Biopharma Update on the Novel Coronavirus: November 10

CV Update_November 10

News information is not all-inclusive and updates are published once a week on Tuesdays. 

 

FDA Actions

Serology test: Last week the FDA authorized the first serology test that detects neutralizing antibodies from a recent or prior SARS-CoV-2 infection.

Warning Letters: The FDA, along with the FTC issued warning letters to the following companies for selling fraudulent COVID-19 products.

Alert: The FDA alerted that false positive results can occur with rapid detection of SARS-CoV-2.

Diagnostics Update: To-date the FDA has authorized 287 individual EUAs, which include 223 molecular tests, 57 antibody tests and 7 antigen tests.

 

Diagnostics

EUROIMMUN, a PerkinElmer company, announced the launch of its anti-SARS-CoV-2 QuantiVacTM ELISA (IgG) antibody test. This quantitative test kit applies a recombinant S1 subunit of the SARS-CoV-2 spike protein, enabling the detection of IgG antibodies.

TScan Therapeutics announced the signing of a research license and option agreement with QIAGEN to develop T cell-based laboratory tests for detecting prior exposure to the novel coronavirus, SARS-CoV-2, using discoveries from TScan’s high-throughput TCR/Target discovery platform.

Oxford Immunotec Global PLC announced that data from a prospective cohort study demonstrated SARS-CoV-2 reactive T cells may be sufficient to five protection from COVID-19 and can be detected and measured using Oxford Immunotec’s T-SPOT® Technology.

 

Testing Therapies, Antivirals and Vaccines

CureVac NV, located in Tübingen, Germany, published detailed interim Phase I data of its COVID-19 vaccine candidate, CVnCoV. The manuscript is currently on medRxiv and will be submitted to a peer-reviewed scientific journal. Please read more here.

With the entire world watching, Pfizer and BioNTech released very promising interim data from the Phase III COVID-19 vaccine trial. The data suggest a 90% efficacy rate for the vaccine.

A multi-institutional research team has developed a nasal spray that effectively blocks the absorption of the SARS-CoV-2 virus in ferrets with direct contact to infected animals, indicating the product could potentially protect against coronavirus disease 2019 (COVID-19) infection. While promising, the researchers say the nasal spray still needs to be tested in humans. 

Humanigen announced positive interim Phase III data of lenzilumab in hospitalized COVID-19 patients. They found the drug had a clinically meaningful impact on patient recovery.

Gilead Sciences’ blockbuster drug, remdesivir, appears to have fallen out of favor with the WHO.  The drug was not included on a draft document viewed by Reuters, outlining the priority drugs it plans to spend donations on in its scheme to supply COVID-19 drugs to poor countries. 

Gilead's remdesivir faces criticism over effectiveness, pricing and government support. Please read more here

The University of Oxford says it hopes to present interim Phase III trial data of its COVID-19 vaccine candidate AZD1222 to regulators by as early as next month.

Spartina Biotechnologies is developing a therapeutic RNAi treatment for the SARS-CoV-2 virus. This therapeutic will be complementary to vaccines and can be quickly adjusted to deal with virus mutation. 

 

Organizational Actions/Announcements 

Eli Lilly and Vancouver-based AbCellera won Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for adults and some pediatric COVID-19 patients.

 

Other Industry News

President-elect Joe Biden hit the ground running this morning with the announcement of his transition team’s COVID-19 advisory board that will be co-chaired by public health experts and includes Rick Bright, a vaccine expert and the former director of the Biomedical Advanced Research and Development Authority (BARDA), who raised concern about President Trump’s response to the pandemic in April. Please read more here

It’s been nearly eight months since the World Health Organization (WHO) officially declared COVID-19 a global pandemic. The magic eight-letter word giving us some semblance of hope and plenty of confusion is: immunity.  Does recovering from a COVID-19 infection make you immune? Please read more here

Although COVID-19 has a fairly broad range of effects, one of the more peculiar has been blood clots. Researchers at the Michigan Medicine – University of Michigan identified a mechanism of how this happens. Please read more here

Researchers at Francis Crick Institute and the University College London found that blood samples from non-infected participants contained antibodies that could recognize common coronaviruses as well as SARS-CoV-2, the virus that causes COVID-19. In another study, published in the International Journal of Infectious Diseases, University of Nebraska researchers also identified antibodies that reacted to SARS-CoV-2 as well as against non-COVID-19 human coronaviruses.

Researchers are generating an unprecedented amount of data around COVID-19, with seemingly new and important studies coming out every day. Here’s a look at some of last week’s COVID-19 research news.

The COVID-19 pandemic changed the biopharma industry and the world irrevocably. The challenges will reverberate even after the pandemic ends, according to panelists at the Cell and Gene Meeting on the Mesa in mid-October. Please read more here

 

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