Our client had identified a clinical candidate aimed at a novel tumour target, with promising activity against a range of cancers. Upon completion of suitable GLP toxicity studies, the company intended to move into Phase I in patients, in combination with chemotherapy. There were a number of pressing issues, including choice of the appropriate nonclinical species, dosing schedule, achieving adequate exposure as well as the potential for greater target organ toxicity when dosed in combination.
ApconiX joined the client’s project team by providing a dedicated project toxicologist, supported by our other experts. With a clear understanding of the project goals and clinical objectives, we delivered a bespoke, focussed nonclinical safety package designed to ensure the right data were provided for regulatory success and rapid initiation of the Phase I patient studies.
A study that provided safety and DMPK data on the novel agent dosed with chemotherapy was also designed and conducted. Although not a regulatory requirement, this allowed a better understanding of the impact of the combination and supported a higher start dose in combination with chemotherapy.
ApconiX managed all aspects of the preclinical safety package, working closely with CROs to ensure appropriate study design, costs, dose level selection, data interpretation as well as timely delivery of quality study reports. Concurrently, we authored the nonclinical sections of the regulatory submission documents and represented the client at a regulatory agency meeting.
With ApconiX as part of the team, our client benefited from our many years of collective experience in preclinical safety, DMPK and drug development. The package was designed to ensure regulatory and clinical objectives were met, keeping to budget and agreed timelines.
The Clinical Trial Authorisation was approved, allowing the compound to move into clinical trials, in combination with chemotherapy. During this phase, we also assisted in the out-licencing of this asset to a third party. We continue to work with the new owners to ensure its further success.