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Corvus Pharmaceuticals Announces Partner Angel Pharmaceuticals Received IND Approval for a Phase 1b/2 Clinical Trial of Soquelitinib in China for the Treatment of Atopic Dermatitis
Globenewswire· 2025-06-25 12:00
Core Viewpoint - Corvus Pharmaceuticals has announced the approval of an IND application for a Phase 1b/2 clinical trial of soquelitinib in China, targeting patients with moderate-to-severe atopic dermatitis, which is expected to begin patient enrollment in Q3 2025 [1][3]. Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing ITK inhibition as a new immunotherapy approach for various cancers and immune diseases [6][7]. - Angel Pharmaceuticals, co-founded by Corvus, is responsible for developing, manufacturing, and commercializing soquelitinib in greater China, with Corvus holding approximately 49.7% ownership [2][5]. Clinical Trial Details - The Phase 1b/2 trial will study a 12-week treatment period with a 400 mg once-daily dose of soquelitinib, building on previous clinical data [3][6]. - The trial will be randomized, double-blinded, and placebo-controlled, enrolling patients with moderate-to-severe atopic dermatitis [3][6]. - The Phase 1b trial will include two cohorts, each with 24 patients, testing different dosing regimens [6]. Market Context - Atopic dermatitis is a growing concern globally, with increasing use of biologics and systemic therapies, particularly in China [3].
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 (CRVS) 2025 Conference Transcript
2025-06-05 14:20
Corvus Pharmaceuticals (CRVS) 2025 Conference Summary Company Overview - **Company**: Corvus Pharmaceuticals - **Lead Product**: Socolitinib, an ITK inhibitor - **Focus Areas**: Oncology, immune diseases, dermatology, and neurology Key Points and Arguments Drug Development and Mechanism - Socolitinib is in a registration phase three trial for peripheral T cell lymphoma and a phase one trial for moderate to severe atopic dermatitis [2][3] - The drug has a novel mechanism of action with a selective blockade of ITK, which is critical in T cell differentiation [3][6] - Socolitinib has an established safety profile in over 100 patients, with some treated for over two years [3][4] Market Potential - The markets for socolitinib are substantial, particularly in cancer, lymphoma, and immune diseases [4][20] - The patent for socolitinib extends until November 2037, with potential for further extensions beyond 2040 [4] Clinical Trials and Results - Phase three trial for peripheral T cell lymphoma shows a 40% response rate, with a median survival of six months for untreated patients [20][21] - The trial is open in four countries, enrolling 150 patients, comparing socolitinib to standard care [21] - In the phase one trial for atopic dermatitis, the mean reduction in EASI score was 54.6 for lower doses and 64.8 for higher doses, compared to 34.4 for placebo [40][41] Safety and Efficacy - No significant safety issues reported; only one grade one nausea event noted [54] - The drug shows a significant reduction in pruritus, with 50% of patients reporting a four-point or more change in PPNRS [56][60] - Efficacy data indicates a statistically significant difference at day 28 with a p-value of 0.036 [50] Future Plans - Corvus plans to extend the phase one trial for atopic dermatitis to include an additional 24 patients, treating for two months instead of one [61][62] - The company is preparing for a phase two trial based on the promising results from the ongoing studies [68] Additional Important Information - The management team has experience in blending lymphoma and immune diseases, drawing parallels to successful drugs like Rituxan and Ibrutinib [5][8] - Socolitinib's specificity for ITK is highlighted as a unique advantage, potentially leading to fewer side effects compared to other treatments [55][66] - The company emphasizes the importance of targeting multiple cytokines for a more effective treatment approach in autoimmune diseases [66][67] This summary encapsulates the critical insights from the conference, focusing on Corvus Pharmaceuticals' strategic direction, clinical advancements, and market opportunities.
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].
Why Is Corvus Pharmaceuticals Stock Soaring On Friday?
Benzinga· 2025-05-09 15:57
Core Insights - Corvus Pharmaceuticals released new interim data from a Phase 1 clinical trial for soquelitinib, showing a favorable safety and efficacy profile in patients with moderate to severe atopic dermatitis [1][6] Efficacy and Safety Data - All three cohorts demonstrated significant responses in EASI 75 and IGA 0 or 1 compared to placebo [2] - The percent reduction in mean EASI scores at 28 days was 54.6% for cohorts 1 and 2 combined receiving soquelitinib versus 30.6% for placebo, while cohort 3 showed a 71.1% reduction compared to 42.1% for placebo [3] - Active drug separation from placebo began at day 15 for cohorts 1 and 2, and at day 8 for cohort 3, with significant superiority at day 28 (p=0.03) [4] Tolerability and Adverse Events - Soquelitinib was well tolerated with no dose-limiting toxicities or clinically significant laboratory abnormalities observed [4] - Grade 1/2 adverse events occurred in 33.3% of soquelitinib patients and 25% of placebo patients, with only one treatment-related adverse event reported [5] Mechanism of Action and Future Plans - Relationships between reductions in certain cytokines and improvement in EASI scores were observed, along with an increase in circulating T regulatory cells [5] - The company plans to continue with key initiatives for soquelitinib, including data from a new extension cohort and a Phase 2 clinical trial by year-end [7] Financial Position - As of March 31, 2025, Corvus had cash and equivalents of $44.2 million, expected to fund operations into Q4 2026 [8] - Following the news, CRVS stock increased by 28.40% to $4.30 [8]
Corvus Pharmaceuticals(CRVS) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:32
Financial Data and Key Metrics Changes - Research and development expenses for Q1 2025 totaled $7.5 million, up from $4.1 million in Q1 2024, primarily due to increased clinical trial and manufacturing costs for socolitinib [5] - Net income for Q1 2025 was $15.2 million, including a non-cash loss of $0.5 million related to Angel Pharmaceuticals, compared to a net loss of $5.7 million in Q1 2024 [6] - Total stock compensation expense increased to $1.3 million in Q1 2025 from $0.7 million in Q1 2024 [6] - As of March 31, 2025, cash, cash equivalents, and marketable securities totaled $44.2 million, down from $52 million at the end of 2024 [6] Business Line Data and Key Metrics Changes - The company is focused on the development of socolitinib for atopic dermatitis, with promising Phase I trial results indicating a favorable safety and efficacy profile [9][26] - Cohort three of the trial showed a mean reduction in EASI score of 71.1% compared to 42.1% in the placebo group, indicating significant efficacy [18] Market Data and Key Metrics Changes - The company continues to enroll patients in its Phase III trial for socolitinib in relapsed peripheral T cell lymphoma, aiming for interim data in late 2026 [28] - Initial data from the Phase II trial for socolitinib in patients with autoimmune lymphoproliferative syndrome (ALPS) may be available in late 2025 or early 2026 [28] Company Strategy and Development Direction - The company plans to initiate a Phase II trial for socolitinib before the end of 2025, evaluating different doses and durations of therapy [25][28] - An extension cohort will evaluate an additional 24 patients at the 200 mg twice daily dose for eight weeks, aiming to optimize the design of the Phase II trial [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the results from the atopic dermatitis trial, highlighting the potential for socolitinib as a new treatment for a range of immune diseases [27] - The company is not dependent on partnerships for development and plans to advance its programs independently, supported by recent cash inflows from warrant exercises [29][88] Other Important Information - The company reported a non-cash gain of $25.1 million from the change in fair value of its warrant liability during Q1 2025 [6] - The safety profile of socolitinib was noted to be favorable, with no significant safety issues observed in the trial [23] Q&A Session Summary Question: Comparison of cohort three EZ75 data with Dupixent - Management acknowledged that cohort three data is competitive with other agents approved for atopic dermatitis and sees potential for socolitinib to be used as an early line of therapy [34] Question: Efficacy curves and potential plateau - Management noted that the response curves are still decreasing, suggesting that continued therapy could yield deeper responses [36] Question: Explanation for efficacy jump between cohorts - The increase in efficacy in cohort three is attributed to the higher dose of the drug, which has shown significant occupancy [39] Question: Phase I study modifications and potential QD dosing - The extended duration cohort will study a single dosing regimen of 200 mg BID, with future trials considering QD dosing options [46] Question: Potential for combination therapies - Management indicated that due to the non-overlapping mechanism of socolitinib, there are opportunities for combination therapies, although the focus remains on monotherapy for now [96]
Corvus Pharmaceuticals(CRVS) - 2025 Q1 - Earnings Call Transcript
2025-05-08 21:30
Financial Data and Key Metrics Changes - Research and development expenses for Q1 2025 totaled $7.5 million, up from $4.1 million in Q1 2024, primarily due to higher clinical trial and manufacturing costs for socolitinib [4][5] - Net income for Q1 2025 was $15.2 million, including a non-cash loss of $0.5 million related to Angel Pharmaceuticals, compared to a net loss of $5.7 million in Q1 2024 [5] - Total stock compensation expense increased to $1.3 million in Q1 2025 from $0.7 million in Q1 2024 [5] - As of March 31, 2025, cash, cash equivalents, and marketable securities totaled $44.2 million, down from $52 million at the end of 2024 [5][6] Business Line Data and Key Metrics Changes - The socolitinib Phase I trial showed encouraging results, with all treatment cohorts demonstrating a favorable safety and efficacy profile compared to placebo [9][25] - Cohort three patients had a mean baseline EASI score of 27-28, significantly higher than cohorts one and two, which ranged from 17-20, indicating worse disease at baseline for cohort three [14] Market Data and Key Metrics Changes - The Phase I trial included 48 patients, with 16 subjects in each of the first three cohorts, and the study is double-blind [10] - The trial endpoints include safety and efficacy measured by EASI and IGA scores, with cohort three showing earlier and deeper responses compared to cohorts one and two [12][25] Company Strategy and Development Direction - The company plans to amend the Phase I trial protocol to include an extension cohort evaluating an additional 24 patients at a 200 mg twice per day dose for eight weeks [23] - The company is on track to initiate a Phase II trial for socolitinib before the end of the year, which will likely evaluate different doses and durations of therapy [24][27] - The company aims to advance socolitinib on multiple fronts, including key data from the next 24 patients in the atopic dermatitis trial expected in Q4 2025 [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the results from the trial, highlighting a favorable safety and efficacy profile for socolitinib [25] - The company is not dependent on any partners for development and plans to push forward with its clinical programs independently [84] Other Important Information - The company recorded a non-cash gain of $25.1 million from the change in fair value of warrants during Q1 2025 [5] - The early exercise of warrants resulted in approximately $31.3 million in cash proceeds, enabling the company to fund operations into late 2026 [6][28] Q&A Session Summary Question: Will socolitinib compete with Dupixent and JAK inhibitors? - Management believes socolitinib's data is competitive with other agents approved for atopic dermatitis and sees potential for it to be used as an early line of systemic therapy [32] Question: What is the expected plateau for efficacy? - Management noted that the efficacy curves are still decreasing, suggesting that continued therapy could yield deeper responses [35] Question: What explains the efficacy difference between cohorts two and three? - The higher efficacy in cohort three is attributed to the doubled dose of the drug compared to cohorts one and two [39] Question: What is the design of the extended duration cohort? - The extended duration cohort will study 24 patients at a 200 mg BID dosing regimen [45] Question: Will the company seek partnerships before Phase II? - The company plans to advance its programs independently and is not dependent on partnerships for development [84] Question: What are the thoughts on potential combinations with other therapies? - Management sees opportunities for combinations due to the non-overlapping mechanism of socolitinib with other drugs, but will focus on monotherapy for now [92]
Corvus Pharmaceuticals(CRVS) - 2025 Q1 - Quarterly Report
2025-05-08 20:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37719 Corvus Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) (State or other jur ...
Corvus Pharmaceuticals(CRVS) - 2025 Q1 - Quarterly Results
2025-05-08 20:02
EXHIBIT 99.1 Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2025 Financial Results Soquelitinib data from cohorts 1-3 of atopic dermatitis Phase 1 clinical trial demonstrate favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 compared to cohorts 1-2 Phase 3 registrational clinical trial of soquelitinib in peripheral T cell lymphoma (PTCL) enrolling with multiple clinical sites open Early exercise of common stock warrants by stockholders provid ...