Qualigen Therapeutics Inc, a biotechnology company, announced it has signed a contract with STA Pharmaceutical Co Ltd (WuXi STA), a subsidiary of WuXi AppTec, for GMP production of AS1411, Qualigen's lead drug candidate for the treatment of COVID-19 and other viral diseases, for potential clinical trials. Preclinical studies at the University of Louisville's (UofL) Center for Infectious Disease have demonstrated the ability of AS1411, a novel aptamer-based molecule, to protect cells from the damaging effects of the novel coronavirus.
"With its industry leading large-scale oligonucleotide manufacturing capability, this new manufacturing contract with WuXi STA will ensure we have adequate supply of AS1411 for our anticipated clinical trials in patients with COVID-19. Securing multisource manufacturing capacity is an integral part of our planning for this potential broad antiviral therapeutic," said Michael Poirier, president, chief executive officer and chairman of Qualigen. "Given the persistence of the pandemic, there continues to be a need to develop treatments for COVID-19. We are encouraged by the AS1411 preclinical data indicating potential effectiveness against SARS-CoV-2, the novel coronavirus that causes COVID-19. Moreover, AS1411 has a strong safety profile as it was previously administered to more than 100 patients with advanced cancers and was well tolerated with no evidence of severe side effects."
In June 2020, Qualigen signed an exclusive license agreement with UofL for US patent rights covering the treatment of COVID-19 with AS1411. Qualigen intends to work with UofL to complete investigational new drug (IND)-enabling studies and plans to file an IND application with the US FDA in early calendar 2021. Qualigen's aim is to initiate a phase 2a clinical study in COVID-19 patients in the first half of calendar 2021