Corvus Pharmaceuticals(CRVS)
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Corvus Pharmaceuticals Announces Interim Data from Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis
Newsfilter· 2024-12-18 12:30
Core Insights - Corvus Pharmaceuticals announced interim data from a Phase 1 clinical trial of soquelitinib for moderate to severe atopic dermatitis, showing a favorable safety and efficacy profile [1][2][4] - The company reported cash proceeds of approximately $12.7 million from the early exercise of common stock warrants [1][18] Clinical Trial Overview - The Phase 1 trial is randomized, double-blind, and placebo-controlled, enrolling 64 patients who have previously failed one prior therapy [2][4] - Patients are assigned to one of four dosing cohorts, with doses including 100 mg twice daily, 200 mg once daily, 200 mg twice daily, and 400 mg once daily [2][3] Efficacy Results - In Cohort 1, the mean EASI score reduction at 28 days was 55.9% for soquelitinib compared to 27.0% for placebo, and at 58 days, it was 69.1% for soquelitinib versus 19.1% for placebo [9][10] - At day 28, 75% of soquelitinib patients achieved EASI 50, while no placebo patients achieved EASI 75 or EASI 90 [9][10] - The treatment effect began early, with improvements noted as soon as eight days into the treatment [9] Safety Profile - No significant safety issues were reported, with only two patients in the soquelitinib group experiencing mild adverse events [13][15] - All patients completed the 28-day dosing period without serious adverse events [13][15] Cytokine Analysis - The trial observed reductions in cytokines IL-5, IL-17, IL-31, IL-33, and TSLP, correlating with clinical improvement in EASI scores [16] - No such relationships were observed in the placebo group, indicating a potential mechanism of action for soquelitinib [16] Ongoing Development - The company is looking forward to completing the Phase 1 trial and initiating further trials for soquelitinib in other immune diseases [2][4] - Initial results from Cohort 2, which includes patients receiving 200 mg once daily, are consistent with those from Cohort 1, with no significant adverse events reported [17] Company Background - Corvus Pharmaceuticals is focused on developing ITK inhibition as a novel approach to treat various cancers and immune diseases, with soquelitinib as its lead candidate [23]
Corvus Pharmaceuticals to Announce Interim Data from Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis on December 18, 2024
Newsfilter· 2024-12-17 21:01
Core Insights - Corvus Pharmaceuticals will announce interim data from a Phase 1 clinical trial of soquelitinib for atopic dermatitis on December 18, 2024 [1] - A conference call and webcast will be held to discuss the clinical data, accessible via phone and the company's website [2] About Soquelitinib - Soquelitinib is an investigational oral small molecule drug that selectively inhibits ITK, impacting T cell differentiation and immune function [3] - The drug has shown potential in treating cancers and autoimmune diseases by shifting T cell differentiation towards regulatory cells [3] - A registrational Phase 3 trial for relapsed peripheral T cell lymphoma has been initiated based on positive Phase 1/1b results [3] About Corvus Pharmaceuticals - Corvus Pharmaceuticals is focused on developing ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [4] - The company’s lead candidate is soquelitinib, with other clinical-stage candidates targeting different cancer indications [4]
Corvus Pharmaceuticals Announces Publication of Biochemistry and Preclinical Data Demonstrating Potential of ITK Inhibition with Soquelitinib as a Novel Approach to Modulate Tumor Immunity
GlobeNewswire News Room· 2024-12-04 21:05
Core Insights - Corvus Pharmaceuticals has published preclinical data on soquelitinib, an ITK inhibitor, indicating its potential to modulate tumor immunity, which is a novel approach in cancer immunotherapy [1][2][3] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing ITK inhibition as a new immunotherapy strategy for various cancers and immune diseases [5] - The lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK [6] Research Findings - The publication details soquelitinib's mechanism of action, which includes suppressing Th2 and Th17 cytokine production while sparing Th1 cytokines, enhancing the effector function of cytotoxic CD8 positive T cells, and increasing memory T cells with improved effector function [2][3] - The research was conducted in collaboration with several academic institutions, including the University of Michigan and Stanford University [3] Clinical Development - Corvus is currently enrolling patients in a Phase 3 clinical trial for relapsed peripheral T cell lymphoma (PTCL) and a Phase 1 clinical trial for moderate to severe atopic dermatitis [4][6] - Plans are in place to initiate a Phase 1 clinical trial of soquelitinib in patients with solid tumors [4]
Corvus (CRVS) is on the Move, Here's Why the Trend Could be Sustainable
ZACKS· 2024-11-15 14:50
Core Viewpoint - The article emphasizes the importance of identifying and maintaining trends in short-term investing, highlighting that sound fundamentals and positive earnings estimates are crucial for sustaining momentum in stocks [1]. Group 1: Recent Price Strength Screen - The "Recent Price Strength" screen is a unique short-term trading strategy that helps identify stocks with strong fundamentals capable of maintaining an uptrend [2]. - Stocks that pass this screen are typically trading in the upper portion of their 52-week high-low range, indicating bullish sentiment [2]. Group 2: Corvus Pharmaceuticals (CRVS) - Corvus Pharmaceuticals is highlighted as a strong candidate for trend investors, having experienced a price increase of 105.3% over the past 12 weeks, indicating investor confidence in its potential upside [3]. - The stock has also seen an 18.2% price increase over the last four weeks, suggesting that the upward trend is still intact [4]. - Currently, CRVS is trading at 83% of its 52-week high-low range, indicating a potential breakout opportunity [4]. Group 3: Fundamental Strength - CRVS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, which are critical for near-term price movements [5]. - The stock has an Average Broker Recommendation of 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term performance [6]. Group 4: Additional Opportunities - Besides CRVS, there are several other stocks that meet the criteria of the "Recent Price Strength" screen, suggesting further investment opportunities [7]. - The article encourages exploring over 45 Zacks Premium Screens tailored to different investing styles to identify potential winning stocks [7].
Corvus Pharmaceuticals Announces New Preclinical Data Highlighting Potential of Soquelitinib to Treat Systemic Sclerosis
GlobeNewswire News Room· 2024-11-14 15:01
Adds to growing body of evidence supporting the potential of ITK inhibition as a novel therapeutic for the treatment of a wide range of immune diseases Data will be presented in a poster at ACR Convergence 2024, the annual meeting of the American College of Rheumatology BURLINGAME, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new preclinical data highlighting the potential of soquelitinib, the Company’s lea ...
Corvus Pharmaceuticals: The Market Likes The Story
Seeking Alpha· 2024-11-13 18:18
Core Insights - The discussion in the biotech community has focused on profitable buy-write or covered call strategies on selected biotech stocks in recent months [1]. Company Spotlight - Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) has experienced a significant increase in its share price recently, raising questions about the sustainability of this rally and the potential for profit-taking [2]. - The investing group, The Biotech Forum, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat discussions and weekly research updates [2].
Corvus Pharmaceuticals(CRVS) - 2024 Q3 - Earnings Call Transcript
2024-11-13 05:02
Financial Data and Key Metrics Changes - Research and development expenses increased to $5.2 million in Q3 2024 from $4 million in Q3 2023, primarily due to higher clinical trial expenses for soquelitinib [7] - The net loss for Q3 2024 was $40.2 million, significantly higher than the net loss of $6 million in Q3 2023, which included a noncash loss from Angel Pharmaceuticals [7] - Cash, cash equivalents, and marketable securities totaled $41.7 million as of September 30, 2024, compared to $27.1 million at the end of 2023 [8] - The company anticipates that its cash runway extends into 2026, aided by the early exercise of common stock warrants [9] Business Line Data and Key Metrics Changes - Soquelitinib is advancing in multiple clinical trials, including a Phase III trial for peripheral T-cell lymphoma (PTCL) and a Phase I trial for atopic dermatitis [10][19] - The Phase I trial for atopic dermatitis is designed to enroll 64 patients, with the first cohort already completed and the second cohort currently enrolling [12][14] - The objective response rate for the Phase III PTCL trial remains at 39%, with a median progression-free survival (PFS) of 6.2 months [22] Market Data and Key Metrics Changes - The FDA has granted orphan drug designation and Fast Track designation for soquelitinib for the treatment of relapsed T-cell lymphoma [19] - The company is enrolling patients at multiple clinical sites for the PTCL trial, aiming for 40 to 50 centers across the U.S., Australia, Canada, and South Korea [20] Company Strategy and Development Direction - The company is focusing on advancing soquelitinib for both oncology and autoimmune diseases, with plans to initiate a solid tumor trial in early 2025 [23][28] - There is a strong emphasis on the potential of soquelitinib in treating a broad range of immune diseases and cancers, supported by preclinical data [18] - The company is also developing second- and third-generation ITK inhibitors targeting various immunology indications, including asthma and inflammatory bowel disease [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress of the atopic dermatitis trial and the potential advantages of soquelitinib, including its oral administration and safety profile [18] - The company plans to present complete data from the atopic dermatitis trial in December and anticipates further data in early 2025 [28] - Management highlighted the importance of the upcoming clinical milestones and the potential for ITK inhibition in immunology and cancer [29] Other Important Information - The company is actively monitoring patients in ongoing trials and has reported sustained responses in several patients [21] - The mechanism of action of soquelitinib is believed to induce an immune response that can handle a broad spectrum of tumors, potentially reducing the emergence of resistance [46] Q&A Session Summary Question: Can you comment on the kinetics of ITK inhibition on clinical scores in atopic dermatitis? - Management noted that improvements are observed within the first week, with expectations for durable effects based on the drug's mechanism of action [32] Question: What is the follow-up time period for the cohorts in the atopic dermatitis trial? - Management confirmed that 28-day data will be reported in December, with complete follow-up for Cohort 1 and partial follow-up for Cohort 2 [36] Question: What is the typical prior therapy for patients enrolled in the atopic dermatitis trial? - Most patients have failed topical therapies, with some not having failed systemic therapies yet [42] Question: How does the company plan to differentiate dosing between oncology and autoimmune diseases? - Management indicated that continuous treatment may not be necessary for atopic dermatitis, unlike cancer treatments [52] Question: What are the criteria for success in the Phase III PTCL trial? - The statistical plan aims for a 1.5-month improvement in PFS over the control arm, with a hazard ratio of about 0.56 [61]
Corvus Pharmaceuticals(CRVS) - 2024 Q3 - Quarterly Report
2024-11-12 21:03
Product Candidates - The lead product candidate, soquelitinib, is currently in a registrational Phase 3 clinical trial for relapsed T cell lymphomas and a Phase 1 trial for atopic dermatitis [107]. - Interim data from the Phase 1/1b trial of soquelitinib showed an objective response rate (ORR) of 39% among 23 evaluable patients, with 6 complete responses (CRs) and 3 partial responses (PRs) [110]. - The optimal dose for soquelitinib was determined to be 200 mg taken twice daily, based on anti-tumor efficacy and pharmacodynamic data [110]. - A new Phase 3 clinical trial for soquelitinib in relapsed peripheral T cell lymphoma (PTCL) has been initiated, aiming to enroll 150 patients who have received at least one prior therapy [110]. - The second product candidate, ciforadenant, is being evaluated in a Phase 1b/2 trial for metastatic renal cell carcinoma (RCC) in combination with ipilimumab and nivolumab, with 46 patients enrolled as of September 30, 2024 [112]. - The efficacy endpoint for the ciforadenant trial is a deep response rate of over 50% tumor volume reduction, exceeding the 32% rate seen in previous combination trials [112]. - The third product candidate, mupadolimab, is designed to enhance immune responses and is awaiting initiation of a potential Phase 2 trial [113]. - Soquelitinib has received Fast Track designation from the FDA for the treatment of adult patients with relapsed or refractory PTCL after at least two lines of systemic therapy [110]. - The company continues to advance next-generation ITK inhibitor candidates aimed at optimizing T-cell modulation for specific immunology indications [111]. Financial Performance - As of September 30, 2024, the company reported a net loss of $40.2 million for the three months and $50.2 million for the nine months, with an accumulated deficit of $384.9 million [116]. - The company has not generated any revenue from product sales to date and expects to continue incurring significant research and development expenses [122]. - Research and development expenses for the three months ended September 30, 2024, were $5.2 million, an increase of $1.3 million compared to the same period in 2023 [130]. - The total operating expenses for the three months ended September 30, 2024, were $7.3 million, compared to $5.6 million for the same period in 2023 [129]. - For the nine months ended September 30, 2024, mupadolimab costs decreased by $0.6 million, primarily due to a $0.4 million reduction in clinical trial expenses and a $0.3 million decrease in manufacturing costs [135]. - For the nine months ended September 30, 2024, unallocated costs increased by $0.4 million, mainly driven by a $0.5 million rise in personnel and related costs [137]. - General and administrative expenses increased by $0.8 million for the nine months ended September 30, 2024, with $0.6 million attributed to personnel and related costs [139]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $41.7 million, up from $27.1 million as of December 31, 2023 [144]. - During the nine months ended September 30, 2024, cash used in operating activities was $17.0 million, resulting from a net loss of $50.2 million [153]. - Cash flows from investing activities for the nine months ended September 30, 2024, showed a net outflow of $21.4 million, primarily due to $49.8 million in marketable securities purchases [156]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $30.4 million, mainly from the issuance of common stock and warrants [158]. - The accumulated deficit as of September 30, 2024, was $384.9 million, compared to $334.7 million as of December 31, 2023 [144]. - The change in fair value of warrant liabilities increased by $32.8 million for the three months ended September 30, 2024, due to a rise in the market price of the company's common stock [140]. - The company expects to continue incurring net operating losses for at least the next several years as it advances its product candidates through clinical development [147]. Research and Development Strategy - The company plans to increase research and development expenses substantially to support ongoing clinical trials for its product candidates [124]. - The company has a 49.7% equity interest in Angel Pharmaceuticals, which was launched with a post-money valuation of approximately $106.0 million [115]. - The company has no manufacturing capabilities and relies on third parties for the supply of its product candidates [121]. - The company anticipates needing additional financing to support its operations and may face challenges in raising capital due to market volatility [120]. - As of September 30, 2024, the company had capital resources of approximately $41.7 million, which is expected to be sufficient to fund operations through 2026 [121].
Corvus Pharmaceuticals(CRVS) - 2024 Q3 - Quarterly Results
2024-11-12 21:02
EXHIBIT 99.1 Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2024 Financial Results Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Enrolling Patients in Second Dosing Cohort Interim Data from Atopic Dermatitis Trial Expected to be Announced December 2024 Registration Phase 3 Clinical Trial of Soquelitinib in Peripheral T Cell Lymphoma (PTCL) Enrolling with Multiple Clinical Sites Open Conference call today at 4:30 p.m. ET / 1:30 p.m. PT BURLINGAME, Calif., Nov. 12, 2024 (GLO ...
Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-11-12 21:01
Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Enrolling Patients in Second Dosing Cohort Interim Data from Atopic Dermatitis Trial Expected to be Announced December 2024 Registration Phase 3 Clinical Trial of Soquelitinib in Peripheral T Cell Lymphoma (PTCL) Enrolling with Multiple Clinical Sites Open Conference call today at 4:30 p.m. ET / 1:30 p.m. PT BURLINGAME, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharm ...