ArcherDX is partnering with the companies below to co-develop companion diagnostic (CDx) tests for their targeted therapeutics.
Archer is co-developing an IVD with Ignyta, Inc. to identify and enroll patients into the Phase 2 STARTRK-2 clinical trial for entrectinib, a tyrosine kinase inhibitor targeting NTRK1/2/3, ROS1 and ALK in solid tumors.
Entrectinib (RXDX-101) is a potent inhibitor of the tyrosine kinases TrkA (encoded by the gene NTRK1), TrkB (encoded by the gene NTRK2), TrkC (encoded by the gene NTRK3), ROS1 (encoded by the gene ROS1), and ALK (encoded by the gene ALK), with IC50 values for kinase inhibition in the low nanomolar range (1.7, 0.1, 0.1, 0.2, and 1.6 nM, respectively). While these proteins play various roles in normal cellular function, rearrangements in these target kinases have the potential to be oncogenic drivers. These rearrangements tend to be mutually exclusive and are present in small percentages in a variety of tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), salivary gland cancer, papillary thyroid cancer, melanoma and sarcoma.
The Studies of Tumor Alterations Responsive to Targeting Receptor Kinases 2 (STARTRK-2; NCT02568267) clinical trial is a basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that are harboring fusions in NTRK1/2/3, ROS1 or ALK.
Archer is co-developing an IVD with Celgene to detect a proprietary gene signature to identify DLBCL patients that are most likely to respond to CC-122, a cereblon-modulating agent under investigation in multiple disease settings.
CC-122 is a non-phthalimide analogue that binds to cereblon; in preclinical studies, CC-122 showed anti-tumor activity in DLBCL patients, including increased T-cell activation and interleukin-2 production, in addition to decreased expression of Aiolos protein. Clinical trials are ongoing in patients with DLBCL exploring the safety and effectiveness of CC-122 with different drug combinations. CC-122 is an investigational compound that has not been approved by any regulatory health authority.
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