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Qualigen, Hande Sciences Partner to Scale-Up Mfg. for IND-Enabling Studies

Hande to provide process development and scale-up batches of material for Qualigen’s GLP toxicology studies for Orphan oncology candidate.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Qualigen Therapeutics, Inc. 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.
 
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, expected to begin 3Q22.
 
Tariq Arshad, MD, MBA, Qualigen’s Chief Medical Officer, commented, “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. 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. Drugs that treat rare cancers such as PDAC qualify for Orphan Drug Designation (ODD) as the prevalence is <200,000 cases. ODD therapeutic programs typically require smaller clinical trials and have an expedited regulatory path.

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