COVID-19 Drug Research Roundup
In a 20-person phase 1 trial, ImmunityBio’s and NantKwest’s hAd5-COVID-19 vaccine candidate was associated with the generation of neutralizing antibodies and T-cell responses against both the SARS-CoV-2 spike protein and the nucleocapsid proteins surrounding the virus. While no serious adverse events were reported in the low-dose arm of the trial, safety analyses are ongoing in the high-dose cohort. The companies are currently planning to study the vaccine in late-stage trials that will enroll volunteers previously infected with SARS-CoV-2.
Johnson & Johnson (J&J) has resumed its clinical trials in Europe studying its COVID-19 vaccine Ad26.COV2.S. The company hit pause on its European trials last month to investigate an adverse event. The restarted trials are at the phase 2 stage in Germany, the Netherlands and Spain, while a phase 1/2 study has restarted in Belgium. J&J has also conducted a global phase 3 trial of 60,000 participants. The company has announced plans to conduct a separate late-stage trial that will assess a two-dose regimen of the vaccine across countries in Europe.
Minneapolis-based health system Allina Health has been chosen as one of the 261 trial sites worldwide to enroll 2,000 ethnically diverse residents of Minnesota to participate in J&J’s 60,000-patient trial of COVID-19 vaccine candidate Ad26.COV2.S.
The first patient has been treated with Israeli COVID-19 vaccine candidate BriLife in a phase 1 trial. The candidate was developed by the Israel Institute of Biological Research. Up to 25,000 doses have been supplied for the 80-person trial, which involves Jerusalem-based Sheba Medical Center and Hadassah University Medical Center. Pending early-stage findings, the vaccine will also undergo testing in a phase 3 trial with 30,000 participants.
Interim analyses of late-stage trial data from Pfizer and BioNTech show their jointly developed COVID-19 vaccine BNT162b2 is more than 90 percent effective. The phase 3 trial started July 27 and has so far enrolled more than 43,000 participants. More than 38,000 participants have received a second dose of the vaccine. The two companies are hopeful that they will have sufficient data to apply for an Emergency Use Authorization later this month.
The FDA has bestowed a Fast-Track designation to Novavax’s investigational COVID-19 vaccine NVX-CoV2373. This designation should accelerate regulatory approval to help move the candidate into phase 3 trials in the U.S. and Mexico by the end of November. Novavax has already started phase 3 trials in the UK.
A phase 3 trial studying China-based Sinovac’s COVID-19 vaccine CoronaVac has been suspended in Brazil. Brazil’s National Agency for Sanitary Surveillance (ANVISA) issued this suspension to assess a serious adverse event that occurred in the study population.
Medicago says its investigational COVID-19 vaccine produced virus-neutralizing antibodies and significant cellular immune responses following the administration of two doses in an early-stage trial. The Canadian drug developer combined its COVID-19 vaccine candidate with GlaxoSmithKline’s vaccine booster. Medicago hopes to move into mid- to late-stage trials with a lower-dose version of the candidate.
According to an interim analysis of global phase 3 trials, Russia’s Sputnik V COVID-19 vaccine was up to 92 percent effective at protecting participants from COVID-19. Findings from this analysis were announced by the country’s sovereign wealth fund. Russian Deputy Prime Minister Tatiana Golikova says Russia plans to produce 500,000 doses of Sputnik V in November. The Philippines will likely join final-stage trials for Russia’s Sputnik V COVID-19 vaccine by the end of this year. Russia’s second COVID-19 vaccine, developed by Siberia’s Vector institute, is expected to enter post-registration trials this month.
Moderna has completed gathering data for a first interim analysis of its large-scale COVID-19 vaccine trial. The company says it hopes to have an announcement on the candidate’s efficacy by the end of November. Moderna has also announced at least 53 study participants became ill with COVID-19, meaning the company can now apply for Emergency Use Authorization. The trial’s independent data and safety monitoring board will determine whether more patients in the vaccine arm or the placebo arm became ill with COVID-19. If a statistically significant proportion of patients became ill in the placebo arm, it means the vaccine is effective.
German drugmaker Curevac says its COVID-19 vaccine candidate CVnCoV can remain stable for at least three months at 41 degrees Fahrenheit (5 degrees Celsius), making it easier to distribute than some competitors’ vaccines. This storage temperature would present fewer distribution challenges than the Pfizer/BioNTech vaccine that must be kept at an ultra-cold -94 degrees Fahrenheit (-70 degrees Celsius). But Curevac is not currently among the frontrunners in the race for an approved vaccine as it is not as far along in its trials as competitors, including Pfizer, AstraZeneca, Johnson & Johnson and Moderna. The company hopes to launch a phase 3 trial by year’s end.
Interim findings from the CAN-COVID phase 3 trial show Novartis’ canakinumab did not improve the odds of survival without intubation in patients with COVID-19-induced pneumonia. Approximately 88.8 percent of patients assigned to canakinumab vs. 85.7 percent of patients assigned to placebo survived without needing mechanical ventilation. Canakinumab, which is being studied in the trial as a treatment for cytokine-release syndrome in 454 hospitalized patients with COVID-19, was not superior to standard care for reducing the trial’s key secondary endpoint of COVID-19-related mortality (4.9 percent vs. 7.2 percent). The CAN-COVID trial is ongoing and will continue to day 127. Full results from the trial are expected by early 2020.
The second group of patients with COVID-19 and respiratory distress have been treated in a phase 1 trial of Ampio Pharmaceuticals’ inhaled Ampion, an anti-inflammatory biologic. This second round of treatment begins following clearance by the study’s safety monitoring committee (SMC), which found the therapy was safe and well-tolerated in the first treatment group. The study plans to enroll up to 40 patients in the U.S., all of whom will be randomized to receive either Ampion or placebo. The first three patient groups that receive the inhaled biologic will be assessed by the SMC.
The Kutsuna Satoshi of the National Center for Global Health and Medicine in Japan says it has not observed any abnormalities in six male patients with COVID-19 who have received blood plasma from recovered COVID-19 donors. Blood plasma is being administered to these patients as part of an early-stage study and currently includes men in their 30s to 60s. Approximately 97 recovered patients have donated their blood plasma for the study. Japan does not have an approval for the emergency use of blood plasma to treat COVID-19.
AstraZeneca’s acalabrutinib did not reduce mortality or help save hospitalized patients with COVID-19 from respiratory failure compared with supportive care alone, according to findings from two phase 2 trials. This contrasts with early clinical data that suggested the Bruton’s tyrosine kinase inhibitor could reduce the hyperinflammatory immune response and diminish the severity of the novel coronavirus.
Mallinckrodt has launched a retrospective study to collect real-world data on its nitric gas inhaled therapy INOmax as a potential treatment for COVID-19 patients with respiratory problems. The company is partnering with research company Pharmerit International to gather data from 200 hospitalized coronavirus adult patients treated with INOmax from Jan. 1 to July 31. The patient data will be assessed for 30 days following their discharge. INOmax is approved in Europe for treating respiratory failure linked with pulmonary hypertension, or high blood pressure in the lungs, but has not been evaluated or approved by the FDA.