The advantages of our in-house, collaborative, medicinal chemistry and chemical development platforms: development of NFX-179 gel, a topically applied therapy for the mitigation of cutaneous neurofibromatosis Type-1. Our work with NFlection Therapeutics led to the first clinical trial of NFX-179 Gel, a topically applied therapy for the mitigation of Cutaneous Neurofibromatosis Type-1.
During a highly successful research collaboration, Charnwood Molecular’s Medicinal Chemistry group supported NFlection in the identification of NFX-179.
Notably, our chemists worked hand in glove with the client, reviewing emerging data and suggesting new targets for synthesis to address specific liabilities in the lead series. Regular project team meetings with the client fostered a culture of collaboration; creating a powerful sense of shared purpose and empowerment through scientist-to-scientist discussions between the client and the chemists working at the bench. Our team also added considerable value by rapidly reacting to emerging information in a data-driven manner, helping to move the project forward towards its next decision point.
Charnwood’s Chemical Development team then provided a rapid delivery of the first scale-up batches of API for non-clinical studies and the confirmation of a robust and efficient synthetic route to support clinical manufacture.
Based on our intimate understanding of the importance of being able to rapidly transition from late discovery to early development, we are always thinking about the way in which we design our synthetic processes throughout lead optimisation. As such, we had a robust route already in hand and conducted an additional package of optimisation and range-finding work to produce a detailed technical package. Notably, this package was validated internally to produce a multi-gram batch of high purity API without the need for column chromatography. Furthermore, this process was subsequently successfully tech-transferred to a GMP manufacture, where it was essentially conducted as delivered with only minor modifications, highlighting the skills of our chemists in delivering substantial cost savings through considered early design work and process development.
Working closely with the Nflection team, this ultimately led to a seamless technology transfer to a cGMP facility where multi-kilo batches were prepared.
This collaboration demonstrates what can be achieved when innovation, research excellence and collaboration form the basis of CRO-Client relationships, and highlights the advantage of the combined Medicinal Chemistry and Process Research capability here at Charnwood Molecular.