NEW YORK – Precision oncology-focused biotech Nuvalent launched on Wednesday after raising $50 million in a Series A financing, which it plans to put toward advancing two drugs targeting ROS1-positive and ALK-positive non-small cell lung cancer.
The funding round was led by investment firm Deerfield Management. Cambridge, Massachusetts-based Nuvalent was founded in 2017, with the goal of developing targeted cancer drugs to which patients will have enduring responses but minimal adverse events.
Nuvalent will use the recently raised funds to launch Phase I/II trials in NSCLC for its lead, internally developed products, NUV-520, a ROS1-selective inhibitor, and NUV-655, an ALK-selective inhibitor, in the second half of 2021 and first half of 2022, respectively.
The Phase I/II trial of NUV-520 will involve NSCLC patients with ROS1 fusions in their tumors. The company designed the drug to remain active in tumors that have developed resistance mutations, such as ROS1 G2032R, D2033N, L2026M, and S1986F. The drug can treat patients with central nervous system metastases but will cause minimal CNS-related adverse events by avoiding interaction with the structurally similar TRK family of proteins, Nuvalent said.
The Phase I/II trial of NUV-655 will involve advanced NSCLC patients with ALK fusions in their tumors. Â The drug has been designed to treat tumors that have developed resistance to earlier-generation ALK inhibitors through an ALK G1202R mutation or compound mutations, such as G1202R/L1196M or G1202R/G1269A. Like NUV-520, Nuvalent also designed this drug to treat CNS metastases but with fewer CNS adverse events.
"Kinase inhibitors remain at the leading edge of targeted therapies for patients with cancer, but the clinical utility of currently available treatments is limited by resistance mutations and off-target effects," Nuvalent CEO James Porter said in a statement. "At Nuvalent, we are leveraging our expertise in structure-based design to solve for the dual challenges of resistance and selectivity, with the goal of driving deeper and more durable responses for patients living with cancer."