CRVS Corvus Pharmaceuticals Inc.

4.02
+0.34  (+9%)
Previous Close 3.68
Open 3.76
52 Week Low 1.01
52 Week High 6.88
Market Cap $112,703,647
Shares 28,035,733
Float 27,773,311
Enterprise Value $52,841,358
Volume 389,917
Av. Daily Volume 2,586,447
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Upcoming Catalysts

Drug Stage Catalyst Date
CPI-006
Solid tumors
Phase 1b
Phase 1b
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CPI-818 (ASH)
Peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL)
Phase 1
Phase 1
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CPI-006
COVID-19
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
CPI-444
Solid tumors - cancer
Phase 1b
Phase 1b
Phase 1b/2 initial data from the RCC cohort at ASCO May 29, 2020. AdenoSig positive group -ORR of 17%. AdenoSig negative group - no partial responses.

Latest News

  1. BURLINGAME, Calif., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that it will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference. The presentation will be on Tuesday, August 11 from 2:55-3:25pm ET.

    A webcast of the presentation will be available live and for 90 days following the event. The webcast may be accessed via the investor relations section of the Corvus website.

    About Corvus Pharmaceuticals
    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against…

    BURLINGAME, Calif., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that it will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference. The presentation will be on Tuesday, August 11 from 2:55-3:25pm ET.

    A webcast of the presentation will be available live and for 90 days following the event. The webcast may be accessed via the investor relations section of the Corvus website.

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and activation of immune cells. These product candidates are being studied in ongoing Phase 1b/2 and Phase 1/1b clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort Phase 1b/2 trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company's third cancer clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. The Company is also evaluating CPI-006 as a treatment for COVID-19 patients.  For more information, visit www.corvuspharma.com.

    INVESTOR CONTACT:

    Leiv Lea

    Chief Financial Officer

    Corvus Pharmaceuticals, Inc.

    650-900-4522

     

    MEDIA CONTACT:

    Sheryl Seapy

    W2O pure

    +1 213-262-9390

     

    Primary Logo

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  2. Provides Update on CPI-006 Phase 1 COVID-19 Study

    Conference Call Today at 4:30 p.m. ET / 1:30 p.m. PT

    BURLINGAME, Calif., July 30, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today provided a business update and announced financial results for the second quarter ended June 30, 2020.

    "In the second quarter, we advanced each of our three clinical oncology programs, highlighted by the presentation of new data at ASCO on the identification of a refined biomarker that enriches for responding patients with renal cell cancer treated with our lead candidate, ciforadenant," said Richard A. Miller, M.D.,  president and chief executive officer of Corvus. "Based on this data…

    Provides Update on CPI-006 Phase 1 COVID-19 Study

    Conference Call Today at 4:30 p.m. ET / 1:30 p.m. PT

    BURLINGAME, Calif., July 30, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today provided a business update and announced financial results for the second quarter ended June 30, 2020.

    "In the second quarter, we advanced each of our three clinical oncology programs, highlighted by the presentation of new data at ASCO on the identification of a refined biomarker that enriches for responding patients with renal cell cancer treated with our lead candidate, ciforadenant," said Richard A. Miller, M.D.,  president and chief executive officer of Corvus. "Based on this data, we are planning to meet with the U.S. Food & Drug Administration (FDA) to discuss the initiation of a pivotal study of ciforadenant in renal cell cancer. For CPI-006 and CPI-818, we have largely completed enrollment in the current portions of their Phase 1/1b studies and expect to report updated results at medical meetings later this year."  

    "We also added a fourth program utilizing our novel immunomodulatory antibody CPI-006 for treatment of patients with mild-to-moderate COVID-19. Our unique approach is based on the ability of CPI-006 to activate B cells, leading to the production of anti-SARS-CoV-2 IgM and IgG antibodies and memory B cells, which has the potential to shorten recovery time and improve long-term protective immunity. The study is advancing on track with the first cohort of five patients fully enrolled and four of five patients now enrolled in the second cohort.  We expect to report anti-SARS-CoV-2 antibody and memory B cell results from our study later this year."

    Recent Achievements

    Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine

    • Presented updated data from the Phase 1b/2 clinical trial of ciforadenant in patients with refractory renal cell carcinoma (RCC) at the ASCO20 Virtual Scientific Program. The data covered 51 patients and showed an objective response rate (ORR) of 17% by RECIST criteria in Adenosine Gene Signature positive patients (n=31) and 0% ORR in the Adenosine Gene Signature negative group (n=20).  The ORR improved to 27% with a refined version of the test, which is based on the measurement of CD68 positive myeloid cells, the downstream target of adenosine.

    CPI-006: Anti-CD73 Antibody with Immunomodulatory Activity

    • Initiated an open-label, Phase 1 study of CPI-006 in COVID-19 patients with mild to moderate symptoms. Patients will receive a single dose of CPI-006, with levels of 0.3, 1.0, 3.0 and 5.0 mg/kg, escalating in four cohorts as the study progresses. Patients will receive medications, therapies, and interventions per standard treatment protocols for COVID-19 for the duration of the study. The primary efficacy endpoint is the change in serum immunoglobulin (IgM and IgG) anti-SARS-CoV-2 levels compared to baseline at day 28. The study will also examine safety and effects on anti-viral memory B cells and other clinical endpoints, including time to resolution of symptoms and duration of hospitalization.

       
    • COVID-19 Study Update:  Since the announcement of the study and enrollment of the first cohort of five patients in early July, four of five patients in the second cohort have been enrolled in the study. As of the cutoff date of July 30, 2020, no dose limiting toxicities had been noted and early anti-SARS-CoV-2 antibody response data was encouraging with relatively high titers of IgG and IgM to both spike and receptor binding domain (RBD) viral proteins observed. In the first two patients receiving the lowest dose of CPI-006 and tested at an early Day 7 time point, IgG titers to spike protein were > 1:25,000 and > 1:50,000.   One of these patients has also completed Day 14 testing, which showed the titers to viral spike protein and RBD had increased to > 1:100,000.  Significant levels of IgM antibodies were also detected. The Company remains on track to report 28-day follow up results from the Phase 1 study later this year.



    • Completed enrollment in three dose escalation arms of the CPI-006 Phase 1/1b cancer clinical trial: monotherapy, combination with ciforadenant and combination with pembrolizumab and we continue to enroll the triplet combination dose escalation arm with ciforadenant and pembrolizumab. Updated clinical data from the Phase 1/1b oncology clinical trial is targeted to be presented later this year. 

    CPI-818: A small molecule ITK inhibitor

    • Completed enrollment in the dose escalation portion (N=16) of the CPI-818 Phase 1/1b clinical trial, which included patients with several types of advanced, refractory T-cell lymphomas. Based on results from this portion of the study, including a confirmed complete response in one patient with peripheral T-cell lymphoma (PTCL) who previously failed chemotherapy and high dose chemotherapy with autologous bone marrow transplantation, the Company selected the CPI-818 optimum dose and began the next portion of the study with a focus on patients with PTCL and cutaneous T-cell lymphoma (CTCL).

    Anticipated Future Events

    • Data from the Phase 1 trial of CPI-006 used to treat COVID-19 patients later this year.

       
    • The Company plans to meet with the FDA to discuss the study design and plans for a ciforadenant pivotal study in advanced refractory RCC using the Adenosine Gene Signature as a biomarker.

       
    • Updated clinical data from the CPI-006 Phase 1/1b oncology clinical trial is planned to be presented later this year.

       
    • Updated clinical data from the CPI-818 Phase 1/1b clinical trial is planned to be presented at the American Society of Hematology (ASH) annual meeting in December 2020.

    Financial Results

    At June 30, 2020, Corvus had cash, cash equivalents and marketable securities totaling $59.3 million, as compared to cash, cash equivalents and marketable securities of $78.0 million at December 31, 2019.  Corvus expects net cash used in operating activities for the second half of 2020 to be between $12 million and $14 million resulting in a cash balance of between $47 million and $45 million at December 31, 2020.

    Research and development expenses for the three months ended June 30, 2020 totaled $7.9 million compared to $10.6 million for the same period in 2019. The decrease of $2.7 million was primarily due to a $0.5 million decrease in ciforadenant clinical trial expenses, a $1.7 million decrease in CPI-006 drug manufacturing costs, a $0.5 million decrease in CPI-818 drug manufacturing costs and a $0.8 million decrease in outside service costs, partially offset by a $1.1 million increase in CPI-006 clinical trial expenses. 

    The net loss for the three months ended June 30, 2020 was $10.6 million, compared to a net loss of $13.0 million for the same period in 2019. Total stock compensation expense for the three months ended June 30, 2020 was $1.4 million compared to $1.9 million of total stock compensation expense for the same period in 2019.

    Conference Call Details

    Corvus will host a conference call and webcast today, Thursday, July 30, 2020, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2020 financial results. The conference call can be accessed by dialing 1-855-327-6837 (toll-free domestic) or 1-631-891-4304 (international) and using the conference ID 10010533. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus' website for 90 days.

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and activation of immune cells. These product candidates are being studied in ongoing Phase 1b/2 and Phase 1/1b clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort Phase 1b/2 trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company's third cancer clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. The Company is also evaluating CPI-006 as a treatment for COVID-19 patients.  For more information, visit www.corvuspharma.com.

    About Ciforadenant

    Ciforadenant (CPI-444) is a small molecule, oral, checkpoint inhibitor designed to disable a tumor's ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine.

    Adenosine Gene Signature and CD68+ Myeloid Cells

    The adenosine gene signature is a biomarker that reflects adenosine induced immunosuppression in the tumor.  These genes express chemokines that recruit myeloid cells including immunosuppressive tumor associated CD68+ myeloid cells, which are thought to mediate resistance to anti-PD-(L)1 treatment. To date, in our clinical trial of renal cell cancer, this biomarker has been associated with a higher rate of response to ciforadenant. CD68+ cells can be enumerated using standard immunohistochemical techniques that are routinely available in pathology laboratories. 

    About CPI-006

    CPI-006 is a potent humanized monoclonal antibody that reacts with a specific site on CD73. It has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies in development for treatment of cancer, such antibodies have been reported to react with a different region of CD73 and are designed to block production of adenosine, which is not involved in the immunomodulatory processes seen with CPI-006.  

    About CPI-818

    CPI-818 is a small molecule drug given orally that has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase). It was developed to possess dual properties: to block malignant T-cell growth and modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas – similar to the role of Bruton's tyrosine kinase (BTK) in B-cells. 

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to the potential safety and efficacy of ciforadenant, CPI-006, and CPI-818, the Company's ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company's Phase 1b/2 clinical trial of ciforadenant, the Company's Phase 1/1b clinical trial of CPI-006,  the Company's Phase 1/1b clinical trial of CPI-818, in each case, for certain cancers, as well as the Company's Phase 1 trial of CPI-006 for COVID-19, the timing of the availability and announcement of clinical data, the suitability of dosing regimen selected for clinical trials, and the impact of COVID-19 and related "shelter in place" orders and other public health guidance measures on our clinical programs and business operations, and the expected cash needs and operating expenses for the second half of 2020. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as "believe," "expect," "anticipate," "intend," "plan," "estimate," "seek," "will," "may" or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the Securities and Exchange Commission on July 30, 2020, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ciforadenant, CPI-006 and CPI-818; the accuracy of the Company's estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the Company's ability to utilize biomarker data and select a suitable dosing regimen; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; the Company's ability to raise additional capital; and the effects of COVID-19 on the Company's clinical programs and business operations. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    INVESTOR CONTACT:

    Leiv Lea

    Chief Financial Officer

    Corvus Pharmaceuticals, Inc.

    +1-650-900-4522

    ll

    MEDIA CONTACT:

    Zack Kubow

    W2O pure

    +1 917-623-1995





    CORVUS PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except share and per share data)

    (unaudited)

     Three Months Ended June 30, Six Months Ended June 30, 
      2020   2019   2020   2019  
    Operating expenses:        
    Research and development$7,857  $10,640  $18,020  $20,059  
    General and administrative 2,910   2,956   6,016   5,842  
    Total operating expenses 10,767   13,596   24,036   25,901  
    Loss from operations (10,767)  (13,596)  (24,036)  (25,901) 
    Interest income and other expense, net 156   618   490   1,280  
    Net loss$(10,611) $(12,978) $(23,546) $(24,621) 
    Net loss per share, basic and diluted$(0.36) $(0.44) $(0.80) $(0.84) 
    Shares used to compute net loss per share, basic and diluted 29,428,249   29,309,150   29,419,741   29,301,505  
             
             



    CORVUS PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

      June 30, December 31,
       2020   2019 
    Assets    
    Cash, cash equivalents and marketable securities $59,258  $77,982 
    Operating lease right-of-use asset  1,996   2,327 
    Other assets  2,923   3,337 
    Total assets $64,177  $83,646 
    Liabilities and stockholders' equity    
    Accounts payable and accrued liabilities and other liabilities $10,577  $9,347 
    Operating lease liability  2,760   3,188 
    Stockholders' equity  50,840   71,111 
    Total liabilities and stockholders' equity $64,177  $83,646 

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  3. BURLINGAME, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and webcast on July 30, 2020 at 4:30 pm ET (1:30 pm PT) to provide a business update and report second quarter 2020 financial results. 

    The conference call can be accessed by dialing 1-855-327-6837 (toll-free domestic) or 1-631-891-4304 (international) and using the conference ID 10010533. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus' website for 90 days.

    About Corvus Pharmaceuticals
    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical…

    BURLINGAME, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and webcast on July 30, 2020 at 4:30 pm ET (1:30 pm PT) to provide a business update and report second quarter 2020 financial results. 

    The conference call can be accessed by dialing 1-855-327-6837 (toll-free domestic) or 1-631-891-4304 (international) and using the conference ID 10010533. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus' website for 90 days.

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and activation of immune cells. These product candidates are being studied in ongoing Phase 1b/2 and Phase 1/1b clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort Phase 1b/2 trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company's third cancer clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. The Company is also evaluating CPI-006 as a treatment for COVID-19 patients.  For more information, visit www.corvuspharma.com.

    INVESTOR CONTACT:

    Leiv Lea

    Chief Financial Officer

    Corvus Pharmaceuticals, Inc.

    650-900-4522



    MEDIA CONTACT:

    Sheryl Seapy

    W2O pure

    +1 213-262-9390

    Primary Logo

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  4. Approach stimulates immune response by activating B cells to enhance antibody production

    Safety and scientific basis supported by ongoing cancer clinical trial

    Study designed to evaluate anti-viral antibody response in up to 30 COVID-19 patients with mild to moderate symptoms

    Company to host conference call and webcast today at 8:30 a.m. ET / 5:30 a.m. PT

    BURLINGAME, Calif., July 07, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that it has initiated a Phase 1 study to investigate a novel immunotherapy approach for patients with COVID-19. The first cohort of five patients enrolled in the study was treated at Temple University Hospital in Philadelphia, PA…

    Approach stimulates immune response by activating B cells to enhance antibody production

    Safety and scientific basis supported by ongoing cancer clinical trial

    Study designed to evaluate anti-viral antibody response in up to 30 COVID-19 patients with mild to moderate symptoms

    Company to host conference call and webcast today at 8:30 a.m. ET / 5:30 a.m. PT

    BURLINGAME, Calif., July 07, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that it has initiated a Phase 1 study to investigate a novel immunotherapy approach for patients with COVID-19. The first cohort of five patients enrolled in the study was treated at Temple University Hospital in Philadelphia, PA. The study is expected to enroll up to 30 patients at several sites in the United States. This follows the U.S. Food and Drug Administration's (FDA) review and acceptance of the Company's investigational new drug (IND) application for the COVID-19 study.

    Corvus is studying an agonistic (immunostimulatory) humanized monoclonal antibody, designated as CPI-006, which has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer. In both in vitro and in vivo studies in cancer patients, CPI-006 has demonstrated binding to various immune cells and the inducement of a humoral adaptive immune response – B cell activation and lymphocyte trafficking leading to the production of antigen-specific immunoglobulin (IgM and IgG) antibodies. Administration of CPI-006 has also led to increased levels of memory B cells, which are the cells responsible for long-term immunity. The similar production of antibodies and memory cells to pathogens such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, may provide immediate and long-term clinical benefits for patients including shortened recovery time and improved long-term protective immunity.

    To date, over 90 cancer patients have been treated with CPI-006 in the Corvus Phase 1/1b study, with dosing as high as 24 mg/kg every three weeks. CPI-006 has been well tolerated in these patients and evidence of B-cell activation and lymphocyte trafficking was observed in patients that received single doses as low as 1 mg/kg. Corvus' study showed that CPI-006 is associated with increases in memory B cells, the emergence of new B cell clones and, in some patients, the production of novel anti-tumor antibodies. These results have been previously reported in presentations at the Society of Immunotherapy of Cancer annual meeting in 2018 and 2019 and in a presentation at the American Society of Clinical Oncology annual meeting in 2019. CPI-006 was designed to bind to an epitope on an antigen known as CD73. This antigen is known to be involved in lymphocyte migration and activation. CPI-006 binds to a distinct region of CD73 and behaves as an agonist that serves as a signal to activate certain immune cells. As previously reported, binding of CPI-006 affects B cells, T cells and antigen presenting cells. The collection of observed changes are consistent with enhanced antigen recognition and induction of an adaptive immune response.

    A recently enrolled patient with advanced metastatic non-small cell lung cancer (NSCLC) was diagnosed with concomitant COVID-19 by nasal swab PCR testing (polymerase chain reaction) at the time of initiating CPI-006 therapy for cancer. The patient was in a very high-risk group for potential progression of her COVID-19 including elderly, prior immunosuppressive therapies for cancer and chronic obstructive pulmonary disease as comorbidities. The patient remained asymptomatic from COVID-19 following treatment with CPI-006. Serum antibody testing demonstrated no anti-SARS-CoV-2 antibody at baseline and the development of high titers of anti-SARS-CoV-2 IgG and IgM of >1:100,000 and 1:3,200, respectively, within six weeks of treatment with CPI-006. The patient's PCR viral test converted to negative along with the rising titers of antibody. The anti-SARS-CoV-2 antibody titers seen in this patient would be considered to be high as recovered patients with serum titers of 1:320 or higher are candidates to donate blood for COVID-19 convalescent plasma therapy. Memory B cells in the blood of this patient also increased to 30% of total B cells, from 16% previously.

    "Our B cell activating monoclonal antibody may be a potential immunotherapy for COVID-19 based on its ability to stimulate the production of anti-SARS-CoV-2 antibodies," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "Our preclinical and clinical research has elucidated important biological mechanisms underlying this approach and we are eager to apply it to addressing the devastating COVID-19 pandemic. We believe that COVID-19 patients treated with CPI-006 may benefit from an improved time to recovery and building longer term immunity. This program will also help inform the potential to apply this approach in treatment of other infectious diseases, including variants of coronaviruses and as adjuvants in subjects who may respond poorly to preventative vaccination. We believe this opens an entirely new area of investigation and opportunities to both treat and prevent serious infectious diseases."

    Dr. Miller added, "This COVID-19 study broadens our pipeline as we continue to advance our core cancer programs with ciforadenant and CPI-006 addressing the adenosine cancer pathway and CPI-818 for T cell lymphomas. Our recent data for ciforadenant at ASCO further confirmed the benefit of blocking the adenosine 2A receptor and has provided the opportunity to initiate a biomarker driven pivotal trial in renal cell cancer. In addition, we remain on track to provide data updates on CPI-006 for cancer and CPI-818 at medical meetings later this year."

    About the Phase 1 Study

    The open-label, Phase 1 study is expected to enroll up to 30 COVID-19 patients with mild to moderate symptoms. Patients will receive a single dose of CPI-006, with levels of 0.3, 1.0, 3.0 and 5.0 mg/kg, escalating in four cohorts as the study progresses. Patients will receive medications, therapies, and interventions per standard treatment protocols for COVID-19 for the duration of the study. The primary efficacy endpoint is the change in serum immunoglobulin (IgM and IgG) anti-SARS-CoV-2 levels compared to baseline at day 28. The study also will examine safety and other clinical endpoints, including time to resolution of symptoms and duration of hospitalization. Data from this study should be available later this year.

    The objective of the study is to show that CPI-006 has the potential to induce the patient to produce an enhanced antibody response to SARS-CoV-2. The expected benefit for patients is the potential eradication of the virus, leading to a better clinical outcome – less severe disease, prevention of complications, and faster recovery – and the potential for long term immunity. If the study meets its objectives, Corvus intends to work with the FDA to initiate a broader, randomized study at a fixed dose of CPI-006 that could potentially be adapted into a pivotal study to support a regulatory submission for FDA approval.

    Conference Call, Webcast and Slide Presentation Details

    Corvus will host a conference call and webcast today, July 7, 2020, at 8:30 a.m. ET (5:30 a.m. PT), to discuss the CPI-006 clinical trial for COVID-19. The conference call can be accessed by dialing 1-877-423-9813 (toll-free domestic) or 1-201-689-8573 (international) and using the conference ID 13706663. The live webcast, which will include presentation slides, may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus' website for 90 days.

    About CPI-006

    CPI-006 is a potent humanized monoclonal antibody that reacts with a specific site on CD73. It has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. Other anti-CD73 antibodies are in development for treatment of cancer. Those antibodies react with a different region of CD73 and are designed to block production of adenosine, which is not involved in the immunomodulatory processes seen with CPI-006.  

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies and the utilization of novel biomarkers to enhance patient selection. Corvus' lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and activation of immune cells. These product candidates are being studied in ongoing Phase 1b/2 and Phase 1/1b clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort Phase 1b/2 trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company's third clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. For more information, visit www.corvuspharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to the potential safety and efficacy of ciforadenant, CPI-006, and CPI-818, the Company's ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company's Phase 1 clinical trial of CPI-006 for COVID-19,  and the impact of COVID-19 and related "shelter in place" orders and other public health guidance measures on the Company's clinical programs and business operations. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as "believe," "expect," "anticipate," "intend," "plan," "estimate," "seek," "will," "may" or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities and Exchange Commission on April 30, 2020, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of CPI-006; the accuracy of the Company's estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; the Company's ability to raise additional capital; and the effects of COVID-19 on the Company's clinical programs and business operations. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    INVESTOR CONTACT:

    Leiv Lea

    Chief Financial Officer

    Corvus Pharmaceuticals, Inc.

    +1-650-900-4522

    MEDIA CONTACT:

    Sheryl Seapy

    W2O pure

    +1 213-262-9390

    Primary Logo

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  5. Elucidation of CD68 as a Downstream Target of Adenosine Refines Adenosine Gene Signature into a Practical Pathology Test Provides Opportunity to Further Enrich Patient Selection for Responders

    Data Includes Additional Patients with Advanced Refractory Renal Cell Cancer, Supporting Earlier Results Published in Cancer Discovery in January

    Data Presented at the ASCO20 Virtual Scientific Program

    BURLINGAME, Calif., May 29, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies and the utilization of novel biomarkers to enhance patient selection, announced updated results from its Phase 1b/2 clinical…

    Elucidation of CD68 as a Downstream Target of Adenosine Refines Adenosine Gene Signature into a Practical Pathology Test Provides Opportunity to Further Enrich Patient Selection for Responders

    Data Includes Additional Patients with Advanced Refractory Renal Cell Cancer, Supporting Earlier Results Published in Cancer Discovery in January

    Data Presented at the ASCO20 Virtual Scientific Program

    BURLINGAME, Calif., May 29, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies and the utilization of novel biomarkers to enhance patient selection, announced updated results from its Phase 1b/2 clinical trial of ciforadenant, its adenosine A2A receptor antagonist, in patients with advanced refractory renal cell carcinoma (RCC). The new data supports and refines the utility of the Adenosine Gene Signature (AdenoSig), which was discovered by Corvus, as a predictive biomarker to identify RCC patients most likely to respond to treatment with ciforadenant. The discovery of the AdenoSig was described in a research article published in Cancer Discovery in January 2020. In the publication, for 30 patients with available tumor biopsies, AdenoSig positive patients had a 17% objective response rate (ORR) by RECIST criteria compared to 0% in AdenoSig negative patients. In the new data, which covers over 50 patients, the ORR remained 17% for the Adenosine Gene Signature and improved to 27% with the refined version of the test, which is based the measurement of CD68 positive myeloid cells, the downstream target of adenosine.

    "We are pleased that the utility of the Adenosine Gene Signature as a biomarker for ciforadenant treatment has been supported in a larger number of patients," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "Through our recent work, we refined the signature to a single, practical IHC test that can be performed in a routine pathology lab based on the enumeration of CD68 positive myeloid cells.  The underlying research that elucidated this refinement also contributed to a better understanding of the role of adenosine and its action in tumors. I am proud of the scientific achievements of our team, which has brought us closer to providing a potential novel, targeted treatment option for RCC patients."

    The updated data covers 51 RCC patients that were treated with ciforadenant monotherapy or in combination with Genentech's Tecentriq® (atezolizumab), an anti-PD-L1 antibody, and whose tumors were biopsied to test with the AdenoSig.  The data were made available today in an on-demand, electronic poster format for registered participants of the ASCO20 Virtual Scientific Program, which is taking place from May 29-31, 2020. The key updates from the presentation include:

    • 31 patients (30 evaluable) were positive for the AdenoSig and 20 patients were negative. Patients had a median of three prior therapies, including 86% that failed a prior anti PD-(L)1 therapy.
    • In the AdenoSig positive group, there were five partial responses (PR, RECIST) for an ORR of 17% and six additional patients that had tumor regression not meeting the criteria for a PR.
    • In the AdenoSig negative group, there were no PRs and no patients with tumor regression.
    • In the AdenoSig positive group, the progression free survival (PFS) curve plateaued at 23% at 40 weeks, compared to declining to 0% in the AdenoSig negative group.

    In addition, the enrollment of new patients in the study was intended to support the study and refinement of the AdenoSig. As part of this work, Corvus investigators demonstrated that CD68 positive (CD68+) myeloid cells, which are known to be myeloid derived suppressor cells, are the downstream target of adenosine present in the tumor microenvironment. Immunohistochemistry (IHC) testing showed that an increase of CD68+ myeloid cells in a tumor further enriched the AdenoSig identification of responders to treatment with ciforadenant. This work indicates that the single CD68+ IHC test could potentially be utilized to enrich patient selection for responding patients and as a substitute for the AdenoSig biomarker previously utilized by Corvus.  The key data related to CD68 presented in the poster include:

    • CD68 analysis was available for 53 patients, including 15 CD68 positive (CD68+) and 38 CD68 negative (CD68-) patients.
    • All but one patient in the study with a PR were in the CD68+ group.
    • The ORR in the CD68+ group was 26.7% (4 of 15), compared to an ORR of 2.6% (1 of 38) in the CD68- group.
    • Treatment with ciforadenant was associated with a reduction of infiltrating CD68+ cells in pre-treatment compared to on-treatment tumor biopsies (paired to individual patients), supporting the biologic effects of ciforadenant and the potential predictive utility of CD68 to identify RCC patients most likely to respond to treatment with ciforadenant.

    About Corvus Pharmaceuticals
    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies and the utilization of novel biomarkers to enhance patient selection. Corvus' lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and activation of immune cells. These product candidates are being studied in ongoing Phase 1b/2 and Phase 1/1b clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort Phase 1b/2 trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company's third clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. For more information, visit www.corvuspharma.com.

    About Ciforadenant
    Ciforadenant (CPI-444) is a small molecule, oral, checkpoint inhibitor designed to disable a tumor's ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.

    Adenosine Gene Signature and CD68+ Myeloid Cells
    The adenosine gene signature is a biomarker that reflects adenosine induced immunosuppression in the tumor.  These genes express chemokines that recruit myeloid cells including immunosuppressive tumor associated CD68+ myeloid cells, which are thought to mediate resistance to anti-PD-(L)1 treatment. To date, in our clinical trial of renal cell cancer, this biomarker has been associated with a higher rate of response to ciforadenant. CD68+ cells can be enumerated using standard immunohistochemical techniques that are routinely available in pathology laboratories. 

    Forward-Looking Statements
    This press release contains forward-looking statements, including statements related to the potential safety and efficacy of ciforadenant, the Company's ability to identify and utilize the adenosine gene signature or the CD68+ gene for purposes of its clinical trials, including the Company's Phase 1b/2 clinical trial of ciforadenant . All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as "believe," "expect," "anticipate," "intend," "plan," "estimate," "seek," "will," "may" or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities and Exchange Commission on April 30, 2020, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ciforadenant; the Company's ability to utilize biomarker data; the results of preclinical studies may not be predictive of future results; and the effects of COVID-19 on the Company's clinical programs and business operations. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    INVESTOR CONTACT:
    Leiv Lea
    Chief Financial Officer
    Corvus Pharmaceuticals, Inc.
    650-900-4522
     

    MEDIA CONTACT:
    Sheryl Seapy
    W2O pure
    +1 213-262-9390

    Primary Logo

    View Full Article Hide Full Article
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