Investigational New Drug (IND) clearance transitions Qualigen Therapeutics from preclinical to clinical-stage company and demonstrates leadership in G4-targeting therapies for areas of high unmet need in oncology
CARLSBAD, Calif., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announces today that the U.S. Food and Drug Administration (FDA) has cleared the Company's IND application for QN-302, a potential best-in-class small molecule G-Quadruplex (G4)-selective transcription inhibitor. Based on this clearance, the Company plans to initiate the Phase 1 clinical trial in the second half of 2023 and will enroll patients with advanced or metastatic solid tumors.
Michael Poirier, Qualigen's Chairman and CEO, commented, "This is a pivotal milestone for our therapeutics pipeline as it transitions us into a clinical-stage company. The IND clearance for QN-302 brings us closer to our objective of developing best in class treatments that can potentially provide new therapeutic options for patients with advanced or metastatic solid tumors. Our clinical team has worked diligently to prepare for this milestone and is now dedicated to start enrolling patients, anticipated to take place in the second half of 2023."
The proposed Phase 1 trial is a multicenter, open-label, dose escalation, safety, pharmacokinetic, and pharmacodynamic study with dose expansion to evaluate safety, tolerability, and antitumor activity of QN-302 in patients with advanced solid tumors that have not responded to or have recurred following treatment with available therapies. The Company anticipates the dosing of at least 24 patients in the Phase 1 trial can be completed in 2024, funded in part by proceeds received by the divestiture of the Company's diagnostics business in July 2023.
About QN-302
QN-302 is a small molecule G-Quadruplex (G4)-selective transcription inhibitor in Phase 1 clinical development for the treatment of G4-expressing solid tumors, such as pancreatic cancer (PDAC), prostate cancer, sarcomas, and others. QN-302 stabilizes G4 complexes prevalent in the promoter region of oncogenes in many tumor types, impeding transcription of G4-containing cancer genes and potentially offering a tumor-agnostic clinical approach to treatment. Orphan Drug Designation (ODD) was granted by the FDA in January of this year for QN-302 for the intended indication of pancreatic cancer.
About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. 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. The investigational 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.
研究性新藥 (IND) 許可 將 Qualigen Therapeutics 從臨床前公司過渡到臨床階段的公司，並在腫瘤學需求高度未得到滿足的領域的 G4 靶向療法方面表現出領導地位
加利福尼亞州卡爾斯巴德，2023 年 8 月 1 日（GLOBE NEWSWIRE）— 專注於開發可能被指定爲孤兒藥的成人和兒科癌症的臨床階段治療公司 Qualigen Therapeutics, Inc.（納斯達克股票代碼：QLGN）今天宣佈，美國食品藥品監督管理局（FDA）已批准該公司對潛在同類最佳小分子 G-Farplex（GPlex）的 QN-302 的IND申請 4)-選擇性轉錄抑制劑。根據這一許可，該公司計劃在2023年下半年啓動1期臨床試驗，並將招收晚期或轉移性實體瘤患者。
Qualigen董事長兼首席執行官Michael Poirier評論說：“這是我們治療產品線的關鍵里程碑，因爲它使我們轉變爲臨床階段的公司。QN-302 的 IND 批准使我們更接近開發一流治療方法的目標，這些療法有可能爲晚期或轉移性實體瘤患者提供新的治療選擇。我們的臨床團隊一直在努力爲這一里程碑做準備，現在致力於開始招收患者，預計將於2023年下半年進行。”
擬議的 1 期試驗是一項多中心、開放標籤、劑量遞增、安全性、藥代動力學和藥效學研究，旨在評估 QN-302 在使用現有療法治療後沒有反應或復發的晚期實體瘤患者的安全性、耐受性和抗腫瘤活性。該公司預計，第一階段試驗中至少有24名患者的給藥可以在2024年完成，部分資金來自於2023年7月剝離公司診斷業務所獲得的收益。
關於 QN-302
QN-302 是一種小分子 G-Qualplex (G4) 選擇性轉錄抑制劑，正處於 1 期臨床開發階段，用於治療表達 G4 的實體瘤，例如胰腺癌 (PDAC)、前列腺癌、肉瘤等。QN-302 穩定了許多腫瘤類型癌基因啓動子區域普遍存在的 G4 複合物，阻礙了含有 G4 的癌症基因的轉錄，並有可能提供一種與腫瘤無關的臨床治療方法。今年 1 月，美國食品藥品管理局批准了 QN-302 孤兒藥稱號 (ODD)，用於胰腺癌的預期適應症。
關於 Qualigen Therapeutics
Qualigen Therapeutics, Inc. 是一家臨床階段的治療公司，專注於開發成人和兒科癌症的治療方法。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；這種結合可通過穩定 G4 不受 “鬆開” 的影響，幫助抑制癌細胞的增殖。據信，Qualigen的Pan-RAS癌基因蛋白質-蛋白質相互作用抑制劑小分子家族中的研究化合物可以抑制或阻斷突變的RAS基因蛋白與其效應蛋白的結合，從而使來自突變的RAS的蛋白質無法造成進一步的傷害。從理論上講，這種作用機制可能有效治療大約四分之一的癌症，包括某些形式的胰腺癌、結直腸癌和肺癌。
