Qualigen Enters Manufacturing Agreement with Hande Sciences

Qualigen Therapeutics, a life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, has partnered with China-based Hande Sciences to conduct manufacturing scale-up activities to support the company’s IND-enabling good laboratory practice (GLP) studies for its lead therapeutic program, QN-302.

The company has chosen Hande for its capabilities in performing custom synthesis and process research and development. Hande specializes in scale-up of small molecules therapeutics and is building a large good manufacturing processes (GMP) manufacturing site, which is expected to be completed in August 2022. The agreement with Hande provides for process development and scale-up batches of material for the company’s GLP toxicology studies, which the company expects to begin in Q3 of 2022.

“We are on track to complete our IND-enabling studies for QN-302 in the third and fourth quarters of 2022 and are excited to partner with Hande, who has an excellent track record of performance,” said Tariq Arshad, MD, MBA, chief medical officer, Qualigen. “We look forward to continuing to execute on our key milestones with highly experienced collaborators in an efficient and cost-effective manner.”

QN-302 is Qualigen’s G-quadruplex (G4)-selective transcription inhibitor platform being developed as a potential treatment for Pancreatic ductal adenocarcinoma (PDAC), in addition to other tumors of high unmet clinical need, such as Prostate Cancer. PDAC represents the vast majority of pancreatic cancers, is one of the world’s most lethal cancers, and the fourth-leading cause of cancer-related death in the United States. In 2019, there were an estimated 89,248 people living with pancreatic cancer in the United States. Drugs that treat rare cancers such as PDAC qualify for Orphan Drug Designation (ODD) as the prevalence is <200,000 cases.2 ODD therapeutic programs typically require smaller clinical trials and have an expedited regulatory path.

Founded in 2007, Hande Sciences is a pharmaceutical contract development and manufacturing organization (CDMO) in China, providing research and development (R&D) and production services for global biotech and pharmaceutical companies. It specializes in process development, scale-up and manufacturing of advanced intermediates and active pharmaceutical ingredients (APIs) under non-GMP and GMP and accelerates the launch of new drugs, providing one-stop chemistry, manufacturing, and controls (CMC) services for the full lifecycle of drug development. Hande has campuses in Suzhou and Changshu where they have recently built a state-of-the-art non-GMP and GMP pilot plant for kilo scale and commercial launch scales up to metric tons with Environmental Health and Safety (EHS) and Quality Assurance (QA) systems that meet the requirements of Asia Pacific, European and US FDA and NMPA requirements.