On October 24, 2018 TP Therapeutics, a clinical-stage precision oncology company developing novel drugs that address treatment resistance, and Almac Diagnostic Services, a global precision medicine company, reported a global collaboration agreement to develop and commercialize a next-generation sequencing (NGS) companion diagnostic (CDx) for repotrectinib, TP Therapeutics’ investigational therapy rationally designed to target ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors (Press release, TP Therapeutics, OCT 24, 2018, View Source [SID1234530193]).
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Under the agreement, Almac will develop the NGS diagnostic based on the ArcherDx’s Anchored Multiplex PCR (AMP) chemistry, with the intent of submitting it for regulatory approval in the United States. The companion diagnostic will initially allow Almac’s CLIA-accredited laboratory in Durham, N.C. to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.
"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," said Dr. J Jean Cui, founder, president and chief scientific officer of TP Therapeutics. "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."
"Molecular testing is critical to identifying patients most likely to benefit from a targeted treatment," said Paul Harkin, managing director, Almac Diagnostic Services. "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."
Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI) developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is much smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.
Co-development of CDx and therapeutic products is critical to the advancement of targeted therapies and precision medicine. Companion diagnostics are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients, based on the individual molecular characteristics of each person. Incorporating a companion diagnostic strategy into a drug development program may help generate more effective treatments with improved safety profiles for patients.
The financial terms of the agreement were not disclosed.