On March 14, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported an upcoming preclinical data poster presentation supporting the ongoing clinical development of its ALK-selective inhibitor, NVL-655 (Press release, Nuvalent, MAR 14, 2023, View Source [SID1234628710]). The data, resulting from a collaboration with the Yonsei University College of Medicine, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, taking place April 14-19 in Orlando, Florida.

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The poster describes the preclinical intracranial antitumor activity of NVL-655 in a brain-implanted xenograft model derived from a patient with lung cancer harboring the alectinib-resistant EML4-ALK v3 G1202R mutation. The poster additionally expands the characterization of NVL-655 alongside other ALK inhibitors. NVL-655 has previously demonstrated intracranial efficacy in a cell line-derived xenograft model as well as broad preclinical activity across diverse ALK resistance mutations and tumor types while maintaining high selectivity for ALK over TRKB. NVL-655 is currently being investigated in the ALKOVE-1 study (NCT05384626), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors.

The poster will be archived on the Nuvalent website at www.nuvalent.com following the presentation.

Details for the poster presentation are as follows:

Title: Preclinical intracranial activity of NVL-655 in an alectinib-resistant patient-derived model harboring EML4-ALK fusion with G1202R mutation
Authors: Jii Bum Lee*1, Mi Ra Yu*1, Mi Ran Yun1, You Won Lee1, Seung Yeon Oh1, Eun Ji Lee1, Anupong Tangpeerachaikul2, Henry E. Pelish2, Byoung Chul Cho1
Presenter: Anupong Tangpeerachaikul, Ph.D.
Permanent Abstract: 4022
Session Category: Experimental and Molecular Therapeutics
Session Title: Tyrosine Kinase and Phosphatase Inhibitors 1
Session Date and Time: Tuesday April 18, 2023 from 9:00 a.m. – 12:30 p.m. ET
Location: Orange County Convention Center, Poster Section 20
1Yonsei University College of Medicine, Seoul, Republic of Korea 2Nuvalent Inc., Cambridge, MA, USA
*Equal contributions

About NVL-655

NVL-655 is a novel brain-penetrant ALK-selective inhibitor created to overcome limitations observed with currently available ALK inhibitors. NVL-655 is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R / L1196M ("GRLM"), G1202R / G1269A ("GRGA"), or G1202R / L1198F ("GRLF"). NVL-655 has been optimized for CNS penetrance to improve treatment options for patients with brain metastases. NVL-655 has been observed in preclinical studies to selectively inhibit wild-type ALK and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and drive more durable responses for patients. NVL-655 is currently being investigated in the ALKOVE-1 study (NCT05384626), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors.