ITK inhibition
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Corvus Pharmaceuticals Appoints David Moore to Board of Directors
Globenewswire· 2025-10-02 20:01
Core Insights - Corvus Pharmaceuticals has appointed David Moore to its Board of Directors, bringing extensive experience from his 27-year career in the pharmaceutical and biotech industries [1][2] - Mr. Moore's background includes leadership roles at Novo Nordisk, where he oversaw successful GLP-1 franchises, which is expected to be a strategic asset for Corvus as it develops its ITK inhibitor platform [2] - Corvus is focused on developing ITK inhibition as a novel immunotherapy approach for cancer and immune diseases, with its lead candidate being soquelitinib [3] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company specializing in ITK inhibition for treating various cancer and immune diseases [3] - The company's lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK [3] Leadership Experience - David Moore has held significant positions at Novo Nordisk, including Executive Vice President of US Operations and President of Novo Nordisk Inc., contributing to corporate strategy and business development [2] - His previous roles also include being an investment partner at Gurnet Point Capital and CEO of Lysovant Sciences, showcasing a diverse background in both operational and investment capacities [2]
Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-07 20:01
Core Insights - Corvus Pharmaceuticals reported positive interim results from the Phase 1 clinical trial of soquelitinib for atopic dermatitis, showing earlier and deeper responses compared to earlier cohorts, with a significant reduction in itch as early as day 8 [1][4][3] - The company is advancing its clinical trials, with ongoing enrollment in Phase 1 trial extension cohort 4 and plans to initiate a Phase 2 trial before the end of the year [1][3] - Corvus is also enrolling patients in a Phase 3 registrational clinical trial of soquelitinib for relapsed/refractory peripheral T cell lymphoma (PTCL) [1][6] Clinical Development - Soquelitinib demonstrated a mean reduction in Eczema Area and Severity Index (EASI) score of 64.8% in cohort 3 at 28 days, compared to 54.6% for cohorts 1 and 2 combined [4] - The Phase 1 trial showed a favorable safety profile, with no dose-limiting toxicities reported [4] - A separate Phase 1b/2 trial in China is planned to further explore soquelitinib's efficacy in atopic dermatitis with a 12-week treatment period [3][4] Financial Performance - As of June 30, 2025, Corvus had cash, cash equivalents, and marketable securities totaling $74.4 million, an increase from $52.0 million at the end of 2024 [9] - The company reported a net loss of $8.0 million for the second quarter of 2025, compared to a net loss of $4.3 million for the same period in 2024 [11] - Research and development expenses for the second quarter of 2025 were $7.9 million, up from $4.1 million in the same period in 2024, primarily due to increased clinical trial costs [10] Strategic Collaborations - Corvus is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) for a Phase 2 clinical trial in autoimmune lymphoproliferative syndrome (ALPS) [5] - The company has partnered with Angel Pharmaceuticals to develop and commercialize its clinical-stage candidates in China [23] Upcoming Events - A conference call and webcast is scheduled for August 7, 2025, to discuss the business update and second-quarter financial results [12][13]
Corvus Pharmaceuticals to Provide Business Update and Second Quarter 2025 Financial Results on August 7, 2025
Globenewswire· 2025-07-31 20:01
Core Viewpoint - Corvus Pharmaceuticals will host a conference call and webcast on August 7, 2025, to provide a business update and report its second quarter 2025 financial results [1]. Group 1: Conference Call Details - The conference call is scheduled for 4:30 pm ET (1:30 pm PT) [1]. - Access to the conference call can be made via a toll-free domestic number (1-800-717-1738) or an international number (1-646-307-1865) [2]. - A live webcast will be available on the investor relations section of the Corvus website, with a replay accessible for 90 days [2]. Group 2: Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [3]. - The lead product candidate is soquelitinib, an investigational oral small molecule drug that selectively inhibits ITK [3]. - The company is developing other clinical-stage candidates targeting a variety of cancer indications [3].
Aclaris Therapeutics Announces Positive Top-Line Results from Open-Label Phase 2a Trial of ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3; Trial Achieves Primary and Key Secondary Endpoints
Globenewswire· 2025-07-29 20:01
Core Insights - Aclaris Therapeutics announced positive top-line results from its Phase 2a trial of ATI-2138, indicating a favorable tolerability profile and comparable efficacy to approved therapies for moderate-to-severe atopic dermatitis [1][2][13] Group 1: Trial Overview - The Phase 2a trial was an open-label, single-arm study involving 14 patients with moderate-to-severe atopic dermatitis, focusing on safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 administered at 10mg BID for 12 weeks [14] - The trial confirmed the strong tolerability profile of ATI-2138, with no severe adverse events reported and most adverse events being mild [6][12] Group 2: Efficacy Results - The mean improvement in Eczema Area and Severity Index (EASI) score at week 12 was 60.5%, with a median improvement of 76.8% among patients receiving ATI-2138 [12] - At week 12, 62.5% of patients experienced a clinically meaningful ≥4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) [9] - Improvements in EASI scores were observed as early as week 1, with significant reductions noted at weeks 4, 8, and 12 [12] Group 3: Pharmacodynamic Results - Pharmacodynamic analyses demonstrated strong downregulation of key inflammatory markers associated with ITK, including Th2 and Th1/Th17-related markers, indicating the therapeutic potential of ITK inhibition [3][10] - Near complete and sustained ITK target occupancy was observed, with reductions in multiple inflammatory pathways linked to ITK [10] Group 4: Future Development Plans - Aclaris plans to further develop ATI-2138 for alopecia areata and explore other indications relevant to its mechanism of action, with ongoing preclinical work for next-generation ITK inhibitors expected to lead to new INDs starting in 2026 [13][16]
Corvus Pharmaceuticals Presents Soquelitinib Preclinical Data Highlighting Potential of ITK inhibition to Treat Systemic Sclerosis at EULAR 2025 Congress
Globenewswire· 2025-06-11 11:00
Core Insights - Corvus Pharmaceuticals announced preclinical data on soquelitinib's potential to treat systemic sclerosis, to be presented at the EULAR 2025 Congress [1] - The presentation was selected as a top 10 abstract by the Emerging EULAR Network, indicating significant interest in the research [1] - The company is focusing on developing soquelitinib for various conditions, including peripheral T cell lymphoma and atopic dermatitis, while considering future trials for systemic sclerosis [2] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company specializing in ITK inhibition for cancer and immune diseases [3] - The lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK [3] - The company is also developing other clinical-stage candidates for various cancer indications [3]
Corvus Pharmaceuticals Announces Full Data from Cohort 3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis
GlobeNewswire News Room· 2025-06-04 11:00
Core Insights - Corvus Pharmaceuticals announced interim data from a Phase 1 clinical trial of soquelitinib for moderate to severe atopic dermatitis, showing cohort 3 (200 mg BID) had earlier and deeper responses compared to cohorts 1 and 2 [1][2][3] - The trial demonstrated a statistically significant improvement in the Eczema Area and Severity Index (EASI) score at day 28, with cohort 3 showing a mean reduction of 64.8% compared to 34.4% for placebo [1][3] - An extension cohort study has been initiated to explore the same dose of soquelitinib for a longer treatment period of 8 weeks [1][14] Efficacy Data - All three cohorts showed statistically significant separation from placebo at day 28, with cohort 3 achieving clinically meaningful reduction in itch as early as day 8 [1][4] - The mean reduction in EASI score for cohort 3 was 64.8%, while cohorts 1 and 2 combined showed a reduction of 54.6% [3][4] - At day 28, no placebo patients achieved IGA 0 or 1 or EASI 75, while cohort 3 had one patient achieving EASI 75 with an 89% reduction in EASI score [7][11] Safety Profile - As of May 28, 2025, soquelitinib was well tolerated with no new safety signals, and only one treatment-related adverse event of grade 1 nausea reported [12] - Grade 1/2 adverse events were observed in 38.9% of patients receiving soquelitinib compared to 25% in the placebo group [12] Biomarker Studies - Reductions in serum cytokines (IL-5, IL-9, IL-17, IL-31, IL-33, TSLP, and TARC) were observed, with cohort 3 showing greater reductions compared to cohorts 1 and 2 [13] - Relationships between cytokine reductions and improvements in EASI scores were noted, with no such relationships in the placebo group [13] Future Directions - The company is optimistic about the potential of soquelitinib as a safe and effective treatment for atopic dermatitis and other immune diseases, with further improvements expected from the extension cohort [2][14] - The extension cohort will enroll 24 patients randomized 1:1 between active and placebo, with an 8-week treatment period [14]
Corvus Pharmaceuticals to Present at the 2025 Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 20:01
Core Viewpoint - Corvus Pharmaceuticals, Inc. is actively engaging with investors at the 2025 Jefferies Global Healthcare Conference, highlighting its innovative approach in immunotherapy and its lead product candidate, soquelitinib [1][3]. Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition as a novel immunotherapy strategy for various cancers and immune diseases [3]. - The company's lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK [3]. - Corvus is developing additional clinical-stage candidates targeting a range of cancer indications [3]. Event Details - The leadership team will present a corporate overview and conduct one-on-one meetings with investors at the conference in New York on June 5, 2025, from 9:20 to 9:50 am ET [1]. - A live webcast of the presentation will be available for 90 days post-event, accessible through the investor relations section of the Corvus website [2].
Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-08 20:02
Core Insights - Corvus Pharmaceuticals reported favorable safety and efficacy data for soquelitinib in atopic dermatitis, showing earlier and deeper responses in cohort 3 compared to cohorts 1 and 2 [1][6] - The company is advancing multiple clinical trials for soquelitinib, including a Phase 3 trial for peripheral T cell lymphoma (PTCL) and a Phase 2 trial for autoimmune lymphoproliferative syndrome (ALPS) [2][5] - Corvus raised approximately $31.3 million through the early exercise of common stock warrants by stockholders [1][10] Business Update and Strategy - Soquelitinib is positioned as a potential new treatment for atopic dermatitis and other immune diseases, with ongoing clinical trials and data expected in the fourth quarter [2][3] - The Phase 3 trial for PTCL is enrolling patients at multiple sites, aiming for a total of 150 participants [5][7] - The company is also developing next-generation ITK inhibitors for specific immunology indications [6] Financial Results - As of March 31, 2025, Corvus had cash, cash equivalents, and marketable securities totaling $44.2 million, down from $52.0 million at the end of 2024 [10][29] - Research and development expenses for Q1 2025 were $7.5 million, an increase from $4.1 million in Q1 2024, primarily due to higher clinical trial costs [11] - The net income for Q1 2025 was $15.2 million, including a gain of $25.1 million from changes in the fair value of the company's warrant liability [12][26]
Corvus Pharmaceuticals Announces Data from Cohorts 1-3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis
GlobeNewswire News Room· 2025-05-08 20:01
Core Insights - Corvus Pharmaceuticals announced new interim data from a Phase 1 clinical trial of soquelitinib for moderate to severe atopic dermatitis, showing a favorable safety and efficacy profile with earlier and deeper responses in cohort 3 compared to cohorts 1 and 2 [1][2][3] Group 1: Clinical Trial Data - The Phase 1 trial included 48 patients, with 32 receiving soquelitinib and 12 receiving placebo, demonstrating significant responses in EASI 75 and IGA 0 or 1 endpoints [3][4] - The percent reduction in mean EASI scores at 28 days was 54.6% for cohorts 1 and 2 combined and 71.1% for cohort 3, compared to 30.6% and 42.1% for placebo, respectively [7][9] - All cohorts showed significant separation from placebo, with the combined soquelitinib treatment group being significantly superior at day 28 (p=0.03) [9][10] Group 2: Safety and Efficacy - Soquelitinib was well tolerated, with no dose-limiting toxicities and only one treatment-related adverse event reported [15] - Biomarker studies indicated reductions in inflammatory cytokines and an increase in T regulatory cells, supporting the drug's mechanism of action [16] Group 3: Future Directions - The trial protocol has been amended to include an additional 24 patients at the 200 mg twice per day dose for an extended treatment period of 8 weeks, aiming to evaluate stronger efficacy [2][18] - The company plans to initiate a Phase 2 trial before the end of the year based on the interim results [2][18] Group 4: Presentation and Communication - Data from the trial will be presented at the Society for Investigative Dermatology 2025 Annual Meeting, with details shared during the company's first quarter 2025 business update conference call [21][22]
Corvus Pharmaceuticals(CRVS) - 2024 Q4 - Earnings Call Transcript
2025-03-25 23:58
Financial Data and Key Metrics Changes - Research and development (R&D) expenses in Q4 2024 were $5.2 million, up from $3.2 million in Q4 2023, primarily due to increased clinical trial expenses for socalitinib [6] - Full year R&D expenses for 2024 totaled $19.4 million, compared to $16.5 million in 2023, reflecting an increase of approximately $2.9 million [7] - The net loss for Q4 2024 was $12.1 million, compared to a net loss of $6.7 million in Q4 2023 [8] - Total stock compensation expense for Q4 2024 was $0.8 million, compared to $0.6 million in Q4 2023 [8] - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $52 million, up from $27.1 million at the end of 2023 [9] Business Line Data and Key Metrics Changes - Socalitinib showed a 39% objective response rate in the Phase 1 trial for relapsed T-cell lymphoma, with a 26% complete response rate, significantly higher than standard chemotherapies [12] - Interim data from the Phase 1 trial of socalitinib in moderate to severe atopic dermatitis indicated significant responses compared to placebo [13] Market Data and Key Metrics Changes - The company is enrolling a registrational Phase 3 trial of socalitinib in patients with relapsed peripheral T-cell lymphoma [12] - The Phase 1 trial for atopic dermatitis includes four cohorts, with a total of 16 subjects each, showing promising efficacy results [15][19] Company Strategy and Development Direction - The company aims to position socalitinib as a first-in-class oral therapy for immune diseases and cancer, leveraging its unique mechanism of action [11] - Plans include advancing multiple clinical trials for socalitinib, including a Phase 2 trial in solid tumors and a Phase 2 trial in atopic dermatitis [29][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of socalitinib, citing a strong body of evidence from clinical and preclinical research [11] - The company anticipates its cash runway will extend into the first quarter of 2026, allowing for the execution of key milestones [10][33] Other Important Information - The company is also advancing other clinical stage development programs, including adenosine A2A receptor antagonists for cancer treatment [30] - The ALPS trial is being conducted under a clinical research agreement with the NIH, targeting a rare autoimmune disease with a patient population of approximately 2,500 in the U.S. [68] Q&A Session Summary Question: Will the May update include full data on cohorts three and additional patients on cohort two? - Management confirmed that the May meeting will report full datasets on cohorts one, two, and three, including biomarker data [38] Question: What efficacy hurdles are being considered for the Phase 2a trial? - Management indicated satisfaction with the efficacy seen in cohorts one and two, noting a significant difference compared to placebo [41][44] Question: What are the plans for cohort four and the rationale for dosing? - Management stated that cohort four is planned at a 400 mg dose, pending review of cohort three data [50][52] Question: What is the addressable patient population for the ALPS indication? - Management noted approximately 2,500 patients in the U.S. with ALPS, emphasizing the potential for long-term treatment [68] Question: What subpopulations are being targeted in the upcoming Phase 2 for atopic dermatitis? - Management indicated that the focus will be on patients with moderate to severe atopic dermatitis who have failed prior treatments [76]