Oncology drugs developer TP Therapeutics has signed an agreement with precision medicine company Almac Diagnostic Services to develop and commercialise a next-generation sequencing (NGS) companion diagnostic (CDx) for its repotrectinib drug.
TP Therapeutics is developing repotrectinib to target ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumours.
As per the agreement, Almac will leverage the ArcherDx’s Anchored Multiplex PCR (AMP) to develop the pan-cancer CDx. The company plans to seek US regulatory approval for the diagnostic.
Initially, the NGS diagnostic will be used at Almac laboratory located in North Carolina to detect tumours with the targeted gene fusions. The identification of this type of tumours will enable selection of patients for repotrectinib treatment.
TP Therapeutics founder, president and chief scientific officer Jean Cui said: “Almac provides us with deep experience in the development and regulatory approval of next-generation sequencing diagnostic assays, which will enable the selection of patients who may not otherwise have access to a targeted therapy like repotrectinib.
“We look forward to working with Almac to co-develop repotrectinib with a next-generation sequencing based companion diagnostic that detects the presence of ROS1, NTRK1-3 and ALK gene fusions.”
Companion diagnostics are intended to identify the presence of a specific biomarker in order to enable targeted therapies for patients depending on their individual molecular characteristics.
Use of a companion diagnostic during a drug development programme is expected to yield more effective therapies with better safety profiles.
Almac Diagnostic Services managing director Paul Harkin said: “Molecular testing is critical to identifying patients most likely to benefit from a targeted treatment.
“We have great expertise in the development of biomarker assays across a wide range of technologies and targets, with an extensive track-record in developing and validating assays under design control and according to regulatory requirements.”