Biopharma Update on the Novel Coronavirus: July 22

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

FDA Actions

New FDA Voices:

• FDA Protects Patients and Consumers from Fraud During COVID-19
• FDA’s Continued Commitment to the Safety and Security of Our Laboratories
• FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability

Extension of Enforcement Discretion Policy: The FDA is extending for another six months (through May 2021), the enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products as a result of challenges presented by COVID-19 pandemic.

Diagnostics Update: To-date the FDA has authorized 186 individual EUAs, which include 153 molecular tests, 31 antibody tests and 2 antigen tests.

Testing Therapies, Antivirals and Vaccines

CanSino Biologics, along with China’s military research unit, reported early data on its Phase II trial for its COVID-19 vaccine, Ad5-nCOV. The results in 508 patients showed antibody and T-cell immune responses. There were no reported serious side effects. The data was published in the journal The Lancet.

The University of Oxford and AstraZeneca reported positive Phase I data for their COVID-19 vaccine candidate. The data was published in The Lancet and in a single dose, induced significant immune responses in most of the patients. It also appeared to be fairly safe. Oxford University, which by many standards, is ahead of everyone in the vaccine development world, is suggesting the end of the year is possible, but being very cautious about that timeline.

As reported by ScienceDaily, a replicating RNA vaccine, with a single immunization, produces antibodies against COVID-19 in mice and primates. The effects occurred within two weeks after injection. The antibodies potentially neutralize the virus is both young and old animals.

Moleculin Biotech announced a second round of testing has confirmed antiviral activity of WP1122 against COVID-19.

Arcturus Therapeutics and Duke-NUS Medical School received approval from Singapore’s Health Sciences Authority to begin clinical trials for a COVID-19 vaccine candidate.

As reported by the San Francisco Business Times, Blade Therapeutics is recruiting for a mid-stage clinical trial for a drug that could stop inflammation caused by COVID-19 and also help repair lung damage.

Researchers with the U.S. Centers for Disease Control and Prevention (CDC) and other investigators evaluated 10 locations across the U.S. for antibodies to COVID-19 from March 23 to May 12, 2020. By testing a cross-section of 16,025 residual specimens, they estimated the proportion of people with detectible antibodies to SARS-CoV-2 in 1.0% in the San Francisco Bay area to 6.9% in New York City. They found that there were six to 24 times more infections per site than reported COVID-19 cases.

RedHill Biopharma initiated a Phase II/III clinical program with opaganib in Brazil as a treatment for COVID-19, which is being run in parallel with an ongoing Phase II study in the U.S. The study will assess opaganib in patients hospitalized with severe SARS-CoV-2 infection. The Phase II/III study is set to enroll up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14. This clinical trial is not powered for statistical significance.

Company Actions

Only days after announcing a COVID-19 vaccine production deal with the UK government, New York-based Pfizer and Mainz, Germany-based BioNTech signed an even bigger deal with the U.S. government.

On Tuesday, Novavax President of Research & Development Dr. Gregory Glenn stated to the International Society for Vaccines Virtual Congress and indicated the company is being, “very aggressive with its timeline” for its COVID-19 vaccine to try to get it to the public by the end of the year.

Other Industry News

In an online hearing before the House Committee on Energy and Commerce’s Oversight and Investigation subcommittee, executives from across the pharmaceutical industry outlined the steps their companies are taking to combat COVID-19 and restore the world to a sense of normalcy. Not only were committee members concerned about whether or not a vaccine could be available by the end of the year, but there were also some concerns expressed that political pressure could push the U.S. Food and Drug Administration to lower its 50% efficacy threshold for potential approval of a vaccine – especially ahead of the November election. Representatives from five companies developing COVID-19 vaccine candidates, Pfizer, AstraZeneca, Merck, Johnson & Johnson and Moderna, each said they were encouraged by early data that has been generated by their research teams and believe it is possible to deliver a safe and effective vaccine by the end of 2020 or early 2021.

Two Chinese nationals have been indicted for hacking into the computer systems of hundreds of companies, governments, non-governmental organizations and more to steal trade secrets, including data on treatments related to COVID-19.

It is one of the big questions during the COVID-19 pandemic. How long do antibodies against SARS-CoV-2, the novel coronavirus that causes the disease, last? And if they are gone, is your immune system still able to offer protection against getting infected again? New research published in The New England Journal of Medicine suggests that the antibodies developed after a mild infection decay and disappear within a few months. However, they may still offer protection.

The criminal fraud trial of Theranos founder Elizabeth Holmes could be delayed until 2021 due to continuing concerns regarding the spread of COVID-19. The trial was initially scheduled for July, but in April had been postponed until October due to the pandemic. A final decision will be made in August.

On Tuesday, Trump urged Americans to wear masks to help reduce and contain the spread of the COVID-19 outbreak.

In an interview with CNBC, US Health and Human Services Secretary Alex Azar said any COVID-19 vaccine sponsored by the government will be free or affordable for Americans.

Avacta Group has partnered with the U.K. government’s CONDOR program to evaluate and clinically validate the high throughput COVID-19 bead-assisted mass spectrometry laboratory assay developed with Adeptrix. Adeptrix’s novel BAMS platform uses Affimer reagents to capture the virus and viral proteins from patient samples and combines this with the power of mass-spectrometry analysis to provide a highly sensitive and specific diagnostic test. The COVID-19 National Diagnostic Research and Evaluation Platform (CONDOR) was created by the UK government to provide a route for evaluating new COVID-19 diagnostic tests in hospitals and in community healthcare settings.

Enzo Biochem, Inc. and Community Pharmacy Enhanced Services Network of New York announced they are partnering to provide COVID-19 testing at 52 of the network’s 155 pharmacies across New York State. The tests will use Enzo’s Amiprobe swab test, which received Emergency Use Authorization from the FDA.