Quebec biotech Theratechnologies has received approval from the U.S. Food and Drug Administration (FDA) to begin Phase 1 clinical trials on TH1902, an anti-cancer drug developed from a therapeutic platform developed by Professor Borhane Annabi of the Department of Chemistry and his team at UQAM's Molecular Oncology Laboratory. Trials will begin in the coming months in patients with advanced endometrial, ovarian, colon, pancreatic and triple negative breast cancers that are resistant to available treatments.
"It's amazing to have been involved in the development of a new drug from A to Z, from the early stages of research to early clinical trials," says Borhane Annabi. We are very proud, especially since the FDA has just granted us the"fast track"designation, which means that our file has passed at the top of the pile. This has a lot of weight and will help in patient recruitment."
The"fast track"designation is intended to facilitate the development and expedite the review process of drugs designed for the treatment of serious medical conditions and to allow patients to access new drugs more quickly, Theratechnologies said in a statement issued on February 4.
This FDA recognition of TH1902 highlights "the vast field of applicability and enormous medical need for innovative, targeted, potentially more effective and better tolerated treatments for cancer," said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer at Theratechnologies.
TH1902 combines docetaxel, a drug already part of the cancer therapeutic arsenal, and a peptide that specifically targets sortilin receptors (SORT1). This new drug vectoring platform is based on inventions by Borhane Annabi's team, developed at UQAM in collaboration with Professor Emeritus Richard Bliveau. The technology specifically targets overexpressed proteins on cancer cells, the sortilin receptors, which serve as a gateway to bring the drug inside these cells.
Several types of cancers express the sortilin receptor (SORT1). Promising preclinical results have already been obtained for triple negative breast cancer, ovarian cancer and, more recently, colon, pancreatic, endometrial and skin cancers. The preclinical assessment of TH1902 is still ongoing for melanoma.
"In animals, treatment has been shown to slow down tumor growth, or even completely eradicat, without causing weight loss or neutropenia, deleterious side effects often associated with chemotherapy," says Borhane Annabi. Now it's all about clinical trials."
The first Phase 1 trial in humans will assess, among other things, the safety of the drug and the maximum tolerated dose. TH1902 will be administered once every three weeks to patients at the MD Anderson Cancer Center at the University of Texas, one of the largest cancer treatment and research centers in the United States.
Patients (in many cases, patients) with advanced and recurrent solid tumors expressing the sortilin receptor and resistant to standard treatments will be able to participate in the study. "These are patients who can no longer be treated, who no longer respond or very little to current treatments," says Borhane Annabi. For those people to whom medicine no longer has much to offer, the trials that are about to begin are a great hope."
The Canadian Cancer Society (CCS) and the Quebec government, through the Quebec Consortium on Drug Discovery (CQDM), will contribute a total of $1.4 million to support ongoing research.
"This is a great partnership between cutting-edge biomedical research and industry, between UQAM and its partners Theratechnologies, CCS and CQDM, who believed in the project and funded it," concludes Borhane Annabi. We hope to be laying the groundwork for a possible success story."
https://www.actualites.uqam.ca/2021/nouvelle-arme-contre-des-cancers-refractaires-aux-traitements-conventionnels