CRVS Corvus Pharmaceuticals Inc.

3.48
-0.1  -3%
Previous Close 3.58
Open 3.58
52 Week Low 1.01
52 Week High 6.88
Market Cap $131,702,549
Shares 37,845,560
Float 23,319,333
Enterprise Value $94,610,672
Volume 1,737,415
Av. Daily Volume 627,831
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Upcoming Catalysts

Drug Stage Catalyst Date
CPI-006
COVID-19 (Mild to Moderate)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
CPI-818
Peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL)
Phase 1
Phase 1
Phase 1/1b data presented at ASH December 6, 2020. 2/7 responses in PTCL patients. 1/11 responses in CTCL patients.
CPI-006
COVID-19
Phase 1
Phase 1
Phase 1 completion of enrollment announced November 9, 2020.
CPI-006
Solid tumors
Phase 1b
Phase 1b
Phase 1/1b trial ongoing.
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., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced the completion of its previously announced underwritten public offering of 9,783,660 shares of its common stock, which includes 1,212,231 shares of common stock pursuant to the underwriters' partial exercise of their option to purchase additional shares of common stock, at a price to the public of $3.50 per share. All shares in the offering were sold by Corvus, with gross proceeds to Corvus of $34.2 million and net proceeds of approximately $31.8 million, after deducting underwriting discounts and commissions and estimated offering expenses.

    Cantor Fitzgerald & Co. and H.C. Wainwright…

    BURLINGAME, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced the completion of its previously announced underwritten public offering of 9,783,660 shares of its common stock, which includes 1,212,231 shares of common stock pursuant to the underwriters' partial exercise of their option to purchase additional shares of common stock, at a price to the public of $3.50 per share. All shares in the offering were sold by Corvus, with gross proceeds to Corvus of $34.2 million and net proceeds of approximately $31.8 million, after deducting underwriting discounts and commissions and estimated offering expenses.

    Cantor Fitzgerald & Co. and H.C. Wainwright & Co. are acting as joint book-running managers for the offering.

    A shelf registration statement on Form S-3 relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission on March 19, 2020. The offering of these securities is being made only by means of a prospectus forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY 10022 or by email at or H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidate is CPI-006, a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical studies. CPI-006 is being evaluated in a Phase 3 clinical trial for the treatment of hospitalized patients with COVID-19 and in a multicenter Phase 1/1b oncology clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company's second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor.

    Investor Contact:

    Leiv Lea

    Chief Financial Officer

    Corvus Pharmaceuticals, Inc.

    +1-650-900-4522

    Media Contact:

    Sheryl Seapy

    W2O pure

    +1-213-262-9390



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  2. BURLINGAME, Calif., Feb. 12, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced the pricing of an underwritten public offering of 8,571,429 shares of its common stock at a price to the public of $3.50 per share, for gross proceeds of $30.0 million before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by Corvus. All of the shares are being offered by Corvus. In addition, Corvus has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,285,714 shares of common stock at the public offering price, less underwriting discounts and commissions.

    Corvus currently expects to use the net…

    BURLINGAME, Calif., Feb. 12, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced the pricing of an underwritten public offering of 8,571,429 shares of its common stock at a price to the public of $3.50 per share, for gross proceeds of $30.0 million before deducting estimated underwriting discounts and commissions and estimated offering expenses payable by Corvus. All of the shares are being offered by Corvus. In addition, Corvus has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,285,714 shares of common stock at the public offering price, less underwriting discounts and commissions.

    Corvus currently expects to use the net proceeds from this offering to fund its Phase 3 clinical trial of CPI-006 and development of its other product candidates, with any remaining proceeds for working capital and general corporate purposes.

    The offering is expected to close on or about February 17, 2021, subject to satisfaction of customary closing conditions.

    Cantor Fitzgerald & Co. and H.C. Wainwright & Co. are acting as joint book-running managers for the offering.

    A shelf registration statement on Form S-3 relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission on March 19, 2020. The offering of these securities is being made only by means of a prospectus forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and a final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY 10022 or by email at or H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidate is CPI-006, a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical studies. CPI-006 is being evaluated in a Phase 3 clinical trial for the treatment of hospitalized patients with COVID-19 and in a multicenter Phase 1/1b oncology clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company's second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to the completion, timing and use of proceeds of the proposed public offering. 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 most recent filings with the Securities and Exchange Commission, including the preliminary prospectus supplement filed with the SEC on February 11, 2021, including documents incorporated by reference therein, which includes the Company's current and future reports filed with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 9, 2020 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on October 29, 2020. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: market conditions and satisfaction of closing conditions related to the proposed public offering; the Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; 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.

    +1-650-900-4522

    Media Contact:

    Sheryl Seapy

    W2O pure

    +1-213-262-9390



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  3. BURLINGAME, Calif., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares to be sold in the offering will be offered by Corvus. In addition, Corvus expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in the offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of…

    BURLINGAME, Calif., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares to be sold in the offering will be offered by Corvus. In addition, Corvus expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in the offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Corvus currently expects to use the net proceeds from this offering to fund its Phase 3 clinical trial of CPI-006 and development of its other product candidates, with any remaining proceeds for working capital and general corporate purposes.

    Cantor Fitzgerald & Co. and H.C. Wainwright & Co. are acting as joint book-running managers for the offering.

    A shelf registration statement on Form S-3 relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission on March 19, 2020. The offering of these securities is being made only by means of a prospectus forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on February 11, 2021 and is available on the SEC's website at www.sec.gov. A copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY 10022 or by email at or H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

    About Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidate is CPI-006, a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical studies. CPI-006 is being evaluated in a Phase 3 clinical trial for the treatment of hospitalized patients with COVID-19 and in a multicenter Phase 1/1b oncology clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company's second clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to the completion, timing and use of proceeds of the proposed public offering. 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 most recent filings with the Securities and Exchange Commission, including the preliminary prospectus supplement filed with the SEC on February 11, 2021, including documents incorporated by reference therein, which includes the Company's current and future reports filed with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 9, 2020 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on October 29, 2020. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: market conditions and satisfaction of closing conditions related to the proposed public offering; the Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; 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.

    +1-650-900-4522

    Media Contact:

    Sheryl Seapy

    W2O pure

    +1-213-262-9390



    Primary Logo

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  4. Novel immunotherapy approach designed to stimulate immune response by activating B cells to enhance polyclonal antibody production and potentially reduce hospitalization and progression to respiratory failure

    Randomized, double-blind, placebo-controlled study expected to enroll ~1,000 patients across global sites with results expected in Q4 2021

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

    BURLINGAME, Calif., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that it has initiated a Phase 3 clinical trial of CPI-006 for the treatment of hospitalized patients with COVID-19. The study is expected to enroll approximately…

    Novel immunotherapy approach designed to stimulate immune response by activating B cells to enhance polyclonal antibody production and potentially reduce hospitalization and progression to respiratory failure

    Randomized, double-blind, placebo-controlled study expected to enroll ~1,000 patients across global sites with results expected in Q4 2021

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

    BURLINGAME, Calif., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that it has initiated a Phase 3 clinical trial of CPI-006 for the treatment of hospitalized patients with COVID-19. The study is expected to enroll approximately 1,000 patients at sites in North America, Europe, South Africa and Latin America.

    "The COVID-19 pandemic has been devastating to patients and the healthcare system, and it is critical that we develop new therapies that can improve patient outcomes," said Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and Director of the Temple Lung Center and one of the lead investigators of the trial. "CPI-006 has already shown promising results in COVID-19 patients and its proposed mechanism of stimulating the immune system to specifically target the SARS-CoV-2 virus may have several potential advantages over existing therapies, including the potential to address recently emerging variants of the virus. We look forward to offering this therapy to our patients as part of the Phase 3 study."

    CPI-006 is a humanized monoclonal antibody that is designed to bind to and activate B cells that Corvus believes has the potential to provide a unique immunotherapy approach for the treatment of infectious diseases, including COVID-19. In a Phase 1 study involving 28 hospitalized, high-risk patients with moderate COVID-19 treated with CPI-006, no patients progressed to requiring mechanical ventilation and the median time to discharge from the hospital was 3.5 days. This compares favorably to published reports showing that, on average, approximately 20% of similarly affected patients will progress to requiring invasive mechanical ventilation. Patients in the study generated high titers of polyclonal antibodies against a diverse range of targets on the SARS-CoV-2 virus that were sustained over several months. They also had increased levels of circulating memory B cells, which could lead to long-term immunity.

    Serum from 2 of 2 patients treated with CPI-006 early in the pandemic (July 2020), and before variants were discovered, were tested in neutralization assays against both the UK variant and wild type receptor binding domain of SARS-CoV-2 (N501Y mutation). Day 28 post CPI-006 treatment serum showed increases in neutralization titers of 4.5 fold and 1.7 fold to the UK variant for the two patients respectively, compared to the wild type virus. These data will require further confirmation with many more additional patients, but suggest that CPI-006 elicited a broad anti-viral response that may address the problem of immune escape.

    The Phase 3 double-blind study, which was designed with guidance from the Food and Drug Administration (FDA), will evaluate the efficacy and safety of CPI-006 compared to placebo in hospitalized patients with mild-to-moderate COVID-19. Patients will be randomized in a 1:1:1 ratio to receive a single intravenous CPI-006 dose of either 2.0 mg/kg or 1.0 mg/kg or placebo; all patients will receive standard of care treatments for COVID-19. The primary endpoint is the proportion of patients progressing to respiratory failure or death during the 28 days after dosing. Respiratory failure is defined as requiring non-invasive or invasive mechanical ventilation. Additional secondary endpoints include time to recovery, time to resolution of COVID-19 symptoms, anti-viral antibody responses, etc. An interim futility and efficacy analysis will be conducted by an independent data monitoring committee when approximately 60% of subjects complete the 28-day post-treatment visit. Results from the study are expected to be available in the fourth quarter 2021.

    "The devastating nature of the pandemic and emerging understanding of this disease compels us to rapidly develop CPI-006 for the treatment of COVID-19," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "We believe CPI-006's novel mechanism of action, supported by Phase 1 results obtained to date, indicate that this agent may be well suited to combat this virus, which is now demonstrating a propensity to mutate, become more transmissible and potentially escape from current vaccination and therapeutic approaches such as the administration of passive anti-viral monoclonal antibodies. The advancement of this study is the top priority for the Company given the growth in new COVID-19 cases and could provide the foundation for its potential use in other infectious diseases. If successful and ultimately approved for treatment, we believe CPI-006 could be an important therapy if it is able to shorten recovery times and keep COVID-19 patients out of the intensive care unit and off of mechanical ventilators, while also providing durable, longer-term immunity and potential protection against re-infection."

    Corvus also announced that in collaboration with its Chinese partner, Angel Pharmaceuticals, it plans to initiate a global Phase 2 trial with CPI-818, an ITK inhibitor, in refractory peripheral T cell lymphoma by the end of 2021. The Company also announced its plans to collaborate with an academic consortium to evaluate ciforadenant, its A2A receptor antagonist, for the first line treatment of metastatic renal cell carcinoma in combination with pembrolizumab and a tyrosine kinase inhibitor.

    Conference Call, Webcast and Slide Presentation Details

    Corvus will host a conference call and webcast today, February 4, 2021, at 8:30 a.m. ET (5:30 a.m. PT), to discuss the Phase 3 CPI-006 clinical trial for COVID-19 and other topics. The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) and using the conference ID 13715838. 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 Corvus Pharmaceuticals

    Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus' lead product candidates are

    CPI-006, a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical studies, and ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor. CPI-006 is being evaluated in a Phase 3 clinical trial for the treatment of hospitalized patients with COVID-19 and in a multicenter Phase 1/1b oncology clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company's third cancer clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, 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 CPI-006

    CPI-006 is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, 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 and small molecules in development for treatment of cancer, such agents 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 an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to 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 Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and in patients with autoimmune diseases. The Company is conducting a Phase 1/1b trial in patients with refractory T-cell lymphomas.

    About Ciforadenant

    Ciforadenant (CPI-444) is an investigational 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.

    About Angel Pharmaceuticals

    Angel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with U.S.-based Corvus Pharmaceuticals and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus' three clinical-stage candidates – ciforadenant, CPI-006 and CPI-818 – in greater China and obtained global rights to Corvus' BTK inhibitor preclinical programs. Under the collaboration, Corvus initially retained a 49.7% equity stake in Angel Pharmaceuticals and designated three individuals on Angel's five-person Board of Directors.

    One of the main strategic rationales for Corvus' collaboration with Angel is to gain clinical study synergies and accelerate development timelines, whereby data from patients enrolled in China studies could potentially be used as part of U.S. regulatory submissions as part of a global pivotal study protocol. Based on the tumor responses observed in the CPI-818 Phase 1/1b clinical trial, the companies are planning to collaborate on the next clinical study for CPI-818 for the treatment of T cell lymphomas.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to the potential safety and efficacy of CPI-006, CPI-818 and ciforadenant, the Company's ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company's Phase 3 clinical trial of CPI-006 for COVID-19, the timing of the availability and announcement of clinical data and certain other product development milestones, and the sufficiency of the Company's cash resources. 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 September 30, 2020, filed with the Securities and Exchange Commission on October 29, 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, CPI-818 and ciforadenant; 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 other foreign countries; whether the FDA accepts data from trials conducted in foreign locations, including China; the unpredictability of any ongoing or future trade dispute between the United States and China; the costs of clinical trials may exceed expectations; the Company's ability to raise additional capital; 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

    +1-949-903-4750

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4418f37c-2b88-4eb5-95b4-e24383051a5e.

     



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  5. Updated interim data from CPI-818's phase 1/1b clinical trial provide evidence supporting its potential as a treatment for T cell lymphomas

    New pre-clinical data provide evidence of CPI-818 potential as a treatment for autoimmune lymphoproliferative syndrome (ALPS)

    BURLINGAME, Calif., Dec. 06, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that new data on CPI-818, the Company's ITK inhibitor, were presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, which is taking place as an all-virtual event from December 5-8, 2020. The data include a poster presentation covering updated data from the Phase 1/1b clinical trial for…

    Updated interim data from CPI-818's phase 1/1b clinical trial provide evidence supporting its potential as a treatment for T cell lymphomas

    New pre-clinical data provide evidence of CPI-818 potential as a treatment for autoimmune lymphoproliferative syndrome (ALPS)

    BURLINGAME, Calif., Dec. 06, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that new data on CPI-818, the Company's ITK inhibitor, were presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, which is taking place as an all-virtual event from December 5-8, 2020. The data include a poster presentation covering updated data from the Phase 1/1b clinical trial for T cell lymphoma and an oral presentation covering pre-clinical data demonstrating its potential for the treatment of autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease.

    "The CPI-818 data presented at ASH continue to show encouraging anti-tumor activity and also extend its potential for the treatment of auto-immune disorders," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "Our Phase 1/1b trial in T cell lymphomas has identified a dose of CPI-818 that was well tolerated, covalently inhibited ITK and demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies.  We are also excited by the pre-clinical data in ALPS, which we believe suggests that ITK inhibition may provide a treatment option for this rare genetic disease as well as other T cell mediated autoimmune disorders. We plan to continue studying CPI-818 for these indications in the coming year, including working with our partner Angel Pharmaceuticals in China, given the higher incidence of T cell lymphomas in Asia."

    CPI-818 is an investigational, orally bioavailable, covalent inhibitor of ITK designed to have low nanomolar affinity. In vitro studies have shown that it potently inhibited T cell receptor signal transduction. The CPI-818 presentations at ASH are outlined below and can be found on the Corvus website on the publications and presentations page.

    CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, Is Well-Tolerated and Active in Patients with T-Cell Lymphoma (Abstract #2068)

    CPI-818 is currently being studied in a Phase 1/1b clinical trial that was designed to select the optimal dose of CPI-818 and evaluate its safety, pharmacokinetics (PK), target occupancy, biomarkers and efficacy. The study employed an adaptive, expansion cohort design, with an initial phase that evaluated escalating doses (100, 200, 400, 600 mg taken twice a day) in successive cohorts of patients, followed by a second phase that is designed to evaluate safety and tumor response to the recommended dose of CPI-818 in disease-specific patient cohorts. By protocol design, treatment is discontinued after one year or upon disease progression. The study enrolled 25 patients from the United States, Australia and South Korea with several types of advanced, refractory T cell lymphomas, including nine patients with peripheral T-cell lymphoma (PTCL), 12 patients with cutaneous T-cell lymphoma (CTCL), four patients with other T-cell lymphomas. All patients had failed multiple prior therapies.

    The poster highlighting updated data from the Phase 1/1b study was presented on Sunday, Dec. 6 by Michael S. Khodadoust, MD, PhD, Division of Medical Oncology, Stanford University School of Medicine. Key highlights from the presentation include:

    • Of the seven evaluable patients with PTCL, there have been two objective tumor responses as of the cut-off date of October 5, 2020 (the "Cut-Off Date"):
      • One patient, who previously failed chemotherapy and high dose chemotherapy with autologous bone marrow transplantation, achieved a complete response (CR) with CPI-818 at month 8 that remained ongoing after 12 months on study. The patient received CPI-818 for 12 months and the CR persisted beyond discontinuation of therapy (per the study protocol, the patient stopped receiving therapy after 12 months on study). As of December 1, 2020, this patient was off all therapy for lymphoma and remains disease free at 14+ months.
      • One patient who failed multiple prior therapies achieved a partial response at four months on therapy and remained on study as of the Cut-Off Date.



    • Of the 11 evaluable patients with CTCL:

      • One patient achieved a complete response in lymph node disease and continued to have stable cutaneous disease at more than 12 months on therapy as of November 2, 2020.
      • Three patients achieved stable disease on therapy for between 3 and 5 months..



    • There was a dose dependent increase in receptor occupancy, with trough occupancy >75% observed at the 200, 400 and 600 mg doses.



    • No dose limiting toxicities and no grade 3 or 4 treatment related adverse events were observed as of the Cut-Off Date.

    The ITK Inhibitor CPI-818 Blocks Activation of T Cells from Autoimmune Lymphoproliferative Syndrome (ALPS) Patients and Is Active in a Murine Model of ALPS (Abstract #95)

    ALPS is a rare genetic disease affecting children that manifests with lymphadenopathy, splenomegaly, cytopenias (low blood counts) and autoimmunity. The disease is caused by a mutation in the Fas gene, which provides instructions for making a signaling protein involved in the induction of apoptosis. The mutation results in immune dysregulation due to abnormally high levels of "double negative" T cells (CD4 and CD8 double negative), which infiltrate the blood, spleen and lymphoid tissues. A similar mutation occurs in Fas-deficient MRL/lpr mice, which are used as a model for this disease. These mice are frequently also used as a model for autoimmune disease.

    The oral presentation was delivered on Saturday, Dec. 5 by V. Koneti Rao, MD, FRCPA, ALPS Unit, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health (NIH). Key highlights from the presentation include:

    • ITK was expressed in double negative T cells from ALPS patients.



    • In vitro, CPI-818 inhibited the activation of stimulated abnormal double negative T cells in ALPS patients.



    • In vivo studies in MRL/lpr mice demonstrated that treatment with CPI-818 reduced lymphadenopathy, splenomegaly, and autoimmune skin and kidney disease.



    • The pre-clinical data support the evaluation of CPI-818 in ALPS patients.

    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 has exhibited immunomodulatory activity and activation of immune cells in preclinical studies. 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, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, 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 CPI-818

    CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to 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 Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and in patients with autoimmune diseases. The Company is conducting a Phase 1 dose escalation trial in patients with refractory T-cell lymphomas.

    Angel Pharmaceuticals

    Angel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with U.S.-based Corvus Pharmaceuticals and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus' three clinical-stage candidates – ciforadenant, CPI-006 and CPI-818 – in greater China and obtained global rights to Corvus' BTK inhibitor preclinical programs. Under the collaboration, Corvus initially retained a 49.7% equity stake in Angel Pharmaceuticals and designated three individuals on Angel's five-person Board of Directors.

    One of the main strategic rationales for Corvus' collaboration with Angel is to gain clinical study synergies and accelerate development timelines, whereby data from patients enrolled in China studies could potentially be used as part of U.S. regulatory submissions as part of a global pivotal study protocol. Based on the tumor responses observed in the CPI-818 Phase 1/1b clinical trial, the companies are planning to collaborate on the next clinical study for CPI-818 for the treatment of T cell lymphomas.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to the potential safety and efficacy of 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 1/1b clinical trial of CPI-818 for certain cancers, the timing of the availability and announcement of clinical data and certain other product development milestones, and the sufficiency of the Company's cash resources. 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 September 30, 2020, filed with the Securities and Exchange Commission on October 29, 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 results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; whether the FDA accepts data from trials conducted in foreign locations, including China; the unpredictability of any ongoing or future trade dispute between the United States and China; the costs of clinical trials may exceed expectations; the Company's ability to raise additional capital; 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

    +1-949-903-4750



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