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Corvus Pharmaceuticals Initiates Clinical Trial of Novel Immunotherapy for Patients with COVID-19

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
llea@corvuspharma.com

MEDIA CONTACT:
Sheryl Seapy
W2O pure
+1 213-262-9390
sseapy@purecommunications.com

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