News
October 14, 2024
Chinese CDE has granted an IND approval to Qurgen (Fuent) China for a Phase I clinical trial, focusing on liver cancers and stomach cancers.
October 4, 2024
The 5th SMC meeting held today to discuss the clinical data of the 3 subjects at the dose level of 1.0 mg/kg, Schedule B (twice/week). All the voting members of the SMC voted to advance to the next dose level at 2.0 mg/kg, Schedule B (twice/week) due to no DLT observed during DLT observation period at 1.0 mg/kg, Schedule B (twice/week).
August 26, 2024
Our clinical trial has 4th SMC meeting today to discuss the clinical data of the 3 subjects at the dose level of 2.0 mg/kg, Schedule A (once/week). All the voting members of the SMC voted to advance to the next dose level at 1.0 mg/kg, Schedule B (twice/week) due to no DLT observed during DLT observation period at 2.0 mg/kg, Schedule A (once/week).
August 19, 2024
Qurgen has successfully GMP manufactured SON-DP, Lot 4 using Qurgen’s own new GMP facility at Qurgen’s subsidiary company: FUENT Pharmaceutics in Suzhou, China. The quality parameters of the newly manufactured SON-DP are either the same or better than our previous 3 Lots of GMP-manufactured SON-DP. The overall quality of all 4 Lots of GMP manufactured SON-DP meets the FDA quality standard of protein drug. With this first manufacture of SON-DP, the Qurgen CMC team is working on optimization of the manufacture SOPs with the hope to increase the lot yield by THREE times in 2025 as comparison with the yield of Lot 4. With three-time yield increase in the GMP manufactured SON-DP, the cost of the drug should be significantly reduced.
July 1, 2024
QURGEN (FUENT) officially engaged with the following 3 sites for Chinese Phase I clinical trial: Zhongshan hospital, Fudan university, Beijing cancer hospital, Beijing University, Jiangsu Renmin province hospital.
June 7, 2024
Our clinical trial has 3rd SMC meeting today to discuss the clinical data of the 3 subjects at the dose level of 1.0 mg/kg, Schedule A (once/week). All the voting members of the SMC voted to advance to the next dose level at 2.0 mg/kg, Schedule A (once/week) due to no DLT observed during DLT observation period at 1.0 mg/kg, Schedule A (once/week).
March 29, 2024
Our clinical trial has 2nd SMC meeting today to discuss the clinical data of the 3 subjects at the dose level of 0.5 mg/kg, Schedule A (once/week). All the voting members of the SMC voted to advance to the next dose level at 1.0 mg/kg, Schedule A (once/week) due to no DLT observed during DLT observation period at 0.5 mg/kg, Schedule A (once/week).
January 23, 2024
Qurgen announces the grand opening of its own 30,000 sqft state-of-the-art GMP facility at Qurgen’s subsidiary company: FUENT Pharmaceutics in Suzhou, China. All the clinical investigational drug SON-DP will be manufactured in our own GMP facility in the future.
January 17, 2024
Our clinical trial has the1st SMC meeting today to discuss the clinical data of the 3 subjects at the lowest dose level of 0.2 mg/kg, Schedule A (once/week). All the voting members of the SMC voted to advance to the next dose level at 0.5 mg/kg, Schedule A (once/week) due to no DLT observed during DLT observation period at 0.2 mg/kg, Schedule A (once/week).
September 19, 2023
Qurgen has achieved a key milestone: the first patient with late stage of rectal adenocarcinoma has received the first dose of SON-DP with no major adverse effects.
August 1, 2023
Qurgen had officially engaged with the following 5 hospitals for the Phase I clinical trial of SON-DP in US for the treatment of solid tumors with the focus on breast, ovarian, pancreatic, and colorectal cancers: MD Anderson Cancer Center, Henry Ford Health System, Carolina BioOncology Institute (CBI), Banner MD Anderson at Banner Gateway Medical Center, Stephenson Cancer Center, University of Oklahoma.
April 23, 2023
Qurgen has obtained the IRB approval from WCG IRB that ensures Qurgen can initiate the US phase I clinical trial in multiple US hospitals.
April 17, 2023
Qurgen had a Pre-IND meeting with the study team of Chinese NMPA to discuss Qurgen’s pre-IND application for a Phase I clinical trial of an anti-cancer drug, SON-DP. Qurgen communicated with NMPA officers for 2 hours and received many constructive comments and suggestions to Qurgen’s future IND application. Official IND submission will be filed at a later day.
December 7, 2022
Qurgen has obtained the FDA approval for a first-in-human Phase I clinical trial IND application for an anti-cancer transcription factor protein drug, SON-DP, for the treatment of the patients with late-stage solid tumors with the focus on: Breast Cancer including triple negative breast cancer, Ovary Cancer, Pancreatic Cancer and Colorectal Cancer.