OXFORD, England–(BUSINESS WIRE)–PsiOxus® Therapeutics, Ltd. (PsiOxus), the gene therapy for cancer company, today announced that it has started a clinical trial with NG-641, a four transgene tumor-microenvironment modifying cancer gene therapy, to cancer patients. This is the first time that a tumor-specific virus containing four different therapeutic transgenes has been administered to cancer patients.
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.
About PsiOxus Therapeutics
PsiOxus aims to be the world’s leading cancer gene therapy company, delivering medicines of value to patients with cancer. Our work is product and platform based with a focus on discovering and developing gene-based immuno-oncology therapies for the treatment of solid tumors. The T-SIGn gene therapy platform is based on the company’s oncolytic virus, enadenotucirev, which has properties that allow systemic IV delivery and payload capacity to deliver multiple genes as a viral vector. While delivered systemically, PsiOxus’ T-SIGn gene therapy products act locally within the tumor micro-environment, replicating only in tumor cells. T-SIGn gene therapy products are “armed” through the addition of genes that cause the tumor to express combinations of biologics including antibodies, cytokines and other immunomodulatory proteins. In effect, the T-SIGn viruses turn the tumor cells into “drug factories” to express combination gene therapy. The result is a revolutionary way to deliver biological anticancer therapeutics that act locally within the tumor microenvironment for the treatment of cancer.
Clinical trials are also ongoing with the unarmed enadenotucirev oncolytic virus in solid tumors in combination trials.