Corvus Pharmaceuticals Provides Update on Clinical Trial of CPI-006 for Patients with COVID-19
Characterization of novel immunotherapy approach with CPI-006 and details of COVID-19 clinical trial results submitted for publication online at medRxiv.org
Patients treated in first two cohorts of Phase 1 study had low pre-treatment titers of antibodies and produced robust antibody responses within 7 days of treatment
Titers of IgG, IgM and neutralizing antibodies continually increased out to 28 days post-treatment
BURLINGAME, Calif., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced updated data from its ongoing Phase 1 study investigating the potential for CPI-006 to provide a novel immunotherapy approach for patients with COVID-19. The results demonstrated that all evaluable patients treated in the first two cohorts (0.3 and 1.0 mg dose of CPI-006) of the study produced significant titers of antibody to SARS-CoV-2 within seven days of receiving the treatment, with levels of antibody, including neutralizing antibodies, continually increasing out to 28 days. In addition, all of these patients were discharged from the hospital with clinical improvement and none experienced any drug-related safety issues. The study has completed enrollment in the third cohort (3.0 mg dose of CPI-006) of five patients, with the overall study expected to enroll up to 30 patients.
“The initial data from the first two cohorts of COVID-19 patients treated with the lowest doses of CPI-006 are very encouraging, with patients promptly achieving high titers of anti-SARS-CoV-2 antibodies despite low pre-treatment levels,” said Richard A. Miller, M.D., president and chief executive officer of Corvus. “We believe the robust antibody responses were induced by the B cell activation triggered with CPI-006 in our study and that such responses may effectively eradicate the SARS-CoV-2 virus within treated patients and provide them with prolonged immunity. These results are consistent with the known activity of CPI-006 shown in vitro and in vivo in our ongoing cancer studies where CPI-006 binding to B cells leads to their activation and differentiation into both antibody-producing plasma cells and memory B cells. We have completed enrollment in the third cohort and we plan to meet with FDA to discuss our plans for a pivotal study.”
Dr. Miller added, “CPI-006’s unique immunotherapy approach to treating COVID-19 may provide advantages over other therapies in development. Specifically compared to passively administered monoclonal antibody approaches, we believe CPI-006 could trigger B cell activation at much lower antibody dose levels and provide activity against potential new mutant variants because it works by activating the immune system to generate polyclonal anti-SARS-CoV-2 antibodies. Based on this unique mechanism, we are considering the potential for CPI-006 to be used earlier, including symptomatic outpatients and in combination with vaccination, with the hope that it could limit or eliminate the need for booster injections and produce long-term immunity.”
CPI-006 COVID-19 Phase 1 Study Update
The Company has submitted a manuscript describing the initial results from the first two cohorts (five patients receiving 0.3 mg dose and five patients receiving 1.0 mg dose) of the study for publication online at medRxiv.org. In the study, the median age of the patients was 64 years (range 28-76 years) and all the patients had comorbidities that increased their COVID-19 risk: diabetes (4), hypertension (2), obesity (7), and/or cancer (2). The median duration of symptoms prior to treatment with CPI-006 was 8 days (range 1-21 days). The key highlights from these 10 patients, include:
Background Information on CPI-006 for the Treatment of COVID-19
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.
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