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TICKERS: NUVL

Biotech Co. Achieves High ORRs in Ph. 1 NSCLC Trial
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Shares of Nuvalent Inc. traded 60% higher to a new 52-week intraday high after the company reported initial data from its Phase 1 ARROS-1 trial of NVL-520 demonstrating positive objective response rates in patients with ROS1-Positive non-small cell lung cancer.

Clinical-stage biopharma firm Nuvalent Inc (NUVL:NASDAQ), which concentrates its efforts on designing targeted therapies for addressing clinically verified kinase targets in cancer, today announced "the initial data from the Phase 1 dose-escalation portion of its ongoing ARROS-1 Phase 1/2 clinical trial of NVL-520 for patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors."

The company stated that today it is presenting the data from the ARROS-1 trial at the 34th EORTC-NCI-AACR (ENA) Symposium in Barcelona, Spain.

The company explained that "NVL-520 is a novel brain-penetrant ROS1-selective inhibitor created with the aim to simultaneously overcome the clinical challenges of emergent treatment resistance, off-target central nervous system (CNS) adverse events, and brain metastases that may limit the use of currently available ROS1 tyrosine kinase inhibitors (TKIs)."

Alexander Drilon, M.D., Chief of Early Drug Development Service, Memorial Sloan Kettering Cancer Center (MSK) and presenting investigator, stated, "The preliminary data supports NVL-520 as a potential best-in-class ROS1-selective inhibitor that may combine, for the first time, potent and selective targeting of diverse ROS1 fusions and secondary ROS1 resistance mutations including G2032R, brain penetrance, and the avoidance of TRK inhibition that can be dose-limiting."

The firm's Chief Medical Officer, Christopher Turner, M.D., remarked, "We are excited to present the first look at the safety and clinical activity of NVL-520 from our ARROS-1 clinical trial."

The company indicated that enrollment in the ARROS-1 trial is ongoing and advised that as of September 1, 2022, 35 patient subjects have been enrolled and dosed with NVL-520 in the Phase 1 portion of the study.

Participants were treated with five evaluated dose levels between once daily 25mg (QD) and 125mg QD. The firm noted that so far, no dose-limiting toxicities or serious adverse events have been recorded.

The company indicated that the preliminary data gathered through the September 13, 2022, cut-off date pertained to 21 heavily pre-treated response-evaluable NSCLC patients and noted that partial responses were observed in 10 of the 21 trial participants (48%).

Trial participants were split into subgroups to better understand the key target characteristics of NVL-520. The company advised that patients with ROS1 G2032R mutations demonstrated an objective response rate (ORR) of 78%, and those with a history of CNS metastases showed an ORR of 73%. The company pointed out that patients classified as being heavily pre-treated, having received two or more prior ROS1 TKIs and one or more prior lines of chemotherapy, exhibited a 53% ORR and those who received prior treatments with either lorlatinib or repotrectinib experienced an ORR of 50%.

The firm's Chief Medical Officer, Christopher Turner, M.D., remarked, "We are excited to present the first look at the safety and clinical activity of NVL-520 from our ARROS-1 clinical trial, which we believe supports NVL-520 as a potential best-in-class ROS1-selective inhibitor that may be capable of overcoming the limitations of current approved and investigational ROS1 TKIs."

"Across all evaluated dose levels, NVL-520 exhibited activity in a heavily pre-treated patient population, many of whom have exhausted all available treatment options and would have been excluded from other investigational ROS1 TKI studies. Importantly, the favorable safety profile and lack of dose reductions or discontinuations due to adverse events reflected in this preliminary data suggest that NVL-520 has the potential to provide deep and durable responses and may be able to move up in the treatment paradigm for patients with ROS1-driven cancers," Dr. Turner added.

The company's CEO James Porter, Ph.D., commented, "We believe today's preliminary results further support Nuvalent's approach of applying innovative chemistry and structure-based drug design to well-defined target product profiles focused on addressing medical needs that have been identified in collaboration with leading physician-scientists . . . Not only has this approach rapidly delivered the encouraging preliminary results for NVL-520 presented today, it underpins our work across our entire pipeline, including parallel lead candidate NVL-655 for ALK-positive NSCLC, and our recently announced development candidate for HER2ex20-driven cancers, NVL-330."

The firm mentioned that the primary objective of the Phase 1 portion of the ARROS-1 clinical trial is to evaluate the safety and pharmacokinetic profile of NVL-520 and to determine the recommended safe and tolerable dose (RP2D) for use in Phase 2.

The Phase 2 portion of the study will then focus on the evaluation of the efficacy and total performance of NVL-520 in additional expanded patient cohorts. These new cohorts will be based on the number and type of anti-cancer therapies that participants underwent previously.

The company noted that "the Phase 2 cohorts are designed to support potential registration in patients with ROS1-positive NSCLC who are kinase inhibitor-naïve and in those who have been previously treated with ROS1 kinase inhibitors."

Nuvalent is a clinical-stage biopharma firm based in Cambridge, Mass., that is engaged in the discovery and development of precision-targeted cancer therapies. The firm works to create innovative small molecules that serve to precisely inhibit clinically proven kinase targets to address the key challenges of resistance and selectivity. The company listed that "it is advancing a robust pipeline with parallel lead programs in ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC), a program in HER2 Exon 20 insertion-positive cancers, and multiple discovery-stage research programs."

Nuvalent started off the day with a market cap of around US$1.07 billion, with approximately 48.41 million shares outstanding and a short interest of about 6.9%. NUVL shares opened 60% higher today at US$35.18 (+US$13.18, +59.91%) over yesterday's US$22.00 closing price and reached a new 52-week high price this morning of US$40.43. The stock traded today between US$30.00 and US$40.43 per share and closed for trading at US$35.34 (+US$13.34, +60.64%).


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