Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced or metastatic HER2-altered NSCLC.
Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD.
Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL 330 in patients with advanced or metastatic HER2 mutant NSCLC.

Start Date18 Jul 2024

Sponsor / Collaborator

Nuvalent, Inc.

NCT05384626 / RecruitingPhase 1/2

A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors.
Phase 1 will evaluate the overall safety and tolerability of NVL-655 and will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors.
Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors.

Start Date09 Jun 2022

Sponsor / Collaborator

Nuvalent, Inc.

EUCTR2021-002477-26-NL / Unknown statusPhase 1/2

A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1)

Start Date22 Feb 2022

Sponsor / Collaborator

Nuvalent, Inc.

100 Clinical Results associated with Nuvalent, Inc.

0 Patents (Medical) associated with Nuvalent, Inc.

Literatures (Medical) associated with Nuvalent, Inc.

04 Apr 2023·Cancer Research

Abstract 4022: Preclinical intracranial activity of NVL-655 in an alectinib-resistant patient-derived model harboring EML4-ALK fusion with G1202R mutation

Author: Lee, You Won ; Cho, Byoung Chul ; Pelish, Henry E. ; Yun, Mi Ran ; Lee, Jii Bum ; Yu, Mi Ra ; Lee, Eun Ji ; Tangpeerachaikul, Anupong ; Oh, Seung Yeon

AbstractIntroduction: NVL-655 is a brain-penetrant, ALK-selective tyrosine kinase inhibitor (TKI) designed to maintain activity against ALK and ALK mutations that confer resistance to currently approved therapies, and to avoid neurological adverse events and dose-limiting toxicities associated with TRK inhibition. Brain metastases are common in ALK-positive non-small cell lung cancer (NSCLC), with an incidence of ~40% at diagnosis and ~60% after progressive disease on the first-generation ALK TKI (crizotinib) due to its limited brain penetration. Second- (ceritinib, alectinib, brigatinib, and ensartinib) and third-generation (lorlatinib) ALK TKIs have higher intracranial responses than crizotinib but are still limited by emergence of resistance mutations, most commonly G1202R-containing single and compound mutations. We previously reported that NVL-655 has intracranial activity in a preclinical model of Ba/F3 EML4-ALK v1 G1202R/L1196M. Here we further demonstrate the intracranial activity of NVL-655 in a preclinical patient-derived model harboring EML4-ALK v3 G1202R.Methods: The YU-1077 cell line was established from a patient with ALK-positive NSCLC after relapse on alectinib and was confirmed to harbor EML4-ALK v3 G1202R alteration. ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, ensartinib, lorlatinib, and NVL-655) were profiled against YU-1077 cells in 3-day viability assays and signaling assays. YU-1077 cells were intracranially implanted in Balb/c nude mice and treated with NVL-655 orally twice daily. Brain tumor burden was monitored weekly using magnetic resonance imaging (MRI).Results: NVL-655 suppressed the viability of YU-1077 cells bearing EML4-ALK v3 G1202R (IC50 < 1 nM) with potency >10-fold that of lorlatinib. NVL-655 at ≤10 nM fully inhibited ALK signaling as measured by ALK, ERK, and S6 phosphorylation, compared to ≥100 nM of lorlatinib required to achieve similar inhibition. Other ALK TKIs tested had limited activity against YU-1077 cells in viability and signaling assays, consistent with the G1202R mutation conferring resistance to first- and second-generation ALK TKIs. In mice intracranially implanted with YU-1077 cells, MRI scans confirmed rapid tumor regression upon treatment with 0.5 and 1.5 mg/kg NVL-655.Conclusion: Patient-derived models are widely viewed as among the most disease-relevant models for evaluating new therapies and drug resistance. Using a xenograft model derived from an alectinib-relapsed patient, we showed that NVL-655 had high intracranial activity against brain tumors bearing the ALK G1202R mutation that confers resistance to multiple ALK TKIs. NVL-655 is being evaluated in a Phase 1/2 clinical trial for patients with advanced NSCLC and other solid tumors harboring ALK rearrangement or activating ALK mutation (ALKOVE-1): NCT05384626. [J. Lee and M. Yu contributed equally.]Citation Format: Jii Bum Lee, Mi Ra Yu, Mi Ran Yun, You Won Lee, Seung Yeon Oh, Eun Ji Lee, Anupong Tangpeerachaikul, Henry E. Pelish, Byoung Chul Cho. Preclinical intracranial activity of NVL-655 in an alectinib-resistant patient-derived model harboring EML4-ALK fusion with G1202R mutation. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4022.

15 Jun 2022·Cancer Research

Abstract 3336: Preclinical activity of NVL-520 in ROS1-driven cancer models with diverse fusion partners and kinase-domain mutations

Author: Pelish, Henry E. ; Keddy, Clare ; Nicholson, Katelyn ; Tangpeerachaikul, Anupong ; Davare, Monika

AbstractThe ROS1 receptor tyrosine kinase can be aberrantly activated by gene rearrangements that generate oncogenic ROS1 kinase fusions. ROS1 fusions have been detected in diverse adult and pediatric cancers including up to 2% of non-small cell lung cancers (NSCLC), 1-9% of cholangiocarcinomas, and 0.5-1% of gliomas and glioblastomas. There are over 50 known fusion partners of ROS1. Notable examples include CD74, EZR, SDC4, and SLC34A2 in NSCLC; GOPC exons 1-3 (short form or GOPC(S)) in cholangiocarcinoma; and GOPC exons 1-7 (long form or GOPC(L)) in glioblastoma. Crizotinib and entrectinib are FDA-approved ROS1 tyrosine kinase inhibitors (TKIs), but clinical emergence of ROS1 resistance mutations S1986F/Y, F2004C/I/V, L2026M, G2032R, and D2033N restricts their therapeutic utility. Due to the diversity of ROS1 fusion partners and kinase-domain mutations, development of novel ROS1 inhibitors that retain potency against fusion variants and resistance mutations would be beneficial to address these clinical needs.NVL-520 is a novel, brain-penetrant ROS1-selective inhibitor that exhibits preclinical activity against ROS1 alterations, including resistance mutations, while also sparing inhibition of TRKB. TRKB inhibition in the central nervous system has been implicated in adverse events observed with FDA-approved dual TRK/ROS1 inhibitor entrectinib and FDA-approved ALK inhibitor lorlatinib. We previously reported the activity of NVL-520 in several cell line and xenograft models bearing CD74-ROS1, EZR-ROS1, and SDC4-ROS1 fusions, with a wild-type kinase domain or a G2032R mutation. Here we report a broader comparative characterization of NVL-520 and other ROS1 inhibitors against a diverse set of ROS1 fusion partners and kinase-domain mutations.NVL-520 showed potent suppression of proliferation and/or ROS1 signaling in Ba/F3, NIH3T3, or human cancer cell lines expressing CD74-, EZR-, SLC34A2-, or GOPC(L)-ROS1 fusions. NVL-520 also retained potent inhibition of Ba/F3 cells expressing ROS1 fusions with F2004C, F2004V, G2101A, or G2032R mutations. To further demonstrate the broad activity of NVL-520, we utilized NIH3T3 cells expressing CD74- or EZR-ROS1 fusions with G2032R or F2004C mutations. NVL-520 robustly suppressed colony formation and downstream effector signaling in the ROS1 G2032R and F2004C resistance mutant context. Lastly, NVL-520 demonstrated inhibition of ROS1 signaling in a human glioblastoma cell line U118MG, which harbors the GOPC(L)-ROS1 fusion. In conclusion, the preclinical profile of NVL-520 supports its potential to address a medical need for patients with a diverse array of ROS1 fusion partners and kinase-domain mutations, both in NSCLC and in other cancers such as glioblastoma. NVL-520 is being evaluated in a Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC or other solid tumors (NCT05118789).Citation Format: Anupong Tangpeerachaikul, Clare Keddy, Katelyn Nicholson, Monika Davare, Henry E. Pelish. Preclinical activity of NVL-520 in ROS1-driven cancer models with diverse fusion partners and kinase-domain mutations [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 3336.

15 Jun 2022·Cancer Research

Abstract 3337: Preclinical activity of NVL-655 in ALK-driven cancer models beyond non-small cell lung cancer

Author: Friboulet, Luc ; Pelish, Henry E. ; Bigot, Ludovic ; Tangpeerachaikul, Anupong

AbstractThe ALK receptor tyrosine kinase can be aberrantly activated by gene fusions, point mutations, or amplification to promote cancer. ALK fusions are detected in approximately 5% of advanced non-small cell lung cancers (NSCLC), 50% of inflammatory myofibroblastic tumors, 50% of adult and 90% of childhood anaplastic large cell lymphomas, and rare cases of cholangiocarcinomas. Over 90 fusion partners of ALK have been identified, each exerting a different influence on the biochemical properties of the fusion protein and its preclinical sensitivity to ALK inhibitors. Besides fusions, ALK point mutations and amplification account for up to 14% and 2% of sporadic neuroblastomas, respectively, with most activating mutations occurring at residues F1174, F1245, or R1275. Some activating mutations, such as those occurring at F1174 and I1171, also confer resistance to FDA-approved ALK inhibitors. Because ALK plays an oncogenic role in diverse cancer types, it is an important therapeutic target for other indications beyond NSCLC.NVL-655 is a novel, brain-penetrant ALK-selective inhibitor that exhibits preclinical activity against ALK alterations, including resistance mutations, while also sparing inhibition of TRKB. TRKB inhibition in the central nervous system has been implicated in adverse events observed with FDA-approved ALK inhibitor lorlatinib. We previously reported the preclinical activity of NVL-655 in several NSCLC models bearing ALK-fusions, including human cell lines, a human cell-line derived xenograft, and a patient-derived xenograft. Here we report a broader characterization of NVL-655 in ALK-driven cancer models beyond NSCLC, alongside other ALK inhibitors that are either FDA-approved or in development.In biochemical assays, NVL-655 showed potent inhibition (IC50 < 10 nM) of ALK with mutations at residues 1151, 1174, or 1275, all of which have been identified in neuroblastoma. In cell-based assays, NVL-655 was observed to inhibit proliferation of a human anaplastic large cell lymphoma cell line harboring NPM1-ALK fusion and human neuroblastoma cell lines harboring ALK activating mutations or amplification. In conclusion, the preclinical profile of NVL-655 supports its potential to address a medical need for patients with ALK-driven disease in both NSCLC and other cancers such as anaplastic large cell lymphoma and neuroblastoma.Citation Format: Anupong Tangpeerachaikul, Ludovic Bigot, Luc Friboulet, Henry E. Pelish. Preclinical activity of NVL-655 in ALK-driven cancer models beyond non-small cell lung cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 3337.

News (Medical) associated with Nuvalent, Inc.

18 Sep 2024

·www.prnewswire.com

Nuvalent Announces Closing of Upsized Public Offering of Common Stock

CAMBRIDGE, Mass., Sept. 18, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the closing of its previously announced upsized underwritten public offering of 5,750,000 shares of Class A common stock, which includes 750,000 shares of Class A common stock sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $100.00 per share. The gross proceeds of the offering were approximately $575.0 million, before deducting underwriting discounts and commissions and other offering expenses. All shares in the offering were offered by Nuvalent. J.P. Morgan, TD Cowen, Jefferies and Stifel are acting as joint book-running managers for the offering. The shares were offered by Nuvalent pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 16, 2023. This offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC's website at . Copies of the final prospectus supplement and the accompanying prospectus can be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected]. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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. SOURCE Nuvalent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

17 Sep 2024

·endpts.com

Capricor expands DMD pact with Nippon Shinyaku; AbbVie’s new eye deal

Plus, news about Vigil Neuroscience, AC Immune and Athira Pharma: Capricor Therapeutics, Nippon Shinyaku expand commercial pact into Europe: The new deal builds off an existing partnership for a Duchenne muscular dystrophy candidate in the US and Japan. Nippon Shinyaku will now be in charge of distribution and commercialization in Europe, with Capricor earning $20 million upfront, $15 million in an equity investment and up to $715 million in milestone payments. Capricor’s stock $CAPR was up about 8% on Tuesday morning. — Max Bayer Ripple Therapeutics inks deal with AbbVie for eye treatment: The drugmaker is paying $21.8 million upfront to license RTC-620, an experimental implant that delivers a treatment that reduces intraocular pressure in patients with open-angle glaucoma or ocular hypertension. According to the deal, Ripple can get up to $290 million in fees and milestones, plus tiered royalties on net sales. — Jaimy Lee FDA lifts partial hold for Vigil Neuroscience asset: The biotech can now continue with a Phase 1 study testing VG-3927 as a treatment for Alzheimer’s disease. Vigil said the agency decision was based on a “complete response submitted by the company.” — Max Bayer J&J makes a second milestone payment to AC Immune: The new lump sum, worth 24.6 million Swiss francs ($29 million), is thanks to the “rapid rate of prescreening” in a Phase 2b trial testing the companies’ Alzheimer’s treatment. The biotech has received 40 million Swiss francs ($47.2 million) in milestone payments from J&J to date. — Max Bayer Athira lays off 70% of staff after failure in Alzheimer’s disease: The company is now prioritizing an oral pill targeting hepatocyte growth factor for ALS and Alzheimer’s. The layoffs will result in a one-time $2.8 million charge, but will save roughly $13.4 million on an annualized basis. It had 65 full-time employees as of Dec. 31. Athira said the cuts will extend its cash runway into the first quarter of 2026. — Max Bayer Nuvalent upsized its public offering. It now plans to raise $500 million , up from $350 million . — Jaimy Lee

Phase 1Phase 2Financial StatementLicense out/in

17 Sep 2024

·www.prnewswire.com

Nuvalent Announces Pricing of Upsized Public Offering of Common Stock

CAMBRIDGE, Mass., Sept. 16, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the pricing of an upsized underwritten public offering of 5,000,000 shares of Class A common stock at a price to the public of $100.00 per share. All shares are being offered by Nuvalent. The gross proceeds to Nuvalent from the offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be approximately $500.0 million. The offering is expected to close on September 18, 2024, subject to the satisfaction of customary closing conditions. In addition, the underwriters have a 30-day option to purchase up to an additional 750,000 shares of Class A common stock at the public offering price less underwriting discounts and commissions. J.P. Morgan, TD Cowen, Jefferies and Stifel are acting as joint book-running managers for the offering. The shares are being offered by Nuvalent pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 16, 2023. The offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC's website at . A final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus can be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected]. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that involve substantial risks and uncertainties. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate," "seek," "look forward," "advance," "goal," "strategy," "promising," "opportunity," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements regarding the proposed offering, including the satisfaction of customary closing conditions relating to the offering and the expected closing of the offering. Actual results may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to market conditions that may affect the timing, terms and conditions of the offering and the satisfaction of closing conditions related to the offering. There can be no assurance that Nuvalent will be able to complete the offering on the anticipated terms, or at all. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the offering, Nuvalent and its business can be found under the caption "Risk Factors" included in Nuvalent's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, Nuvalent's preliminary prospectus supplement filed with the SEC on September 16, 2024 and other filings that Nuvalent may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Nuvalent expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. SOURCE Nuvalent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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Pipeline Snapshot as of 28 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Neladalkib ( ALK )	ALK positive Non-Small Cell Lung Cancer More	Phase 2 Clinical
Zidesamtinib ( ROS1 )	Reactive oxygen species 1 positive non-small cell lung cancer More	Phase 2
NVL-330 ( HER2 exon 20 )	HER2 ex20ins mutation in non-small cell lung cancer More	Phase 1
ALK IXDN(Nuvalent, Inc.) ( ALK )	ALK positive Non-Small Cell Lung Cancer More	Discontinued

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