Biopharma Update on the Novel Coronavirus: November 17
News information is not all-inclusive and updates are published once a week on Tuesdays.
Antibody EUA: The FDA issued a EUA for the monoclonal antibody therapy bamlanivimab for the treatment of COVID-19 in adult and pediatric patients.
Detection Kit: The FDA issued a EUA for cPass SARS-CoV-2 Neutralization Antibody Detection Kit, the first serology test authorized to detect neutralizing antibodies from recent or prior COVID-19 infection.
Coronavirus Treatment Acceleration Program (CTAP): The FDA updated the dashboard on the CTAP webpage.
- 560+ drug development programs are in the planning stages
- 370+ trials reviewed by FDA
- 5 COVID-10 treatments authorized for emergency use
- 1 treatment approved by FDA
Diagnostics Update: To-date the FDA has authorized 288 individual EUAs, which include 223 molecular tests, 58 antibody tests and 7 antigen tests.
There have been some concerns over the accuracy of COVID-19 rapid antigen tests—the clinical diagnostic tests that evaluate for active infections by testing for the presence of the virus’s antigens. This was heightened by a tweet by Tesla’s chief executive officer Elon Musk, who claimed that he was tested positive twice and tested negative twice on the same day. Please read more here.
Fluidigm announced its COVID-19 Community Connect, a program to link federal, state and local governmental entities, public health agencies, academic institutions, workforces, individuals and a network of high-complexity labs to deliver saliva-based COVID-19 testing. The company received an FDA EUA for Advantage Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test for COVID-19 in late August.
Testing Therapies, Antivirals and Vaccines
Only a week after Pfizer and BioNTech’s preliminary data readout of its COVID-19 vaccine suggested a 90% efficacy rate, Moderna reported interim efficacy data for its vaccine of 94.5%. This is particularly excellent news given the surge of the disease and the distribution difficulties surrounding the Pfizer-BioNTech effort.
BioNTech CEO Uğur Şahin is the scientist behind the first COVID-19 vaccine to get Emergency Use Authorization (EUA) approval from the U.S. Food and Drug Administration (FDA). Before last week's results, he was hopeful, but not positive, his vaccine would trigger a strong enough immune response to really target the virus and eliminate it. He’s singing a different tune now.
After yesterday’s news that Moderna reported interim efficacy data for its COVID-19 vaccine of 94.5%, only a week after Pfizer and BioNTech’s preliminary data readout of its COVID-19 vaccine suggested a 90% efficacy rate, the U.S. and western countries have the promise of two effective and reasonably safe vaccines. There are similarities between the two, and a few differences. Here’s a look.
Days after Pfizer and BioNTech announced their mRNA vaccine for COVID-19 demonstrated 90% efficacy at an interim analysis, Russia is claiming the vaccine it authorized in the fight against the novel coronavirus is 92% effective following an interim analysis of its ongoing Phase III study. Please read more here.
Eli Lilly’s antibody neutralizing antibody bamlanivimab (LY-CoV555) is the latest bright spot in the battle against COVID-19. Despite the green light from the U.S. Food and Drug Administration (FDA) as an emergency treatment, there are some questions about how effective the treatment will actually prove to be due to labeling limitations. Please read more here.
Yet another drug has failed to improve conditions for COVID-19 patients in a clinical trial. AstraZeneca reported that the CALAVI Phase II trials of Calquence (acalabrutinib) in hospitalized patients with respiratory symptoms of COVID-19 failed to meet the trials’ primary efficacy endpoint.
Researchers at Washington University School of Medicine in St. Louis published the results of a clinical trial evaluating an antidepressant, fluvoxamine, for early treatment for COVID-19. The study was published in JAMA, The Journal of the American Medical Association, and was funded by the COVID-19 Early Treatment Fund (CETF).
Synairgen announced last week that its data from the SG016 trial was published in the journal The Lancet Respiratory Medicine. The trial, which included 101 hospitalized COVID-19 patients, looked at SNG001 as a potential treatment.
Vitamin D has long been understood to be important for bone health and development, ever since mothers first began giving their children cod liver oil to prevent childhood rickets. But the “sunshine vitamin” has more to offer, and is essential to a balanced, healthy immune system. The study completed by UCM was a retrospective one that looked back over patients who had their vitamin D levels measured within one year before being tested for COVID-19 from March 3 to April 10, 2020.
Vaxart announced new data from its Hamster Challenge Study today, showing that its oral COVID-19 vaccine candidate can potentially reduce viral load and induce a significant immune response.
San Francisco-based Vir Biotechnology and its chief executive officer, George Scangos, believe it has a terrific antibody therapy against SARS-CoV-2, the virus that causes COVID-19. But while most of the world has heard of the antibodies developed by Eli Lilly and AbCellera, which received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA), and the cocktail by Regeneron Pharmaceuticals, which was used to treat President Trump (and has yet to receive a EUA), nobody’s really heard much about Vir’s therapeutic. Please read more here.
J&J announced it was initiating a second Phase III study assessing its vaccine candidate in a two-dose regimen. The company said it wants to ensure that patients who receive its vaccine receive the highest levels of protection, which prompted the latest study.
Inovio will initiate the Phase II portion of its Phase II/III study of its vaccine candidate, INO-4800. The Phase II segment of the trial is designed to evaluate safety, tolerability and immunogenicity of INO-4800 in a two-dose regimen.
RedHill Biopharma’s RHB-107 (upamostat) was approved for a Phase II/III trial in patients with symptomatic COVID-19 who do not require hospitalization. RHB-107 is a first-in-class, oral inhibitor of several serine proteases, and has demonstrated antiviral and possible tissue-protective effects.
Tonix Pharmaceuticals announced preliminary data after vaccination of non-human primates with TNX-1800, a live attenuated COVID-19 vaccine candidate. The vaccine is a modified horsepox virus, live vaccine engineered to express the SARS-CoV-2 spike protein.
CytoDyn filed a protocol with the FDA for a Phase II trial of leronlimab for COVID-19 patients suffering from “long-hauler” symptoms. Leronlimab is a humanized IgG4 monoclonal antibody that blocks CCR5.
Johnson & Johnson secured more than $1 billion in additional funding for its COVID-19 vaccine research through an expansion of its partnership with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.
Pfizer laid out a pilot delivery program for its COVID-19 vaccine.
Samsung Biologics partnered with Eli Lilly and Company to accelerate the worldwide supply of Lilly’s COVID-19 antibody therapies. They inked a long-term manufacturing deal.
Other Industry News
NECI’s digital process manufacturing tools helped Moderna accelerate its COVID-19 vaccine from a genetic sequence to a manufactured product in record time.
After months of urging the public to wear masks and facial coverings to help stop infected people from spreading COVID-19, the Centers for Disease Control and Prevention (CDC) now states in newly released guidance that masks also protected the mask wearer from being infected. Please read more here.