NEW YORK – MapKure announced a partnership with Personalis on Monday to use its NGS assay, the NeXT Platform, to screen patients for a Phase I clinical trial of its BRAF inhibitor, BGB-3245.
MapKure will use Personalis' NeXT Platform, an exome/transcriptome scale NGS-based assay, as a confirmatory test for patients enrolled in the study. MapKure will also be able to use the results to determine if BGB-3245 has activity in other biomarkers. The Phase Ia/Ib study will enroll patients with advanced or refractory solid tumors that have a BRAF mutation.
BGB-3245 is designed to inhibit both monomeric and dimeric forms of activating BRAF mutations including V600 and non-V600 mutations, RAF fusions, and BRAF gene alterations. The drug has also shown activity in tumors that have BRAF and MAPK resistance.
The trial will have a dose escalation and expansion phase. In the expansion phase, the trial will include two patient cohorts: patients with BRAF non-V600 mutations and patients with BRAF V600 mutated melanoma or NSCLC who have developed resistance to BRAF or MEK inhibitors.
Menlo Park, California-based Personalis will also work with MapKure to develop a companion diagnostic to BGB-3245 for regulatory submission, once biomarkers have been identified in this trial, said Personalis CEO John West, in a statement. The financial details of the partnership were not disclosed.
"With new cancer immunotherapy and combination therapies, there is an increasing need for the development of more advanced composite biomarkers that can model the complex biology driving the response and resistance to cancer treatment," West said. "Our NeXT Platform provides biotechnology companies, like MapKure, with comprehensive genomic information from the entire exome and transcriptome, and provides information that can support the identification of new, advanced biomarkers."