Nuvalent to Present New Preclinical Data on ALK-Selective Inhibitor, Neladalkib, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2025
Nuvalent (NUVL) announced it will present new preclinical data for two of its cancer therapies at the AACR Annual Meeting 2025 in Chicago (April 25-30). The presentations will feature detailed characterization of neladalkib, their ALK-selective inhibitor, and zidesamtinib, their ROS1-selective inhibitor.
The first presentation on April 28 will focus on mutagenesis screens supporting neladalkib's potential best-in-class profile as a brain-penetrant and TRK-sparing ALK inhibitor. The second presentation on April 29 will showcase the crystal structure of drug-resistant ROS1 G2032R in complex with zidesamtinib, highlighting its best-in-class potential as a clinical-stage ROS1 inhibitor.
Nuvalent (NUVL) ha annunciato che presenterà nuovi dati preclinici per due delle sue terapie contro il cancro durante il AACR Annual Meeting 2025 a Chicago (dal 25 al 30 aprile). Le presentazioni includeranno una caratterizzazione dettagliata di neladalkib, il loro inibitore selettivo ALK, e zidesamtinib, il loro inibitore selettivo ROS1.
La prima presentazione del 28 aprile si concentrerà sugli schermi di mutagenesi a supporto del potenziale profilo di eccellenza di neladalkib come inibitore ALK penetrante nel cervello e risparmiatore di TRK. La seconda presentazione del 29 aprile mostrerà la struttura cristallina della variante resistente ai farmaci ROS1 G2032R in complesso con zidesamtinib, evidenziando il suo potenziale di eccellenza come inibitore ROS1 in fase clinica.
Nuvalent (NUVL) anunció que presentará nuevos datos preclínicos para dos de sus terapias contra el cáncer en la AACR Annual Meeting 2025 en Chicago (del 25 al 30 de abril). Las presentaciones incluirán una caracterización detallada de neladalkib, su inhibidor selectivo de ALK, y zidesamtinib, su inhibidor selectivo de ROS1.
La primera presentación el 28 de abril se centrará en pantallas de mutagénesis que respaldan el potencial perfil de mejor en su clase de neladalkib como un inhibidor de ALK que penetra en el cerebro y ahorra TRK. La segunda presentación el 29 de abril mostrará la estructura cristalina de la variante resistente a fármacos ROS1 G2032R en complejo con zidesamtinib, destacando su potencial de mejor en su clase como un inhibidor de ROS1 en etapa clínica.
누발렌트 (NUVL)는 AACR 연례 회의 2025에서 두 가지 암 치료법에 대한 새로운 전임상 데이터를 발표할 것이라고 발표했습니다. 이 회의는 시카고에서 4월 25일부터 30일까지 열립니다. 발표에서는 넬라달키브, 그들의 ALK 선택적 억제제, 그리고 지데삼티닙, 그들의 ROS1 선택적 억제제에 대한 자세한 특성이 포함될 것입니다.
4월 28일에 있을 첫 번째 발표는 넬라달키브의 뇌 침투 및 TRK 절약 ALK 억제제로서의 최상의 프로필 가능성을 뒷받침하는 변이 유전자 검사를 중심으로 진행됩니다. 4월 29일에 있을 두 번째 발표는 약물 저항성 ROS1 G2032R과 지데삼티닙의 복합체에 대한 결정 구조를 보여주며, 임상 단계 ROS1 억제제로서의 최상의 가능성을 강조합니다.
Nuvalent (NUVL) a annoncé qu'il présentera de nouvelles données précliniques pour deux de ses thérapies contre le cancer lors de la AACR Annual Meeting 2025 à Chicago (du 25 au 30 avril). Les présentations incluront une caractérisation détaillée de neladalkib, leur inhibiteur sélectif ALK, et zidesamtinib, leur inhibiteur sélectif ROS1.
La première présentation, le 28 avril, se concentrera sur des écrans de mutagenèse soutenant le potentiel de profil de meilleure classe de neladalkib en tant qu'inhibiteur ALK pénétrant le cerveau et épargnant TRK. La deuxième présentation, le 29 avril, mettra en avant la structure cristalline de la variante résistante aux médicaments ROS1 G2032R en complexe avec zidesamtinib, soulignant son potentiel de meilleure classe en tant qu'inhibiteur ROS1 en phase clinique.
Nuvalent (NUVL) gab bekannt, dass es neue präklinische Daten für zwei seiner Krebstherapien auf dem AACR Annual Meeting 2025 in Chicago (vom 25. bis 30. April) präsentieren wird. Die Präsentationen werden eine detaillierte Charakterisierung von neladalkib, ihrem ALK-selektiven Inhibitor, und zidesamtinib, ihrem ROS1-selektiven Inhibitor, beinhalten.
Die erste Präsentation am 28. April wird sich auf Mutagenesetests konzentrieren, die das potenzielle Best-in-Class-Profil von neladalkib als ein in das Gehirn eindringender und TRK-sparender ALK-Inhibitor unterstützen. Die zweite Präsentation am 29. April wird die Kristallstruktur des medikamentenresistenten ROS1 G2032R im Komplex mit zidesamtinib zeigen und sein Best-in-Class-Potenzial als klinischer ROS1-Inhibitor hervorheben.
- Both drug candidates show potential best-in-class profiles in their respective categories
- Neladalkib demonstrates brain-penetrant capabilities, expanding its therapeutic potential
- Zidesamtinib shows promising activity against drug-resistant ROS1 G2032R mutation
- None.
Details of the poster presentations are as follows:
Title: Mutagenesis screens support potential best-in-class profile for neladalkib (NVL-655), a brain-penetrant and TRK-sparing ALK inhibitor
Authors: Anupong Tangpeerachaikul*1, Henry E. Pelish1
Abstract Number: 1729
Session Category: Experimental and Molecular Therapeutics
Session Title: Kinase and Phosphatase Inhibitors 1
Session Date and Time: April 28, 2025, from 9:00 a.m.– 12:00 p.m. CT
Location: Poster Section 21
Poster Board Number: 4
Title: Crystal structure of drug-resistant ROS1 G2032R in complex with zidesamtinib, a clinical-stage ROS1 inhibitor with best-in-class potential
Authors: Joseph M. Magrino*1, Anupong Tangpeerachaikul1, Scot Mente1, Henry E. Pelish1
Abstract Number: 5616
Session Category: Experimental and Molecular Therapeutics
Session Title: Kinase and Phosphatase Inhibitors 3
Session Date and Time: April 29, 2025, from 2:00 p.m.– 5:00 p.m. CT
Location: Poster Section 20
Poster Board Number: 26
*Presenter, corresponding author; 1Nuvalent, Inc.,
About Zidesamtinib
Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.
About Neladalkib
Neladalkib is a novel brain-penetrant ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received breakthrough therapy designation for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.
About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the expected timing of data announcements; the potential benefits and effects of Nuvalent's product development candidates; the potential of Nuvalent's pipeline programs, including zidesamtinib and neladalkib; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies and clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our zidesamtinib or neladalkib product candidates; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Nuvalent's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements.
View original content to download multimedia:https://www.prnewswire.com/news-releases/nuvalent-to-present-new-preclinical-data-on-alk-selective-inhibitor-neladalkib-and-ros1-selective-inhibitor-zidesamtinib-at-aacr-annual-meeting-2025-302411308.html
SOURCE Nuvalent, Inc.
FAQ
What new data will Nuvalent (NUVL) present at AACR 2025?
When and where will Nuvalent (NUVL) present its neladalkib data at AACR 2025?
What are the key features of Nuvalent's (NUVL) neladalkib cancer therapy?
What will Nuvalent's (NUVL) zidesamtinib presentation focus on at AACR 2025?
