On Jul. 7, 2020, Corvus Pharmaceuticals 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 FDA’s 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.