We identified outsourced providers and established contracts for medicinal chemistry, DMPK, in vivo pharmacology and preclinical development.

 

Kinase Inhibitor – Lead Optimisation to Preclinical Development

Overview

A mid-sized biotech with a proprietary technology platform had diversified their portfolio to encompass the application of their platform to drug discovery and was ready to identify their first drug candidates for progression into clinical development.

The client challenge:
Their goal was to deliver a highly selective kinase inhibitor for the treatment of inflammatory disorders into preclinical then clinical development. The challenge for the client was how to integrate in-house expertise with outsourced capabilities to overcome a series of technical challenges that would allow several candidate molecules to be positioned for GLP toxicology studies with sufficient GMP material to be Phase I ready.

How we helped:

We identified outsourced providers and established contracts for medicinal chemistry, DMPK, in vivo pharmacology and preclinical development.

We were instrumental in the development of a novel micronised formulation to aid oral bioavailability, reproducibility and dose proportionality. Preliminary toxicology was conducted with minimal safety findings and large compound exposures producing large safety margins and confirming the decision to micronise the drug.

Finally, Contract Manufacturing Organisations were invited to tender for the manufacture of a 5kg GMP batch of Active Pharmaceutical Ingredient (API). A highly cost effective solution was identified with manufacture in India but with local management in Europe providing excellent communication between client and CMO. The material was delivered to specification on time and on budget.

The results:

The outcome for the client was the delivery of an excellent drug candidate that was Pharma quality and poised for GLP toxicology studies. This demonstrated the utility of their platform to identify lead molecules and also their ability to develop drug candidates from these leads, which was consequently a contributing factor in successfully positioning the company for trade sale.

Our Team
Xenovium is made up of passionate professionals, all experts in their respective fields with substantial pharmaceutical, biotech or commercial experience. Find out more about us here…
Contact Us
  • Xenovium Ltd,
    Chesterford Research Park, Little Chesterford, Saffron Walden, CB10 1XL