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Corvus Pharmaceuticals Presents Final Data from Soquelitinib Phase 1/1b T Cell Lymphoma Trial
Globenewswire· 2025-12-08 15:30
Patients in 200 mg BID cohort had median progression free survival of 6.2 months and median overall survival of 28.1 months, comparing favorably to results with other therapies Data supports ongoing registration Phase 3 trial in r/r PTCL, Phase 1 trial in atopic dermatitis and potential expansion into other immune and inflammatory diseases Highlights ITK inhibition novel mechanism of action affecting T cell receptor signaling and T cell differentiation Presented in an oral session at the 67th American Soci ...
Corvus Pharmaceuticals (NasdaqGM:CRVS) FY Conference Transcript
2025-11-10 14:30
Summary of Corvus Pharmaceuticals FY Conference Call Company Overview - **Company**: Corvus Pharmaceuticals (NasdaqGM:CRVS) - **Focus**: Development of first-in-class immune modulators for cancer and immune diseases - **Lead Program**: Soquelitinib, an oral targeted therapy inhibiting ITK (interleukin-2-inducible T-cell kinase) [2][3] Key Points and Arguments Clinical Trials and Data - **Current Trials**: - Phase III trial for peripheral T-cell lymphoma (PTCL) - Phase IB trial and upcoming Phase II trial for moderate to severe atopic dermatitis (AD) [2] - **Phase I Data**: - 28-day data shows safety profile similar to placebo - Efficacy demonstrated with a statistical separation from placebo at p=0.036 [5] - Observed potential remissive effect with continued separation of treatment curves after stopping at 28 days [5][10] - **Cohort Four**: - Same dose as cohort three (200 mg b.i.d.) - Focus on 56 days of efficacy to assess incremental benefits [9][11] Biomarkers and Mechanism - **Mechanism**: - Targets TH2 and TH17 pathways, blocking cytokines like IL-4 and IL-17, which are relevant for AD [4] - **Biomarkers**: - Increased Tregs and decreased IL-5, IL-17, and IL-31 observed in clinical trials [7] - Plans for skin biopsies in Phase II trial to further assess biomarkers [7][32] Market Opportunity - **Atopic Dermatitis (AD)**: - High unmet need for safe and effective oral therapies - Each 1% market share in AD equates to $1 billion; significant opportunity with only 15% penetration of advanced therapies [26] - **Asthma Study**: - Planned study for asthma, another TH2-driven disease, targeting a market of 60 million patients [27][28] Competitive Landscape - **Differentiation**: - First-in-class selective ITK inhibitor with oral administration preferred by patients - Limited competition in the oral space, with most alternatives being injectables [34][35] - **Partnerships**: - Collaboration with Angelini Pharma for a Phase II AD trial in China [39] Financials - **Cash Position**: - As of September 30, the company has $65 million in cash, providing runway through Q4 2026 [41] Additional Considerations - **Future Trials**: - Phase II study design includes multiple arms and aims to stratify by prior systemic therapies [19][22] - **Data Reporting**: - Upcoming data expected in January, including efficacy and biomarker results [33] This summary encapsulates the critical insights from the conference call, highlighting Corvus Pharmaceuticals' strategic focus, clinical advancements, market potential, and financial health.
Corvus Pharmaceuticals(CRVS) - 2025 Q3 - Earnings Call Transcript
2025-11-04 22:30
Financial Data and Key Metrics Changes - Research and development expenses for Q3 2025 totaled $8.5 million, an increase from $5.2 million in Q3 2024, primarily due to higher clinical trial and manufacturing costs for soquelitinib and increased personnel-related costs [4] - The net loss for Q3 2025 was $10.2 million, significantly improved from a net loss of $40.2 million in Q3 2024, which included a $32.8 million non-cash loss related to warrant liability [4] - Cash, cash equivalents, and marketable securities as of September 30, 2025, were $65.7 million, up from $52 million at December 31, 2024, with expectations to fund operations into Q4 2026 [5] Business Line Data and Key Metrics Changes - The primary focus remains on the development of soquelitinib for atopic dermatitis and T-cell lymphomas, with several important milestones upcoming [6] - Enrollment in the extension cohort 4 of the phase I trial has been completed, with results expected in January [11] - The phase II atopic dermatitis trial is on track to initiate in early Q1 2026, involving approximately 200 patients who have failed prior therapies [12] Market Data and Key Metrics Changes - There is increasing interest in drugs with novel mechanisms to address atopic dermatitis and other inflammatory diseases, positioning soquelitinib favorably in the market [6] - The company is exploring potential next opportunities for its platform, indicating a broad market potential beyond current indications [7] Company Strategy and Development Direction - The company aims to establish selective blockade of ITK as a new therapeutic approach to autoimmune inflammatory diseases, leveraging the data from ongoing trials [16] - Plans to expand into other immune-related diseases, including asthma and hidradenitis suppurativa, are in consideration, with multiple trials intended to be run simultaneously [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of soquelitinib in atopic dermatitis and other immune diseases, citing encouraging clinical evidence [16] - The upcoming ASH presentation is expected to provide further insights into the efficacy of soquelitinib in T-cell lymphoma, which may also support its use in other immune diseases [14][20] Other Important Information - The company appointed David Moore to its board of directors, enhancing its strategic resources [15] - The final results from the phase 1b clinical trial of soquelitinib for T-cell lymphomas will be presented at the American Society of Hematology meeting in December [14] Q&A Session Summary Question: Can you provide context on the ASH abstract and the data to be presented? - Management highlighted impressive overall survival data and emphasized the drug's novel mechanism of action, which shows significant activity in T-cell lymphomas [18][19] Question: What are the expectations for the upcoming atopic dermatitis readout? - Management aims to confirm previous results in a larger patient cohort and assess whether extended treatment duration improves efficacy [21][23] Question: What are the plans for advancing soquelitinib in other indications? - The company is making plans to move into other immune-related diseases, with asthma and dermatologic conditions being key targets [24][32] Question: Will there be a post hoc analysis for Dupixent and JAK-exposed patients? - Management confirmed that post hoc analysis will be conducted to evaluate the drug's efficacy in these populations [36] Question: What is the timeline for the phase II trial and potential launch? - The phase II trial is expected to have a futility interim analysis at the end of 2026, with full data anticipated by the end of 2027 [34] Question: Are there plans for partnerships or licensing deals for soquelitinib? - The company is open to evaluating partnership opportunities while pushing forward with its cancer and immunology programs [41]
Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-04 21:01
Core Insights - Corvus Pharmaceuticals is advancing the development of its ITK inhibitor, soquelitinib, for treating atopic dermatitis and T cell lymphomas, with significant clinical trials underway [3][4][5] Clinical Development - Enrollment in the Phase 1 trial extension cohort 4 for soquelitinib in atopic dermatitis has been completed, involving 24 patients receiving a 200 mg BID dose over an 8-week treatment period, with data expected in January 2026 [7] - The Phase 2 trial for atopic dermatitis is set to begin in early Q1 2026, targeting approximately 200 patients who have not responded to prior therapies [7] - The Phase 3 registrational trial for soquelitinib in relapsed/refractory peripheral T cell lymphoma (PTCL) is currently enrolling patients across multiple sites, with the final Phase 1/1b results to be presented at the American Society of Hematology Annual Meeting [6][8] Financial Overview - As of September 30, 2025, Corvus reported cash, cash equivalents, and marketable securities totaling $65.7 million, an increase from $52.0 million at the end of 2024, with expectations to fund operations into Q4 2026 [9] - Research and development expenses for Q3 2025 were $8.5 million, up from $5.2 million in Q3 2024, primarily due to increased clinical trial and manufacturing costs [10] - The net loss for Q3 2025 was $10.2 million, a significant reduction from a net loss of $40.2 million in the same period of 2024, which included a non-cash loss related to warrant liability [11] Strategic Collaborations - Corvus is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) for a Phase 2 clinical trial of soquelitinib in Autoimmune Lymphoproliferative Syndrome (ALPS), aiming to enroll up to 30 patients [5] Product Information - Soquelitinib is an investigational oral small molecule designed to selectively inhibit ITK, which plays a crucial role in T cell immune function, potentially benefiting patients with various cancers and autoimmune diseases [14][18]
Corvus Pharmaceuticals to Present Final Data from Soquelitinib Phase 1/1b T Cell Lymphoma Trial at the 67th American Society of Hematology Annual Meeting & Exposition
Globenewswire· 2025-11-03 14:02
Core Insights - Corvus Pharmaceuticals is set to present final data from its Phase 1/1b trial of soquelitinib for T cell lymphoma at the 67th ASH Annual Meeting in December 2025 [1] - Soquelitinib is a selective interleukin-2-inducible T cell kinase (ITK) inhibitor, currently in a Phase 3 clinical trial for relapsed/refractory T cell lymphoma and a Phase 1 trial for atopic dermatitis [2] Group 1 - The oral presentation will take place on December 8, 2025, from 10:30 AM to 12:00 PM, with the specific presentation scheduled for 11:15 AM to 11:30 AM [1] - The publication number for the presentation is 778, focusing on the final results of the Phase 1 trial with soquelitinib [1] Group 2 - Corvus Pharmaceuticals is pioneering ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [2] - The company’s lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK [2]
Corvus Pharmaceuticals to Present at the Guggenheim 2nd Annual Healthcare Innovation Conference
Globenewswire· 2025-10-31 11:30
Core Insights - Corvus Pharmaceuticals, Inc. will engage with investors through one-on-one meetings and a fireside chat at the Guggenheim 2 Annual Healthcare Innovation Conference in Boston, MA on November 10, 2025 at 8:30 am ET [1] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [3] - The company's lead product candidate is soquelitinib, an investigational oral small molecule drug that selectively inhibits ITK [3] - Corvus has additional clinical-stage candidates targeting a range of cancer indications [3] Event Details - A live webcast of the fireside chat will be available, along with access for 90 days post-event, through the investor relations section of the Corvus website [2]
Corvus Pharmaceuticals to Provide Business Update and Third Quarter 2025 Financial Results on November 4, 2025
Globenewswire· 2025-10-28 20:01
Core Points - Corvus Pharmaceuticals, Inc. will host a conference call and webcast on November 4, 2025, at 4:30 pm ET to provide a business update and report third quarter 2025 financial results [1] - The conference call can be accessed via a toll-free number or through a link for instant access, with a replay available for 90 days on the company's website [2] - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition for immunotherapy targeting various cancers and immune diseases, with its lead product candidate being soquelitinib [3]
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].