TP Therapeutics and Almac Diagnostic Services have launched a global collaboration to develop a pan-cancer companion diagnostic test for TP’s repotrectinib, aimed at drug-resistant tumors with ROS1, NTRK1-3 and ALK mutations.
Almac will develop the next-generation sequencing diagnostic on ArcherDx’s Anchored Multiplex PCR platform, and plans to submit it to the FDA for approval in guiding the selection of patients for repotrectinib treatment from its laboratory in Durham, North Carolina. The financial terms of the deal were not disclosed.
“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 J. Jean Cui, TP’s founder, president and chief scientific officer.
TP raised $80 million earlier this month in a mezzanine funding round as it looks to move repotrectinib into phase 2 research in early 2019. In addition, the company is considering combination studies with EGFR inhibitors such as Tagrisso in patients that have seen their non-small cell lung cancer progress.
In addition, the company hopes to have three active clinical assets in its pipeline over the next 18 months, with IND filings for a dual CSF1R/MET inhibitor and an RET inhibitor program planned for the first and second halves of 2019, respectively.