Home Madrid university Nuvalent will present new preclinical data on NVL-655 and a poster on the ongoing ARROS-1 trial for NVL-520 at the annual meeting of the IASLC World Conference on Lung Cancer 2022

Nuvalent will present new preclinical data on NVL-655 and a poster on the ongoing ARROS-1 trial for NVL-520 at the annual meeting of the IASLC World Conference on Lung Cancer 2022

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Preclinical Activity of Selective ALK Inhibitor NVL-655 in a Model of Lorlatinib-Resistant NSCLC with a Compound Resistance Mutation Continues to Support the Potential for a First-Order Profile

CAMBRIDGE, Mass., July 13, 2022 /PRNewswire/ — Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, announced today that it will present two posters for its parallel lead programs, NVL-655, a selective ALK inhibitor and NVL-520, a selective ROS1 inhibitor, at the IASLC 2022 World Conference on Lung Cancer Annual Meeting (WCLC) ongoing August 6-9, 2022 in Vienna, Austria. Posters will be archived on the Nuvalent website at www.nuvalent.com.

The first poster characterizes NVL-655 alongside other ALK inhibitors in a patient-derived model of lorlatinib-resistant ALK-positive non-small cell lung cancer (NSCLC) with the resistance mutation to compound G1202R/T1151M appeared under treatment. NVL-655 has already demonstrated differentiation through broad preclinical activity on various ALK oncoproteins, resistance mutations and tumor types while maintaining high selectivity for ALK over TRKB. Nuvalent recently announced that the first patient received a dose of NVL-655 in the Phase 1/2 ALKOVE-1 study for patients with advanced ALK-positive NSCLC and other solid tumors.

An “Ongoing Trial” poster will also be presented with the background and design of the ongoing ARROS-1 Phase 1/2 study of NVL-520 for patients with advanced ROS1-positive NSCLC and other solid tumors. The multicenter, open label, dose escalation and expansion trial is currently evaluating NVL-520 as an oral monotherapy in the Phase 1 study. Nuvalent expects to share preliminary ARROS-1 dose escalation data in the second half of 2022.

The details for the electronic poster presentations are as follows:

Title: Preclinical Activity of NVL-655 in a Patient-Derived NSCLC Model with Lorlatinib-Resistant G1202R/T1151M ALK Mutation
Authors: H.Mizuta1L. Bigot1A. Tangpeerachaikul2SE Pelish2L. Friboulet1
Abstract number: EP08.02-020
Session category: Metastatic non-small cell lung cancer
Session title: Targeted molecular treatments
Session date and time: August 7, 2022, 9:45 a.m.6:00 PM CEST

1Gustave Roussy, Villejuif, France; 2Nuvalent, Inc., Cambridge, MAUNITED STATES

Title: NVL-520, a highly selective ROS1 inhibitor, in patients with ROS1-positive advanced solid tumors: the ARROS-1 phase 1/2 study
Authors: A.Drillon1, SHI. Or2S.Gadgeel3Mr Johnson4A. Spira5G.Lopes6B. BessesevenE. Felip8AJ van der Wekken9A. CallestenMJ de Miguel11DR Camidge12Y.Elamine13S.Liu14J.Bauman15D. Haggstrom16G.Riley17SE Pelish17VW Zhu17JJ Lin18
Abstract number: EP08.02-041
Session category: Metastatic non-small cell lung cancer
Session title: Targeted molecular treatments
Session date and time: August 7, 2022, 9:45 a.m.6:00 PM CEST

1Memorial Sloan Kettering Cancer Center, New York/NY/UNITED STATES ,2University of California Irvine Medical Center, Orange/CA/UNITED STATES ,3Henry Ford Cancer Institute, Detroit/MI/UNITED STATES ,4Sarah Cannon Research Institute, Nashville/TN/UNITED STATES,5NEXT Oncology – Virginia Cancer Specialists, Fairfax/VA/UNITED STATES ,6Sylvester Comprehensive Cancer Center at University of Miami and the Miller School of Medicine, Miami/FL/UNITED STATES ,sevenGustave Roussy Institute, Villejuif Cedex/FR,8Vall d’ HospitalHebron, Barcelona/ES,9University of Groningen, University Medical Center Groningen,Groningen/NL,tenGregorio Marañón University Hospital, Madrid/ES,11 START Madrid-HM CIOCC, Madrid/ES,12University of Colorado Cancer Center, Anschutz Medical Campus, Aurora/CO/UNITED STATES ,13MD Anderson Cancer Center, Houston, TX/UNITED STATES ,14Georgetown University, washington d.c./UNITED STATES ,15Fox Chase Cancer Center, philadelphia cream/PA/USA,16Levine Cancer Institute, Atrium Health, Charlotte/NC/UNITED STATES ,17Nuvalent, Inc., Cambridge/Massachusetts/UNITED STATES ,18Massachusetts General Hospital, Boston/Massachusetts/UNITED STATES

About NVL-655

NVL-655 is a novel, selective brain-penetrating ALK inhibitor created to overcome the limitations seen 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 mutation G1202R 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 adverse effects. effects of TRK-related CNS seen with dual TRK/ALK inhibitors and drive longer lasting responses for patients. NVL-655 is currently being studied in the ALKOVE-1 study (NCT05384626), a Phase 1/2 first-in-man clinical trial for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) and other solid tumors.

About NVL-520

NVL-520 is a novel brain-penetrating selective ROS1 inhibitor designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with the prevalent G2032R resistance mutation and those with S1986Y resistance /F, L2026M or D2033N mutations. NVL-520 has been optimized for cerebral penetrance to potentially improve treatment options for patients with brain metastases. NVL-520 has been observed in preclinical studies to selectively inhibit wild-type ROS1 and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid the adverse effects of TRK-related CNS observed with dual TRK/ROS1 inhibitors and drive longer lasting responses for patients. NVL-520 is currently being studied in the ARROS-1 study (NCT05118789), a first-in-man Phase 1/2 clinical trial for patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors.

About Nuvalent

Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for cancer patients, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we are developing innovative small molecules that have the potential to overcome resistance, minimize adverse events, treat brain metastases and generate responses more durable. Nuvalent is advancing a robust pipeline with leading parallel programs in ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC), as well as several discovery-stage research programs. We regularly post information that may be important to investors on our website at www.nuvalent.com. Follow us on twitter (@nuvalent) and LinkedIn.

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 strategy, business plans and orientation of Nuvalent; the clinical development programs for NVL-520 and NVL-655 and their schedule; the potential clinical effect of NVL-520 and NVL-655; the design and recruitment of the ARROS-1 and ALKOVE-1 studies and their schedule; the potential of Nuvalent’s pipeline programs, including NVL-520 and NVL-655; Nuvalent’s research and development programs for the treatment of cancer; risks and uncertainties associated with drug development; and the distribution of capital. The words “may”, “could”, “will”, “could”, “should”, “should”, “expect”, “plan”, “anticipate”, “aim”, “goal”, ” intends to”, “believe”, “expect”, “estimate”, “seek”, “predict”, “future”, “project”, “potential”, “continue”, “target”, or the negative of these terms and similar words or phrases are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involves a high degree of risk, and only a small number of research and development programs lead to commercialization of a product. You should not place undue reliance on these statements or the scientific data presented. All forward-looking statements contained in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and factors that may cause actual events or results to differ. differ materially from those expressed or implied by any forward-looking statement. the forward-looking statements contained in this press release, including, without limitation: the risks that Nuvalent may not be able to fully enroll the ARROS-1 or ALKOVE-1 studies or that enrollment may take longer than expected; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs, delays or other unforeseen obstacles; the risks that Nuvalent may not be able to offer drug candidates from its HER2 Exon 20 and ALK IXDN programs; the direct or indirect impact of COVID-19 or other global geopolitical circumstances on the timing and timing and anticipated results of Nuvalent’s clinical trials, strategy and future operations, including the ARROS-1 and ALKOVE studies -1; the timing and outcome of Nuvalent’s anticipated interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section titled “Risk Factors” of the Company’s Annual Report on Form 10-K for the fiscal year ended. December 31, 2021, as well as any subsequent filings with the Securities and Exchange Commission. Further, any forward-looking statements represent Nuvalent’s views only as of the current date and should not be relied upon as representing its views as of any subsequent date. Nuvalent expressly disclaims any obligation to update forward-looking statements.

SOURCE Nuvalent, Inc.