Corvus Hosting R&D Symposium on November 12 to Highlight COVID-19 Program and Updated Study Data Presented at SITC Annual Meeting
Data shows CPI-006 provided enhanced and prolonged polyclonal humoral immunity to SARS-CoV-2
Plans to initiate pivotal, randomized, double blind trial in December with results expected mid-2021
Tullia C. Bruno, PhD, Assistant Professor, Department of Immunologyat UPMC Hillman Cancer Center. Dr. Brunowill provide an overview of B cell biology and antibodies. Gerard J. Criner, M.D., Chair and Professor, lead investigator of the CPI-006 COVID-19 Phase 1 study, and Chair and Professor, Thoracic Medicine and Surgery at the Lewis Katz School of Medicineat Temple University. Dr. Crinerwill provide an overview of current COVID-19 therapies.
Members of the Corvus team will provide an overview of the preclinical biology and data on CPI-006, plans for the CPI-006 pivotal study for patients with COVID-19, and a general pipeline update covering the Company’s cancer programs. The speakers will be available for questions and answers during the program.
Corvus’ COVID-19 program includes its fully enrolled Phase 1 study investigating the potential for CPI-006 to provide a novel immunotherapy approach for hospitalized patients with COVID-19. This novel immunotherapy may provide a therapeutic benefit from the activation of a polyclonal antibody response to the SARS-CoV-2 virus and the induction of long term immunity through active immunization. Based on the study data to-date, the Company plans to initiate a pivotal, randomized, double blind study of CPI-006 in hospitalized COVID-19 patients in December with results expected around mid-2021.
Separate from the R&D Symposium, the updated data from the CPI-006 COVID-19 Phase 1 study is being presented in a poster presentation and separate oral presentation at SITC on
The data presented at SITC include results from 22 patients enrolled in the Phase 1 study utilizing a cut-off date of
- All patients had relatively low titers of anti-SARS-CoV-2 antibodies at the time of hospitalization despite having varying durations of prior COVID-19 symptoms from 1-21 days (median 5 days); all patients had a confirmed COVID-19 diagnosis by positive PCR nasal swab testing.
- All evaluable patients had prompt anti-SARS-CoV-2 antibody responses within 7 days of administration of CPI-006 at all dose levels.
- All patients recovered and were discharged from the hospital at a median of 4 (range 2-23) days.
- As of the
November 4, 2020cut-off date, there were no drug-related toxicity or safety issues reported.
The results presented at SITC build on the initial data from the first two cohorts (0.3 mg and 1.0 mg doses) of the study that was published online at medRxiv.org in
Background Information on CPI-006 for the Treatment of COVID-19
Corvus is studying an immunostimulatory humanized monoclonal antibody, designated as CPI-006, which the Company believes 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, and increased levels of both memory CD4+ and CD8+ cells, which are the cells responsible for long-term immunity. The similar production of antibodies and memory cells to pathogens such as SARS-CoV-2 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. The study design is evaluating CPI-006 monotherapy and in combination with ciforadenant and combination with pembrolizumab. Another cohort of the study is evaluating the triplet of CPI-006, ciforadenant and pembrolizumab. As of the
R&D Symposium Conference Call, Webcast and Presentation Slides
The R&D Symposium 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 13712583. 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
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 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.
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.
Adenosine Gene Signature
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.
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 1/1b clinical trial of CPI-006 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 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
Chief Financial Officer
Source: Corvus Pharmaceuticals, Inc.