ARCHAMPS, France & GENEVA--(BUSINESS WIRE)--Regulatory News:
Genkyotex (Paris:GKTX) (Brussels:GKTX) (Euronext Paris & Brussels: FR00011790542 – GKTX), a biopharmaceutical company and the leader in NOX therapies, announced today that data in multiple preclinical models showed that GKT831, the Company’s NOX1 and NOX4 inhibitor, efficiently targeted cancer associated fibroblasts (CAFs) and delayed tumor growth. The results from this study were published in the Journal of the National Cancer Institute (https://doi.org/10.1093/jnci/djx121).
Professor Gareth Thomas at the University of Southampton, United Kingdom (UK), senior author of the study, was also awarded a Small Molecule Drug Discovery grant by Cancer Research UK (CRUCK) to further evaluate the optimal clinical development strategy for GKT831 in oncology. CRUCK is a leading cancer research and awareness charity based in the UK. The objective of the funded program is to inform the design of a potential clinical trial of GKT831 in combination with current chemo- and immunotherapeutics.
The tumor stroma is composed of extracellular matrix produced by CAFs and also includes immune cells and blood vessels. The presence of CAFs is associated with poor survival in many cancer types and are thought to have a number of different roles in cancer development, including promoting metastasis, resistance to chemotherapy and shielding tumors from the immune system. Accordingly, CAFs are a promising therapeutic target. In the published study, Professor Thomas and his colleagues demonstrated that an abundance of CAFs was linked to patient survival, and identified NOX4 as a critical regulator of CAF accumulation in many common cancer types. GKT831 prevented CAF formation in tumors, slowed tumor growth and reversed the CAF phenotype in cells grown from patients’ tumors.
“Based on our results, we believe that GKT831 has the potential to be an effective adjunctive cancer treatment,” said Professor Thomas. “We are excited to initiate a translational research program to further evaluate GKT831 in oncology. We are now focused on assessing the impact of GKT831 on improving the response of certain common cancers to immunotherapy and chemotherapy. We are grateful to CRUK for their continued support of our work.”
“We are very impressed by these results which suggest that NOX4 inhibition with GKT831 can effectively target the tumor stroma,” said Philippe Wiesel, M.D., Executive Vice President and Chief Medical Officer of Genkyotex. “Importantly, this may have broad applicability across many common cancer types.”
Genkyotex recently announced the initiation of patient enrollment into a Phase 2 study of GKT831 in primary biliary cholangitis, a progressive fibrotic liver disease. Dosing of the first patient is expected shortly with interim top-line results anticipated in the first half of 2018, and full results expected in the second half of 2018.
Genkyotex is the leading biopharmaceutical company in NOX therapies, listed on the Euronext Paris and Euronext Brussels markets. A leader in NOX therapies, its unique therapeutic approach is based on a selective inhibition of NOX enzymes that amplify multiple disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration.
Genkyotex’s platform enables the identification of orally available small-molecules that selectively inhibit specific NOX enzymes. Genkyotex is developing a pipeline of first-in-class product candidates targeting one or multiple NOX enzymes. The lead product candidate, GKT831, a NOX1 and NOX4 inhibitor entered a phase II clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease) in the second quarter of 2017. This product candidate may also be active in other fibrotic indications. Its second product candidate, GKT771, is a NOX1 inhibitor targeting multiple pathways in angiogenesis, pain processing, and inflammation, and should enter a phase I clinical study at the end of 2017.
Genkyotex also has a versatile platform well-suited to the development of various immunotherapies (Vaxiclase). A partnership covering the use of Vaxiclase as an antigen per se (GTL003) has been established with Serum Institute of India Ltd (Serum Institute), the world’s largest producer of vaccine doses, for the development by Serum Institute of cellular multivalent combination vaccines against a variety of infectious diseases. This partnership could generate up to $57 million in future revenues for Genkyotex, before royalties on sales.
For further information, please go to www.genkyotex.com
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This press release may contain forward-looking statements by the company with respect to its objectives. Such statements are based upon the current beliefs, estimates and expectations of Genkyotex’s management and are subject to risks and uncertainties such as the company's ability to implement its chosen strategy, customer market trends, changes in technologies and in the company's competitive environment, changes in regulations, clinical or industrial risks and all risks linked to the company's growth. These factors as well as other risks and uncertainties may prevent the company from achieving the objectives outlined in the press release and actual results may differ from those set forth in the forward-looking statements, due to various factors. Without being exhaustive, such factors include uncertainties involved in the development of Genkyotex’s products, which may not succeed, or in the delivery of Genkyotex’s products marketing authorizations by the relevant regulatory authorities and, in general, any factor that could affects Genkyotex’s capacity to commercialize the products it develops. No guarantee is given on forward-looking statements which are subject to a number of risks, notably those described in the registration document (document de reference) registered by the French Markets Authority (the AMF) on 29 June 2017 under number R.17-048., and those linked to changes in economic conditions, the financial markets, or the markets on which Genkyotex is present. Genkyotex products are currently used for clinical trials only and are not otherwise available for distribution or sale.