Nuvalent Announces First Patient Assay in ARROS-1 Phase 1/2 Clinical Trial of NVL-520, Its New Selective ROS1 Inhibitor

ARROS-1 trial including patients with advanced ROS1 positive NSCLC and other solid tumors

Clinical development of the parallel main program, NVL-655, in ALK-positive cancers is expected to begin in the first half of 2022

CAMBRIDGE, Mass., January 7, 2022 / PRNewswire / – Nuvalent, Inc. (Nasdaq: NUVL), a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the first patient has been assayed in ARROS-1, its Phase 1/2 clinical trial evaluating NVL-520 in patients with a Advanced ROS1-positive non-small cell lung cancer (NSCLC) and other advanced solid tumors. NVL-520, the lead product candidate of Nuvalent, is a novel selective inhibitor of ROS1 designed to address the clinical challenges of emerging resistance to treatment, adverse CNS events and brain metastases that may limit the use of inhibitors of ROS1. ROS1 kinase currently available.

Nuvalent, Inc. (PRNewsfoto / Nuvalent, Inc.)

“Initiating the dosing of NVL-520 in patients in ARROS-1 is an important milestone for Nuvalent as we move from a preclinical to clinical stage company,” said Christophe turner, MD, chief medical officer of Nuvalent. “We designed NVL-520 to meet a specific target product profile developed in collaboration with leading physician-researchers currently actively treating patients with ROS1-induced cancers. We are encouraged by the preclinical data generated to date, which provides evidence that NVL-520 represents a differentiated, selective inhibitor of ROS1 with the potential to overcome the limitations of current tyrosine kinase inhibitor therapies and provide a novel therapeutic option for patients in need. “

ARROS-1 is a phase 1/2, multicenter, open-label, dose-escalating, expanding trial evaluating NVL-520 as oral monotherapy. The phase 1 dose escalation phase of the study is open and recruits patients with advanced ROS1-positive solid tumors who have already been treated with at least one prior treatment with ROS1 tyrosine kinase (TKI) inhibitor (TKI), and will assess the overall safety and tolerability of NVL-520 as well as determine the recommended phase 2 dose (RP2D), characterize the pharmacokinetic profile and assess preliminary anti-tumor activity.

Once a safe and tolerable dose is determined as RP2D, the trial is designed to proceed directly to the Phase 2 Multiple Cohort Extension phase, which will assess the overall activity of NVL-520 in patients. with ROS1 positive advanced NSCLC and other advanced solids. tumors. The Phase 2 part will look at several patient cohorts based on the number and type of previous cancer therapies they have received. The Phase 2 cohorts are designed to support potential registration in ROS1-positive patients with NSCLC who are kinase inhibitor naïve and in those who have previously been treated with ROS1 kinase inhibitors.

“Nuvalent wisely designed the ARROS-1 trial to support the goal of seamless acceleration of the first human dose exploration of NVL-520 in Phase 2 cohorts that are structured to assess multiple opportunities for potential recording, “said Darlene Noci, ALM, Senior Vice President of Product Development and Regulatory Affairs for Nuvalent. “Through a parallel assessment of NVL-520 in naïve TKI and clearly defined cohorts of pretreated patients, we aim to generate data to comprehensively assess NVL-520 throughout the ROS1-induced cancer treatment paradigm. .

In addition to NVL-520, Nuvalent is advancing a strong pipeline including the development of NVL-655 as a parallel lead program for the potential treatment of patients with ALK-positive NSCLC, as well as multiple discovery-phase research programs. .

“Our goal in 2022 is to establish Nuvalent as an operationally effective clinical-stage biotechnology company with an active internal R&D pipeline. We are on track for the planned IND submission for NVL-655 which should allow the opening of our second Phase 1/2 clinical trial for recruitment during the first half of the year, and continue to plan for the expansion of the portfolio with several new drug candidates discovered internally ”, stated James porter, Ph.D., CEO of Nuvalent. “By prioritizing a pipeline of new small molecules designed to overcome the dual challenge of kinase resistance and selectivity, we aim to deliver new drugs that may not only provide additional therapeutic options, but have the potential. to advance earlier in the treatment paradigm and become the best treatments for cancer patients. “

Nuvalent finished 2021 with $ 288.4 million in cash, cash equivalents and marketable securities (unaudited), which, based on its current operating plans, is expected to finance its operations until 2024.

About the NVL-520

NVL-520 is a selective brain-penetrating 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 the S1986Y resistance mutations. / F, L2026M or D2033N. NVL-520 has been optimized for brain penetrance to potentially improve treatment options for patients with brain metastases. NVL-520 has been observed in preclinical studies to selectively inhibit ROS1 over the family of structurally related tropomyosin receptor kinases (TRKs) in order to potentially avoid the TRK-related CNS adverse events seen with dual inhibitors. TRK / ROS1 and result in longer lasting responses for patients with ROS1- mutant variants. NVL-520 is currently being investigated in the ARROS-1 study, a first phase 1/2 human clinical trial for patients with non-small-scale lung cancer. advanced (NSCLC) cells and other solid tumors.

About Nuvalent

Nuvalent, Inc. (Nasdaq: NUVL) is a 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 strong pipeline with leading parallel programs in ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC), as well as multiple discovery-phase 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 l orientation of Nuvalent; the NVL-520 and NVL-655 clinical development program and schedule; the potential clinical effect of NVL-520; the design and recruitment of the ARROS-1 study and its schedule; the potential of Nuvalent’s pipeline programs, including NVL-520 and NVL-655; Nuvalent’s research and development programs for cancer treatment; the risks and uncertainties associated with drug development; capital allocation; and the future financial and operating results of Nuvalent and its expectations therein. The words “may”, “could”, “will fly”, “could”, “should”, “should”, “expect”, “plan”, “anticipate”, “intend to”, ” believe “,” expect “,” estimate “,” seek “,” predict “,” the future “,” project “,” the potential “,” continue “,”,,, although all statements prospectives do not contain these identifying words. The development and commercialization of drugs 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 the current expectations and beliefs of management and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to occur. 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 fully enroll in the ARROS-1 study or that this may take longer than expected; unexpected concerns that may arise from additional data, analysis or results obtained during the ARROS-1 study; the occurrence of adverse safety events; the risks of unforeseen costs, delays or other unforeseen obstacles; the risks associated with: the impact of COVID-19 on the countries or regions in which Nuvalent operates or operates, as well as the timing and timing and anticipated results of its clinical trials, strategy and of its future operations, including the ARROS-1 study; the timing and results of Nuvalent’s planned interactions with regulatory authorities; obtain, maintain and protect its intellectual property; and potential variations in cash, cash equivalents and marketable securities estimated on the basis of the completion of financial close procedures and the publication of full results for fiscal year 2021. These risks and uncertainties, as well as ” others, are described in more detail in the section entitled “Risk Factors” in the Company’s quarterly report on Form 10-Q for the quarter ended. September 30, 2021, as well as any subsequent filing with the Securities and Exchange Commission. Further, any forward-looking statement represents the views of Nuvalent only to date and should not be construed as representing its views at any later date. Nuvalent expressly disclaims any obligation to update forward-looking statements.

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