利用 QN-302 作爲晚期胰腺癌潛在治療方法的方法。”“迄今爲止，該試驗中的三名胰腺癌患者最終未能通過包括標準護理在內的廣泛先前治療，隨後接受了最低劑量的 QN-302，沒有觀察到劑量限制毒性（DLT）或重大不良事件（SAE），據報道，在給藥期內生活質量 “良好”。此外，兩名患者在數月的治療中沒有出現任何疾病進展。”
The Annual AACR Conference is a focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine.
年度AACR會議是癌症研究界的焦點，科學家、臨床醫生、其他醫療保健專業人員、倖存者、患者和倡導者齊聚一堂，分享癌症科學和醫學的最新進展。
Highlights from this QN-302 Poster
這張 QN-302 海報的精彩片段
Abstract #105 - "Early clinical experience with a novel first-in-class G-quadruplex experimental anti-cancer drug" Tariq Arshad, Stephen Neidle, Sreenivasa Chandana, Erkut Borazanci and Nehal Lakhani - Results demonstrated that for the first five patients (three of whom were PDAC patients), QN-302 is overall well-tolerated (no SAE) and they have reported a "good" quality of life during the dosage period, with some early indications of stable PDAC disease. All PDAC patients had ultimately failed extensive prior therapy. Dose escalation initiated (patient #101-004) after three patients successfully completed cycle 1 of the initial dose. Dose escalation will be continued, with more patients being enrolled in the coming months. One patient was withdrawn from study 3/1/2024 after 4 months of stable disease. One patient was withdrawn from study on 3/12/24, after 3 weeks and a third patient is still in the study as of 3/13/24, 3 months after dosing start.
摘要 #105- “一種全新的同類首創G-四聯體實驗抗癌藥物的早期臨床經驗“ 塔裏克·阿爾沙德、斯蒂芬·內德爾、斯里尼瓦薩·尚達納、埃爾庫特·博拉贊奇和內哈爾·拉哈尼- 結果表明，對於前五名患者（其中三名是 PDAC 患者），QN-302 總體耐受性良好（無 SAE），他們報告在給藥期內的生活質量 “良好”，有一些早期跡象表明 PDAC 疾病穩定。所有PDAC患者在之前的大量治療中最終都失敗了。在三名患者成功完成初始劑量的第 1 週期後，劑量遞增開始（患者 #101 -004）。劑量將繼續增加，未來幾個月將招收更多患者。一名患者在病情穩定4個月後退出了2024年3月1日的研究。一名患者在3周後於24年3月12日退出研究，第三名患者在開始給藥3個月後，截至24年3月13日，仍在研究中。
In addition, Qualigen presented three other posters on QN-302 at AACR, as follows:
此外，Qualigen 在 AACR 上還展示了另外三張關於 QN-302 的海報，如下所示：
Abstract #5928 - "Structure-activity relationships for the pan-quadruplex experimental drug QN-302 and two analogs probed with comparative transcriptome profiling and molecular modeling" Ahmed Ahmed, Shozeb Haider, Tariq Arshad, and Stephen Neidle
摘要 #5928- “通過比較轉錄組分析和分子建模探討了泛四聯體實驗藥物 QN-302 和兩種類似物的結構-活性關係” 艾哈邁德·艾哈邁德、肖澤布·海德爾、塔裏克·阿爾沙德和斯蒂芬·內德爾
Abstract #3350- "The pan-quadruplex drug QN-302 targets up-regulated genes in pancreatic cancer and in other cancer types which correlate with poor prognosis" Stephen Neidle, Ahmed Abdullah Ahmed and Tariq Arshad
摘要 #3350- “泛四聯藥物 QN-302 靶向胰腺癌和其他與預後不佳相關的癌症類型中上調的基因” 斯蒂芬·內德爾、艾哈邁德·阿卜杜拉·艾 還有塔裏克·阿爾沙德
Abstract #576 - "The pan-quadruplex drug QN-302 selectively down-regulates key pathway targets in pancreatic cancer cells that are up-regulated in human pancreatic cancer" Stephen Neidle, Ahmed Abdullah Ahmed and Tariq Arshad
摘要 #576- “泛四聯藥物 QN-302 選擇性地下調人類胰腺癌中被上調的胰腺癌細胞中的關鍵通路靶標” 斯蒂芬·內德爾、艾哈邁德·阿卜杜拉·艾 還有塔裏克·阿爾沙德
About QN-302
關於 QN-302
QN-302, a novel tetra-substituted naphthalene diimide derivative invented and initially developed at University College London, is a potent binder to quadruplex (G4) sequences in the promoters of cancer genes, with 1-2 nM anti-proliferative activity in human pancreatic cancer (PDAC) cell lines. QN-302 has significant anti-tumor activity in xenograft, orthotopic and genetic (KPC) models of PDAC and retains high activity in gemcitabine-resistant PDAC cell lines. The drug is bio-available and well tolerated at therapeutic doses in the various animal models.
QN-302 是一種新的四取代萘二亞胺衍生物，最初由倫敦大學學院發明和開發，是癌症基因啓動子中四聯體（G4）序列的有效粘合劑，在人類胰腺癌（PDAC）細胞系中具有1-2 nM的抗增殖活性。QN-302 在 PDAC 的異種移植、原位和遺傳 (KPC) 模型中具有顯著的抗腫瘤活性，並在耐吉西他濱的 PDAC 細胞系中保持高活性。在各種動物模型中，該藥物具有生物利用度並且在治療劑量下具有良好的耐受性。
QN-302 is being developed by Qualigen Therapeutics Inc. It was granted Orphan Drug status for Pancreatic Ductal Adenocarcinoma (PDAC) by the FDA in January 2023 and granted Investigational New Drug (IND) clearance in August 2023 by the FDA for phase 1 clinical trial in advanced or metastatic solid tumors. This trial is being conducted at two cancer centers in the USA. In this first-in-human Phase 1 dose-finding study, the study design is for QN-302 to be given once a week, intravenously over 60 min, on Day 1, Day 8, and Day 15 of a 28-Day cycle. The study is designed to use a standard oncology 3+3 dose escalation design, with enrollment of 3 patients per cohort and expansion to 6 patients in the event of a DLT (Dose Limiting Toxicity). Five patients have been enrolled to date in the trial, two with colorectal adenocarcinoma as their primary cancer. Both were subsequently withdrawn from the trial, due to non-QN-302 issues (Grade 2 anemia: disease progression). One completed one cycle of QN-302 with no serious adverse effects (SAE).
QN-302 由Qualigen Therapeutics Inc開發，於2023年1月被美國食品藥品管理局授予胰腺導管腺癌（PDAC）孤兒藥地位，並於2023年8月獲得美國食品藥品管理局批准用於晚期或轉移性實體瘤的1期臨床試驗。該試驗正在美國的兩個癌症中心進行。在這項首次人體 1 期劑量發現研究中，研究設計爲在 28 天週期的第 1 天、第 8 天和第 15 天給藥一次 QN-302，靜脈注射超過 60 分鐘。該研究旨在使用標準的腫瘤學3+3劑量遞增設計，每個隊列招收3名患者，如果出現DLT（劑量限制毒性），則擴大到6名患者。迄今爲止，已有五名患者參加了該試驗，其中兩名患者以結直腸腺癌爲原發癌症。由於非QN-302問題（2級貧血：疾病進展），兩者隨後都退出了試驗。一個人完成了 QN-302 的一個週期，沒有出現嚴重的不良反應 (SAE)。
About Qualigen Therapeutics, Inc.
關於Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is an early-clinical-stage biotechnology company. Until the sale of its diagnostic business in 2023, Qualigen had a 20+ year history developing, marketing and selling medical devices in the United States and internationally. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against "unwinding," help inhibit cancer cell proliferation. QN-302 is currently in a Phase 1a clinical trial. The preclinical compounds within Qualigen's family of Pan-RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes' proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers.
Qualigen Therapeutics, Inc. 是一家處於早期臨床階段的生物技術公司。在2023年出售診斷業務之前，Qualigen在美國和國際上開發、營銷和銷售醫療器械已有20多年的歷史。我們正在研究的 QN-302 化合物是一種小分子選擇性轉錄抑制劑，對癌細胞中普遍存在的 G4 具有很強的結合親和力；這種結合可以通過穩定 G4 的免受 “解開” 來幫助抑制癌細胞的增殖。QN-302 目前處於 1a 期臨床試驗中。據信，Qualigen的pan-RAS癌基因蛋白質相互作用抑制劑小分子家族中的臨床前化合物會抑制或阻斷突變的RAS基因蛋白與其效應蛋白的結合，從而使突變的RAS中的蛋白質無法造成進一步的傷害。理論上，這種作用機制可能有效治療約四分之一的癌症，包括某些形式的胰腺癌、結直腸癌和肺癌。
For more information about Qualigen Therapeutics, Inc., please visit
有關 Qualigen Therapeutics, Inc. 的更多信息，請訪問
Contact:
聯繫人：
Michael Poirier
Qualigen Therapeutics, Inc.
760.452.8111
mpoirier@qlgntx.com
邁克爾·普瓦里爾
Qualigen Therapeutics, Inc
760.452.8111
mpoirier@qlgntx.com
Source: Qualigen Therapeutics, Inc.
資料來源：Qualigen Therapeutics, Inc.
譯文內容由第三人軟體翻譯。