공고 • Oct 06
Corvus Pharmaceuticals, Inc. Announces Updated Data from Its Ongoing Phase 1 Study Investigating the Potential for CPI-006
Corvus Pharmaceuticals, Inc. 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 updated data includes 56-day follow-up results from the first two cohorts and initial results from the third cohort of the study. The 56-day follow-up results showed a dose-response, with higher and more prolonged titers of anti-SARS-CoV-2 antibodies in the 1.0 mg/kg cohort compared to the 0.3 mg/kg cohort. In addition, the results showed increased levels of memory B cells and memory T cells, and there have been no reports of any drug-related safety issues in any of the 15 patients treated as of September 17, 2020. To-date, the first three cohorts of the study have been enrolled and the final cohort is currently enrolling patients. A new study site, El Centro Regional Medical Center in El Centro, CA, which is affiliated with the U.C. San Diego Health Care Network and serves Imperial and Riverside counties in southern California, has also begun enrolling patients. The Company continues to anticipate that it will complete the study and report results during the fourth quarter of 2020, including a presentation of data at the Society for Immunotherapy of Cancer annual meeting in November. Based on these interim data, and assuming the remainder of the data in the study supports it, the Company plans to initiate a pivotal, randomized, double blind study in hospitalized COVID-19 patients before year-end. The open-label, Phase 1 study is expected to enroll up to 30 hospitalized 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. In the first three cohorts of the study, the median age of the patients was 63 years (range 26-76 years) and 12 of 15 patients are minorities at higher risk for COVID-19 disease complications All of the patients had comorbidities that increased their COVID-19 risk including diabetes, hypertension, obesity, chronic lung disease and/or cancer. The median duration of symptoms prior to treatment with CPI-006 was 5 days (range 1-21 days). The key highlights from these 15 patients, beyond the data already reported from the first 10 patients in the medRxiv manuscript, include:14 of 14 patients with pre-treatment serum samples available had low pre-treatment levels of anti-SARS-CoV-2 antibodies independent of the duration of their prior COVID-19 symptoms. IgG and IgM antibody titers against the SARS-CoV-2 trimeric spike and/or receptor binding domain (RBD) increased in all evaluable patients within 7 days of a single infusion of CPI-006. As previously reported, one patient did not have a pre-treatment serum sample available but had a sample collected one day after receiving CPI-006 and this sample exhibited a high titer, which continued to increase as of September 28, 2020. In 11 of 11 patients with serum samples available to be tested, the combined IgG and IgM antibody responses continued to increase out to 28 days post treatment with CPI-006 as of September 28, 2020, in-line with the prior study data. In three of three patients tested, memory B cells, and memory CD4 and CD8 T effector memory cells, increased at 28 days post-treatment, and for one of such patients, memory B cells increased from 1.8% to 7.9% of B cells at 56 days post-treatment. As of September 28, 2020, 14 of 15 patients were discharged from the hospital with clinical improvement after a median of 4.5 days. One patient remains in the hospital with improvement of symptoms. There have been no drug-related toxicity or safety issues reported. Dose-Response Observed in Cohort 1 and Cohort 2 The 28-day and 56-day anti-SARS-CoV-2 antibody data for patients receiving 0.3 mg/kg (cohort 1) and 1.0 mg/kg (cohort 2) doses showed a dose-response with higher and more prolonged titers observed in the 1.0 mg/kg cohort compared to the 0.3 mg/kg cohort. IgG and IgM titers to trimeric spike and receptor binding domain of SARS-CoV-2 were measured and compared to convalescent serum obtained from recovered COVID-19 patients. Geometric mean titers (and range) were evaluated and revealed robust response at 28 days for both cohorts with higher and more sustained levels at day 56 seen in the 1.0 mg cohort. Day 56 titers to RBD were 37,286 as compared to 144,815 in patients receiving 0.3 and 1.0 mg/kg, respectively. Sustained and high IgM titers were also observed and exhibited a similar dose-response.