SEKISUI XenoTech Receives New US Patent for a Method to Evaluate Xenobiotics as Immune-Modulators of Drug Transport and Metabolism in Hepatocytes

KANSAS CITY, KS, UNITED STATES - May 12, 2020 - SEKISUI XenoTech has been awarded US patent # 10,648,968 “In vitro test system to evaluate xenobiotics as immune-modulators of drug transport and metabolism in human hepatocytes.”

In 2014, SEKISUI XenoTech patented an in vitro test system to evaluate whether an immuno-modulating drug can change expression of drug metabolizing enzymes in human hepatocytes and how it will interact with human hepatocytes. Xenobiotic metabolism is a core interest of SEKISUI XenoTech, and the company has now received this divisional patent to cover small molecule drugs in addition to the previously patented method that covered biologics or large molecule drugs.

Developed by Dr. Maciej Czerwinski, this in vitro process evaluates drug candidates for direct and cytokine-mediated effects on cytochrome P450 (CYP) enzyme expression. The original patent was for examination of biologic drugs and this divisional patent expands application of the invented test system for evaluation of small molecule drugs. First, the cytokine release assay examines the effects of the drug on the level of cytokines in the whole blood ex vivo. In the second step, effects of the cytokines on the expression of drug-metabolizing enzymes are evaluated in hepatocytes in vitro. Consideration is given to the appropriate drug concentration that will yield the most relevant data on the release of cytokines and their downstream impact. Our patented and novel approach yields cytokine release information and detects the direct and cytokine-mediated effects of small molecules on CYP and drug transporter expression.

Small molecule drugs still encompass the majority of compounds in development and increasingly these molecules are designed to modulate the immune system. Those that may be associated with the release of pro-inflammatory cytokines warrant evaluation before first in-human (FIH) clinical trials. Examination of cytokines stimulated by small molecule drugs is important since these signaling molecules can suppress drug-metabolizing enzymes. Cytokine-mediated suppression of drug metabolizing enzymes can change the clearance of concomitantly administered small molecule drugs and thereby precipitate a drug-drug interaction.

FDA recognizes the potential for drugs that are cytokines or cytokine modulators to change the plasma concentration of co-administered drugs. “It is crucial for developers and testing organizations to evolve and rise to meet new technological advances. As improvements are made in the way therapies are developed it is important to provide innovation and processes that match the needs of drug developers. SEKISUI XenoTech is committed to driving innovation as a means of supporting both safety assessment and effective pipeline development for our clients. We are also constantly adapting to stay abreast of the latest advances and provide expertise on the effects of drugs and the regulatory policies to protect potential patients. We are extremely proud of the work we do and the expanding expertise of our scientists,” stated VP of Scientific Consulting, Dr. Brian Ogilvie.

For more information regarding this newly patented and novel approach, please visit www.xenotech.com or contact SEKISUI XenoTech using the information below.

About SEKISUI XenoTech

SEKISUI XenoTech, LLC is a global Contract Research Organization with unparalleled ADME / DMPK / Drug-Drug Interactions experience utilized by 98% of top pharma companies and numerous other organizations. For the past 25 years, the company has offered proven drug development expertise in evaluating drug candidates in compliance with regulatory requirement and guidance prior to entrance to market. The company offers a variety of in vitro and in vivo safety assessment studies for drug candidate evaluation, as well as an extensive selection of products for drug metabolism and pharmacokinetic research. For additional information, please refer to the company's website at www.xenotech.com or call (913) 438-7450.