TP Therapeutics and Almac Diagnostic Services have signed a collaboration agreement for the development and commercialization of a next-generation sequencing (NGS) companion diagnostic (CDx) for repotrectinib therapy.
Image: Almac’s new facility in Durham, North Carolina. Photo: Courtesy of Almac Group.
The repotrectinib investigational therapy of TP Therapeutics is designed to target ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors.
As per the terms of the agreement, Almac will develop the NGS diagnostic based on the ArcherDx’s Anchored Multiplex PCR (AMP) chemistry.
The companion diagnostic, which is planned to be submitted for regulatory approval in the US, will initially enable Almac’s CLIA-accredited laboratory in Durham, North Carolina to identify tumors with the targeted gene fusions, allowing physicians to select appropriate patients to be treated with repotrectinib.
TP Therapeutics founder, president and chief scientific officer J 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.”
Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI) developed to treat patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements.
The therapy is claimed to be a macrocyclic TKI, which is much smaller than current ROS1, TRK family and ALK inhibitors. It has been designed to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.
TP Therapeutics stated that the co-development of CDx and therapeutic products is crucial for the advancement of targeted therapies and precision medicine.
These companion diagnostic tests have been designed to confirm the presence of specific biomarkers that can help physicians in selecting effective therapies for their patients, based on the individual molecular characteristics of each person.
The incorporation of companion diagnostic strategy into the drug development program could help in developing more effective treatments with improved safety profiles for patients.
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.
“We are very pleased to work with TP Therapeutics on such a promising investigational therapy as repotrectinib.”