On March 5, 2020 PsiOxus Therapeutics, Ltd. (PsiOxus), the gene therapy for cancer company, reported that it has started a clinical trial with NG-641, a four transgene tumor-microenvironment modifying cancer gene therapy, to cancer patients (Press release, PsiOxus Therapeutics, MAR 5, 2020, View Source [SID1234555209]). This is the first time that a tumor-specific virus containing four different therapeutic transgenes has been administered to cancer patients.
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PsiOxus also announced today that Dr Tom Lillie has been appointed as Chief Medical Officer. Dr Lillie, who previously held senior oncology roles at Amgen and then MSD (known as Merck in the USA and Canada), where he was most recently Vice President, Oncology Global Medical Affairs, will be based in their Oxford, UK Head Office.
"With NG-641, our approach of systemically delivering gene therapy vectors to turn tumor cells into drug factories is being deployed to deliver a bispecific T-cell activating protein to target cancer-associated fibroblasts (CAFs) via the fibroblast activation protein (FAP). This mechanism allows us to target one of the most important immunosuppressive cells in the tumor microenvironment" stated Dr Brian Champion, the Chief Scientific Officer of PsiOxus.
In addition to the FAP-targeted T-cell activator, NG-641 also delivers three other molecules to further recruit and activate T-cells to induce an anti-tumor immune response. NG-641 is thus the first quadrivalent viral gene therapy vector for cancer to be studied in patients.
The Phase 1 STAR study is being conducted at multiple cancer centers in the United States and will assess the safety, tolerability and preliminary anti-tumor activity of NG-641 in subjects with solid tumors. The ClinicalTrials.gov identifier for the NG-641 study is: NCT04053283. A link to the ClinicalTrials.gov listing for the study can be found here.
Dr John Beadle, Chief Executive Officer of PsiOxus stated, "It is a great pleasure to welcome Dr Tom Lillie to our leadership team. He brings exceptional expertise related to cancer drug development and immunotherapy including the clinical development, launch and marketing of oncolytic viruses and checkpoint inhibitors".
Dr Tom Lillie added, "I am pleased to join PsiOxus at this exciting time as our third cancer gene therapy enters clinical evaluation. I look forward to the opportunity to work with the rest of the PsiOxus team as we continue to develop innovative gene therapy products to treat and benefit cancer patients."
PsiOxus’ proprietary T-SIGn platform uses the enadenotucirev oncolytic virus as a vector to deliver combinations of therapeutic transgenes to carcinomas to fight cancer. All T-SIGn products are administered intravenously and are designed to selectively infect and replicate only in tumor cells. NG-348 and NG-350A are PsiOxus’ other T-SIGn viruses which have entered clinical trials.