Nuvalent Begins Dosing in HEROEX-1 Trial of NVL-330 HER2 Inhibitor

CAMBRIDGE, Mass., July 22, 2024 -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, has announced the launch of its HEROEX-1 clinical trial. This Phase 1a/1b trial will evaluate NVL-330, a newly developed HER2-selective inhibitor, in pre-treated patients with non-small cell lung cancer (NSCLC) exhibiting HER2 alterations.

HER2 alterations, including amplifications and mutations, are significant drivers of NSCLC, with exon 20 mutations being particularly common. Although therapies targeting HER2 exist, no tyrosine kinase inhibitors (TKIs) have yet been approved for HER2-mutant NSCLC patients. According to Dr. Christopher Turner, Chief Medical Officer at Nuvalent, there is a clear need for a therapy that not only addresses HER2 exon 20 mutations but also minimizes gastrointestinal and skin toxicities by selectively targeting HER2 over wild-type EGFR. Furthermore, such a therapy should be brain-penetrant to effectively combat brain metastases. NVL-330 has shown promise in preclinical studies by meeting these criteria, which supports its evaluation in the HEROEX-1 trial.

The HEROEX-1 trial is a multicenter, open-label study that will assess the safety and tolerability of NVL-330 in patients with advanced HER2-altered NSCLC, including those with exon 20 mutations. The trial's objectives include determining the recommended Phase 2 dose (RP2D), understanding the pharmacokinetic profile, and evaluating preliminary anti-tumor activity.

James Porter, Ph.D., Chief Executive Officer at Nuvalent, emphasized that this trial marks a significant milestone for the company, being the third program to enter clinical development within three years. He attributed this rapid progress to the dedication of Nuvalent's team and their commitment to developing targeted therapies for cancer patients.

NVL-330 is designed as a brain-penetrant HER2-selective tyrosine kinase inhibitor. It aims to treat HER2-altered tumors, including those with HER2 exon 20 insertion mutations, while avoiding adverse events associated with off-target inhibition of wild-type EGFR. Additionally, NVL-330 is intended to address brain metastases effectively. Currently, NVL-330 is under investigation in the HEROEX-1 Phase 1a/1b trial for pre-treated patients with advanced HER2-altered NSCLC.

Nuvalent, Inc. is a clinical-stage biopharmaceutical company dedicated to creating targeted therapies for cancer patients. The company focuses on overcoming the limitations of existing therapies for clinically validated kinase targets. With expertise in chemistry and structure-based drug design, Nuvalent aims to develop innovative small molecules that can overcome resistance, minimize adverse events, address brain metastases, and achieve more durable responses. The company is advancing a robust pipeline with investigational candidates targeting ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, along with multiple discovery-stage research programs.

By leveraging deep scientific expertise, Nuvalent strives to bring precisely targeted therapies to cancer patients, thus making significant advancements in the field of oncology. The initiation of the HEROEX-1 trial is a testament to Nuvalent's commitment to rapid progress and innovation in developing treatments for difficult-to-treat cancers.

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