News

As a leading specialist CRO for drug metabolite provision, Hypha has formed a partnership with Cypex Limited, experts in the provision of a variety of recombinant xenobiotic metabolising enzymes, wherein Hypha will scale-up and purify metabolites made by Cypex enzymes.

We are excited to announce the official launch of our One-Stop Metabolite Shop, which offers a complete solution for pharma and agrochemical companies to access small molecule metabolites.

Hypha is able to offer clients a combination of a number of biological and chemical techniques, meaning that clients can quickly establish a method to identify and scale up any type of metabolite.

Hypha are looking forward to presenting two posters at the ISSX meeting held in Portland US from 28th to 31st July 2019.

One is a joint poster with Cyclerion Therapeutics on “Use of Microbial Biotransformation to Produce Scalable Quantities of a Glucuronidated Metabolite of the Clinical Stage Soluble Guanylate Cyclase Stimulator Praliciguat” (P10).

Our newsletter this quarter looks at the use of microbial biotransformation to synthesize glucuronide metabolites, with a particular emphasis on the production of acyl glucuronides, arising from the metabolism of carboxylic acid-containing drugs.

Hypha are excited to present a poster describing the application of PolyCYPs enzyme kits to create oxidised derivatives of drug candidates. In this project conducted joint with AstraZeneca, we show that PolyCYPs enzymes were able to synthesize all monohydroxylated derivatives of a drug lead candidate.

We have just published an article on “Accessing Difficult-to-Synthesise Metabolites in Drug Development Programmes” in the April 2019 edition of European Biopharmaceutical Review. Access to major and/or disproportionate metabolites is important to ensure adherence to regulatory guidelines issued by the FDA and EMA, as well as to comply with internal safety standards set by pharmaceutical companies themselves.

Hypha are pleased to announce the official launch of their PolyCYPs® kit, which provide a fast and easy way to access CYP-derived metabolites and oxidised derivatives of drugs.

Enzymes in the kit have been mined from some of Hypha’s most talented actinomycete bacteria, providing a wide variety of CYPs proven to have a high success rate of producing human metabolites and other hydroxylated derivatives.

Lisbet has >20 years’ experience in challenging organic synthesis, process chemistry, CMC development and project management within the pharmaceutical industry (H. Lundbeck A/S, Novo Nordisk Pharmatech A/S), biotech start-ups (Lipideon A/G) and multiple academic institutions (Max Planck Institute of Coal Research Germany, ETH Zurich Switzerland, Harvard University USA, Technical University of Denmark).

We are pleased that a paper by Salter et al., 2018 has been published in Xenobiotica. The paper, entitled Microbial Biotransformation – An Important Tool for the Study of Drug Metabolism, describes some interesting projects Hypha have undertaken for Merck and Janssen with several difficult-to-synthesize hydroxylated and glucuronidated metabolites.

A 2018 Nature Reviews Drug Discovery paper by Bostrom et al on “Expanding the medicinal chemistry synthetic toolbox” features examples of the outputs of Hypha’s hydroxylation technology. Hydroxylation is a key tactic to consider as part of a late stage functionalization strategy where small changes can result in improved activity, selectivity, solubility and lipophilicity.

Zhou et al.  presented a poster at the 2018 ISSX Conference in Montreal on “Elimination of [14C]-LY3023414 by Aldehyde Oxidase and CYP Enzymes in Humans Following Oral Administration.”  Both AO and CYP enzymes were responsible for the metabolic clearance of LY3023414 with the non-CYP enzymes mediating approximately half of the clearance of the drug. Hypha Discovery made three of the metabolites used in this study undertaken by Lilly.

Hypha Discovery have issued a policy detailing our position on data protection in relation to the GDPR regulations that came into force at the end of May 2018. You can read this policy via the link below.