Nuvalent Inc.

• US
• Nuvalent Inc.
• Health-Care

NUVL

We are a preclinical stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer. We focus our discovery efforts on small molecule inhibitors of kinases, a class of cellular targets that can play a central role in cancer growth and proliferation. In particular, we focus on “clinically proven” kinase targets, or those for which therapies have been developed by others to target those kinases, and that such drugs have demonstrated sufficient clinical efficacy and safety data to be approved by the United States Food and Drug Administration, or FDA, or similar regulatory agency and are established and used in the clinical setting. We leverage our team’s deep expertise in chemistry and structure-based drug design to develop innovative small molecules that are designed to overcome the limitations of those existing therapies.

These limitations can include kinase resistance, or the emergence of new mutations in the kinase target that can enable resistance to existing therapies, kinase selectivity, or the potential for existing therapies to inhibit other structurally similar kinase targets and lead to off-target adverse events, and limited brain penetrance, or the ability for the therapy to treat disease that has spread or metastasized to the brain. By prioritizing target selectivity, we believe our drug candidates have the potential to overcome resistance, minimize adverse events, optimize brain penetrance to address brain metastases, and drive more durable responses. We are advancing a robust pipeline of product candidates with parallel lead programs in cancers driven by genomic alterations in the ROS1 and ALK kinases (i.e., ROS1-positive and ALK-positive, respectively), along with multiple discovery-stage research programs. All of our programs are currently preclinical, and we plan to initiate our first clinical trial in the second half of 2021.

Our first lead product candidate, NVL-520, is a brain-penetrant ROS1-selective inhibitor, designed to inhibit wild-type ROS1 fusions and remain active in the presence of mutations conferring resistance to approved and investigational ROS1 inhibitors. We have submitted an IND for NVL-520 and, subject to such submission taking effect, plan to initiate a first-in-human clinical trial investigating NVL-520 in ROS1-positive non-small cell lung cancer (“NSCLC”) and other advanced solid tumors in the second half of 2021. We have designed our planned first-in-human trial for NVL-520 as a “Phase 1/2 trial” under a combined clinical trial protocol, which includes both a Phase 1 and Phase 2 portion.

The Phase 1 dose escalation portion has the potential to transition directly into a Phase 2 multiple cohort expansion portion once a safe and tolerable dose is determined as the recommended Phase 2 dose (“RP2D”). Our second lead product candidate, NVL-655, is a brain-penetrant ALK-selective inhibitor, designed to inhibit wild-type ALK fusions and remain active in the presence of mutations conferring resistance to first-, second-, and third-generation ALK inhibitors. IND-enabling studies are ongoing and initiation of a first-in-human clinical trial investigating NVL-655 in ALK-positive NSCLC and other advanced cancers is planned for the first half of 2022. 

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