Qualigen Therapeutics Engages TD2 as Contract Research Organization for Preclinical Development

Qualigen Therapeutics, Inc. recently announced it has appointed the renowned contract research organization (CRO) Translational Drug Development (TD2) to lead the preclinical development of lead drug candidate QN-302. Qualigen is initially investigating QN-302 for the potential treatment of pancreatic ductal adenocarcinoma (PDAC), which represents the vast majority of pancreatic cancers.

“This is an important step forward in our development work to bring QN-302 through the IND process and into the clinic,” said Tariq Arshad, MD, MBA, Qualigen’s Chief Medical Officer. “TD2’s expertise is focused on early stage preclinical and clinical oncology drug development. Its unique approach, geared at identifying clinical and regulatory strategies where there is the greatest opportunity for success in the clinic, was among the key reasons for partnering with TD2.”

TD2 is a precision oncology drug development organization integrating preclinical, clinical, and regulatory expertise and providing expert drug development services, including the design and execution of oncology clinical trials. TD2 has a proven track record of obtaining IND clearances and managing complex trial designs, including recruitment for Orphan diseases, to accomplish first patient dosing as quickly as possible.

“We are eager to begin our collaboration with Qualigen and to develop a research program for QN-302 that results in a suitable dataset for regulatory clearance. Our shared goal is to accelerate the compound into the clinic where it may address an unmet medical need that, to date, has few options,” added Stephen Gately, PhD, President and CEO of TD2.

QN-302 is Qualigen’s genomic quadruplex (G4)-selective transcription inhibitor platform being developed as a potential treatment for PDAC, in addition to other tumors of high unmet clinical need. PDAC is one of the world’s most lethal cancers, and the fourth-leading cause of cancer-related death in the US. Each year, an estimated 460,000 people globally—and 60,000 in the US—are diagnosed with PDAC, and it annually causes approximately 430,000 deaths worldwide and 48,000 in the US. Qualigen believes that QN-302 may ultimately be eligible to obtain Orphan Drug Designation, with potential for key regulatory advantages.

Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for cancer, as well as maintaining and expanding its core FDA-cleared FastPack System, which has been used successfully in diagnostics for over 20 years. 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. Our investigational QN-247 compound inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). The investigational compounds within Qualigen’s RAS-F family of 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. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions. For more information, visit www.qualigeninc.com.

TD2 is a leader in precision oncology, providing innovative services for improved drug development. Using a dedicated, expert team with broad experience and understanding in cancer medicine, TD2 is uniquely positioned to support accelerated development of novel therapeutics. Rigorous and high-throughput translational preclinical development services, combined with regulatory affairs expertise, enables customized clinical trial design and execution. The broad suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process with the ultimate goal of accelerating patient access to promising treatments. For more information, visit www.TD2inc.com.