Biopharma Update on the Novel Coronavirus: July 29

CV Update_July 29

News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays. 

 

FDA Actions

EUAs: The FDA issued EUAs for the following.

Diagnostics Update: To-date the FDA has authorized 193 individual EUAs, which include 158 molecular tests, 33 antibody tests and 2 antigen tests.

 

Diagnostics 

The FDA issued a EUA for Eli Lilly’s qualitative detection molecular test for SARS-CoV-2.

 

Testing Therapies, Antivirals and Vaccines

Genentech announced that its Phase III clinical trial of Actemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalized COVID-19 patients associated with pneumonia.

Moderna published data in The New England Journal of Medicine late yesterday in non-human primate studies of its MRNA-1273 vaccine against COVID-19. The bottom line is that the vaccine protected against infection in the nose and lungs and prevented pulmonary disease in all the monkeys. Both doses protected against the virus replicating in the lungs and lung inflammation. The larger dose protected against viral replication in the nose.

New York-based Pfizer and Mainz, Germany-based BioNTech picked their COVID-19 vaccine candidate and plan to begin a global Phase II/III safety and efficacy clinical trial. The company had four different vaccine candidates. After reviewing preclinical and clinical data from Phase I/II clinical trials and having discussions with the U.S. Food and Drug Administration (FDA) and other countries’ regulators, they selected BNT162b2 to take into larger studies.

CNBC interviewed Pfizer’s CEO, Albert Bourla on the companies aggressive COVID-19 vaccine timeline. Most of the large trial participants should be vaccinated by the end of August and preliminary data available by late September or early October. The company will seek regulatory review for the vaccine candidate BNT162b2 as early as October.

As reported by CNN, Russia intends to approve the world’s first COVID-19 vaccine. Russia is working towards a date of August 10 or earlier for approval of the vaccine. The vaccine was created by the Moscow-based Gamaleya Institute.

Netherlands-based Intravacc and Celonic Group signed an agreement to develop a COVID-19 vaccine based on an immunogenic Spike (S) protein of SARS-CoV-2 combined with Intravacc’s proprietary Outer Membrane Vesicle (OMV) technology. Preclinical studies will start shortly to select the best candidate protein for the vaccine. The collaboration aims to accelerate the development of Intravacc’s COVID-19 OMV protein vaccine, which is expected to enter clinical testing in 2021.

 

Company Actions/Announcements

The UK government signed a COVID-19 vaccine deal with GlaxoSmithKline and Sanofi, securing up to 60 million doses of an experimental treatment.

Less than one week after forging a vaccine manufacturing agreement with NovavaxFUJIFILM Diosynth Biotechnologies announced its College Station, Texas facility was selected by the federal government to support COVID-19 vaccine candidate manufacturing.

Gilead announced that Health Canada issued conditional marketing authorization for Veklury® (remdesivir) indicated for the treatment of COVID-19 in individuals aged 12 years of age and older, weighing at least 40 kg, with pneumonia requiring supplemental oxygen.

As reported by the Financial Times, Moderna is pitching its COVID-19 vaccine at about $50 - $60 per course. 

TScan Therapeutics pre-published data identifying the precise targets of T cells isolated from COVID-19 convalescent patients. Immunodominant targets were shared among patients with the same human leukocyte antigen (HLA) type and were primarily located outside the spike protein. These findings have been submitted for scientific review and publication with the goal of guiding COVID-19 vaccine development that may confer broad, durable immunity by eliciting a robust T cell response. These discoveries may also enable the development of reliable T cell-based diagnostic tests to determine longer-term immunity and inform the development of therapeutic agents.

Avacta Group plc announced an expansion of its collaboration and license agreement with Daewoong Pharmaceutical Co. Ltd. and AffyXell Therapeutics, the joint venture established in South Korea by the two companies, to develop stem cell treatments incorporating Avacta’s neutralising Affimer therapy for the treatment of seriously ill patients with COVID-19 and to also prepare to rapidly develop similar therapies for future global pandemics.

 

Other Industry News

The news regarding potential therapeutic options for COVID-19 patients is dominated by vaccines, monoclonal antibodies and other similar treatments. As the understanding about the novel coronavirus continues to unfold, some researchers are honing in on the microbiome and its role in the disease. Since the global pandemic began earlier this year, researchers at the U.C. San Diego Center for Microbiome Innovation (CMI) have been striving to better understand how the human microbiome is involved in the development and severity of COVID-19. Researchers have since been evaluating samples from patients worldwide to find biological and epidemiological discoveries about the SARS-CoV-2 virus.

As reported by MedPage Today, two German studies, both published in JAMA Cardiology show that the extent of direct cardiac involvement from COVID-19 could be concerning for long-last complications. One study showed that many recovered COVID-19 patients still had abnormal cardiac MRI findings at a median of 71 days after diagnosis.

Last Friday, Trump signed four executive orders to help bring U.S. drug prices to compare to those costs overseas. On Tuesday, Pfizer CEO Albert Bourla told investors the executive orders will cause “enormous destruction” as the industry races for treatments and vaccines for COVID-19.

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